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Operating Instructions and Production Recommendations

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1. button to select ok button to confirm lifting arm power plug and USB en interface main power switch emergency off Pic 1 UNGUATOR 2100 Uncuaton TECHNOLOGY 2 Initial operation The interfaces for the power cord and USB cable are located on the rear side of the UNGUATOR 2100 The power O I switch is also the emergency switch and is located at the bottom right side Please check that the power switch of the UNGUATOR 2100 is switched off First connect the power cord to the UNGUATOR 2100 and then to the socket outlet You may now switch on the UNGUATOR 2100 using the power switch Tha device is now ready for operation 3 Display operation The control panel with four buttons Esc and ok for manual control or command input and a display are located on the front of the UNGUATOR 2100 The start screen will appear on the display after switching on the UNGUATOR 2100 using the power switch Plc 2 Display with splash screen The start screen shows the current number of preparations and the version of the Microprocessor software stored 4 Language menu Pic 3 Language set up it the Esc key to move from the start screen to the language menu The and keys will get you to the next or previous language setting Enter Ok to confirm your selection and move back to the start screen 5 UNGUATOR Technology The
2. screen by hitting the ok button One may return to the INDI CATE 1 screen using the same procedure The remaining data for the mixing program are represented on the INDICATE 2 screen These are the corresponding mix parameters of mixing stages 9 to 16 and those of the free spin program As on the INDICATE 1 screen the mixing program number and Jar size can also be read Hitting the Esc button will from either the INDICATE 1 or INDICATE 2 screen with return you to the main MANUAL PREPARATION menu 6 4 11 3 Edit a manual preparation The EDIT menu option is the core of the MANUAL program Here users can edit both the pre grind and free spin program and mix the parameters of the speed of the lifting and mixing motor as well as number of strokes or mixing time of the 16 mixing stages First select the pasting program by using the and buttons and confirm with the ok button The following programs are available pasting 00 which means the 01 mixing stage starts directly skipping pasting and programs 01 to 03 The mixing pa rameters of the individual pasting programs are shown in Tab 2 Uncuaton TECHNOLOGY PRE FSP Strokes Speed of the MB Speed of the lift Prog No No ing motor in rpm DEE fous a w ja Tab 2 Mixing parameters of the grinding programs from 00 to 03 The free spin program can be set aft
3. UNGUATOR Technology reduces the mechanical preparation of formulation ointments to the least common denominator The core of UNGUATOR Technology consists of the patented arrangement of the UNGUATOR Mixing Blade adapted to the requirements of prescription ointments and the UNGUATOR Jar that serves as both a hygienic mixing jar and a hygienic dispensing jar The principle of the preparation method using UNGUATOR Technology in the closed UNGUATOR Mixing System is quick and easy to learn true to the motto learning by doing A little experience will make it easy to prepare ointments though they may seem rather complicated at first Using the UNGUATOR Technology enables the pharmacy to better prepare prescription ointments in a shorter period of time compared to conventional methods that were used prior to the invention 1994 For the first time it is possible to not only standardize ointments but also validate them 5 1 UNGUATOR mixing machines The current UNGUATOR mixing machines UNGUATOR B R UNGUATOR e s UNGUATOR 2100 and UNGUATOR Q are useful and advanced improvements on the first UNGUATOR launched in 1994 They are designed for a working capacity of approx 500 work hours which corresponds to approximately 15 000 to 20 000 preparations The UNGUATOR mixing machines feature a high safety standard and were tested by TUV Rheinland Germany for safety The devices are manufactured under license and maintained b
4. Uncuaton TECHNOLOGY The remaining time of the respective mixing program stage will show on the upper part of the display in minutes or seconds and the current speed of the mixing motor is indicated in percent A progress bar illustrates the overall mixing progress on the lower part of the display The automatic free spin program will complete the mixing process oN ORS AL eel Pic 25 Main menu Selecting Mixing Type With the mixing process finished the display of the UNGUATOR 2100 will indicate the mixing parameters that have been run through These are mixing time number of revolutions of the UNGUATOR MB number of strokes and the identification number of the preparation In addition the number of the preparation and the software of the UNGUATOR 2100 will display Hitting the ok button will get you back to the start screen To remove the UNGUATOR Mixing System screw off the UNGUATOR Jar Lid The UNGUATOR Mixing System is removed from the bayonet holder by twisting the UNGUATOR MB shaft counterclockwise Then the UNGUATOR Mixing System can be removed by pulling downward Hitting the ok button will get you back to the start screen 6 4 1 Emulsion Emulsifying semisolid substances with water at room temperature Example Eucerin c aqua aa Up to 200ml we recommend using the UNGUATOR Disp Blade Cold stored foundations make the emulsification more difficult Heating up the liquid to be
5. any malfunctions cannot be remedied using the above information 7 4 Potential sources of nonconformances e The UNGUATOR Jar bottom was not pressed fully down to the stop position prior to weighing out or filling First and foremost it is not imperative to accommodate specifically light constituents in an UNGUATOR Jar of equal weight although the filling volume is 40 more than the rated volume Please use the next largest UNGUATOR jar for the mixing e The air was not removed before the mixing preocess of semisolid preparations from the UNGUATOR Jar Then the mixing blade centrifuges the ointment against the UNGUATOR Jar wall forming an air column inside in which the UNGUATOR MB cannot clean itself and unmixed constituents may adhere to the UNGUATOR MB e The UNGUATOR Jar bottom has not been moved up The penetrating UNGUATOR MB will generate an overpressure at high rate of speed that cannot be compensated when the movable bottom yields Thus the overpressure may cause mixed material mainly liquid constituents to squeeze out of the seals on the threaded UNGUATOR Jar Lid between UNGUATOR Jar bottom and UNGUATOR Jar body and along the shaft of the UNGUATOR MB 1 e The sealing lip on the UNGUATOR Jar bottom does not retain liquids during the emulsifying process Before starting the mixing process particularly for large amounts of liquids the region round the sealing lip of the UNGUATOR Jar bottom should be
6. as emulsions suspensions gels or suppositories common in a pharmacy where the mixing processes have already been preprogrammed in the closed system for all UNGUATOR Jar sizes the user can also mix combination mixtures i e liquids in the open vessel using the UNGUATOR 2100 at 120 to 600 rpm Users already familiar with UNGUATOR Technology will recognize many of the functions from the UNGUATOR B B R and e s in the DIRECT program This program allows for mixing process with both manual stroke and automated stroke where the mixing parameter speed of the mixing motor and the mixing time may still be changed during the mixing process Up to 180 mixing programs can be stored in the machine using the MANUAL program Each of these 180 programs allows the user to change numerous mixing parameters Users can the addition of a free spin motion program for each of these 180 programs The single mixing stages are defined by the mixing parameters of lifting motor speed and mixing motor speed in addition to the number of strokes or duration of the mixing stage 360 000 settings per mixing stage are possible due to the various values of the mixing parameters This results in a practically unlimited variety of optional programs that can be used to mix an ointment using the MANUAL program The UNGUATOR 2100 has a USB interface Using a PC and with the aid of the UNGUATOR Assist Software the UNGUATOR 2100 can be controlled and
7. cps 120V 60Hz cps or rated country specific voltage installed according to the regulations of DIN VDE 0100 e UNGUATOR devices have been designed for operation under normal room atmospheric conditions Recommended values Ambient temperature between 15 30 C 59 86 F and relative air humidity less than 80 e The device should be allowed to acclimatize for approx 30 minutes at commissioning and or after extended storage time in cold rooms e _UNGUATOR power switch and cable must be easily accessible e Do not immerse UNGUATOR devices in water e UNGUATOR devices should only be operated by authorized persons e Only operate the UNGUATOR MB with correctly attached UNGUATOR jars or in a plastic beaker provided for a reaction mixture e Do not touch rotating parts e Keep long hair ties and cables away from rotating parts e During the automatic lifting function of the UNGUATOR always keep long hair parts of the body or objects away from the lifting mechanism Immediately turn off the power switch in an emergency or pull the power plug e Always keep the air vents on the driving head back or underside of the devices free when using the device e Using the UNGUATOR devices not according to these operating instructions or with line products that the manufacturer did not deliver or recommend may impair safety and will void the warranty e UNGUATOR devices have not been designed for operation under hazardous conditi
8. down position of the oscillation arm for easy retrieval Please keep in mind though that this means the UNGUATOR SMB could drop out of the bayonet receptor upon the slightest touch This is why the UNGUATOR SMB should be twisted loose from the bayonet holder in counterclockwise direction then pulled out downward and placed into the vessel with the reaction mixture prior to moving the oscillation arm into its retrieval position Confirm with ok once the retrieval position has been reached Pic 27 Combination mix When the mixing process is complete the UNGUATOR 2100 display will indicate the mixing parameters that have been run through These are mixing time number of revolutions of the UNGUATOR MB number of strokes and the identification number of the preparation In addition the number of the preparation and the software of the UNGUATOR 2100 will display The vessel with the reaction mixture and the UNGUATOR MB should be removed and the UNGUATOR Jar Lid screwed off of the oscillation arm Hitting the ok button will get you to the start screen 6 4 11 Manual Program Generally speaking ointments prepared individually and in batches in a pharmacy can be optimally prepared using the standard formulation programs The individual programming with the MANUAL program is first and foremost meant for study and research purposes but also for mixing processes that have to be run under stringent
9. lost at the bottom The lifting technique of the UNGUATOR Mixing Le System prevents this from happening so that the result of the mixing process is not just a homogeneous ointment but also one with the desired ratio of active ingredients Pic 5 UNGUATOR e s 5 1 3 UNGUATOR 2100 The UNGUATOR 2100 shows all the advantages of its predecessors and can therefore automatically control the mixing parameters for each UNGUATOR Jar size and different types of ointments The user may program individual mixing parameters with a maximum of 180 additional programs can be stored The UNGUATOR 2100 can be connected to a PC via an USB interface J Pic 6 UNGUATOR 2100 An integrated microprocessor measures the actual revolutions of the UNGUATOR Mixing Blade carried out by the UNGUATOR 2100 This guarantees that the selected mixing program will always be identical even for paste like preparations which usually might demand more power from the mixing motor This makes it easy to develop new ointments cosmetics etc using the UNGUATOR 2100 since only the composition changes and not the mixing program As a result ointments can now finally be reliably reproduced in smaller quantities The adjustable stroke speed or the speed of the upward or downward motion of the automated oscillation arm is another unique feature of the UNGUATOR 2100 This allows the UNGUATOR Mixing Blade to rotate at lower
10. malfunctions If the UNGUATOR device does not work it may be due to a little thing that you may be able to correct yourself Before you take the unit for repair please follow instructions below e If the UNGUATOR device cannot be switched on please check to ensure that there is electricity available and that the plug of the power cord has been correctly connected to the device and the socket e Should faults or damage occur please also read the manufacturer s notes on the machines metal foot e Please note the machine type serial number and the occurring error message and contact your local UNGUATOR dealer and or certified UNGUATOR service partner 8 2 Notes on maintenance e To preserve gears and motor for continuous untroubled operation the UNGUATOR e s should either be sent to your representative in your individual country please contact your UNGUATOR dealer or to SMS Elap GmbH amp Co KG after 20 000 preparations or after five 5 years for maintenance e After sales service and maintenance service will be billed for expenses and wearing parts at reasonable price according to the cost estimate within the warranty period as well e Upon request an UNGUATOR loaner may be provided for a one time charge that can be used while your UNGUATOR is away for maintenance and repair Uncuatorn TECHNOLOGY 8 3 Notes on safety e UNGUATOR devices must only be connected to grounding type receptacles with 230V 50Hz
11. mix 24 6 4 11 Manual Program 26 6 4 11 1 Use a manual preparation 27 6 4 11 2 Indicate a manual preparation 28 6 4 11 3 Edit a manual preparation 28 Uncuaton TECHNOLOGY 6 4 11 4 Delete a manual preparation 30 6 4 11 5 Pregrind program 31 6 4 11 6 Number of strokes 31 6 4 11 7 Mixing time 32 6 4 11 8 Minimum mixing times for the Direct and Manual programs 32 6 4 11 9 Selecting the UNGUATOR Jar size 33 6 4 12 Requirements for the ingredients of a prescription 33 6 5 Preparing the mixing process 34 6 6 After the mixing process is complete 35 7 General notes on the UNGUATOR Mixing System 36 7 1 Patent protection 36 7 2 Identification number 36 7 3 Operating errors 37 7 4 Potential sources of nonconformances 39 7 5 Quality assurance of the ointments 40 8 Service and warranty 40 8 1 Notes on malfunctions 40 8 2 Notes on maintenance 40 8 3 Notes on safety 41 8 4 Technical data of the UNGUATOR 2100 42 8 5 Quality and material 42 9 References 43 10 Bibliography 43 11 Manufacturer s Certificate Declaration of Conformity 45 12 Distribution manufacturing and customer service 46 Index of tables Tab 1 Quality improvement with increasing automation 5 Tab 2 Mixing parameters of the grinding programs from 00 to 03 29 Tab 3 Parameters of free rotation from 00 to 02 29 Tab 4 Steps of velocity available for the mixing and lifting motor 30 Tab 5 Minimum values for m
12. ok button The last of the selectable mix parameters is mixing time which may be between 10 seconds and 2 hours Use the and buttons to change mixing time After mixing time is confirmed with the ok button the oscillation arm will automatically move to its starting position Now the user will be prompted to mount the UNGUATOR Jar or the UNGUATOR mixing unit The already prepared UNGUATOR Mixing System is inserted into the bayonet receptor of the UNGUATOR 2100 from below and pushed up as far as it will go The UNGUATOR Jar Lid and the UNGUATOR Jar housing should both be held in one hand simultaneously When the ok button on the UNGUATOR 2100 is pressed the bayonet receptor will grip immediately and hold until the mixing process is complete The programmed mixing time is run through at the speed step set The remaining mixing time and the current speed of the UNGUATOR MB display throughout the entire mixing process During the mixing process the UNGUATOR MB speed and mixing time parameters can be changed via the and buttons Select the mixing parameter s to be changed and confirm via the ok button We recommend moving the UNGUATOR Jar up and down steadily from the stop on the UNGUATOR Jar Bottom to the stop on the UNGUATOR Jar Lid every second The free spin program can also be selected in this operating mode In free spin the UNGUATOR MB is positioned close to the
13. raw materials used comply with Regulation EU No 10 2011 The following monomers and additives which are subject to a specific migration limit SML are included according to suppliers in the used materials ur Beier Er en natur Polyamid SML T 15 mg kg white SMB Formaldehyd SML 15 mg kg Polyethylen Ref Nr 68320 SML 6 mg kg i all 1 3 Dioxolan SML 5 mg kg Ref Nr 89040 SML 25 mg kg salt white disposable Caprolactan SML T 15 mg kg w Compliance with these specific migration limit is certified by the polymer manufacturers The traceability of Regulation EC No 1953 2004 of the product is ensured by the lot number and the application of manufacture Specification for intended use Kind types of food or procedures for which the material is suitable aqueous media acidic media issued by GAKo Germany production control as of January 2013 issued by GAKo Germany production control The certificate has been produced electronically and is valid without a signature 12 Distribution manufacturing and customer service GAKO Konietzko GmbH Oberer Stephansberg 49g GRAD 96049 Bamberg Germany Phone 49 0 951 582 55 Fax 49 0 951 500 602 Email kontakt unguator com Web www unguator com GAKO International GmbH Dantestrasse 27 ga ko 80637 Munich Germany International Phone 49 0 89 15 88 16 88 Fax 49 0 89 15 881485 Email contact unguator com Web www un
14. the UNGUATOR Mixing System if necessary The Jar connected to the UNGUATOR 2100 is not an UNGUATOR Jar This Jar has to be replaced with an UNGUATOR Jar A UNGUATOR Jar Lid was screwed onto the UNGUATOR Jar aslant and the UNGUATOR MB cants on automatic insertion The operating error can be remedied by unscrewing the UNGUATOR Jar followed by its correct placement on the UNGUATOR Jar In the event that the oscillation arm was pulled too far out of its starting position the shaft of the UNGUATOR MB may not be centered in the holder after running through a complete stroke This can be fixed manually but please take care to only grasp the shaft taper The selection of the wrong UNGUATOR MB can also cause this operating error please see below Size selection of the UNGUATOR Jar does not correspond with the actual size at which Size selection of the UNGUATOR Jar does not correspond with the actual size at which mixing takes place Shortening of the stroke range by pushing up the UNGUATOR Jar Bottom will change the selected size of the UNGUATOR Jar for the UNGUATOR 2100 The mixing process may now be started again by selecting the correct UNGUATOR Jar size The movable bottom does not have to be pushed up to execute the pre grind program If the material to be mixed is a paste comes cold from the refrigerator or the UNGUATOR MB has to penetrate a larger volume of not freely flowing solid substances such as z
15. 200 ml Excellent mixing results will be achieved when using microfine powder with a high content of lubricious aerosil which is considered as Soft in Soft S S preparation Please select low rpm level 0 650 rpm preferably applying the manual Hand mode changing from Auto to Hand Please have the mixing time extended accordingly Crystalline active ingredients We recommend pulverizing active crystalline ingredients in a mortar prior adding into the UNGUATOR Jar Should a solvent for the active crystalline ingredient be part of the formulation the ingredients may then also be dissolved in the UNGUATOR Jar For example urea with water Then the remaining formulation ingredients can be added The crystalline substance may also dissolve during the mixing process if the solvent is an ingredient of the ointment base Waxes hydrophilic ointment etc Either pour warm water alone lt 85 C 185 F or the heated remaining ingredients constituents over Cera Lanette N etc in the UNGUATOR Jar or pour water in the substances and heat them either in a heated water bath lt 85 C 185 F or carefully observed in a microwave oven Formulations without water containing components may be melted already directly inside the UNGUATOR Jar by placing the jar in the water bath Please note that the UNGUATOR MB must not go in a microwave oven Furthermore isolated areas of heat concentration may develop when
16. 31 Screen INDICATE 2 29 Pic 32 After finishing the pregrinding program 31 Uncuaton TECHNOLOGY 1 Installation information Select a suitable location for the UNGUATOR 2100 CAUTION The UNGUATOR 2100 weighs 36 7 Ibs 16 7 kg It is recommended to have an assistant while carrying and moving the equipment to the final destination Ensure that there is enough space to operate the UNGUATOR e s This must include sufficient space around the UNGUATOR e s to provide good ventilation Select a suitable environment e Solid horizontal surface e Away from direct air flow from air conditioning systems heaters open windows or fans e Keep the temperature between 15 30 C 59 86 F and maximum humidity of 80 e Clean dry and dust free Remove all components from the cardboard box Check to ensure that the following components are included in your shipment e UNGUATOR 2100 mixing device e Power cable e Operating instructions Please contact your responsible UNGUATOR dealer and or supplier immediately in case that components are missing or arrived damaged Afterwards we will not accept any claims regarding missing or defect items they will be for your account Please hold on to the original cardboard box and packing material in case you have to send your UNGUATOR 2100 in for service UNGUATOR 2100 display Esc button to cancel or delete the program button to select
17. Operating Instructions and Production Recommendations al Ungunfor 21 OO Uncuaton TECHNOLOGY Dear UNGUATOR user thank you for choosing the UNGUATOR Mixing Technology a quality system for advanced prescription compounding Please read the operations manual carefully For additional information about the use and operation of the UNGUATOR Mixing Technology please feel free to contact us at contact unguator com Table of Content 1 Installation information 1 2 Initial operation 3 3 Display operation 3 4 Language menu 3 5 UNGUATOR Technology 4 5 1 UNGUATOR mixing machines 4 5 1 1 UNGUATOR B R 5 5 1 2 UNGUATOR e s 5 5 1 3 UNGUATOR 2100 6 5 1 4 UNGUATOR Q 6 5 2 UNGUATOR Assortment 7 5 2 1 UNGUATOR Mixing Blade MB 7 5 2 2 UNGUATOR Jar 10 5 2 3 UNGUATOR Varionozzles 13 5 2 4 UNGUATOR Applicators 13 5 2 5 UNGUATOR Spindle 14 5 2 6 UNGUATOR Coupling 15 5 2 7 Air Dynamic Pumpball System 15 6 General Guidelines for the UNGUATOR Technology 16 6 1 Preparing the UNGUATOR Mixing System 16 6 2 Weighed portion of the formulation 16 6 3 The mixing process with the UNGUATOR 2100 17 6 4 Standard formulation programs 18 6 4 1 Emulsion 19 6 4 2 Emulsion 19 6 4 3 Normal 20 6 4 4 Suspension lt 2 20 6 4 5 Suspension gt 2 21 6 4 6 Gel 21 6 4 7 Suppositories 21 6 4 8 Powder 22 6 4 9 Direct Program 22 6 4 9 1 Automated stroke 23 6 4 9 2 Manual stroke 24 6 4 10 Combination
18. R SMB is suitable for the production of all recipes For suspension ointments and glass cleaning operations we recommend the use of the UNGUATOR Disp Blade UNGUATOR Disposable Blade Disp Blade The UNGUATOR Disp Blade is suitable for all UNGUATOR devices The mixing blade of the UNGUATOR Disp Blade is connected to the UNGUATOR Disp Blade shaft by twisting the blade counterclockwise and can be disconnected after the mixing process with a clockwise turn The material contact in the ointment is three times as high as when using the Disp Blade compared to the UNGUATOR SMB at the same mixing speed The counter rotating twist of the mixing blades causes intensive material vibration in the material to be mixed and achieves good product quality faster than using the UNGUATOR SMB We do however recommend using the same mixing time as for the UNGUATOR SMB In the process of final quality control the mixing blade can be picked up and discarded with the small end of the shaft or left inside the jar Cleaning is limited to the UNGUATOR Disp Blade shaft We recommend using the UNGUATOR Disp Blade for substances that may discolor the regular blade This type of UNGUATOR Pic 9 UNGUATOR Disposable Blade MB also comes with different shaft lengths The range of UNGUATOR Jar sizes that can be used for the application is marked for orientation on the weak end of the shaft 15 100 ml and 200 ml respectively As
19. TOR Applicator aids the precise filling of the suppository forms It may be reheated using a hair dryer or an infrared lamp A batch of approximately 5 to 10 is recommended 6 4 8 Powder Mixing powder to fill capsules We recommend using the UNGUATOR Disp Blade for sizes up to 200 ml Excellent mixing results will be achieved when using microfine powder with a high content of lubricious aerosil which is considered as Soft in Soft preparation Please select low rpm level 0 650 rpm preferably applying the manual Hand mode changing from Auto to Hand Please have the mixing time extended accordingly To minimize the grinding noise along the sealing lip of the UNGUATOR Jar Lid when mixing powder the lip may be widened a bit using the shaft of the UNGUATOR MB The powder can be evenly distributed from the dispensing opening using the capsule filling device 6 4 9 Direct Program First select the DIRECT program using the and buttons in the main menu Confirmed selection with the ok button and the menu SELECT UNGUATOR JAR will show Select UNGUATOR Jar size using the and buttons and confirm using the ok button then the DIRECT PREPARATION menu will be displayed Pic 26 Menu DIRECT PREPARATION First select one of the six possible speed steps of the lifting motor that determine the speed of the oscillation arm usi
20. UATOR Applicators reduce the extracted quantity of low viscosity formulations and are particularly helpful in cases where the ointment must be precisely applied UNGUATOR Applicator short The UNGUATOR Applicator short with a diameter of 1mm is obligatory for nose and ear ointments The UNGUATOR Applicator short comes with a cap to close the applicator a UNGUATOR Applicator long Pic 19 Applicator short UNGUATOR The UNGUATOR Applicator long with a diameter of 2 mm allows formulations to be introduced into large orifices of the body or probes Moreover the UNGUATOR Applicator long also comes inside each UNGUATOR 200 ml Jar to help pushing up the bottom of this A jar size in full The UNGUATOR Applicator long is generally available da both with and without cap a Pic 20 Applicator long UNGUATOR 5 2 5 UNGUATOR Spindle The UNGUATOR Spindle serves as a dispensing system for UNGUATOR jar sizes 300 ml or 500 ml UNGUATOR Jars that come with UNGUATOR Spindles The spindle has to be removed by rotating it clockwise prior the mixing process The bottom can be slid up and down when the UNGUATOR Spindle is screwed slightly 1 2 to max 1 turn counterclockwise without perforating the movable bottom a slight resistance can be felt before the bottom is perforated Air can be decreased by placing the UNGUATOR Jar onto the table and using both hands pushing the jar against the table Before giving the
21. UNGUATOR Jar to the customer the UNGUATOR Spindle must be screwed in the UNGUATOR Jar counter clockwise from the bottom till it locks into place The UNGUATOR Spindle must be turned clockwise to extract the ointment To remove the ointment the UNGUATOR Spindle must be twisted to the right One turn dispenses approx 20 ml of the contents of the UNGUATOR Jar Caution If the movable bottom is accidentally perforated or the spindle is permanently locked in the bottom of the jar the UNGUATOR Jar may only serve as dispensing or storage vessel and can no longer be used for the mixing process Entnahme Extract Vor Gebrauch Jar Preparation Spindel links eindrehen bis zum Anschlag Screw spindle to the left to properly engage After the ointment is prepared 3 Extract cream turn spindle to the right Spindel rechts drehen und entfernen Turn spindle to the right and pull down 4 1 2 3 Entnahme Spindel rechts drehen Nach Salbenherstellung Pic 21 How to operate the UNGUATOR Spindle Pic 22 UNGUATOR Spindle Uncuaton TECHNOLOGY 5 2 6 UNGUATOR Coupling The UNGUATOR Coupling connects two UNGUATOR Jars by the threads of their dispensing openings and is very useful when preparing ointments in larger batches Transferring a formulation from a larger UNGUATOR Jar into a smaller UNGUATOR Jar using the UNGUATOR Coupling will ensure hygiene from the mixing process to
22. Unscrew the UNGUATOR Jar Lid from the oscillation arm and or twist the UNGUATOR MB shaft counterclockwise This will only require a quarter turn which may already have happened when releasing the jar from the oscillation arm For this reason we recommend holding the UNGUATOR Mixing System tightly with one hand when removing it from the UNGUATOR In the next step the UNGUATOR Jar Lid is opened and the UNGUATOR MB removed Since this is also an opportunity execute a quality check the UNGUATOR Jar Lid should also be opened after mixing when using the UNGUATOR Disp Blade Practice has proved that if the surface of the ointment looks smooth and if the minimum defined mixing time has elapsed homogeneity inside the UNGUATOR Jar in fall can be expected Push the UNGUATOR MB out of the UNGUATOR Jar Lid The ointment on the mixing blade can be fallen off into the UNGUATOR Jar using a spatula When using the UNGUATOR Disp Blade the mixing blade can be removed from the UNGUATOR Jar and disposed or left inside the UNGUATOR Jar Leaving the blade inside the jar will have no effect on dispensing the ointment through the UNGUATOR Jar Lid Removal of the mixing blade is recommended particularly when giving the ointment to elderly clients since it might otherwise cause confusion if the ointment is traditionally dispensed The UNGUATOR Jar Lid is screwed back onto the UNGUATOR Jar body and equipped with an UNGUATOR Variono
23. Verp Vorschrift DK 11 94 Examined acc to central lab pack regul DK 11 94 Lichtdurchl ssigkeit Opaqueness OK Partikelgehalt Particle Concentration OK Farbbest ndigkeit Color Fastness OK Dichtigkeit Seal Integrity OK Mikrobiologie Microbiology OK gez signed Grieser head of quality assurance GAKO www unguator com Pic 10 Certificate of Analysis for the UNGUATOR jar of 50 ml The body of the UNGUATOR Jar sizes 300 to 1000 ml can be cleaned in a dishwasher as long as it has not left the pharmacy Asepsis has to be ensured before reuse though The movable bottom of the UNGUATOR Jar is not suitable for the dishwasher and the sealing lip of the UNGUATOR Jar Lid may be destroyed after repeated mixing The corresponding UNGUATOR Jar Lids or jar bottoms can be ordered in sets of five and used for the economical reuse of the body The UNGUATOR Jar is subject to periodic inspections in accordance to the German ZL packing regulation DK 1I 94 All plastic materials which come into contact with food are made with the legal requirements of the plastic Regulation EU N 10 2011 and Regulation EU N 1935 2004 in their current form A certificate of analysis is issued after batch defined examinations The documentation of primary packaging materials at the pharmacy stipulates that the manufacturer s test certificate certificate of analysis is retained after receiving visual inspection This certificate is aff
24. added may accelerate the emulsification Sometimes the heat that occurs during the mixing process inside the jar may already be sufficient and formation of emulsions 6 4 2 Emulsion Emulsifying of semisolid substances to be melted Examples Emulsific aquosa Lanette Cera Up to 200ml we recommend using the UNGUATOR Disp Blade Emulsions should always be heated then when UNGUATOR Jars of 300 ml to 500 ml are used Melting semisolid substances using max 85 C 185 F hot water can be achieved by three methods 1 Addition of hot water lt 85 C 185 F 2 Covering with cold water heat up to 200 ml in the hot water bath lt 85 C 185 F 3 Covering with cold water careful heating in the microwave mind max temperature To attain an even structure heated emulsions should be stirred until they have cooled to room temperature with a few intervalled strokes using a water jacket or by using cooling phases at medium speed during which the UNGUATOR Jars are placed in the refrigerator if necessary 6 4 3 Normal Mixing semisolid substances from low viscous to pasty Examples Off the shelf pharmaceutical ointments with base s concentrated active substances with base s liquid active ingredients in base s First the ointment base should be weighed out into the UNGUATOR Jar Then the remaining constituents should be added accordingly 6 4 4 Suspension lt 2 Mixing semisolid substances with a portion o
25. amic Pumball System even thick pastes can be dispensed via the small dispensing opening in the screw cap or transferred to small UNGUATOR Jars using the UNGUATOR Coupling The material outlet velocity depends on viscosity which may be reduced through heating The air pressure that had developed in the lower chamber of the UNGUATOR Jar can be relieved by opening the valve screw This is mandatory after the transfer process using the UNGUATOR Coupling before the smaller UNGUATOR Jar is removed Otherwise this may result in considerable contamination of the immediate environment depending on the formulation viscosity 6 General Guidelines for the UNGUATOR Technology 6 1 Preparing the UNGUATOR Mixing System The UNGUATOR Mixing System consists of an UNGUATOR Jar an UNGUATOR MB and the components of the formulation to be mixed First the UNGUATOR jar cap small white screw cap of the UNGUATOR Jar and then the UNGUATOR Jar lid large red or white screw cap must be unscrewed from the UNGUATOR Jar Second the UNGUATOR MB is inserted into the UNGUATOR Jar housing sliding the UNGUATOR Jar down The UNGUATOR Jar lid is then slid onto the UNGUATOR MB standing in the UNGUATOR Jar housing and pressed down firmly using both thumbs Ensure that the sealing lip of the UNGUATOR Jar lid opening is not damaged by the bayonet noses because the ointment may otherwise rise on the UNGUATOR MB shaft during the m
26. any number of mixing programs can be changed and stored The database makes label printing easy The UNGUATOR 2100 will automatically assign an identification number to each finished preparation This serves to document the mixing process making it reproducible and is shown on the display 6 4 Standard formulation programs The 7 standard formulation programs EMULSION EMULSION NORMAL SUSPENSION lt 2 and SUSPENSION gt 2 as well as GEL and SUPPOSITORIES can be selected from the main menu SELECT MIX TYPE With few exceptions the procedure is identical for all of these standard formulations and they are described below First select one of the standard formulation programs using the and buttons Confirm the selection with the ok button Next on the menu SELECT UNGUATOR JAR will appear Select the UNGUATOR Jar size using the and buttons and confirm using the ok button The oscillation arm will automatically move to its starting position The user will be prompted then to mount the UNGUATOR Jar or the UNGUATOR mixing unit The UNGUATOR MB shaft of the prepared UNGUATOR Mixing System is run upward through the opening of the oscillation arm Then the male thread of the UNGUATOR Jar Lid is screwed into the oscillation arm Pressing the ok button will initiate the mixing process after the UNGUATOR Mixing System has been screwed tightly onto the oscillation arm
27. ation arm Pressing the ok button will initiate the mixing process The remaining mixing time and the current speed of the UNGUATOR MB are displayed throughout the entire mixing process The UNGUATOR MB speed and mixing time param eter can be changed during mixing using the and buttons Selection of the mixing parameters to be changed is made using the ok button Once the mixing time is over the UNGUATOR 2100 will automatically run the free spin program With the mixing process finished the display of the UNGUATOR 2100 will indicate the mixing parameters that have been run through These are mixing time number of revo lutions of the UNGUATOR MB number of strokes and the identification number of the preparation In addition the number of the preparation and the software of the UNGUA TOR 2100 will display To remove the UNGUATOR Mixing System screw off the UNGUATOR Jar Lid from the oscillation arm clockwise The UNGUATOR Mixing System is removed from the bayo net holder by twisting the UNGUATOR MB shaft counterclockwise Then the UNGUATOR Mixing System can be removed by pulling downward Hitting the ok button will get you to the start screen 6 4 9 2 Manual stroke Once the manual stroke has been selected the user may depending on UNGUATOR Jar size select up to 10 different speed steps for the UNGUATOR MB using the and buttons and confirm this using the
28. be ordered with UNGUATOR Jar Lids in gt the special colors green blue and white Upon special demand Pic 12 UNGUATOR Jar and defined quantity UNGUATOR Jars from 20 to 200ml may also be ordered in customized colors CUncuaton TECHNOLOGY All UNGUATOR Jars come sealed in plastic packaging Cleaning or disinfection prior usage could put the certified asepsis at risk We would recommend storing the UNGUATOR Jars in its plastic packaging after opening for protection against possible dust contamination The UNGUATOR Jar sizes 300 to 1000 ml are particularly well suited as storage and transfer vessels for semisolids and other preparations Since the contents dispensed using the movable jar bottom are always close to the lid The UNGUATOR Jar solves the problem of the unsightly contents in traditional porcelain vessels used previously Evaporation formation of crust contamination and oxidation processes can thereby be avoided to a great extent Furthermore the contents of the UNGUATOR Jar can be moved close to the lid after spatula dispensing using the UNGUATOR Spindle or the AirDynamic Pumpball System Analysenzertifikat Certificate of Analysis Dat 01 03 2012 UNGUATOR Kruke Jar EINWEGEFASS VOR GEBRAUCH NICHT SPULEN DISPOSABLE DO NOT RINSE BEFORE USAGE NENN FULL NOMINAL FILLING VOL 50 70 ml PZN 0471975 INHALT PACKING UNIT 10 ST pcs ART PROD NR 808 CHARGE 1234 56P78 Gepr ft nach ZL
29. carefully brushed with foundation so as to improve its sealing quality e The sealing lip of the UNGUATOR Jar Lid has been damaged by the shaft tappets of the UNGUATOR MB upon perforating the lid This will cause ointmentto creep up the shaft e The UNGUATOR Jar Lid is not tightened correctly and not held during the manually guided stroke This may cause the UNGUATOR Jar Lid to unscrewed during the mixing process resulting in a large mess e The user failed to remove air again or to mount a UNGUATOR Varionozzle or UNGUATOR Applicator before dispensing This will cause the user to first push the air out of the opening and the ointment will follow in a gush 1 7 5 Quality assurance of the ointments Simple test methods convincingly demonstrate the good homogenizing capability of the UNGUATOR Mixing System Perform a homogeneity test when receiving the UNGUATOR device and document the results After a year or when needed you can repeat the test Use a recipe with a colored substance for example iron oxide micronized or Sudan Red and work this in a semi solid base You can spread out the finished recipe in a glass plate or in a microscope slide and check under the microscope the solids distribution and the grain size For a short term statement about the solids distribution in the formula basis you can test in different levels of the UNGUATOR Jars and examine these as described 8 Service and warranty 8 1 Notes on
30. e for the unpracticed user Tab 3 4 and Tab 3 6 give reference values for this 6 4 11 8 Minimum mixing times for the Direct and Manual programs The following tabulated reference values can be derived for ointment preparation using the DIRECT and MANUAL programs These minimum values are stated as min sec and dependant on the size of the UNGUATOR Jar type of ointment and speed of the mixing motor as variables Size of the UNGUATOR Jar Type of 15 30 ml 50 a100 ml 200a 300 500 ml 1000 ml formulation ml 02 00 02 30 04 30 06 10 08 15 02 00 02 20 04 10 05 30 07 40 Suppositories 01 40 02 10 04 00 N Zoo Tab 5 Minimum values for the mixing time at 2500 rpm in min s Normal S S 01 40 02 10 04 00 05 10 07 10 Size of the UNGUATOR Jar formulation ml D EEE Gel 4x1 min 4x1 min with with 1500 U min 1500 U min And pause And pause after 5 mins after 5 mins Tab 6 Minimum values for the mixing time at 1750 rpm in min s Uncuaton TECHNOLOGY 6 4 11 9 Selecting the UNGUATOR Jar size The selection of the UNGUATOR Jar size was designed to protect the UNGUATOR 2100 from overloads For example the maximum speed of the UNGUATOR MB was limited to 2000 rpm when a 1000 ml UNGUATOR Jar has been selected 6 4 12 Requirements for the ingredients of a prescription Powder Mixing powder to fill capsules We recommend using the UNGUATOR Disp Blade for sizes up to
31. edients Used as a dispensing jar the UNGUATOR Jar corresponds to the guidelines for quality assurance from the German Chamber of Pharmacists Apothekerkammer With its small dispensing opening comparable to a tube and without an environmental contamination surface the UNGUATOR guarantees the minimization of negative quality interference demanded by section 13 ApBetrO Pharmacist Operating Regulations including those caused by germs on the fingers when dispensing the ointment Consequently the user can remove the prescription ointment from the UNGUATOR Jar very hygienically The UNGUATOR Jar is resistant to hot water baths and microwaves with temperatures below 85 C 185 F Higher temperatures may alter the tightness of the UNGUATOR Jar and the displaceability of the bottom push up process might be negatively impacted The UNGUATOR material becomes brittle at temperatures below 0 C 32 F UNGUATOR Jars are available in the following sizes 15 28 ml 20 33 ml 30 42 ml 50 70 ml 100 140 ml 200 280 ml 300 390 ml 500 600 ml and 1000 1250 ml rated volume filling volume The standard color for the UNGUATOR Jar housing is white and the UNGUATOR Jar Lid is red The 300 ml 500 ml and 1000 ml UNGUATOR Jars come with white lids In addition the 20 ml to 200 ml UNGUATOR Jars are available in the pastel colors pink light yellow light blue and turquoise Furthermore UNGUATOR Jars from 20 to 200 ml can
32. enu will show Select UNGUATOR Jar size using the and buttons and confirm with the ok button and the PROGRAM SELECT menu will show Select one ofthe programs 01 to 20 for the respective sizes of UNGUATOR Jar selected in the previous step using the and buttons Confirm with the ok button and a new menu will show on the display This is the main MANUAL PREPARATION menu Here the user can select among USE INDICATE EDIT and DELETE options in the main MANUAL PREPARATION menu using the and buttons The menu option selected must be confirmed with the ok button 6 4 11 1 Use a manual preparation The oscillation arm will automatically move into its starting position Now the user will be prompted to mount the UNGUATOR Jar or the UNGUATOR mixing unit The UNGUATOR MB shaft of the prepared UNGUATOR Mixing System is run upward through the opening of the oscillation arm Then the male thread of the UNGUATOR Jar Lid is screwed into the oscillation arm Pressing the ok button will initiate the mixing process after the UNGUATOR Mixing System has been screwed tightly onto the oscillation arm The upper part of the display shows the current speed of the mixing motor in percent during the mixing process A progress bar illustrates the overall mixing progress on the lower part of the display When the mixing pr
33. er pre grind program selection is confirmed with the ok button The options available here are the free spin 00 motion program i e end of mixing process without free spin or free spin program 01 or 02 i e the UNGUATOR MB will cleanitself beforetheendofthemixing processbymeansofhigh speedrotationinaposition close to the lid in the free spin program Confirm this select too by hitting the ok button FSP Time Suitable jar size Speed of the MB Prog No In min sec Volume in ml In rpm TE 02 enabled 300 1000 2000 Tab 3 Parameters of the rotation from 00 to 02 One of the 16 mixing stages can be directly selected on the Prog Stage line using the and buttons Confirm the mixing stage selected with the ok button This will call up the selection of mixing parameters Exactly like in the previous selection pro cesses the various mixing parameters speed of the lifting motor and the UNGUATOR MB and number of strokes or duration of the mixing time can be changed using the and buttons in each case and are to be confirmed with the ok button It is also possible to select or confirm individual mixing parameters by hitting the Esc button but here the selection does not jump to the following but to the previous data record Since the number of strokes and the mixing time depend directly on each other the user may either pre select the number
34. f microfine agglomerated optionally fine grained solid substances of less than 2 Examples Cortisones antibiotics fungicides metronidazole We recommend using the UNGUATOR SMB If there is no concentrated active substance we recommend a pregrinding process e g by use of a pregrind program in the case of a suspension with a content of less than 2 active ingredients For pregrinding the solids with low base content are weighed out into the UNGUATOR Jar The movable bottom remains in the low est position in order to make use of the full capacity of the jar including both lid and bottom areas for the dispersion process The degree of dispersion reached by pregrinding should be checked to ensure that no active substance particles or Uncuanton TECHNOLOGY agglomerates are too large either microscopically or using a strong magnifying glass Usually the spreading on a glassplate e g object slide is sufficient to prevent innomogene ity Eventually the pregrinding process needs to be repeated depending on the examination Due to a high speed grinding process a warming of the formulation up to 50 C 122 F may occur Since this warming may not be suitable for some of the substances e g metronida zole we recommend continiously checking the temperature In order to gently work the substances making use of these programs the rpm and lifting speed can be individually selected and adjusted The relatively large surface of
35. guator com International Distribution Rights International distribution of the UNGUATOR line of products is generally regulated and monitored by the company GAKO International GmbH Germany GAKO International works with selected distribution partners in defined territories on a global basis If you notice generic or copied products being distributed under the registered trademark UNGUATOR please contact us immediately following the GAKO contact details mentioned above Your courtesy and support helps to prevent losses in terms of intellectual property quality and customer satisfaction GAKO International GmbH Dantestrasse 27 80637 Munchen GERMANY phone 49 0 89 15 88 16 88 fax 49 0 89 15 88 14 85 mail contact unguator com ww UNGUATDR om
36. h the UNGUATOR Spindle or the Air Dynamic System the air will escape between the UNGUATOR Jar Lid and the UNGUATOR Jar housing Then the UNGUATOR Mixing System should be tightly screwed down This process is called air diminution Air diminution will not only prevent ointment exudation at the sealing zones of the UNGUATOR Jar through reduction of any overpressure that may have developed The mixing result is also optimized since there is no trapped air We recommend mainly in the case of intermingling large quantities of powder that air diminution be repeated after 15 seconds of the mixing process When pre grinding by pasting the solids with some foundation in the UNGUATOR Jar we recommend positioning the movable UNGUATOR Jar Bottom as far downward as possible This will guarantee that the large surface area of the inside wall of the UNGUATOR Jar also including the lid and bottom can be used for dispersion between the friction surfaces of the UNGUATOR MB and the inside surface area of the UNGUATOR Jar housing Consequently no air diminution need be carried out before peg rinding At this point of the mixing process device specific settings will need to be implemented Uncuaton TECHNOLOGY and the UNGUATOR Mixing System connected to the UNGUATOR 6 6 After the mixing process is complete The UNGUATOR Mixing System is released and removed from the UNGUATOR oscillation arm once the mixing process is finished
37. heating in a microwave To avoid this we recommend coarsely blending the content of the jar during heating using a spatula at intervals Please also keep in mind that a microwave will only heat aqueous substances Generally it is sufficient to homogenize heated mixtures in three cooling intervals of six minutes each and apply 10 strokes each using the UNGUATOR at high speed Homogenization of solid substances takes slightly longer The cooling time and hence the cooling interval can be shortened in the refrigerator or by using a water jacket The UNGUATOR MB should remain in the UNGUATOR Jar during the cooling phase For emulsions it makes sense in some cases to pregrind ingredients using the whole fatty phase and a low portion of water by a pregrinding The remaining water can then be filled in the UNGUATOR Jar in additional steps when the mixing process is interrupted The advantage of pregrinding where the basic ingredients are mixed evenly along the UNGUATOR Jar wall is a relatively fast bonding of the liquid constituents This in turn assures an increased tightness of the sealing lips even for large UNGUATOR Jars and extended mixing processes 6 5 Preparing the mixing process Together with the UNGUATOR Jar Lid the UNGUATOR MB should be loosely screwed onto the UNGUATOR Jar housing after the formulation constituents have been weighed in By pushing up the UNGUATOR Jar Bottom with a thumb or for large UNGUATOR Jars wit
38. ial work is required Heating The heat that develops from the friction between the UNGUATOR MB and the inside wall of the UNGUATOR Jar is required Decreased viscosity increases the wetability of powders and accelerates the penetration of potential powder pockets Even the emulsifying readiness of fats and oils is benefited by heat A temperature of 54 C 129 F was the maximum taken after 6 minutes of mixing a highly pasty preparation made of vaseline and zinc oxide aa at full speed This temperature increase is generally safe for the substances used in the pharmaceutical field Ointments of low viscosity only heat slightly 2 Volatile substances such as ethereal oils or alcohol do not evaporate from the closed UNGUATOR Mixing System Cleaning the UNGUATOR MB The UNGUATOR MB is normally cleaned with a paper towel and if necessary held under a hot water faucet and then dried with the paper towel UNGUATOR MBs can also be cleaned in a dishwasher The UNGUATOR devices as well as the UNGUATOR line of products should never be treated with sharp edged objects or abrasive cleaning agents 5 2 2 UNGUATOR Jar The UNGUATOR Jar is both the mixing and the dispensing jar and is therefore designed as an expendable or disposable jar The UNGUATOR Jar guarantees evaporation free and contamination free preparation in the air reduced mixing space The UNGUATOR Jar Lid closes the UNGUATOR Jar to ensure no loss of active ingr
39. inc oxide or sulfur then the elevated load might be greater than the mechanical switch over counterforce This means that the UNGUATOR MB cannot make the stroke to its full height at the beginning of the mixing process and changes the stroke direction before it has reached the UNGUATOR Jar Lid of the UNGUATOR Jar Bottom Here we recommend a manually assisted push up at the first full stroke when working with large UNGUATOR Jars 500 and 1000 ml possibly even 300 ml or briefly heating up the material to be mixed in the microwave to reduce viscosity The reversing force of approx 6 7 to 11 2 lbs 30 50 N for the oscillation arm has been purposely selected low as safety precaution If reversing force is higher or inappropriately sensitively controlled this can result in injuries due to force or the possible destruction of glass vessels located underneath Irreversible software faults caused by current transients or strong electromagnetic fields in the vicinity can only be remedied by customer service Uncuaton TECHNOLOGY For functionally testing reason the UNGUATOR 2100 has to be switched off at first The device can be switched on again after 20 seconds No UNGUATOR MB can be attached to the device during start up or reboot It is best to change the UNGUATOR Jar size when performing a function test and running a mixing process with a filled UNGUATOR Jar of 30 or 50 ml size for example Please contact customer service for
40. ing the Delete menu option will irrevocably delete the complete data record of the mixing program currently selected This means that all the mixing parameters of all 16 mixing stages will be set to 0 and the pre grind program as well as the free spin program will be set to 00 or disabled In the event that the menu option Delete was selected the UNGUATOR 2100 will ask once more whether the selected mixing program should be really deleted Confirm using the ok button or abort using the Esc button Uncuaton TECHNOLOGY 6 4 11 5 Pregrind program While the pre grind program is running the lower part of the display shows PREGRINDING ACTIVE The mixing process is interrupted after the pre grind program has ended and the display shows the following prompt Picture 30 After the pre grinding program The user has now the option of detaching Pic 32 After finishing the pregrinding program the UNGUATOR Mixing System from the oscillation arm and the bayonet receptor and removing it by pulling it downward Pre grinding results can be checked by opening the UNGUATOR Jar Lid Depending on the result of the quality check either the mixing process can be continued the pre grind program run through once more or the mixing process terminated Hit the ok button to continue the mixing process The oscillation arm will automatically move into its starting position The remaining formulati
41. ixed to the plastic packaging of the UNGUATOR Jars It may be removed from the plastic packaging as needed and added to the records Notes on Dispensing Ointment Each customer should be given specific instructions at how to apply the UNGUATOR Jars when speaking to the individual client The use of the UNGUATOR Spindle should be explained for large UNGUATOR Jars size 300 500 ml Low viscosity ointments should be equipped with an UNGUATOR Applicator or an UNGUATOR Varionozzle to reduce the dispensed volume Medium viscosity ointments can easily be extracted through the regular opening of the UNGUATOR Jar Very pasty ointments e g pasta zinc may not necessarely be pressed through the regular opening even by using a spindle In this case once the UNGUATOR Jar lid has been removed the ointment can be extracted with the help of a spatula similar to handling conventional jars with a regular lid If the UNGUATOR Jar Lid has been removed the ointment should be pushed up close to the lid after each dispensing process using the UNGUATOR Spindle or the AirDynamic System The diameter of the dispensing nozzle allows simple dosing of the quantity of ointment to be applied using approximate values The regular dispensing nozzle in the screw lid of each UNGUATOR Jar has a diameter of 8mm The varionozzles or applicators reduce the diameter to 4 2 or 1 mm The approximate values represented in the following diagrams may also be hel
42. ixing process Third the UNGUATOR MB is carefully removed from the UNGUATOR Jar and the UNGUATOR Jar lid will be moved all the way in the direction of the Blade Both parts i e the UNGUATOR MB and the UNGUATOR Jar lid are put down or possibly tarde on the balance together with the UNGUATOR Jar 6 2 Weighed portion of the formulation Generally oily greasy aqueous and pulverized ingredients can be weighed out into the UNGUATOR Jar all at the same time It is however advantageous to consider certain general procedures to optimize the mixing results Generally know how gained from the traditional preparation of ointments is very helpful when using the UNGUATOR Mixing System As already mentioned at the beginning of the operating instructions true to the Uncuanton TECHNOLOGY motto learning by doing Listed below are the seven different general procedures used to produce the routine standard formulations in pharmaceutical preparation of ointments EMULSION EMULSION NORMAL SUSPENSION lt 2 SUSPENSION gt 2 as well as GEL and SUPPOSITORIES Due to the rapid heat generation powder mixtures should be processed only at very low speed In the following these standard formulations will be defined and the recommended procedure on weighing described This will produce a code of practice for orientation This does not exclude other possible methods for optimization For mixtures with high liquid content ensure that the oi
43. ixing time of 2500 rpm in min s 32 Tab 6 Minimum values for mixing time of 1750 rpm in min s 32 Index of Pictures Pic 1 UNGUATOR 2100 2 Pic 2 Display with initial screen 3 Pic 3 Language Menu 4 Pic 4 UNGUATOR B R 5 Pic 5 UNGUATOR e s 5 Pic 6 UNGUATOR 2100 6 Pic 7 UNGUATOR Q 6 Pic 8 UNGUATOR Standard Mixing Blade SMB 7 Pic 9 UNGUATOR Disp Blade 8 Pic 10 Handling the UNGUATOR Disposable Blade Disp Blade 8 Pic 11 Assignment of the UNGUATOR SMB with different length of shaft 9 Pic 12 UNGUATOR Jar 10 Pic 13 Certificate of analysis for the e g 50m UNGUATOR Jar 12 Pic 14 Dispensing with regular UNGUATOR varionozzle 12 Pic 15 Dispensing with UNGUATOR 1mm varionozzle or UNGUATOR applicator short 12 Pic 16 Dispensing with UNGUATOR 2mm varionozzle or UNGUATOR applicator long 12 Pic 17 Dispensing with UNGUATOR varionozzles 4 mm 12 Pic 18 UNGUATOR Varionozzles 1 2 4 mm 13 Pic 19 UNGUATOR Applicator short 14 Pic 20 UNGUATOR Applicator long 14 Pic 21 UNGUATOR Spindle 15 Pic 22 How to operate the UNGUATOR Spindle 15 Pic 23 UNGUATOR Coupling 15 Pic 24 UNGUATOR Air Dynamic Pumpballsystem 16 Pic 25 Main menu Selecting Mixing Type 19 Pic 26 Menu DIRECT PREPARATION 23 Pic 27 Combination mix 25 Pic 28 Menu PROGRAM SELECT 27 Pic 29 Main menu MANUAL PREPARATION 27 Pic 30 Screen INDICATE 1 29 Pic
44. lable UNGUATOR Mixing devices 5 2 1 UNGUATOR Mixing Blade MB The UNGUATOR Standard Mixing Blade and the UNGUATOR Disposable Blade are designated as the UNGUATOR MBs The UNGUATOR MBs are steadily guided up and down inside the UNGUATOR Jar Their special design results in a tight contact between the mixing blade and the inside wall of the UNGUATOR Jar which serves primarily for the comminuting of the substances during the mixing process Additionally forced mixing in the whole mixing space is achieved through the shape and vibration of substances while preparing the ointment The lubricating effect of the foundation ointment protects the UNGUATOR Jars and the UNGUATOR MB against abrasion Discolorations of the mixing blade are mostly irreversible and therefore harmless All UNGUATOR MBs are dishwasher safe UNGUATOR Standard Mixing Blade SMB UNGUATOR SMBs are adjusted to the size of each individual UNGUATOR Jar While the UNGUATOR SMBs for 100 and 200 ml and for the 300 and 500 ml jars have the same mixing blade diameter their shaft length differs This must be taken into consideration especially when using the devices with automatic stroke lead since the use of the wrong length may cause problems with the automated stroke Pic 8 UNGUATOR SMB Always make sure the UNGUATOR MB being used is the right length and that it is clean prior to use For example with isopropanol 70 The UNGUATO
45. lid and the UNGUATOR MB will perform a self cleaning process through high speed rotation With the mixing process finished the UNGUATOR 2100 display will indicate the mixing parameters that have been run through These are mixing time number of revolutions of the UNGUATOR MB number of strokes and the identification number of the preparation In addition the number of the preparation and the software of the UNGUATOR 2100 will display The UNGUATOR Mixing System is removed from the bayonet receptor by twisting the UNGUATOR MB shaft counterclockwise and then pulling it out in downward direction Hitting the ok button will get you to the start screen 6 4 10 Combination mix The sequence of the COMBINATION MIX program serves to speed up the dissolving process or that of a chemical reaction in a medium of constant good flow properties It is done without reciprocating motion Uncuaton TECHNOLOGY First select the COMBINATION MIX program in the main menu using the and buttons Confirm with the ok button The oscillation arm will automatically move into the full down position and the display will prompt the user to mount the mixing tools These consist of the UNGUATOR Jar Lid of a 1000 ml UNGUATOR Jar a vessel with the combination mix and a UNGUATOR SMB or Disp Blade appropriate for the vessel Ensure that the overall diameter of the UNGUATOR MB is smaller than the inside dia
46. ll System are patented in selected countries UNGUATOR and AirDynamic are registered trademarks exclusively available from the company GAKO The UNGUATOR Mixing System with its versatile and comprehensive line products captivates with its simplicity Everything the pharmacist needs for the production of pharmaceutical ointments and cosmetics is covered by the UNGUATOR Mixing System 7 2 Identification number The 9 digit identification number used to unmistakably mark preparations has the follow ing structure The first two digits represent the type of ointment 01 Emulsion 06 Gel 02 Emulsion 07 Suppositories 03 Normal 08 Direct 04 Suspension lt 2 09 Manual 05 Suspension gt 2 00 Combination mix The third and forth digits stand for the size of the UNGUATOR Jar 01 15ml 06 200ml 02 20ml 07 300ml 03 30ml 08 500ml 04 50ml 09 1000ml 05 100ml 00 Combination mix Uncunton TECHNOLOGY The fifth and sixth digits stand for the MANUEL mixing program 00 no manual mixing program 01 Manual mixing program no 01 02 Manual mixing program no 02 etc The seventh and eighth digit stands for the number of pasting programs 00 no pregrinding program 01 1 pregrinding program performed 02 2 pregrinding programs performed Etc The ninth or last digit stands for an interruption of the mixing process 0 mixing process interrupted 1 without interruption F
47. ly controlled conditions or do not require the quality assuring energy input of the standard formulation programs The preparation of concentrated active substances or the preparation of subcomponents but also preparations following a given graduated scheme and emulsions may require these mixing processes Pic 28 Menu SELECT PROGRAM The MANUAL program allows for the Pic 29 Main menu MANUAL PREPARATION storage of 180 different mixing programs Each UNGUATOR Jar size is assigned to 20 mixing programs Using a PC and appropriate software the number of mixing programs that can be stored is practically unlimited A mixing program consists of a re grind program 1 3 enabled 0 disabled a main mixing program subdivided into 16 mixing stages and a ree spin program 1 or 2 enabled 0 disabled So each main program can be preceded by a pre grind program and be followed by a free spin program First select the MANUAL program using the and buttons in the main menu Confirm with the ok key and the UNGUATOR JAR SELECTION menu will show Select UNGUATOR Jar size using the and buttons and confirm with the ok button and Uncuaton TECHNOLOGY the PROGRAM SELECT menu will show First select the MANUAL program using the and buttons in the main menu Confirm with the ok key and the UNGUATOR JAR SELECTION m
48. meter of the vessel The UNGUATOR Jar Lid should be tightly screwed upside down above the oscillation arm with the threads facing upward The vessel will be placed together with the reaction mixture and the UNGUATOR SMB onto the mounted UNGUATOR Jar Lid Then the UNGUATOR SMB should be inserted into the bayonet receptor of the UNGUATOR 2100 moved up as far as it goes then twisted clockwise Confirm the assembly by hitting the ok button and the user will be prompted to move the oscillation arm into mixing position The oscillation arm can be moved upward by pressing the button and downward by pressing the button Confirm with ok once the desired mixing position has been reached The speed of the UNGUATOR MB can be changed using the PARAMETERS SELECT menu using the and buttons Select speeds between 120 and 600 rpm in 12 steps and confirm using the ok button Then the mixing time parameters can be set using the and buttons Available mixing times are between 2 minutes and 2 hours Start the mixing process by confirming the mixing time using the ok button The remaining mixing time and the speed of the UNGUATOR MB display throughout the entire mixing process After the mixing process has been completed the user will be prompted to move the oscillation arm into the retrieval position using the and buttons We recommend the full
49. ng Technology and System compared to conventional manufacturing methods with mortar and pestle are frequently mentioned in the literatures below e Preparation of GMP compliant ointments in the pharmacy is possible 2 4 e Formulations for ointment is standardized 4 8 e Excellent homogenity 2 4 9 e Improved microbiology 3 8 e Risk of contamination is greatly reduced in the preparation process hygienic production in a closed system no transfer to a separate container 2 3 4 8 e Hygienic extraction of the formulation minimum threat of contamination by the user 2 3 4 8 e Enhanced product quality in an improved packaging ensures longer product shelf life 3 4 10 Bibliography e 1 1 Jahr UNGUATOR R hrsystem Deutsche Apothekerzeitung DAZ Nr 43 Jhg 135 1995 S 115 117 Konietzko A GAKO Konietzko GmbH Bamberg e 2 Der UNGUATOR ein neuartiges Salbenr hrwerk Pharmazeutische Zeitung PZ Nr 30 Jhg 141 1996 S 30 33 Alberg et al Pharmaz Technologie TU Braunschweig e 3 Keimzahl in wasserhaltigen Dermatika Pharmazeutische Zeitung PZ Nr 29 Jhg 142 1997 S 36 40 Alberg et al Pharmaz Technologie TU Braunschweig e 4 Alternativen zum Salbenr hren im Vergleich Pharmazeutische Zeitung PZ Nr 36 Jhg 142 1997 S 24 31 Zobel et al Pharmaz Technologie Univ Frankfurt a M e 5 Das UNGUATOR R hrsystem URSY als Alternativverfahren f r die Herstellung dermatol
50. ng the and buttons and confirm with the ok button Speed steps 01 to 05 stand for Uncuaton TECHNOLOGY slow to fast upward and downward stroke of the automated oscillation arm see 3 2 1 The speed of the lifting motor can not be changed during the mixing process The automated movement of the oscillation arm is suspended when selecting speed step O and the oscillation arm is moved into its full down position before the mixing process starts which allows for a manually guided stroke 6 4 9 1 Automated stroke Once the automated stroke has been selected the user may depending on the size of the UNGUATOR Jar choose from up to 10 different speed steps of the UNGUATOR MB using the and buttons and confirm this with the ok button The last of the selectable mix parameters is mixing time which may be between 10 seconds and 2 hours Change mixing time with the and buttons After mixing time is confirmed with the ok button the oscillation arm will automatically move to its starting position Now the user will be prompted to mount the UNGUATOR Jar or the UNGUATOR Mixing Unit The UNGUATOR MB shaft of the prepared UNGUATOR Mixing System is run upward through the opening of the oscillation arm Then the male thread of the UNGUATOR Jar Lid is screwed into the oscillation arm Be sure the UNGUATOR Mixing System has been screwed tightly onto the oscill
51. ntment base on the UNGUATOR Jar Bottom is first carefully placed around the sealing lip This enhances the leak tightness of the UNGUATOR Jar when it is filled For UNGUATOR Jars of 200 ml and up an active ingredient proportion of less than 5 of the active ingredient can be filled alternating with the foundation ointment over two or more levels to speed up vertical intermixture 6 3 The mixing process with the UNGUATOR 2100 The UNGUATOR 2100 is the result of continuous improvements of the UNGUATOR Technology of the year 2000 The integrated programmable microprocessor that automates the UNGUATOR 2100 Mixing System turns the device into a universal machine for the production of formula tions The UNGUATOR 2100 operates with 2 quiet high duty permanent motors and is an intelligent ointment stirring machine for recipes of 15 1000ml When preparation type and size of the UNGUATOR Jar have been selected the microprocessor controls the mixing parameters for uniform and reproducible product quality Unlike its predecessor the speed of the lifting motor can be increased or reduced on the UNGUATOR 2100 This means that the oscillation arm will move up and down faster or slower For mixing processes that are carried out at low mixing motor speed homogeneity of the substances by thoroughly mixing them can be optimized thanks to a slow upward or downward stroke of the UNGUATOR Mixing System In addition to the formulations such
52. ocess is complete the UNGUATOR 2100 display will indicate the mixing parameters that have been run through These are mixing time number of revolutions of the UNGUATOR MB number of strokes and the identification number of the preparation In addition the number of the preparation and the software of the UNGUATOR 2100 will display To remove the UNGUATOR Mixing System screw off the UNGUATOR Jar Lid The UNGUATOR Mixing System is removed from the bayonet receptor by twisting the UNGUATOR MB shaft counterclockwise Then the UNGUATOR Mixing System can be removed by pulling downward Hitting the ok button will get you to the start screen 6 4 11 2 Indicate a manual preparation The Indicate menu option allows the user to get a quick general idea about the currently stored mix parameters of the mixing program selected The tabulated data can be retrieved with the two screens INDICATE 1 and INDICATE 2 When selecting the Indicate menu option the INDICATE 1 screen will display first which in addition to program number and Jar size selected also displays the current mix parameters stored on the UNGUATOR 2100 strokes and mixing time respectively as well as the speed of the UNGUATOR MB and the lifting motor of the pre grind program as well as the first 8 mixing stages Pic 30 Screen INDICATE 1 Pic 31 Screen INDICATE 2 Change to INDICATE 2
53. of strokes or the mixing time So if the number of strokes is determined within a mixing stage and the mixing time is set afterward then the data record of mixing parameter number of strokes will be deleted again and the record of mixing parameter mixing time will be stored Step Speed of the lift Step Speed of the Max jar size allowed ing motor in rpm MB in rpm Nominal volume in ml Pc w m Pcs o m P ce w m Tab 4 Steps of velocity available for the mixing and lifting motor When all mixing parameters of the 16 mixing stages have been confirmed with the ok button the user is returned to the MANUAL PREPARATION menu The user may also leave the Change menu backwards by confirming all mixing parameters hitherto set using the Esc button The microprocessor will immediately accept all changes that were made during the navigation through menu option Change as a change of the existing mixing program and store it under the number of the program selected Here it does not matter if the menu option was properly exited using the ok button or by termination through the Esc button The UNGUATOR 2100 will not prompt for storage of the new settings at any time but will overwrite the old ones with the new data records directly upon change Please check the changed data at the Indicate menu option prior to initiating the mixing process 6 4 11 4 Delete a manual preparation Select
54. ogischer Individualrezepturen Deutscher Dermatologe 46 Heft 6 1998 S 545 549 Zobel et al Pharmaz Technologie Univ Frankfurt a M e 6 Bedienungsanleitung UNGUATOR R hren im geschlossenen System 1998 A Konietzko GAKO Konietzko GmbH Bamberg 7 System zur Salbenherstellung im Vergleich Pharmazeutische Zeitung PZ Nr 38 Jhg 143 1998 S 53 65 R Eifler Bollen Zentrallaboratorium Deutscher Apotheker ZL Eschborn e 8 Voigt R Pharmazeutische Technologie F r Studium und Beruf Jhg 2000 9 Auflage S 314 315 Deutscher Apothekerverlag Stuttgart e 9 Qualit tssicherung bei Rezeptur und Defektursalben UNGUATOR Technologie Apotheker amp Wirtschaft Nr 7 Jhrg 2 2001 S 40 41 Albrecht Konietzko 96049 Bamberg kontakt unguator com Verlag medical economics Leipzig e 10 Qualit tssicherung in der Rezeptur Pharmazeutische Zeitung PZ Nr 14 Jhg 146 2001 S 42 47 R Eifler Bollen NRF Eschborn Prof Dr H M ller Zentrallaboratorium Deutscher Apotheker ZL Eschborn et al e 11 Leitliniezur Qualit tssicherung nichtsterilen Rezeptur und Defekturarzneimittel Pharmazeutische Zeitung PZ Nr 29 Jhg 145 2000 Seiten 105 116 Deutsche Apothekerkammer e 12 Fl ssige Chlorhexidin Cremes R hren ist kritisch Pharmazeutische Zeitung PZ Nr 10 Jhg 147 2002 Seiten 54 56 e 13 Mit zeitgem en Herstellungsverfahren r hren Pharmazeutische Zeitung PZ Nr 13 Jhg 147 2002 Seite 60 Disk
55. on constituents can now be weighed in the UNGUATOR Jar closed tight again and the UNGUATOR Mixing System screwed into the oscillation arm Then restart the mixing process by hitting the ok button The button can be pressed to re run the pre grind program The oscillation arm will automatically move into its starting position The UNGUATOR Jar needs to be reclosed and the UNGUATOR Mixing System screwed into the oscillation arm Confirm pre grind program restart by hitting the ok button The user will again see the prompt shown in the display after the pre grind program has finished The Esc can be pressed to reject or abort the mixing process The UNGUATOR 2100 will then return to the start screen 6 4 11 6 Number of strokes One upward motion and one downward motion of the UNGUATOR Mixing System taken together is one stroke In addition to mixing motor speed the number of times the UNGUATOR MB covers the path from the lid to the bottom and back again is of critical importance for vertical intermixture We recommend using at least 50 strokes for a good vertical intermixture regardless of UNGUATOR Jar size at max Mixing motor speed 6 4 11 7 Mixing time The option of setting the mixing time has been designed solely for special tasks in the field of research or for users with adequate know how This is because the variable speed of the lifting motor and the influence on final product quality is unreadabl
56. ons Heed the relevant safety regulations when handling hazardous substances e g combustible liquids such as alcohol or similar substances e UNGUATOR devices correspond to the safety standards for laboratory equipment They have to be positioned to prevent any interference or use by unauthorized persons e The device must not be disposed of in ordinary domestic waste Please deliver the device to the available collecting and recycling systems at the end of its life cycle 8 4 Technical data of the UNGUATOR 2100 ET E UNGUATOR Jar sizes 15 1000 ml Weight 36 75 Ibs Dimensions L x W x H in mm 356x 221 x 642 Testing certifications CE TUV GS 8 5 Quality and material Manufacturing facilities for the UNGUATOR line of products is certified according to DIN EN ISO 9001 2008 Regular quality control ensures both outstanding and sustainable quality of the UNGUATOR Mixing Technology e The UNGUATOR Aplicators Couplings and Jars are made out of Polypropylen PP and the regular UNGUATOR Varionozzles of Polyethylen PE e The UNGUATOR SMB is made out of Polyoximethylen e The UNGUATOR Disp MB is made out of Polyamid e The shaft of the UNGUATOR MB is made of NIRO Stainless steel quality standard 1 4301 and hardened titanium nitride golden color The utilized material and pigments are physiologically classified as safe Uncuaton TECHNOLOGY 9 References The advantages of the UNGUATOR Mixi
57. or instance the identification number 090504021 stands for a mixing process using the Manual mixing program with a 100 ml UNGUATOR Jar with Manual mixing program n 04 and two pregrinding performances 7 3 Operating errors The quality assurance of optimized ointment production using the UNGUATOR 2100 requires that operating errors be registered and displayed If a problem occurs the display will show the following error indication Mixing tool not locked Jar disengaged Wrong Jar size Lifting motor overload and Mixing motor overload If necessary switch the device off after an operating error The UNGUATOR 2100 will normally function again after the device is switched off and the operating error corrected The UNGUATOR 2100 has been test operated centered aligned and tested using the UNGUATOR MB included As a rule any UNGUATOR MBs delivered after 1996 are compatible with the UNGUATOR 2100 UNGUATOR MBs that are bent in the plastic region or shaft are not suitable UNGUATOR MBs other than those supplied with the UNGUATOR 2100 may cause problems on coupling We recommend contacting customer service should this occur The UNGUATOR MB should not press too deeply into the UNGUATOR Jar so that the oscillation arm can guide it up to the stop of the bayonet receptor For this reason we recommend manually pulling up the UNGUATOR MB as far as it will go after screwing in
58. pful to weight out concentrated active substances or regular trituration from the UNGUATOR Jar 7 _ _ _ _ 5 os s o 5 ns g v 2 3 i 2 L 2 ie 2 m Quantity of ointment in ml 3 Quantity of ointment in ml 2 Pic 14 Dispensing with regular UNGUA 2 Pic 15 Dispensing with UNGUATOR 1mm TOR varionozzle 2 varionozzle or UNGUATOR applicator short wl oll 5 mn 5 Oo a OoOo Ss EE oes no mpe F ppa g o S nn au a 15 is a dd 2 u 5 Ta 5 E j tt u In t A 5 f 3 o P 4 Quantity of ointment in ml S5 Quantity of ointment in ml Pic 16 Dispensing with UNGUATOR 5 Pic 17 Dispensing with UNGUATOR 3 2mm varionozzle or UNGUATOR 3 varionozzles 4 mm applicator long Uncuaton TECHNOLOGY 5 2 3 UNGUATOR Varionozzles The UNGUATOR Varionozzles with inner diameters of 1 2 or 4mm can be pressed into the regular nozzle of any UNGUATOR jar They reduce the opening size making J it possible to safely dose even low formulations The Pic 18 UNGUATOR Varionozzles viscosity of the finished product normally specifies the 1 2 4mm diameter of the UNGUATOR Varionozzles The softly rounded surface allows ointment to be pleasantly spread directly on your skin The coloring wa selected corresponding to the wavelength of light e 4mm red long wavelength light e 2 mm yellow e 1mm blue short wavelength light 5 2 4 UNGUATOR Applicators The UNG
59. signment of the UNGUATOR MB Please take care to use the correct UNGUATOR MBs for the corresponding UNGUATOR Jar Pic 11 Mix up may cause failure messages Please also take care to ensure that the right shaft is used with Unlock the UNGUATOR Disp Blade Both shafts available are marked for use with sizes 15 100 ml or 200 ml in the UNGUATOR Jar Lock They have to be combined with the correct UNGUATOR Disp LE Blade and while the same UNGUATOR Disp Blade is used for SD the 100 and 200 ml UNGUATOR Jar sizes it needs a different SS shaft for each See also the operating instructions that come Pic 10 Handling the with the shafts UNGUATOR disp Blade Uncuaton TECHNOLOGY Pic 11 Assignment of the UNGUATOR SMB with different length of shafts Flowing recesses of the UNGUATOR SMB The flow adapted shape of the UNGUATOR SMB generally cleans itself during the rotating penetration of the ointment Unmixed ingredients may adhere to recesses of flow of the UNGUATOR SMB depending on ointment s ingredients compatibility of weighted formulation and also if the UNGUATOR Jar is considerably under filled e g large volumes of powder These remnants should be transferred into the UNGUATOR Jar using a spatula when about half of the mixing time is complete The air should be decreased again following this process When using the UNGUATOR Disp Blade however there are no recesses of flow and no remed
60. speed while the UNGUATOR Jar quickly travels up and down or vice versa This new function is particularly useful using a low rotating speed of the UNGUATOR Mixing Blade since it allows the UNGUATOR Mixing Blade to mix an ointment homogeneously with a slow stroke 5 1 4 UNGUATOR Q The UNGUATOR Q is the result of continuous improvement of the UNGUATOR e s from the year 2003 It combines both the mixing functions of the UNGUATOR e s and the operating concept of the UNGUATOR 2100 The basic functionality of the e s System with the setting parameters of the mixing rotation speed and time are retained A significant innovation in the UNGUATOR Q is the possibility of scaling one mixing program already created to another jar size This enables a constant quality of the recipes and as a consequence has a tremendous time saving result since recalculation can be time consuming and complex Pic 7 UNGUATOR Q Uncuaton TECHNOLOGY 5 2 UNGUATOR Assortment Appart from the UNGUATOR Standard Mixing Blade SMB the UNGUATOR Disposable Blade Disp Blade and the UNGUATOR Jars the UNGUATOR Assortment provides additional and useful components These include dosing aids such as the UNGUATOR Varionozzles and UNGUATOR Applicators removal or transfer aids such as the UNGUATOR Spindle the UNGUATOR Coupling and the patented AirDynamic PumpballSystem All UNGUATOR products are compatible with all currently avai
61. the UNGUATOR SMB benefits the formation of an agglomer ate grinding process This can be quickly homogenized with the rest of the base even when using larger UNGUATOR Jar sizes After finalizing the pregrinding process both the remain ing base and all substances will be weighed in 6 4 5 Suspension gt 2 Mixing semisolid substances with a portion of microfine agglomerated optionally finegrained solid substances of more than 2 Examples Zincum oxydatum acidum salicylicum We recommend using the UNGUATOR SMB For suspensions with ingredient content above 2 pregrinding is not required For preparation please add 50 of the required base in the UNGUATOR jar first and then include the micronized solid parts Add the remainder of the base on top of the ingredients in order to avoid remaining powder sticking to the blades 6 4 6 Gel Mixing of gel Example Hydroxypropyl cellulose 400 We recommend using the UNGUATOR Disp Blade for up to 200 ml Basic gel approaches are mixed with several intervals at high speed during the required swell time thus preventing agglomerations and slightly reducing soaking time Principlerelated trapped air will normally clear after the preparation would settle for a while 6 4 7 Suppositories We recommend using the UNGUATOR Disp Blade for up to 200 ml The heating of fat suppository base ointment may be carried out using an infrared lamp over the open UNGUATOR Jar An UNGUA
62. the end user The 200 ml UNGUATOR Jar becomes a convenient transfer device to smaller UNGUATOR Jars when their UNGUATOR Jar bottoms are d carefully pressed towards the work surface using an UNGUATOR Pic UNGUATOR Applicator long screwed on a 30 ml UNGUATOR Jar Coupling In addition to the UNGUATOR Coupling required for transferring from a 300 ml or 500 ml UNGUATOR Jar into a smaller UNGUATOR Jar both the UNGUATOR spindle and the AirDynamic Pumpball System may also be used Dispensing and transferring a formulation via the regular UNGUATOR Jar nozzle from a 1000 ml UNGUATOR Jar is practically only possible using the AirDynamic Pumpball System We recommend transferring the formulation after mixing as soon as possible since the formulation is still warm and less viscous 5 2 7 AirDynamic Pumpball System The AirDynamic Pumball System optimizes batch preparation within the closed system e Contamination free transfer e Contamination free storage The AirDynamic Pumball System has been designed to apply with UNGUATOR Jars from size 300 ml to 1000 ml to extract mixtures An adapter connected to a pumpball is affixed to the center hole on the body s bottom of the UNGUATOR Jar with an air tight connection By pumping air into the lower chamber of the Pic 24 UNGUATOR AirDynamic UNGUATOR Jar using the pumball the pressure thus Pumpen generated moves the bottom upward Thanks to the AirDyn
63. ussion A Konietzko GAKO und Dr H Reimann NRF Uncuaton TECHNOLOGY 11 Manufacturer s Certificate Declaration of Conformity for plastic materials which come into contact with food UNGUATOR Jar cap Polypropylene natura UNGUATOR Jar lid Polypropylene natura red white green blue UNGUATOR Jar body Polypropylene natura i UNGUATOR Jar bottom Polypropylene Polyethylene UNGUATOR Jar bottom cap Polypropylene natura additional UNGUATOR products UNGUATOR Spindle Polypropylene natura UNGUATOR Aplicator long with Polypropylene natura cap UNGUATOR Aplicator short with Polypropylene natura cap UNGUATOR Coupling Polypropylene natura UNGUATOR Varionozzle blue Polypropylene natura yellow pink UNGUATOR Disp Blade Polyamide white UNGUATOR SMB Polyoxymethylene 1 The licensed manufacturer SMS ELAP GmbH amp Co KG D 98544 Zel la Mehlis is DIN EN ISO 9001 2000 certified 2 Declarations of conformity for materials and color concentrates of the materials vendors are deposited at the licensed manufacturer All products listed are manufactured according to the legal requirements of plastic Regulation EU No 10 2011 and EU No 1935 2004 in their current version For applications according to formal specification both the overall and specific migration are under the legal limits of 1Omg dm3 according to Regulation EU No 10 2011 The materials and
64. y defined service partners Product quality product uniformity and reproducibility of ointments prepared individually and in batches were improved with the increasing automation of the UNGUATOR units starting with the individual model B R through e s Q and 2100 model Method of Pharmaceutical Uniformity of Lifting arm Mixing parameters ointment Quality ointment preparation UNGUATOR e s individually programmable UNGUATOR Q fully automatic 5 1 1 UNGUATOR B R The UNGUATOR B R is the basic machine with controlled mixing motor and manual jar guidance 5 1 2 UNGUATOR e s Pic 4 UNGUATOR B R The UNGUATOR e s machine was developed for efficient individual and batch preparations The automated stroke enables the user to leave the UNGUATOR e s during the mixing process to serve a customer for instance or to prepare the next formulation at the same time The precisely set sensor for the automatic oscillation arm will always ascertain at each upward or downward stroke the exact position of the UNGUATOR Jar bottom or lid This guarantees that the UNGUATOR Jar is always accessible to the UNGUATOR Mixing Blade despite the inevitable vertical motion during the mixing process If the stroke length of the first stroke was taken as a constant value then the active ingredient weighed out in the lower region of the UNGUATOR Jar might not be included in the mixing process by the UNGUATOR Mixing Blade getting
65. zzle as needed Then a UNGUATOR Jar Lid together with an UNGUATOR Applicator is screwed on Large UNGUATOR Jars will be equipped with a spindle or the AirDynamic System Also in this case like in the the regular mixing process air diminution should be repeated A squirting out of the ointment when first dispensed can be prevented by eliminating cavities that may have developed during the mixing process The UNGUATOR Jar Lid or the UNGUATOR Applicator may now be fasten in place A label may be attached on the UNGUATOR Jar prior forwarding to the client preferably together with a short illustration of how to use and apply UNGUATOR dispensing system It is also a good idea to record the individual mixing parameters together with the results according to the final validation 7 General notes on the UNGUATOR Mixing System In its quality regulations for processing any semisolid preparation the German Chamber of Pharmacists is recommending to apply for dispensing and mixing a jar having a small dispensing nozzle since the year 2000 7 1 Patent protection The UNGUATOR Mixing System consists of UNGUATOR Technology the UNGUATOR mixing machines and various UNGUATOR assortment The UNGUATOR Mixing System and UNGUATOR Technology and the AirDynamic Pumpball System integrated therein are inventions of the pharmacist Albrecht Konietzko from Bamberg in Germany The UNGUATOR Technology and the AirDynamic Pumpba

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