Operating Instructions and Production Recommendations
Contents
1. Quick ID Start complying with the minimum mixing time for the selected formualtion is recommended Depending on the composition and size of the formulation the individual minimum mixing time for any given formulation may vary The following time values for each rpm serves as benchmark which should be adjusted after each modification of rpm Size of the UNGUATOR Jar Type of formulation 50 100ml 200 300ml Tab 5 Minimum values for mixing time at 2150 rpm in min s Size of the UNGUATOR Jar 03 00 03 50 06 30 08 30 Tab 6 Minimum values for mixing time at 1650 rpm in min s 6 6 Selecting the UNGUATOR Jar Size The maximum rpm for jar sizes 100ml and greater is restricted This is a safety feature to optimize the power exposure for all material jars and mixing blades particularly when using larger UNGUATOR jars 6 7 Condition of the ingredients for any formula Powder Generally powders should be used as microfine substances In order to ensure better wetting of powders in aqueous formulations micronized substances should be added only after any liquid constituents For a solids content less than 2 we recommend applying a pregrinding process together with approx 30 of the ointment base see paragraph 6 3 4 pregrinding program Crystalline active ingredients In order to avoid complex postprocessing e g w ointment mill we recommend pulverizing active crystalline agents with the help of a2. Blade Polyamide white UNGUATOR SMB Polyoxymethylene 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 10mg dm3 according to Regulation EU No 10 2011 The materials and 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 Material Color concentrate u BE Sr ee natur Polyamid SMLI T 15 mg kg Formaldehyd SML 15 mg kg Polyethylen Ref Nr 68320 SML 6 mg kg 1 3 Dioxolan SML 5 mg kg Ref Nr 89040 SML 25 mg kg Trioxan SML 5 mg kg calculated as Zn salt white disposable Caprolactan SML T 15 mg kg Polyoxymethylen blade other colors 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 The certificate has been produced electronically and is valid withou
3. embedding the micronized solids afterwards You may now add the remaining base covering the active ingredients in order to avoid powder residue sticking on the blade If a formulation shows some higher content of solids e g pastes heating of the formulation during the mixing process may occur This temperature rise may be reduced applying cooled bases or a cooling pad If you are processing temperature sensitive active ingredients we recommend selecting the Qick ID Start program see paragraph 6 3 1 which would allow you to customize the mixing parameters accordingly Gel The Gel program allows a quick and homogeneous preparatoin of gels and viscous solutions and facilitate the incorporation of bulking agents in liquid and semi solid bases e g preparation of ultrasonic contact electrode or antiperspirant gel The incorporation of a welling agent such as Bentonit or Aarosil in a semi solid basis is another situation for applying the gel program To ensure a homogeneous processing we recommend applying disposable mixing blades for jar sizes up to 200ml and standard mixing blades for larger batches To prepare please weigh out the liquid phase into the UNGUATOR jar Soluble solids may be added and dissolved directly in the jar The welling agent is then sprinkled on If the welling agent is incorporated into a semi solid base you may embed the welling substance between the base layers That way you would obtain a f
4. Applicators reduce the dispensed quantity of low viscosity formulations and are particularly helpful in cases where the ointment must be applied precisely 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 U NG UATOR Applicator long Pic ig ADE short 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 jar size in full The UNGUATOR tn Applicator long is generally available both with and without cap Pic 20 Applicator long 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 UNGUATOR Jar to the customer the
5. The UNGUATOR Standard Mixing Blade and the UNGUATOR Disposable Blade are designated UNGUATOR MB s The UNGUATOR MB s 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 comminuting the substances during the mixing process Additionally forced mixing in the whole mixing unit is achieved through the shape and vibration of substances while preparing the ointment The lubricating effect of the ointment and substances generally protects the UNGUATOR Jars and the UNGUATOR MB against abrasion Discolorations of the mixing blade are mostly irreversible and therefore harmless All UNGUATOR MB s are dishwasher safe UNGUATOR Standard Mixing Blade SMB UNGUATOR SMBs are adjusted to the size of each _ individual UNGUATOR Jar While the UNGUATOR SMBs SF 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 particulary when using the UNGUATOR e s and the UNGUATOR 2100 since the use of the wrong lenght may cause problems Pic 8 UNGUATOR SMB with the automated stroke Always make sure the UNGUATOR MB used is the right lenght and that it is clean prior use e g with isopropanol 70 The UNGUATOR SMB is suitable for the production of all formulations For susp
6. The splash screen of your device might vary from brelow picture 34 The top bar shows the total number of preparations and current software version code of the device By pressing any key the Start Menu will appear Cincunlor TECHNOLOGY A Pic 2 Display with splash screen 4 Menu navigation On the right of the UNGUATOR Q face you will find a panel with keys Esc and ok By operating the keys or you may move up and down the navigation bar Pressing ok you may select and confirm Pressing the Esc key you move back one step Additional options u Pic 3 Select display language and key sound Pressing the Esc key you will move from the Start Menu to the setting options Here you may change the background color of your display the operating language and acti vate or deactivate a key sound Changes in the language or in the color background might take a few seconds loading prior being activated After pressing the Esc key you will reach the Start Menu again You will find descriptions of the Start menu programs in the following chapter 6 3 Formulation programs 5 UNGUATOR Technology The UNGUATOR Technology reducesthe mechanical preparation offormulation ointments to the least common denominator The core of UNGUATOR Technology consists of the patented arrangement of the UNGUATOR Mixing B
7. be obtained for service repairs e UNGUATOR MBs UNGUATOR Jars and UNGUATOR Accessories are excluded from Cincunlon TECHNOLOGY warranty e The warranty claim will lapse should an unauthorized party have tempered with the device Damages caused by improper use as well as force majeure or other external influences are excluded from any warranty claims e The parts replaced at maintenance and repair will become property of GAKO e Claims beyond the free rectification of faults e g indemnification cannot be made within the warranty period e Repairs within warranty will be exclusively carried out by certified service partner 8 3 Notes on maintenance e To preserve gears and motor for continuous untroubled operation please contact your local UNGUATOR dealer after 20 000 preparations and 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 8 4 Notes on safety e UNGUATOR devices must only be connected to grounding type receptacles with 230V 50Hz 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 u
8. defined mixing time homogeneity for the total product inside the jar can be expected The UNGUATOR MB shall now be pushed out of the UNGUATOR jar lid The ointment still attached to the standard mixing blade can be scraped off the blades using a spatula When using the UNGUATOR disp bade the mixing blade can be removed from the UNGUATOR jar and discarded or left inside the jar Leaving the disposable blade inside the jar will have no adverse effects in any way Nevertheless removing the disposable mixing blade is recommended particularly when forwarding the ointment to elderly clients to prevent confusion The lid may now be screwed back onto the jar body and equipped with an UNGUATOR Varionozzle if required Then the little cap and or an UNGUATOR Applicator would be fastened loosely Large UNGUATOR jars will be equipped with the spindle or the AirDynamic System In any case similar to prior the mixing process air diminution should be repeated A squirting of the ointment when initially extracted may be prevented by eliminating cavities that may have developed during the mixing process The UNGUATOR lid and or the UNGUATOR Applicator may now be fastened in place A label may be attached prior forwarding to the client preferably together with a short illustration of how to use and operate the UNGUATOR jar and dispensing system The operator also might want to individually record the mixing parameters and results of
9. flow and no remedial work is generally 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 ensur
10. of the UNGUATOR Jar when it is filled For UNGUATOR Jars of 200ml 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 Q The UNGUATOR Q is the result of continuous improvements of the UNGUATOR Technology The integrated programmable software that automates the UNGUATOR Q Mixing System completely turns the device into a universal machine for the production of formulations The UNGUATOR Q works with two quiet high duty permanent motors and is an intelligent ointment mixing machine for formulation from 15 500ml You can work in the ranges of O to 2400 rpm and produce homogeneous formulations It is also possible to set intervals and the device gives you the opportunity to interrupt the formula manufacturing in a controlled manner After selecting a program and the size of the UNGUATOR Jar a microprocessor controls the mixing parameters for a consistent and reproducible product quality After the completion of each preparation the UNGUATOR Q automatically assigns an identification number It is used for simple documentation and the accurate reproduc tion of the mixing process and will appear on the display after the mixing process After selecting a program and the size of the UNGUATOR Jar a microprocessor controls the mixing parameters for
11. your local UNGUATOR dealer The UNGUATOR MB should not be pressed too deep in the UNGUATOR Jar thus the lifting arm can reach the bayonet For this reason we recommend that after screwing the UNGUATOR mixing unit on the UNGUATOR MB shaft should by manually drawn back to the jar lid Error The UNGUATOR jar cannot be screwed in the lifting arm because the shaft of the UNGUATOR MB seems to be too long Troubleshooting The UNGUATOR MB must be replaced with the appropriate UNGUATOR MB with the correct shaft length 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 Error The lifting arm is unintentionally moved with the hand too far from the starting position and the shaft is no longer aligned to the opening Troubleshooting The shaft can be moved by hand to the start position The shaft touches the hole and is lead into the opening Error The UNGUATOR MB does not penetrate completely in the mixture since the formula is to pasty firm or in powder form Troubleshooting The reverse power of the lifting arm is from 3 to 5kp intentionally low to avoid material damages For this reason the UNGUATOR Q registers the resistance and the return of the stroke direction To ensure the complete mixing of the recipe you can for example warm cold recipe substances in room temperature or assist pasty mixtures by hand Further help is u
12. 00ml and standard mixing blades for larger batches In preparation the entire ointment base should be weigh out inside the jar covering the bottom Then add the required amount of liquid or solution in room temperature In some cases you may experience difficulties emulsifying refrigerated bases In that case the process of emulsification can be accelerated by adding heated liquid Emulsion The Emulsion program allows you to accomplish prescription bases and creams from molten individual components with a cold mixing program being integrated e g preparation of DAC base cream or cold cream DAB To ensure a homogeneous processing we recommend applying disposable mixing blades for jar sizes up to 200ml and standard mixing blades for larger batches Since the UNGUATOR jars can be heated up to max 85 C 185 F in either water or microwave oven you may melt defined components of your formulation directly in the jar Do do so all components of the formulation including aqueous phase in the UNGUATOR jar and heat the complete formulation up in a microwave oven at low wattage and open cap Inspection should be done at regular and short time intervals using a thermometer in order to avoid overheating of the formulation In case the basis should not contain any water the components that are to be melted may be softened directly in the UNGUATOR jar on a water bath To support cooling off during the mixing process attaching a coo
13. ATOR 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 Weighing 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 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 ointment base on the UNGUATOR Jar Bottom is first carefully placed around the sealing lip This enhances the leak tightness
14. D will be lost appears This is a safety feature to optimize the power exposure for all material jars and mixing blades particularly when using larger UNGUATOR jars Proceed with the identification number by entering speed rpm and time mm ss for each step of the six possible mixing levels The time is specified in upper and lowercase letters whereas each letter is assigned to a specific time value ee SR Ip w Te fo fe ja fr e hee Mie E ea Fe a ee ee a Is Rc bh Tab 3 Letter Time correlation Set with or the desired time interval and confirm your selection with ok The input of rpm is defined with the numbers 0 9 each number assigned to a specific speed level Se es ee ee Tab 4 Number Rpm correlation un Set with or the desired rpm and confirm your selection with ok With this option you may define up to 6 mixing stages With Esc you may go back to the previous step and edit if necessary By confirming the final ID stage you also confirmed the completed identification number in total In case the entered identification number shows less than 6 mixing stages you may still conclude earlier To do this set the time to 0 using or after you defined your final mixing level Once you confirmed with pressing ok the remaining mixing level will automatically be set to 0 Another question regarding the desired jar si
15. Operating Instructions and Production Recommendations Uncumflor Q Cneuator 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 Menu guide 3 5 UNGUATOR Technology 4 5 1 UNGUATOR mixing machines 5 5 1 1 UNGUATOR B R 5 5 1 2 UNGUATOR e s 6 5 1 3 UNGUATOR 2100 6 5 1 4 UNGUATOR Q 7 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 AirDynamic Pumpball System 16 6 General guidelines for the UNGUATOR Technology 16 6 1 Preparing the UNGUATOR Mixing System 16 6 2 Weighing portion of the formulation 17 6 3 The mixing process 17 6 4 Formulation programs 18 6 4 1 Quick ID Start 18 6 4 2 Auto Q 21 6 4 3 Individual 22 6 4 4 Standard 21 6 4 5 Manual 26 6 5 Mixing time 27 6 6 Selecting the UNGUATOR Jar size 27 6 7 Condition of the ingredients for any formula 28 6 8 After the mixing process is complete 29 6 9 Identification number 30 6 10 Operating er
16. R jar and its content must be avoided at all times The cooling time and hence the cooling interval decreased in the refrigerator or by using a cooling jacket pad The UNGUATOR MB should remain in the UNGUATOR jar during the cooling phase Thermolabile substances Active ingredients or substances with thermolabile characteristics should be handled with caution To protect the substances we recommend a maximum 1500rpm Examine the formulation related to frictional heat that needs to be cooled with the help of a cooling jacket or cool down periods in a refrigerator if required 6 8 After the mixing process is complete The UNGUATOR Mixing System shall be released and removed from the UNGUATOR oscillation arm once the mixing process has been completed 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 in your 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 to execute a quality check the UNGUATOR jar lid should also be opened after mixing with UNGUATOR disposable blades Practice has proven that if the surface of the final ointment looks smooth complying with the minimum
17. TOR 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 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 ointment to 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 3 Quality assurance for 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 time period of one year or whenever needed you may repeat the test Use a prescription formulation with a colored substance e g iron oxide micronized or sudan red worked in a semi solid base You can spread out the finished mixture on a glass plate or a microscope slide and check the solids distribution
18. 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 Cneuator TECHNOLOGY Entnahme Vor Gebrauch amp Jar Preparation 2 amp z 3 2 bed gt 5 i B ES fue s i HH H 25 Dans 22 S HE 23 f s e22 ae 3 E B25 23 2 8282 Se je M 5 2 8 Ec CO e Es ge l FEF 5 3 c gt EB a5 Sags t Ex or Zonas ww J km a i at Pic 21 How to operate the UNGUATOR Spindle Pic 22 UNGUATOR Spindle 5 2 6 UNGUATOR Coupling The UNGUATOR Coupling connects two UNGUATOR Jars by the threads of their dispensing openings and is very useful when gt 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 the end user P The 200ml UNGUATOR Jar becomes a convenient transfer device to smaller UNGUATOR Jars when their UNGUATOR Jar bottoms
19. a consistent and reproducible product quality After the completion of each preparation the UNGUATOR Q automatically assigns an identification number It is used for simple documentation and the accurate reproduction of the mixing process and will appear on the display after the mixing process 6 4 Formulation programs 6 4 1 Quick ID Start In the program Quick ID Start you can quickly enter a defined or previously created mixing program using a certain identification ID code The program automatically transforms any mixing program to different jar sizes without recalculating them This scaling process is based on the original ID code in combination with the current jar size For this purpose enter a previously defined identification code e g a pre created or documented formulation Pic 25 Program Quick ID Start Ungunlor TECHNOLOGY The first number of the UNGUATOR identification code provides information about the jar size whereby each jar size is assigned to one of the following numbers Junguator Jar e de P e Jar in ml Tab 2 Number Jar size correlation Enter the specific UNGUATOR jar size you like to start with by pressing the and key confirming your selection with the ok key For jar sizes 100ml and greater the advice You have chosen a jar size which speed range is defined differently due to quality assurance reasons All previous settings of the I
20. agrams may also be helpful to weight out concentrated active substances or regular trituration from the UNGUATOR Jar 5 o 5 es s EN s m o oOo n m D ss Q oOo o n gt EEE 5 1 5 E r E j 4 a a t t us is 6 5 S Quantity of ointment in ml 5 Quantity of ointment in ml 5 Pic 14 Dispensing with regular 5 Pic 15 Dispensing with UNGUATOR 1mm UNGUATOR varionozzle amp varionozzle or UNGUATOR applicator short m ns nn TE _ a j Qe aa Quantity of ointment in ml Quantity of ointment in ml Pic 16 Dispensing with UNGUATOR Pic 17 Dispensing with UNGUATOR 2mm varionozzle or UNGUATOR varionozzles 4 mm applicator long Lenght of ointment rope in cm Lenght of ointment rope in cm 5 2 3 UNGUATOR Varionozzles The UNGUATOR Varionozzles with inner diameters of 1 2 or A mm can be pressed into the dispensing opening of the UNGUATOR jar lid They reduce the opening size making it possible to safely dose even low viscosity formulations Pic 18 UNGUATOR The viscosity of the finished product normally specifies the Varionozzles diameter of the UNGUATOR Varionozzles The softly rounded surface allows ointment to be pleasantly distributed on the skin 3 The coloring was selected corresponding to the wavelength of light e 4mm red long wavelength light e 2mm yellow e 1mm blue short wavelength light 5 2 4 UNGUATOR Applicators The UNGUATOR
21. and the grain particle 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 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 In any case of problems or damage of the device please also mind the manufacturer s notes on the machines metal foot 8 2 Manufacturer s service and warranty The manufacturer will accept independent from the obligations of the vendor against the buyer a warranty period of twenty four 24 months from the date of purchase Please retain the packaging material or request its replacement from your respective representative in your individual country please contact your local UNGUATOR dealer e Deficiencies that can be related to faults in the material or manufacturing defects will be remedied free of charge within the warranty period e The respective representative in your individual country please contact your UNGUATOR dealer must be informed of necessary warranty repairs A cost estimate can
22. are carefully pressed towards the work surface using an UNGUATOR Applicator long screwed on a 30 ml UNGUATOR Jar Fig 23 UNGUATOR 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 1000ml 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 Pumball 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 300ml to 1000ml 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 UNGUATOR Pic 24 UNGUATOR AirDynamic Jar using the pumball the pressure thus generated Pumpballsystem moves the bottom upward Thanks to the AirDynamic Pumball System even thick pastes can be dispensed via the small dispensing opening in the screw cap or transferre
23. aster dispersion of the welling agent in the base After each mixing performance the UNGUATOR Q will create an identification number ID code which contains all mixing parameters You will be prompted to either save record or reject them Saving the formulation allows you to also assign an individual name Rejecting the identification number would not allow the data being retrieved again and the information is lost The initial formulation and its parameters still remain If the mixing process has been interrupted the UNGUATOR Q does not create any identification number You may continue mixing on your own responsibility or starting the mixing process over 6 4 5 Manual The Manual program offers the option to mix a formulation without the automatic lift ing arm In this case the movement is executed manually by the operator With the Manual program you may start the process directly without retrieving any data from previously saved mixing programs To begin select the UNGUATOR jar size using the or key and enter with ok From jar size 100ml and greater the maximum rpm is restricted This is a safety feature to optimize the power exposure for all material jars and mixing blades particularly when using larger UNGUATOR jars Afterwards you may choose the initial mixing time with or The time is set to a maximum of 10 minutes to begin with Enter with ok At the next step
24. available from the company GAKO The UNGUATOR Mixing System with its versatile and comprehensive line products capti vates with its simplicity Everything the pharmacist needs for the preparation of pharma ceutical ointments and cosmetics is covered by the UNGUATOR Mixing System 7 2 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 UNGUA
25. bleshooting With cold emulsions the basis cream must cover the complete UNGUATOR Jar Bottom and along the lower jar wall until it is well distributed When you prepare large quantities of liquids for example the production of gels it is important to use the appropriate mixing program Those programs are constructed in order to avoid an excessive stirring speed and excess pressure on the UNGUATOR jar Error The sealing lip on the UNGUATOR jar bottom does not retain liquids during the emulsifying process Troubleshooting Please be aware that when setting up the UNGUATOR jar lid with the UNGUATOR mixing shaft the sealing lip is not damaged by the bayonets of the shaft Reduce the air prior the mixing process and use the appropriate mixing program Error The user failed to decrease 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 Troubleshooting Depending on the viscosity of the formula apply an UNGUATOR Varionozzle or UNGUATOR Applicator UNGUATOR Q Error The UNGUATOR Q does not mix and the lifting arm only moves up and down Troubleshooting The mixing motor of the UNGUATOR Qis overloaded Reducethe rotation speed with the key until the mixing motor restarts Overloading of the mixing motor can be avoided by using solid or stored room temperature base ointme
26. d 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 Cncualon TECHNOLOGY 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 mixing process Third the UNGUATOR MB is carefully removed from the UNGUATOR Jar and the UNGU
27. e 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 the UNGUATOR Q in for service display Esc button to exit or abort a program button to select button to select lifting arm power plug main power switch emergency off Pic 1 UNGUATOR Q Cneuator TECHNOLOGY 2 Initial Operation On the back of the UNGUATOR Q you will find the interface for the power cord The power switch O I is also the emergency switch and it is located at the base of the machine on the right side Initially check if the power switch of the Unguator is switched off Second connect the power cable to the device and finally connect the power cable to the outlet Now you can turn the power switch of the UNGUATOR QMS on using the I O The device is ready to be used During cold weather condition plan in advance 30 minutes to allow the UNGUATOR Q to acclimate 3 Display operation The face of the UNGUATOR Q device shows both a panel with four keys Esc ok for manual control or command input and a display screen After turning the UNGUATOR Q on pressing the main power switch a splash screen appears on the display
28. e no loss of active ingredients Used as a dispensing jar the UNGUATOR Jar corresponds to the guidelines for quality assurance from the German Chamber of Pharmacists Apothekerkammer Uncuaton TECHNOLOGY 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 Pic 12 UNGUATOR Jar 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 mi 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
29. each final product validation 6 9 Identification Number The 13 digit identification number ID code to clearly identify each preparation has the fol lowing format E SS Please enter the D code B o5 05 D5 o5 os os sire of the ID Pic 27 Identification number The first number of the UNGUATOR identification code provides information about the jar size whereby each jar size is assigned to one of the following numbers UNGUA 1 2 3 5 7 TOR jar Tab 7 Number Jar size correlation As from the second position the mixing time and the rotation speed in 6 mixing stages are represented The time specification is represented with large and lowercase letters in which each letter correlates to a defined time value Uncuaton TECHNOLOGY CC CO CH CO CO CC 6 oso oss ors ors om oss ou os oso os ao HC CC CH CH CH a ER CI U 02 20 02 30 02 40 02 50 03 00 03 10 03 20 03 30 03 40 03 50 04 00 04 20 04 40 05 00 05 20 05 40 06 00 06 25 06 50 07 15 07 40 08 05 08 30 09 00 09 30 10 00 Tab 8 Letter Time correlation The input of the rpm is assigned to the numbers 0 9 in which each number correlates to a defined rpm value evei jo a 2 da Js Is 7 fe fs rom o 600 00 1000 a200 1200 1650 2900 2150 2200 Tab 9 Number Rpm correlation 6 10 Operating errors The quality assurance system of the UNGUATOR Q makes sure that operating errors shall be sensitively registered and dis
30. ectly without retrieving a previously saved mixing program Select with or the specified UNGUATOR jar size and confirm with ok From a jar size 100ml and greater the maximum rpm is restricted This is a safety feature to optimize the power exposure for all material jars and mixing blades particularly when using larger jars Afterwards you may choose the initial mixing time with or The time is set to a maximum of 10 minutes to begin with Enter with ok At the next step you may enter the initial mixing speed rpm With ok you may confirm your selection and the mixing process begins During the mixing process you may modify the mixing time if needed with pushing the or key With ok you can also move to the rpm setting The speed may also be adjusted with or As soon as the new rpm would not be changed for more than 3 seconds the new speed level will automatically become effective and the mixing process will be adjusted accordingly An additional mixing level will be started After pushing ok you may go back to the time setting again According to this procedure it is possible to save 6 different mixing levels Since each of the 6 mixing level can be max 10 minutes long the total mixing time is 60 minutes After each completed mixing process the UNGUATOR Q generates an identification number which contains all mixing parameters You have the oppo
31. end of the shaft 15 100 ml and 200 ml respectively Assignment of the UNGUATOR MB Please take care to use the correct UNGUATOR SMB for the corresponding UNGUATOR Jar see Pic 8 Selecting the wrong shaft blade may cause problems and failure messages Please also ensure that the right shaft is used when working with the UNGUATOR Disp Blade Both available shafts are marked for use with sizes 15 100ml or 200ml in the UNGUATOR Jar They have to be combined with the correct UNGUATOR Disp Blade and while the same UNGUATOR Disp Blade is used for the 100 and 200ml UNGUATOR Jar sizes it still needs a different shaft for each See also the operating instructions that come with the disposable blade shafts 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
32. ension 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 UNGUATOR Disp Blade is connected to the UNGUATOR Disp Blade shaft by twisting the blade counterclockwise and can be disconnected after the mixing process i with a clockwise turn 4 ee 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 a intensive material vibration in the material to be mixed and achieves EI good product quality faster than using the UNGUATOR SMB We gt gt do however recommend using the same mixing time as for the SS UNGUATOR SMB Unlock Fig 9 UNGUATOR disposable blade Pic 10 Handling the UNGUATOR disp blade In the process of final quality control the mixing blade can be picked Cneuator TECHNOLOGY 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 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
33. ents 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 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 that may be individually saved The UNGUATOR 2100 can be connected to a PC via USB interface An integrated microprocessor measures the actual revolutions of the UNGUATOR Mixing Blade carried out by Pic 6 UNGUATOR 2100 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 formulations cosmetics etc using the UNGUATOR 2100 since only the composition would change but not the mixing program As a result ointments can now finally be reliably reproduced even 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 Cncunlon TECHNOLOGY the UNGUATOR Mixing Blade to rotate at lower speed while the UNGUATOR Jar quickly travels up and down and vice v
34. ersa 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 of the UNGUATOR Q is the possibility of scaling one mixing program already created automatically to another jar size This enables a constant quality of the formulations and as a consequence has a tremendous time saving result Pic 7 UNGUATOR Q since recalculation can be very time consuming and complex 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 Pumpball System All UNGUATOR products are compatible with all currently available UNGUATOR Mixing devices 5 2 1 UNGUATOR Mixing Blade MB
35. lade 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 Uncuatorn TECHNOLOGY 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 by defined service partners Product quality product uniformity and reproducibility of ointments prepared individually and in batches were improved with the increasing automation of
36. light yellow light blue and turquoise Furthermore UNGUATOR Jars from 20 to 200 ml are available with special colors lids green blue and white Upon special demand and defined quantity UNGUATOR Jars from 20 to 200ml may also be ordered in customized colors 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 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 re
37. ling jacket pad on the outside of the jar for smaller jar sizes or repeating the mixing process for larger jar sizes might be applicable Normal soft in soft The Normal and or soft in soft S S program may be applied to mix semi solid substances in the range of low viscosity to pasty e g incorporation of formulation concenrates in bases or mixing two bases To ensure a homogeneous processing you may use UNGUATOR standard or disposable mixing blades You may first start with 50 of ointment base and weigh the required substance on top Afterwards cover the substance with the remaining base At a jar size 200ml or greater you may also implement multiple layering in order to ensure a faster mixing of the final formulation Suspension lt 2 After a pregrinding process has been completet the Suspension lt 2 program gives you the opportunity to finalize the formulation with ointment base Suspension gt 2 Selecting the Suspension gt 2 program you may incorporate solids with a content gt 2 homogeneously in an ointment base e g incorporation of zinc oxide salicylic acid or bismuth gallate in ointment base Cncunlon TECHNOLOGY To ensure a homogeneous processing we recommend applying a standard mixing blades For suspensions with an active ingredient content of more than 2 a pregrinding process is not required You may initially load the jar with approx 50 of the required ointment base
38. mortar prior adding to 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 while mixing e g urea in water Then the remaining formulation ingredients can be added Crystalline substances may also dissolve during the mixing process if the solvent is an ingredient of the ointment base Components to be melt Components that have been weigh out to fuse may be placed inside an UNGUATOR jar douse with heated aqueous or oily phases of you formualtion constituents lt 85 C 185 F to melt the content in full In case this process does not sufficiently melt all constituents the formulation inside an UNGUATOR jar might be heated in a warm water bath lt 85 C 185 F or carefully observed in a microwave oven In order to ovoid overpressure please mind having the white cap on the lid removed Formulations without water containing components may be melted already directly inside the UNGUATOR Jar by placing the jar in a warm water bath Please be aware that UNGUATOR MB s must not go in the microwave oven Furthermore due to irregular mixing of adipose and water phases reaching the melting point might happen with a delay since only aqueous parts can be heated in a microwave oven Cncunlon TECHNOLOGY Please urgently mind the operation manual of your microwave oven An excessive temperature rise for both UNGUATO
39. nder 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 conditions Heed the relevant safety regulations when handling hazardous substances e g combustible liquids such as alcohol or similar substances e UNGUATOR devices cor
40. nt or by reducing the starting speed 6 11 Cleaning the UNGUATOR Q Always unplug the UNGUATOR Q from the wall outlet before performing a cleaning Do not use aggressive cleaning agents or abrasive cleaners For cleaning we recommend daily wiping the surface with a damp cloth with mild detergent and immediately drying it with a dry cloth For disinfecting the display can be lightly sprayed and wiped with isopropanol 70 Make sure that no liquid enters the device If liquid enters the interior of the UNGUATOR Q keep the device turned off and inform customer service An unauthorized opening of the UNGUATOR Q device is not recommended 7 General recommendations for 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 UNGUATOR Technology and the AirDynamic Pumpball System integrated therein are inventions of the German pharmacist Albrecht Konietzko Bamberg Germany The UNGUATOR Technology and the AirDynamic Pumpball Cncunlon TECHNOLOGY System are patented in selected countries UNGUATOR and AirDynamic are registered trademarks exclusively
41. peated 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 11 94 All plastic materials which come into contact with food are manufactured according to the legal requirements of the EU plastic regulation N 10 2011 and N 1935 2004 version 01 2013 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 affixed to the plastic packaging of the UNGUATOR Jars It may be removed from the plastic packaging as needed and added to the records 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 Verp Vorschrift DK 11 94 Examined acc to central lab pack regul DK 11 94 Lichtdurchl ssigkeit Opaqueness 0K Partikelgehalt Particle Concentration Farbbestandigkeit Color Fastness Dichtigkeit Seal Integrity Mikrobiologie Microbiology gez signed G
42. played If a problem occurs the display will show the following error message Mixing tool not locked in place Lifting motor overload and Mixing motor overload If necessary switch off the device after an operating error The UNGUATOR Q device will generally function normally again after remedy Irreversible software faults caused by current transients or strong electromagnetic fields in the vicinity can only be remedied by authorized customer service points For functionally testing reasons the UNGUATOR Q has to be switched off first The device can be switched on again after 20 seconds Please make sure that no UNGUATOR MB is attached to the device during start up or rebooting process We recommend changing the UNGUATOR jar size for the initial functionality testing process and e g running a mixing process with a filled UNGUATOR jar size 30 or 50ml Please contact your local UNGUATOR dealer for any malfunctions that cannot be remedied using above information to troubleshoot UNGUATOR Mixing blades MB The UNGUATOR Q has been tested with the UNGUATOR MB s that were initially enclosed centered and aligned All UNGUATOR MB s delivered after the year 1996 are compatible with the UNGUATOR Q Please do not use any bent or damaged UNGUATOR MB Other UNGUATOR MB used rather than the ones supplied with the UNGUATOR Q may cause problems of coupling If this is the case we recommend contacting
43. respond 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 9 Technical data of the UNGUATOR Q wow zow som in 10 stages electronically controlled A Tab 10 Technical data of the UNGUATOR Q Cincunlon TECHNOLOGY 10 Manufacturer s certificate Declaration of Conformity for plastic materials which come into contact with food UNGUATOR Jar cap Polypropylene natural oly 2 UNGUATOR Jar lid Polypropylene natural red white green blue UNGUATOR Jar body Polypropylene natural 1 The licensed manufacturer SMS UNGUATOR Jar bottom Polypropylene ELAP GmbH amp Co KG D 98544 Zel Polyethylene la Mehlis is DIN EN ISO 9001 2000 UNGUATOR Jar bottom cap Polypropylene natural i i certified Further UNGUATOR line items 2 Declarations of conformity for UNGUATOR Spindle Polypropylene natural j materials and color concentrates of the materials vendors are UNeukroRe Ana FR 5 Re 7 deposited at the licensed icator long wi ro ene natura Pi 5 i a oly i o p UNGUATOR Aplicator short with olypropylene natural cap UNGUATOR Coupling Polypropylene natural o UNGUATOR Varionozzle blue Polypropylene natural yellow pink UNGUATOR Disp
44. rieser head of quality assurance GAKO Konietzko GmbH www unguator com Plc 13 Certificate of Analysis for the UNGUATOR jar of 50 ml Notes on Dispensing Ointment Each customer should be given specific instructions at how to apply the UNGUATOR Jars when handing to the individual client The use of the UNGUATOR Spindle should be explained for large UNGUATOR Jars 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 Cneuator TECHNOLOGY diameter to 4 2 or 1 mm The approximate values represented in the following di
45. rm in start position for the Manual mixing program 26 Pic 27 Identification Number 30 Tables Tab 1 Quality improvement with increasing automation 5 Tab 2 Number Jar size correlation 19 Tab 3 Letter Time correlation 19 Tab 4 Number Rpm correlation 20 Tab 5 Minimum values for mixing time at 2150 rpm in min s 27 Tab 6 Minimum values for mixing time at 1650 rpm in min s 27 Tab 7 Number lar size correlation 30 Tab 8 Letter Time correlation 31 Tab 9 Number Rpm correlation 31 Tab 10 Technical data of the UNGUATOR Q 38 Cncunlon TECHNOLOGY 1 Installation information Select a suitable location for the UNGUATOR Q CAUTION The UNGUATOR Q weighs almost 30 Ibs 16 5 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 Q This must include sufficient space around the UNGUATOR Q to provide proper ventilation Select a proper 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 Q mixing device e Power cable e Operating instructions Please contact your responsibl
46. rors 31 6 11 Cleaning the UNGUATOR Q 34 Cincunlon TECHNOLOGY 7 General notes on the UNGUATOR Mixing System 34 7 1 Patent protection 34 7 2 Potential sources of nonconformances 35 7 3 Quality assurance of the ointments 36 8 Service and warranty 36 8 1 Notes on malfunctions 36 8 2 Manufacturer s service and warranty 36 8 3 Notes on maintenance 37 8 4 Notes on safety 37 9 Technical data of the UNGUATOR Q 38 10 Manufacturer s certificate 39 11 Distribution manufacturing and customer service 40 Pictures Pic 1 UNGUATOR Q 2 Pic 2 Display with start image 3 Pic 3 Select menu display language and key tones 4 Pic 4 UNGUATOR B R 5 Pic 5 UNGUATOR e s 6 Pic 6 UNGUATOR 2100 6 Pic 7 UNGUATOR Q 7 Pic 8 UNGUATOR SMB 8 Pic 9 UNGUATOR disposable blade 8 Pic 10 Handling the UNGUATOR disp blade 8 Pic 11 Assignment of the UNGUATOR SMB with different length of shaft 9 Pic 12 UNGUATOR Jars 11 Pic 13 Certificate of analysis for the UNGUATOR Jar of 50ml 12 Pic 14 Dispensing with regular UNGUATOR varionozzle 13 Pic 15 Dispensing with UNGUATOR 1mm varionozzle or UNGUATOR applicator short 13 Pic 16 Dispensing with UNGUATOR 2mm varionozzle or UNGUATOR applicator long 13 Pic 17 Dispensing with UNGUATOR varionozzles 4 mm 13 Pic 18 UNGUATOR Varionozzles 13 Pic 19 UNGUATOR Applicator short 14 Pic 25 Program Quick ID Start 18 Pic 26 Lifting a
47. rtunity to save record or reject the number Saving the formulation enables you to individually name it Rejecting the identification number would not allow the data being retrieved again and the information is lost In case more than 6 mixing levels have been entered or if the mixing process was interrupted for any reason the UNGUATOR Q does not create an identification number You may continue mixing on your own responsibility or starting the mixing process over 6 4 3 Individual The archive of the individually created and previously saved mixing programs is listed in the Individual program With or you may browse a list in alphabetical order and enter your selection with ok At the next step you may define your jar sizes with or entering with ok The UNGUATOR Q scales and adjusts all previously entered mixing parameters automatically for the selected jar size Scaling is limited to min 5 seconds and max 10 minutes for each mixing level Hence smaller or greater time intervals cannot be processed Please note As a professional user you are responsible for the quality of the final formulation Please always check the quality of the final product prior delivering to the client After each completed mixing process the UNGUATOR Q generates an identification number which contains all mixing parameters You have the opportunity to save record or reject the number Saving the form
48. stribution of the active ingredient in an ointment base Cncunlon TECHNOLOGY As an example incorporation of corticoids antibiotics fungicides or hormones in an ointment base In order to ensure a homogeneous processing we recommend using the UNGUATOR standard mixing blade First load approximately 30 of the defined ointment base in the UNGUATOR jar embedding the micronized agents afterwards The agent has to be integrated in the ointment base in order to avoid powder residue sticking on the blade The movable bottom shall remain at the lowest position during the pregrinding process in order to utilize the complete inner wall of the UNGUATOR jar as grinding surface Please inspect the preparation for agglomerates or qualitative abnormalities after the grinding process is completed If required the pregrinding process may be repeated After the pregrinding process has been completet additional components of the formulation can be added and the ointment base may fill up the jar to the desired volume Any additional processing of the prescription should be prepared according to the galenic nature of the composition Emulsion The Emulsion program offers the opportunity to incorporate liquids at room temperature in water absorbing bases e g preparation of hydrous hydrophilic or hydrous wool wax alcohol ointment To ensure a homogeneous processing we recommend applying disposable mixing blades for jar sizes up to 2
49. sually no longer necessary UNGUATOR Jar Error The jar connected to the UNGUATOR Q is not an UNGUATOR jar Troubleshooting The jar has to be substituted for an UNGUATOR jar Cncunlon TECHNOLOGY Error The UNGUATOR jar lid is wrongly screwed on the UNGUATOR jar and the UNGUATOR MB tilted at automatic hub Troubleshooting The UNGUATOR jar should be unscrewed and correctly screwed together Error The UNGUATOR jar bottom was not pressed fully down to the stop position prior to weighing out or filling Troubleshooting Particularly lite components are not going to be accommodate in the Error The user failed to decrease air again or to mount a UNGUATOR Varionozzle or UN GUATOR 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 Solution Depending on the viscosity of the formula mount the UNGUATOR Jar with a UNGUATOR Varionozzle or Applicator Error The air was not removed from the jar prior mixing semisolid preparations Troubleshooting 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 Error In formulations with a large amount of liquid components and cold emulsions the UNGUATOR jar bottom does not retain liquids during the emulsifying process Trou
50. t a signature 11 Distribution manufacturing and customer service GAKO Konietzko GmbH Oberer Stephansberg 49g 96049 Bamberg Germany GA Phone 49 0 951 582 55 Fax 49 0 951 500 602 Email kontakt gako de Website www unguator com GAKO International GmbH Dantestra e 27 D 80637 Munich ga ko International Phone 49 0 89 15 88 16 88 Fax 49 0 89 15 88 14 85 Email contact unguator com Website www unguator com 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 UNGUATOR amp om
51. 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 Mortar and Per pestle UNGUATOR unguaror a Er Totally automatic 2100 Tab 1 Quality improvement with increasing automation 5 1 1 UNGUATOR B R The UNGUATOR B R is the basic machine with controlled mixing motor and manual jar guidance Pic 4 UNGUATOR B R 5 1 2 UNGUATOR e s 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 Pic 5 UNGUATOR e s 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 lost at the bottom The lifting technique of the UNGUATOR Mixing System prev
52. ulation enables you to individually name it Rejecting the identification number would not allow the data being retrieved again and the information is lost If the mixing process has been interrupted the UNGUATOR Q does not generate any identification number You may continue mixing on your own responsibility or starting the mixing process over If you wish to modify or edit any individual formulation select the defined formulation with or and press down the ok key for min 3 seconds You may then adjust and modify the formulation To save it please press down the ok key again for min 3 seconds To delete any individual formulation select the defined formulation with or and press down the ESC key for min 3 seconds You may now delete the defined formulation To verify a security inquiry will appear which you may accept or reject 6 4 4 Standard The Standard program allows you to choose from a list of standard mixing programs based on the galenic administration of the particular formulation to be manufactured With or you may browse the list of programs and enter with ok At the next step un you are prompted to define the jar sizes with or which you enter with ok Pregrinding program The pregrinding program serves to moisten solids in the preparation of suspensions with an active substance content lt 2 allowing a homogeneous di
53. you may enter the initial mixing speed rpm With ok you may confirm your selection and the electronic mixing arm moves in the lowest position in order to lifting can be manually handled The prepared mixing unit and or mixing blade shaft may now be attached to the bayonet slot The guiding hand of the operating person shall simultaneously cover both the jar lid and jar body tightly prior starting the mixing process by entering the ok key The UNGUATOR mixing unit shall now be evenly and at a moderate rate moved up and down all the way from the bottom to the top of the jar lid and vice versa During the mixing process you may modify the mixing time if needed by pushing the or key With ok you may also move to the rpm setting The speed may also be adjusted with or After pushing ok you may go back to the time setting again Pic 26 Lifting arm Due to the possibility of handling the jar manually the Manual in start position for program does not create any identification number after the the Manual mixing mixing process has been completed al Cncunlon TECHNOLOGY For any UNGUATOR jar size 200ml or greater we recommend choosing one of the programs that would apply an automatic stroke That way you prevent any potential jam or damage of the material involved 6 5 Mixing Time When creating an individual mixing operation with either one of the programs Auto Q or
54. ze will appear If you wish to prepare the same jar size with the entered identification number again confirm the proposed jar size with ok If you have entered an identification number for a specific jar size but would like to prepare a formulation with a different size enter the actual jar size with or and confirm with ok The UNGUATOR Q now automatically scales all previously entered mixing parameters adjusted for the actual jar size Scaling is limited to a minimum of 5 seconds and maximum 10 minutes for each mixing level Hence smaller or greater time intervals cannot be processed Please note As a professional user you are responsible for the quality of the final formulation Please always check the quality of the final product prior delivering to the client After each completed mixing process the UNGUATOR Q generates an identification number which contains all mixing parameters You have the opportunity to save record or reject the number Saving the formulation enables you to individually name it Rejecting the identification number would not allow the data being retrieved again and the information is lost If the mixing process has been interrupted the UNGUATOR Q does not create any identification number You may continue mixing on your own responsibility or starting the mixing process over Cincunlon TECHNOLOGY 6 4 2 Auto Q With the program Auto Q you may begin a mixing process dir
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