Microbial Air Sampling
Contents
1. Item Instrument RCS High Flow Microbial Air Sampler High performance instrument for multiple sample volumes up to 1 999 liters and a flow rate of 100 L min includes two rechargeable 9 6 V Ni Cd batteries rotor protection cap RCS Management Software serial cable and carry case contains a Bluetooth module for wireless data transmission of sample data to an external PC Accessories Universal Rapid Battery Charger For rapid charging of 9 6 V and 7 2 V Ni Cd batteries 220 V EU compatible with RCS Plus 110 V US 9 6 V Ni Cd Battery Ni Cd replacement battery for uninterrupted use of the RCS High Flow Microbial Air Sampler Battery Discharger For complete discharging of the residual capacity of 9 6 V and 7 2 V batteries reconditions and prevents battery memory effects compatible with RCS Plus Power Supply For continuous operation of RCS High Flow 230 240 V EU 110 V US Tripod For convenient use of the RCS High Flow at heights up to three meters compatible with RCS Plus Table top Tripod For horizontal operation of the RCS High Flow Microbial Air Sampler on smooth surfaces to minimize vibrations compatible with RCS Isolator and RCS Plus Table top Stand for RCS High Flow For vertical use of the RCS High Flow prevents accidental damage RCS Compressed Gas Adapter Autoclavable adapter for use of the RCS High Flow to monitor microorganisms in compressed gasses designed for pressure of 1 bar co2. Biotest From Nature for Life Biotest Microbiology Product List HYCON RCS Microbial Air Sampler 2010 HYCON Agar Strips and Contact Slides HYCON APC Airborne Particle Counters Biotest Molecular Microbiology MMB Service Repair and Calibration Certificate No ane This is to certify that GBU Global Business Unit Mikrobiologie der Biotest AG with the sites n Braun Str 9 Landsteinerstr 5 69214 Eppelheim Germany Wernher vo many conform to the Management ISO 9001 2008 63303 Dreieich Ger has been found to System Standard he following product or service ranges This certificate is valid for Development production and sales of culture media instruments and molecular biological test systems for hygiene control and microbiological testing Initial Certification date Place and date 21 07 2009 Essen 21 07 2009 This certificate is valid until r the Accredit ed Unit j 20 07 2012 DNV ZERTIFZIERUNG UND UMWELTGUTACHTER GwaH The audit has been performed under the Nik aus Ki supervision of 1s Hatzfeld al Management Representative Dr Beatrix Miche Lead Auditor Lack of fulfilment of conditions as set oul in in the Certification Agreement may render th js Certificate invalid DNV Zertifizierung und Umweltgutachler GmbH aaa 14 45329 Essen 1t Tel 49 201 7296 300 Fax 49 201 7206 333 www dn de zer fizierung Biotest is a pharmaceutical biotherapeutic and industrial m
3. and growth supplements Selective Agar Media B Sheep Blood Agar for determination of total count of fastidious and pathogenic microorganisms YM Rose Bengal Agar with streptomycin and chloramphenicol for determination of yeasts and molds with growth supplements SDX Sabouraud Dextrose Agar with modified Pharmacopeia formulation for determination of yeasts and molds with neutralizers Tween 80 L a Phosphatidylcholine and growth supplements Item No 931 250 020 931 250 100 931 255 020 931 255 100 931 256 020 931 256 100 931 296 100 931 291 100 931 260 020 931 280 020 931 284 020 931 284 100 Surface Sampling Package size 20 100 20 100 20 100 100 100 20 20 20 11 Surface Sampling HYCON Contact Slides agar media for microbial surface monitoring in flexible foil individually packaged 25 cm Item Item No Package size SDX y Gamma irradiated Sabouraud Dextrose Agar with modified Pharmacopeia formulation double wrapped for determination of yeasts and molds in aseptic environments with neutralizers Tween 80 L a Phosphatidylcholine and growth supplements 931 285 020 20 C MacConkey Agar for determination of coliform bacteria with growth supplements 931 270 020 20 Accessories Blank Strip Kit Sterile empty strips for manual production of culture media for special applications 931 200 020 20 Incubation Rack for Contact Slides 940 946 1 Safet
4. No MMB Bacteria Prep Kit 100 preparations 944 501 MMB Salmonella Prep Kit 100 preparations 944 505 MMB Campylobacter Prep Kit 100 preparations 944 511 MMB Listeria Prep Kit 100 preparations 944 515 MMB E coli Prep Kit 100 preparations 944 521 MMB DNA RNA Virus Prep Kit 100 preparations XXX XXX MMB Food Pathogen Detection Kits for real time PCR detection MMB Food Pathogen Detection Kits use the principle of real time PCR as a very sensitive and specific detection method The internal amplification control leads to reliable results The kits conform to methods according to 64 LFGB and the corresponding ISO EN DIN standards MMB Salmonella V Kit 100 reactions 944 0n MMB Salmonella R Kit 100 reactions 944 012 MMB Salmonella LC Kit 100 reactions 944 013 MMB Campylobacter V Kit 100 reactions 944 021 MMB Campylobacter R Kit 100 reactions 944 022 MMB Campylobacter LC Kit 100 reactions 944 O23 MMB Listeria monocytogenes V Kit 100 reactions 944 031 Molecular Microbiology MMB Food Pathogen System Item MMB Listeria monocytogenes R Kit 100 reactions MMB Listeria monocytogenes LC Kit 100 reactions MMB Listeria Screening V Kit 100 reactions MMB STEC Screening V Kit 100 reactions MMB STEC Screening R Kit 100 reactions MMB STEC Screening LC Kit 100 reactions MMB Staphylococcus aureus V Kit 100 reactions MMB Vibrio cholerae V Kit 100 reactions MMB Legionella pneumoph
5. 0 um e Aluminum housing Built in thermal printer e Calculations according to ISO 14644 and FS 209 E Touchscreen display e Meets JIS standards User defined warning signals Includes power supply internal battery isokinetic probe sample tubing table top tripod RS 232 interface cable APCOne Data Download Utility Software CD operation manual CD Accessories FMS Facility Monitoring System To control a network of particle counters compatible with APC M3 and Handheld models HYTREL Tubing for remote sampling per meter Serial Cable RS 232 3 m for serial number as of xxxx 0999 Purge Filter Assembly for APC Portable Table top Tripod Thermal Printer Paper 5 rolls Isokinetic Probe 28 3 l min Isokinetic Probe for HEPA filter testing 28 3 L min Carrying Case With wheels and handle APC Compressed Gas Adapter Compatible with all APC models Nozzle Set for APC Compressed Gas Adapter 28 3 L min APCOnen Download Utility Software Compatible with 21 CFR Part n including Download Utility Software CD APCOnen security dongle APCOnen Validation handbook APCOnen Security Dongle APCOnen Download Utility Software APC Portable Oualification Handbook For performing complete IO OO and PO of APC Portable Airborne Particle Counter available in German and English 20 200 5 5 8 80 0 0 08 e LLL Item No 942 400 942 017 190 605 190 200 942 426 190595 942 110 000 942 439 191
6. 3 Miscellaneous Service Repair and Calibration Item HYCON RCS Microbial Air Samplers Calibration RCS High Flow RCS Isolator RCS Plus Ex RCS Standard Calibration Anemometer Hourly Rate for Service and Repair HYCON APC Particle Counter Calibration APC M3 APC Portable Calibration APC ErgoTouch APC ErgoTouch Pro APC Handheld Calibration Sensor for temperature and relative humidity Calibration Air velocity sampling probe Calibration Differential pressure sensor Hourly Rate for Service and Repair Special Service Shipping only within Germany Qualification Service RCS High Flow APC M3 APC ErgoTouch Pro APC Handheld APC Portable Item No 940 006 940 007 940 001 942 981 942 982 1 5 hours 1 5 hours 1 5 hours 940 001 upon request Contact Customer Service Biotest AG Landsteinerstralse 5 63303 Dreieich Germany E mail mail biotest de Technical Support Biotest AG Technology Center Microbiology Wernher von Braun Straf e 9 69214 Eppelheim Germany E mail hycon biotest de Service Repair Calibration Biotest AG Technology Center Microbiology Wernher von Braun Straf e 9 69214 Eppelheim Germany E mail hyconservice biotest de Phone Phone Fax Fax Phone Fax Phone Fax o 800 9425626 only within Germany 49 0 6103 801496 o 800 9978000 only within Germany 49 0 6103 801505 49 0 6221726 5130 49 0 6221726 513
7. 522 942 456 000 if li it 942 675 L at 942 665 1 942 700 942 162 942 701 942 407 Molecular Microbiology MMB Food Pathogen System The MMB Food Pathogen System is designed for fast and reliable real time PCR detection of food pathogens It consist of a preparation kit for isolation of nucleic acids and a real time PCR kit The fail safe analysis of bacterial cultures pre enrichment or food samples can be done within a few hours PCR kits are available for all common real time PCR instruments using the FAM channel 522 nm for detection of the pathogen specific probe and device specific detection channels for the internal amplification control Instruments Instrument VIC V ROX R LC F2 553 nm 602 nm 640 nm Applied Biosystems ABI 7000 7300 7500 7700 7900 SDS StepOne X BioRad iCycler X BioRad iO5 x Roche LightCycler 1 5 X Roche LightCycler 2 0 X Roche LightCycler 480 X Eppendorf ep realplex X Eppendorf ep realplex X Stratagene MxSeries X OIAGEN Rotor Gene O former Corbett Research RotorGene x MMB Food Pathogen Prep Kits for the isolation of bacterial or viral DNA MMB Food Pathogen Prep Kits are optimized for DNA purification from bacterial cultures or food samples pre enrichment The isolated DNA is ready to use for a detection reaction with a suitable MMB Food Pathogen Detection Kit High efficiency yields of quality DNA guarantee highest sensivity and accurate results Item Item
8. 9 49 0 6221726 5141 49 0 6221726 5149 Miscellaneous Miscellaneous Biotest AG General Terms and Conditions 1 Scope of Application and Definitions 1 1 The Biotest General Terms and Conditions Terms and Conditions shall govern all interactions and transactions between Biotest and the customer the two parties These Terms and Conditions therefore shall also apply to all future transactions and interactions between the two parties wi thout explicitly entering into any additional agreements These Terms and Conditions shall be deemed accepted upon the receipt of our goods and or services at the latest Any unilateral conditions such as but not limited to will not be accepted by Biotest 1 2 Any changes to these Terms and Conditions must be confirmed by Bio test in writing 6 6 1 3 The words us our ours shall mean Biotest the words you your yours shall mean the customer 2 Validity of Contracts 2 1 Any offers contained in brochures advertisements price lists etc are without any commitment and subject to change without notice including but not limited to price quotations Any samples illustrations etc as well as all details of the performance data shall only be binding if expressly specified We will be bound by individual offers for the period specified in the offer or if not specified therein for a period of 30 calendar days 2 2 Each order must be con
9. 9 5 6 Stainless steel 942 284 P36050 5O Oe 6 Aluminum 942 286 P56050 S 5O O 5 0 3 6 Stainless steel 942 288 P56050 5O O 5 0 3 6 Aluminum 942 290 P52050 S 50 OG 2 Stainless steel 942 292 P52050 50 0 5 2 Aluminum 942 294 additional charge for o 3 uim sensitivity of model P56xxx Item Item No Accessories FMS Facility Monitoring System To control a network of particle counters compatible with APC Handheld and Portable models 942 O17 Serial Interface Cable RS 232 3 m compatible with APC Portable 190 200 USB Schnittstellenkabel 191550 13 Airborne Particle Counting HYCON APC M3 Airborne Particle Counter Item Sample Tubing Per meter Table top Tripod For isokinetic probe Thermal Printer Paper 5 rolls for APC M3 series Lithium lon Battery 14 4 V External Battery Charger Isokinetic Probe 100 L min Isokinetic Probe 75 L min Isokinetic Probe 50 L min Isokinetic Probe for HEPA filter testing 100 L min Temperature and Relative Humidity Sensor Air Velocity Probe Differential Pressure Sensor Carrying Case With wheels and handle Purge Filter Assembly APC Compressed Gas Adapter Compatible with all APCs Nozzle Set for APC Compressed Gas Adapter 100 L min Nozzle Set for APC Compressed Gas Adapter 75 L min Nozzle Set for APC Compressed Gas Adapter 50 L min APCOnen Download Utility Software Compatible with 21CFR Part 11 including Download Utility Software CD APCOnen security dongle APCOnen validat
10. CON RCS Standard Microbial Air Sampler Item Item No Instrument RCS Standard Microbial Air Sampler Instrument for use in unclassified areas multiple sample volumes up to 320 liters and a separation volume of 40 L min including four D batteries plastic protection cap and carrying case 940 O15 Accessories Power Supply 110 230 240 V For continuous operation of the RCS Standard 940 042 Tripod For convenient use of the RCS Standard at heights up to three meters compatible with RCS Isolator 940 030 Infrared Remote Control Only for RCS Standard with serial number as of 25000 compatible with RCS Plus with serial number greater than 4999 940 341 Replacement Impeller Drum matte 940 511 Replacement Impeller Blade 940 500 Floor Plate For use of RCS Standard in an upright position 942 020 Sterile Sleeves 10 pieces for covering the RCS Standard to protect against cross contamination 940 O50 Calibration Set For verifying and correcting the angle of the Impeller Blade recommended at least once a week 940 060 Microbial Air Sampling HYCON Agar Strips agar media for RCS Microbial Air Samplers Item Item No Package size Total Count TC Tryptic Soy Agar for determination of the total count 941 105 5O TSM Modified Tryptic Soy Agar with neutralizers against disinfectants and growth supplements for identification of the total count of fastidious and sublethally damaged microorganisms 941 135 5O TC y Gamma irradiate
11. D F Quick Start Guide 942 550 m Accessories only for APC ErgoTouch Spare Battery 43 4A U len Batter Vang Fue Capion ane Gewe Uam hiker Da ni Cauah imed Cut ost Disasaeimtle Meat Abr 7 7 942 511 Replacement Power Supply 942 512 Replacement USB Cable 191 550 Aluminum Carrying Case 942 520 EEIIUGSISIIIIUGIIILISIIIIIIUIIICLII GUULILLITIGGUIH IG IUICI OAAULLOLLHLOGAOAA Dh AAi A e U OUL LAL OSAAALLLULLLLULLALLLLLLLcC 171717171111 1111 11 11 11 15 Airborne Particle Counting HYCON APC ErgoTouch Airborne Particle Counter Item Table top Stand Accessories only for APC ErgoTouch Pro Spare Battery Replacement Power Supply External Battery Charger Replacement USB Cable Temperature and Relative Humidity Probe Aluminum Carrying Case External Printer Printer Paper 10 rolls APC ErgoTouch Pro Qualification Handbook For performing complete IO OO and PO of APC ErgoTouch Pro Airborne Particle Counters available in German and English Accessories for both Instruments Purge Filter Assembly Isokinetic Inlet 16 Item No 940 930 942 561 942 562 942 563 191 551 942 565 942 570 942 610 942 611 942 507 942 601 942 602 3 HYCON APC ErgoTouch Airborne Particle Counter Item Isokinetic Probe For remote sampling Isokinetic Probe for HEPA filter testing 2 83 L min Tubing For remote sampling per meter Barbed Inlet For re
12. No 940 818 940 320 940 321 940 320 900 940 325 940 720 940 725 940 100 Se z 940 130 E fo Microbial Air Sampling HYCON RCS Plus Microbial Air Sampler Item Instrument RCS Plus Ex Microbial Air Sampler For use in explosive areas high performance instrument for multiple sample volumes up to 1 999 liters and a flow rate of 50 L min including two rechargeable 7 2 V Ni Cd batteries infrared remote control battery compartement key rotor protection cap and carrying case Accessories Universal Rapid Battery Charger For rapid charging of 9 6 V and 7 2 V Ni Cd batteries 220 V EU compatible with RCS High Flow 110 V US 7 2 V Ni Cd Battery Replacement Ni Cd battery for uninterrupted use of the RCS High Flow Microbial Air Sampler Battery Discharger For complete discharging of the residual capacity of 9 6 V and 7 2 V batteries reconditions and prevents battery memory effects compatible with RCS High Flow Tripod For convenient use of the RCS Plus at heights up to three meters compatible with RCS High Flow Table top Tripod For horizontal operation of the RCS Plus RCS Plus Ex Microbial Air Samplers compatible with RCS Isolator and RCS High Flow Rotor Autoclavable spare rotor only for RCS Plus with serial numbers up to 4999 each combination of sampler and rotor must be calibrated separately Rotor Autoclavable spare rotor only for RCS Plus with serial numbers as
13. arties The same applies if the residence or habitual abode of the customer is not known at the time when an action is brought We may however also institute legal action against the customer at the customer s general place of jurisdiction 11 2 These Terms and Conditions are governed exclusively by the laws of the Federal Republic of Germany 11 3 Should any of the provisions of these Terms and Conditions or a provisi on within the scope of any other agreements be or become ineffective the validity of all other provisions or agreements shall not be affected Rather both parties together shall replace an ineffective provision by an effective provision that comes closest to the extent legally admissible to the econo mic intent and purpose of the ineffective provision 27 Biotest From Nature for Life Biotest AG Global Business Unit Microbiology 698900101
14. crobial Air Sampler Item Instrument RCS Isolator Microbial Air Sampler Stationary instrument with encapsulated airflow path to be used in Isolators and under laminar flow devices or filling lines sample volumes up to 1 999 liters with a flow rate of 100 L min including sampling unit operating unit connection cable with secured plug rotor protection cap infrared remote control and carrying case Accessories Universal Battery Charger For charging the built in 12 V NiMH battery Support Stand for Sampling Unit Stainless steel tripod for vertical affixation of sampling unit Tripod For convenient use of the RCS Isolator at heights up to three meters compatible with RCS Standard an adapter for connection with the tripod is required Tripod Adapter For affixing the RCS Isolator to tripods or installations Table top Tripod For horizontal operation of the RCS Isolator Microbial Air Sampler compatible with RCS High Flow and RCS Plus Infrared Remote Control For convenient use of RCS Isolator compatible with RCS High Flow Item No 940 215 and serial number up to 38000 Sampling Unit For replacement at an existing installation Rotor Autoclavable spare rotor compatible with RCS High Flow Each combination of sampler and rotor must be calibrated separately Protection Cap Autoclavable stainless steel protection cap compatible with RCS High Flow and RCS Plus Air Outlet Tubing PVC outlet air tube to redire
15. ct the exhausted air into less critical areas Tri Clamp Cable Transfer For use in isolators to connect the operating unit to the sampling unit through the isolator wall Item No 940 810 940 820 940 816 940 030 940 817 940 335 940 241 940 813 940 230 940 415 940 814 940 815 HYCON RCS Isolator Microbial Air Sampler Item Alternative Cable Transfer Anemometer Portable airflow measuring device for calibrating RCS Microbial Air Samplers compatible with RCS High Flow and RCS Plus CalibSo Calibration Software for secure and comfortable computer aided calibration and data backup compatible with RCS High Flow Anemometer plus CalibSo Special price combination available only in selected markets Adhesive Tapes 60 pieces for calibration of the RCS High Flow adhesive ring foils to seal the air inlet holes in the rotor compatible with RCS High Flow and RCS Plus RCS Compressed Gas Adapter Autoclavable adapter for use of the RCS High Flow to monitor microorganisms in compressed gasses designed for pressure of 1 bar compatible with RCS High Flow Nozzle Set for RCS Compressed Gas Adapter Set of five nozzles to extend the inlet pressure range to o1 7 0 bar RCS Validation Handbook Comprehensive compendium of validation data for the RCS Microbial Air Samplers RCS High Flow RCS Isolator RCS Plus and Agar Strips German English Microbial Air Sampling Item
16. d Tryptic Soy Agar double wrapped for determination of total count in aseptic environments 941 115 40 TCl y Gamma irradiated Tryptic Soy Agar with neutralizers double wrapped for determination of total count in aseptic environments and in peroxide containing air 941 125 40 PEN y Gamma irradiated Tryptic Soy Agar with Penase for determination of total count in penicillin containing air in aseptic environments 941 716 40 LAC y Gamma irradiated Tryptic Soy Agar with broad spectrum cephalosporinase for determination of total count in aseptic environments containing antibiotics 941 706 40 Selective Agar Media YM Rose Bengal Agar with streptomycin for determination of yeasts and molds 941196 50 SDX Sabouraud Dextrose Agar with modified Pharmacopeia formulation for determination of yeasts and molds 941 205 50 SDX y Sabouraud Dextrose Agar with modified Pharmacopeia formulation for determination of yeasts and molds in aseptic environments 941 215 40 Microbial Air Sampling HYCON Agar Strips agar media for RCS Microbial Air Samplers Item Item No Package size DG 18 Dichloran Glycerine Agar for determination of yeasts and molds compliant with TRBA 430 941 225 DE S Mannitol Salt Agar for determination of staphylococci 941 405 25 C MacConkey Agar for determination of coliform bacteria 941 505 25 Accessories Blank Strip Kit Sterile empty strips for manual production of culture media for special a
17. data with barcode reader bluetooth module and software HYCON ID USB Barcode Reader Barcode scanner with USB connection for reading barcode data in the laboratory such as after incubation HYCON ID Barcode Printer Set Including software and labels to create user specific barcode labels Item No 940 244 940 250 940 320 940 321 940 320 900 940 325 940 360 940 368 940 365 Microbial Air Sampling HYCON RCS High Flow Microbial Air Sampler Item Item No HYCON ID Bluetooth Barcode Reader For the extension of the HYCON ID System to work with additional RCS High Flows includes bluetooth scanner and battery 940 361 HYCON ID Battery Charger Additional charger for charging bluetooth barcode scanners 940 362 RCS Validation Handbook Comprehensive compendium of validation data for the RCS Microbial Air Samplers RCS High Flow RCS Isolator RCS Plus and Agar Strips contains Oualification Handbook for the RCS High Flow German 940 100 English 940 130 RCS Oualification Handbook For performing complete IO OO and PO of the RCS High Flow German 940 105 English 940 135 Battery Compartment Key Only for RCS High Flows manufactured prior to 2001 compatible with RCS Plus 940 450 Infrared Remote Control Only for RCS High Flow with item number 940 215 and serial numbers lower than 38001 compatible with RCS Isolator 940 241 Microbial Air Sampling HYCON RCS Isolator Mi
18. ficulties in the procurement of materials operational breakdowns strikes lock outs shor tage of staff or means of transport governmental action etc even if any such events occur with our suppliers or their sub contractors as well as in the event of time limits and dates agreed in a binding manner We shall be entitled as a result of any such delays to postpone the delivery by the dura tion of the hindrance plus a reasonable starting period or to withdraw from the contract in whole or in part with respect to the portion not yet perfor med This applies also if we are already in default 26 4 3 If the hindrance persists for a period of more than three months the cu stomer shall be entitled after setting a reasonable additional time limit to withdraw from the contract with respect to the portion not yet performed 4 4 If we are in default the customer may withdraw from the contract after the expiration of an additional time limit The term of the additional time limit to be set by the customer by law shall be six weeks The time limit starts upon the receipt by us of the notification of the setting of the additional time limit 4 5 The extended liability during default 287 German Civil Code is exclu ded 4 6 We shall at any time be entitled to ship partial deliveries 5 Transfer of risk The risk shall transfer to the customer once the consignment is handed over to the person carrying out the transport or has left our pla
19. firmed by us in writing to be valid 2 3 Any side agreements amendments or supplements shall only be valid if confirmed by us in writing 3 Delivery Prices Changes in prices 3 1 Delivery conditions shall be FCA Dreieich Incoterms 2000 To avoid quality problems and damages of the goods the customer is obliged to entrust one of our recommended forwarding agents 3 2 All prices are net prices exclusive of VAT and any duties which shall be paid by the customer at its statutory rate from time to time if applicable 3 3 We reserve the right not to accept orders below 500 If the single in voice value is below 1 000 for diagnostic products an additional handling fee of 150 will be charged per invoice of diagnostic products If the single invoice value is below 5 000 for therapeutic products an additional hand ling fee of 250 will be charged per invoice of therapeutic products 3 4 Shipping charges for same day deliveries or outside regular working hours courier fees etc shall be borne by the customer 3 5 70 will be charged for each delivery containing solid carbon dioxide dry ice 4 Delivery times 4 1 While it is our goal to always meet the specified delivery dates they cannot be promised 4 2 We shall not be liable for any delays in delivery as a result of force majeure or other events that render the delivery materially more difficult or impossible including but not limited to subsequent dif
20. ge and or transport instructions as printed on the packaging of our products are not observed all liability on our part shall cease The burden of proof with regard to proper storage shall lie with the customer 6 6 The scope of our warranty for replacement deliveries and remedying defects corresponds to the scope of our warranty for the original delivered item 6 7 We shall be available to the customer for inquiries and advice to the best of our knowledge in respect of the use of the products We shall ho wever only be liable pursuant to section 7 below in such case that separate remuneration is agreed upon therefor 7 Damages and limitation of liability 71 We shall be liable for damages a for culpably caused damage to life limb and health b to the extent that we have assumed a warranty for a special quality of the delivered item or performance our capability to procure the same or Biotest AG General Terms and Conditions any other warranty provided that damage is incurred as a result of a non fulfilment of such warranty c on account of damage caused in a wilful or grossly negligent manner by us or our agents d in lieu of complete performance on account of culpable defective delive ries or services in the event of material breaches of duty e in the event of a slightly negligent violation of material contractual du ties limited however to the typical and foreseeable damage f in accordance with the provisi
21. icrobiology company involved in research and production specializing in the application areas of immunology and hematology In the Pharmaceutical segment Biotest develops and markets immunoglobulins coagulation factors and albumins derived from human blood plasma fractionation These are used to treat diseases of the immune and hematopoietic systems In the Biotherapeutic segment Biotest promotes the clinical development of monoclonal antibodies including those used to treat rheumatism and leukemia The industrial microbiology segment includes reagents and systems for microbiology such as those used for hygiene monitoring and microbial identification Biotest employs approximately 2 000 people worldwide Shares of Biotest AG are listed on the SDAX of the German Stock Exchange Deutsche B rse About Biotest coe Contents About Biotest Contents HYCON RCS Microbial Air Samplers RCS High Flow RCS Isolator RCS Plus RCS Plus EX RCS Standard Agar Media for RCS Instruments HYCON Agar Strips HYCON Contact Slides HYCON APC Airborne Particle Counters APC M3 APC Ergo Touch APC Handheld APC Portable MMB Food Pathogen System Hygiene Screening System HSS Miscellaneous Service Repair and Calibration Contact Information General Terms and Conditions of Biotest AG iii iv e CO Oo A e 11 21 23 24 25 26 HYCON RCS High Flow Microbial Air Sampler
22. ila V Kit 100 reactions MMB Clostridium perfringens V Kit 100 reactions MMB Bacillus cereus V Kit 100 reactions MMB Norovirus V Kit 100 reactions 22 m Emi m om uw m m m m g Item No 944 032 944 033 944 061 944 041 944 042 944 043 944 O51 944 071 944 081 944 091 944 101 XXX XXX Molecular Microbiology Hygiene Screening System HSS The Hygiene Screening System is designed for the rapid identification of microorganisms of the genera Corynebacterium Staphylococcus Macrococcus Micrococcus Kocuria and Kytococcus Additionally some coryneform bacteria and Nesterenkonia halobia are detected The system is optimized for the LightCycler 2 0 Roche Diagnostics The system uses highly specific HybProbe probes for the simultaneous detection of all the above mentioned genera within 90 minutes In addition the most important species and species groups within these genera can be identified via melting curve analysis Bacterial colonies as starting material are are prepared using the Suspension Buffer This buffer allows the preparation of target DNA templates in less than 5 minutes followed by a qualitative real time PCR analysis using highly specific HybProbe probes Item Item No Hygiene Screening System Hybridization Probes 96 reactions 943 101 Suspension Buffer 800 tests 943 102 Enzyme Mix 200 U Taq Polymerase UNG 96 reactions 943 103 Melting Peaks leonpas dasste 2
23. ion handbook APCOnen Security Dongle APCOnen Download Utility Software APC M3 Qualification Handbook For performing complete IO OO and PQ of APC M3 particle counters available in German and English 14 I LLL Item No 191570 191595 942 112 000 191560 942 254 942 436 942 437 942 438 191520 942441 942 446 942 451 942 456 000 942 465 942 675 942 650 942 655 942 660 942 700 942 162 942 701 942 207 only in conjunction with new instrument or recalibration Airborne Particle Counting HYCON APC ErgoTouch Airborne Particle Counter Item Item No Instrument e 0 0 oe BE ErgoTouch APC ErgoTouch Airborne Particle Counter Handheld particle counter with a flow rate of 2 83 L min and three channels 0 3 um and o 5 um fixed and middle channel adjustable 0 5 1 0 2 0 2 5 um including power supply battery isokinetic inlet purge filter assembly USB cable Ergolrak Lite Data Download Utility CD operation manual CD Quick Start Guide 942 500 eo 0 oe Zi BE ErgoTouch Pro APC ErgoTouch Pro Airborne Particle Counter md Handheld particle counter with a flow rate of 2 83 L min and six channels Ab iotest calibrated to 0 3 0 5 1 0 3 0 5 0 10 0 um user configurable in 0 1 um increments 0 3 to 10 0 um including power supply battery isokinetic inlet stylus purge filter assembly USB cable e ErgoTrak Lite Data Download Utility CD operation manual C
24. mote sampling APC Compressed Gas Adapter Compatible with all APCs Nozzle Set for APC Compressed Gas Adapter ErgoTouch version Airborne Particle Counting Item No 942 603 191520 191 822 191 824 942 675 942 680 Airborne Particle Counting HYCON APC Handheld Airborne Particle Counter Instruments APC Handheld Airborne Particle Counter Handheld particle counters with a flow rate of 2 83 L min and one two or four channels e APC1Channel 0 3 um e APC 2 Channel 0 5 5 0 um e APC Plus 0 3 0 5 1 0 5 0 um APC TEN 0 5 1 0 5 0 10 0 um Includes power supply battery isokinetic inlet RS 232 serial cable APCWin Data Download Utility CD operation manual CD carrying case Model Flow rate Minimum Number of number L min sensitivity um channels H3101 APC 1 Channel O 3 1 H5201 APC 2 Channel Os 2 52015 APC 2 Channel 0 5 2 H5201 APC 2 Channel RS 485 ub 2 H3401 APC Plus O3 4 H34015 APC Plus 0 3 A H3401 APC Plus RS 485 0 3 4 H5401 APC TEN O 5 4 H5401S APC TEN 0 5 4 Item Accessories FMS Facility Monitoring System To control a network of particle counters compatible with APC M3 and Portable models Thermal Printer 110 V Thermal Printer 220 V Serial Cable RS 232 3 m for serial numbers as of xxxx 0999 Purge Filter Assembly 0 2 um Remote Sample Probe and Tubing For remote sampling Isokinetic Probe for HEPA filter testing 2 83 L min Table top Tripod Thermal Printe
25. mpatible with RCS Isolator Nozzle Set for RCS Compressed Gas Adapter Set of five nozzles to extend the inlet pressure range to 0 1 7 0 bar Rotor Autoclavable spare rotor compatible with RCS Isolator Each combination of sampler and rotor must be calibrated separately Protection Cap Autoclavable stainless steel protection cap compatible with RCS Isolator and RCS Plus Microbial Air Sampling Item No 940 216 940 370 940 371 940 275 940 380 940 270 940 271 940 330 940 335 940 920 940 720 940 725 940 230 940 415 Microbial Air Sampling HYCON RCS High Flow Microbial Air Sampler Item Air Outlet Ring Autoclavable spare part Sterile Sleeves 10 pieces for covering the RCS High Flow to protect against cross contamination compatible with RCS Plus Anemometer Portable airflow measuring device for calibrating RCS Microbial Air Samplers compatible with RCS Isolator and RCS Plus CalibSo Calibration Software for secure and simple computer aided calibration and data backup compatible with RCS Isolator Anemometer plus CalibSo Special price combination available only in selected markets Adhesive Tapes 60 pieces for calibration of the RCS High Flow adhesive ring foils to seal the air intake holes in the rotor compatible with RCS Isolator and RCS Plus HYCON ID Set Complete solution for wireless identification and documentation of microbial air sampling
26. nt or distribu tion centre respectively for shipment If it becomes impossible to ship for reasons other than our own fault the risk shall transfer to the customer upon notification of the readiness for shipment 6 Warranty and duty to examine 6 1 Any details in brochures price lists and other information as well as product describing information sent to the customer by us shall in no event be interpreted as being warranties for a specific quality of the de livered item any such warranties as to quality must be expressly agreed upon in writing 6 2 Notwithstanding warranty claims if any under the provisions below the customer shall also accept a delivered item with minor defects 6 3 If the delivered item is defective or becomes defective within the pro duct shelf life or if no shelf life is specified within the warranty period as a result of manufacturing defects or defects in material we shall at our own option deliver a replacement item or remediate the defect The limita tion period for warranty claims is 12 months from the time of the transfer of risk 6 4 The customer shall notify us of any defects in writing without undue delay and no later than one week following delivery enclosing the delivery note and if possible a sample Any defects that cannot be discovered within such period even after careful examination shall be notified to us in writing without undue delay following their discovery 6 5 If the stora
27. of 5000 each combination of sampler and rotor must be calibrated separately Protection Cap Autoclavable stainless steel protection cap compatible with RCS Isolator and RCS High Flow Item No 940 312 940 370 940 371 940 375 940 380 940 330 940 335 940 410 940 41 940 415 Microbial Air Sampling HYCON RCS Plus Microbial Air Sampler Item Item No Sterile Sleeves 10 pieces for covering the RCS Plus RCS Plus Ex to protect against cross contamination compatible with RCS High Flow 940 250 Anemometer Portable airflow rate measuring device for calibrating RCS Microbial Air Samplers RCS Plus RCS Plus Ex compatible with RCS Isolator and RCS High Flow 940 320 Adhesive Tapes 60 pieces for calibration of the RCS High Flow adhesive ring foils to seal the air inlet holes in the rotor compatible with RCS Isolator and RCS High Flow 940 325 RCS Validation Handbook Comprehensive compendium of validation data for the RCS Microbial Air Samplers RCS High Flow RCS Isolator RCS Plus and Agar Strips German 940 100 SN fa English 940 130 Battery Compartment Key compatible with RCS High Flow with manufacturing date before 2001 940 450 Infrared Remote Control Only for RCS Plus with serial number up to 4999 940 340 Infrared Remote Control Only for RCS Plus with serial number greater than 4999 compatible with RCS Standard 940 341 Microbial Air Sampling HY
28. ons of the German Drug Law the German Product Liability Act and any other mandatory statutory provisions on liability g in lieu of performance on account of a culpable breach of collateral du ties if the customer can no longer reasonably be expected to accept the performance or if the delivery or service by us is rendered impossible 7 2 If none of the criteria specified in section 7 1 above is met we shall not be liable for damages Any exclusions or limitations of liability shall also apply to our employees 7 3 Sections 7 1 and 7 2 above apply to all claims for damages on any legal grounds whatsoever including but not limited to the liability for tort or culpa in contrahendo 7 4 The customer shall take appropriate action to avert and minimise da mage 7 5 In case of product liability claims brought forward to the customer the customer shall immediately inform us and to the best of its abilities coo perate with us in the defence of such claims 8 Retention of title 8 1 Pending the satisfaction of all claims including claims with respect to account balances that we may have against the customer and its group companies now and in the future on any legal grounds whatsoever as well as pending the complete indemnification against any and all contingent liabilities assumed by us in the customer s interest the following security shall be furnished to us It shall be understood that we will release the security at our own o
29. pplications 941 605 5O Cover Slides Cover slide for Agar Strips to prevent desiccation during incubation 941 900 100 Incubation Rack for Agar Strips 940 941 1 Safety Tweezer Holder 940 910 1 HYCON Contact Slides agar media for microbial surface monitoring in flexible foil individually packaged 25 cm Item Total Count TC Tryptic Soy Agar for determination of the total count with neutralizers Lecithin L Histidine Sorbitol Monooleate Complex Tween 80 and growth supplements TC y Gamma irradiated Tryptic Soy Agar double wrapped for determination of total count in aseptic environments with neutralizers Lecithin Sorbitol Monooleate Complex Tween 80 and growth supplements DE y Gamma irradiated modified Dey Engley Agar D E Agar double wrapped for determination of total count in aseptic environments with neutralizers Lecithin Sorbitol Monooleate Complex Sodium Thioglycolate Sodium Bisulfite and growth supplements PEN y Gamma irradiated Tryptic Soy Agar with Penase double wrapped for determination of total count in penicillin containing air with neutralizers Lecithin L Histidine Sorbitol Monooleate Complex Tween 80 and growth supplements LAC y Gamma irradiated Tryptic Soy Agar with broad spectrum cephalosporinase double wrapped for determination of total count in environments containing antibiotics with neutralizers Lecithin L Histidine Sorbitol Monooleate Complex Tween 80
30. ption once its value persistently exceeds the value of the claims by more than 20 8 2 Title to the goods shall remain with us Any processing or transformati on shall at all times be made for us as manufacturer with us however not being obliged in any manner If our co ownership expires as a result of a combination it is hereby agreed that the customer s co ownership of the uniform object passes to us in the proportion of the value invoice value The customer shall keep our co ownership free of charge Any goods to which we are entitled co ownership are hereafter referred to as conditio nal goods 8 3 The customer may process conditional goods in the ordinary course of business and sell them subject to a reservation of title provided that the customer is not in default Any pledging or assignment as security shall not be admissible The customer hereby assigns to us by way of security all claims arising from the resale or any other legal grounds insurance tort in respect of conditional goods We hereby revocably authorise the customer to collect the claims assigned to us in its own name and for our account If requested by us the customer shall disclose the assignment and provide us with the necessary information and documents 8 4 If third parties encroach upon conditional goods the customer shall refer to our title and notify us without undue delay Any costs and damage shall be borne by the customer 8 5 In the even
31. r Paper 5 rolls Universal Battery Charger Isokinetic Inlet 2 83 L min Carrying Case Custom Wall Bracket Airborne Particle Counter Housing Item No Aluminum 942 001 Aluminum 942 005 Stainless steel 942 006 Aluminum 942 007 Aluminum 942 300 Stainless steel 942 301 Aluminum 942 302 Aluminum 942 310 Stainless steel 942 311 Item No 942 017 942 020 000 942 022 000 190 200 942 035 942 041 191520 942 050 942 110 000 942 158 190 190 190 210 942 899 090 18 I O HYCON APC Handheld Airborne Particle Counter Item APC Compressed Gas Adapter Compatible with all APC models Nozzle Set for APC Compressed Gas Adapter 2 83 L min APCOnen Download Utility Software Compatible with 21CFR Part 11 including Download Utility Software CD APCOnen security dongle APCOne11 validation handbook APCOnen Security Dongle APCOnen Download Utility Software APC Handheld Oualification Handbook For performing complete IO OO und PO of APC Handheld Airborne Particle Counter available in German and English Airborne Particle Counting Item No 942 675 942 670 942 700 942 162 942 701 942 107 19 Airborne Particle Counting HYCON APC Portable Airborne Particle Counter Item Instrument Particle Counter APC Portable Model number P3610 Portable instrument for multiple sample volumes up to 10 ft3 283 liters Flow rate of 28 3 L min e 6channels from 0 3 to1
32. t of a breach of contract by the customer including but not limited to default in payment we may take back the conditional goods Miscellaneous at the customer s expense The taking back or attachment of conditional goods by us shall not constitute a withdrawal from the contract 9 Payment 9 1 Our invoices are payable as specified in our offer or if not specified within 30 days from receipt of the invoice or the respective delivery of goods without any deductions following the expiration of such time limit without payment the customer is in default The payment date shall be the date on which we receive the funds Notwithstanding any provisions of the customer to the contrary we shall be entitled to determine the claims against which the payment shall be set off 9 2 We expressly reserve the right to refuse to accept cheques and bills of exchange Acceptance shall in any event only be on account of payment Discount and bill fees shall be due immediately at the expense of the cu stomer 9 3 If the customer is in default we may charge interest at a rate of 8 per centage points above the base rate published by Deutsche Bundesbank from time to time The interest shall be due immediately We reserve the right to assert additional damages 9 4 We will charge a lump sum amount of 5 respectively 6 US for each written reminder following the occurrence of the default in payment of an invoice in respectively in US or any o
33. ther currency 9 5 If the customer fails to comply with its payment obligations and in particular fails to honour a cheque or bill of exchange stops payments or if we realise otherwise following the conclusion of the contract that our claim for payment is jeopardised due to a lack of financial strength or liqui dity of the customer we may declare all of our claims against the customer immediately due and payable even if we have accepted cheques or bills of exchange We may in such case also suspend deliveries demand advance payments or the furnishing of security and may further withdraw from the contract following the expiration of a reasonable additional time limit and claim damages if applicable 9 6 The customer shall only be entitled to set offs or deductions if we have given our express written consent or if the counterclaims are undisputed and have become res judicata 10 Termination or withdrawal for good reason 10 1 We can terminate the contract or withdraw from the contract for good reason particularly in cases where the customer has filed for insolvency or has permanently stopped payments or where insolvency proceedings have been initiated with regard to the assets of the client or where initiation of such proceedings has been declined for insufficiency of assets 11 Place of jurisdiction Applicable law Partial invalidity 11 1 It is agreed that Frankfurt am Main is the place of jurisdiction for any disputes for both p
34. y Tweezer Holder 940 910 1 Airborne Particle Counting HYCON APC M3 Airborne Particle Counter Instruments APC M3 Airborne Particle Counter High performance instrument for multiple sample volumes up to 1 m APC M3 Flow rate 100 75 50 L min A faber Dareiala eiue Airborne Particle Gounter 2 or 6 channels from 0 3 to 10 um Stainless steel or aluminum case Integrated thermal printer Calculations according to ISO 14644 and FS 209 E Touchscreen display Meets JIS standards User defined warning signals Self diagnostics of flow rate and battery charge level USB Client and RS 232 data ports Weight 8 2 to 10 2 kg Custumer specific channel sizes from 0 3 to 100 um for P56xxx model numbers Includes power supply isokinetic probe sample tubing table top tripod USB cable APCOne Data Download Utility Software CD user manual CD Model Flow rate Minimum Number of Housing Item No number L min sensitivity um channels P36100 S 100 013 6 Stainless steel 942 260 P36100 100 O 3 6 Aluminum 942 262 P56100 S 100 O 5 0 3 6 Stainless steel 942 264 P56100 100 0503 6 Aluminum 942 266 P52100 S 100 0 5 2 Stainless steel 942 268 P52100 100 O 5 2 Aluminum 942 270 P36075 S 75 0x3 6 Stainless steel 942 272 P36075 75 0 3 6 Aluminum 942 274 P56075 S 15 O5 03 6 Stainless steel 942 276 P56075 75 Oo 6 Aluminum 942 278 P52075 S 75 O 5 2 Stainless steel 942 280 P52075 75 0 5 2 Aluminum 942 282 P36050 S 50
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