manufacturers of pharmaceuticals and of medical devices, hospitals, care units, medical practices and others
The services mentioned below are only a part of our extensive spectrum of available services. Please don't hesitate to contact us specifically in case you should not find in the list what you are looking for.
As a laboratory accredited according EN ISO/IEC 17025 (Guideline 90/385 EWG and Guideline 93/42 EWG) BIOSERV Analytics offers:
Hygiene Controls - Hygiene audits
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production hygiene
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personnel hygiene
Microbiological and physicochemical analyses
Testing of hygienic environments
Controls of washing machines
Microbiological evaluation of the functionality of autoclaves and hot air sterilizators with bioindicators
Examination of drinking water
Peer assessment of officially drawn countersamples
Examination of ventilation and air conditioning equipment Prüfung according to VDI 6022
Judicial expertises
Training and consulting
Consulting and cooperation in the generation of Quality Management Systems and of HACCP-concepts (HACCP = Hazard Analysis and Critical Control Point)
Development and introduction of customer-specific electronic database systems for the backtracking of procedures.
Please contact us for further information: info@bioserv-analytics.com
Examinations according the Pharmacopeia Europea and other Pharmacopeias
Microbiological counts
Microbiological differentiation by culture, biochemistry, microscopy and serology
Microbiological isolation and culture from
- Food
- Potable water
- Pool water
- Condensate water from air conditioning systems according to DIN 19643-1 und VDI 6025
- Pharmaceutical preparations (sterile and insterile)
- Medical devices
- and any other materials and substrates
Microbiological test systems
- Evaluation of sterilization procedures according to DIN ISO 11138 and to the EG-GMP-Guidelines, chapter. 12.F "sterilization by vapor" and chapter 12.K "sterilization by hot air"
- Verification of sufficient conservation according to the Pharm. Eu., Supplement 2001, 5.1.3, criteria A and B
- Sterility testing according to the Pharm. Eur., Supplement 2001, 2.6.1 and EN ISO 11737 (direct feeding, filtration method)
- Validity testing of sterility testing results and sterilization procedures according to Pharm. Eur., Supplement 2001, 2.6.1 and EN ISO 11737
- Examination of non-sterile products according to the Pharm. Eur. 1997, Supplement 1999, 2.6.12
- Examination of dish washing machines according to DIN 10510 and DIN 10512
Testing for biocompatibility / innocuousness according to EN ISO 10993 / Pharm. Eur.
Testing for pyrogens / endotoxins according to EN ISO 10993-11, Pharm. Eur. and USP XII
Examinations of hygienic environments and environmental examinations of clean rooms and laminar flow hoods
- Determination of the number of germs on surfaces, fitments, and objects in the pharmaceutical and medical area including personnel monitoring according to ISO 10113-2 / EG-GMP-Guideline, chapter 12
- Determination of airborne germs in the context of control of hygienic surroundings and of environments according to ISO 10113-3 / EG-GMP-Guideline, chapter 12
- Determination of the particle number in clean rooms regarding the compliance with the requirements of the EG-GMP Guideline
Consulting and other services
- Consulting and support with the establishing of Quality Management Systems and HACCP concepts
- Risk analysis
- Specification of measures for monitoring
- Documentation of the monitoring results
Quality management systems
- Consulting and support with the compilation of Qualitiy Management Handbooks
- Quality management documentations in the frame of EN ISO 9001, 13485, and EN ISO/IEC 17025
Realization of hygiene trainings
Developing of cleaning and desinfection schedules
Organisation of the sample transport
Compilation of representative documents and certificates
Services under aseptic conditions
Please contact us for more information: info@bioserv-analytics.com