Services
Analysis Laboratory
Bioster laboratories were born to supply a complete package of analysis assuring
the quality of the sterilization service and the certification for the medical devices,
pharmaceutical and cosmetic products.
The long experience in the medical device field grants the permanent upgrading of adopted method,
in compliance with the reference normative and standards; the continuous investments
in the most advance instruments, a permanent instruction and a deep technical training
of the staff assure high quality services and on time delivery of results and documents.
Bioster laboratories developed basic microbiological and chemical tests and analyses
to fulfill the validation requirements of the various sterilization processes,
according to different Pharmacopoeias and technical guide lines.
In details, the analyses and measurements services offered by Bioster laboratories are the following:
• Biological indicators sterility test, to certify the sterilization
processes by ethylene oxide and steam. Laboratories carry out certified validation of biological indicators reduced
time incubation to meet customers need to deliver the product on time.
• The results of research, enumeration, characterization of
bioburden can keep product microbial charge constantly limited and under control.
Customers may use contamination data to monitor and manage the production quality.
• Bioster laboratories perform product sterility test and Lal test to verify the absence
of endotoxins, in compliance to the certification requested by the Pharmacopoeia.
All the adopted analyses methods are validated according to the most advanced technical standards.
Furthermore, the laboratories perform microbiological tests for packaging shelf life certification
and challenge test to verify the preservative properties of products.
The chemical tests include:
• Ethylene oxide residual in different products and materials
• Chlorethanol and ethylene glycol residuals
• Desorption curves, validated according to ISO technical guide
lines and Pharmacopoeias
• Volatile organic chemicals in different products
Identification and limit for chemical tests on medical device, row materials, environment percentage of cross linking test and chemicals release tests on irradiated polymers.
Bioster laboratories carry out mechanical test to certify the performance of materials of medical devices,
textiles, and protective devices, for example dynamometric tests, leak test, bursting test.
Bioster laboratories offer consultancy for choosing the proper analysis method considering an high benefit/cost
ratio and interpretation of results to support the customer in continuous quality improvement and business performance.
Tests, methods and activities of Bioster laboratories have official authorisation from
Italian Ministry of Health, are periodically audited by Italian and European control organisations,
certified by the German TÜV Product Service and by F.D.A. for the USA market.
