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All the media listed in this catalog are prepared in our production laboratory which, like the other departments that manufacture consumable goods at IMV Technologies, was awarded ISO 9002 certification by AFAQ (No. QUAL/1999/13123). Beyond this recognition of our quality control system, we believe it is important to highlight several points relating to the measures we take to guarantee the intrinsic quality of our products. Our employeesAll employees in charge of critical manufacturing steps have solid experience in the preparation of sterile products and, especially, in what is called "aseptic filling". |
The premises
Our workshops comply with Good Manufacturing Practices for the pharmaceutical industry, with control of positive pressure, temperature, hygrometry and dust. Of course aseptic vial filling is carried out in a class 100 clean zone (Federal Standard 209C) under laminar flow.
Starting materials
All our starting materials comply with the requirements of one or more pharmacopoeias (Eur. Ph., USP, BP, JP). Ingredients not described in a pharmacopoeia meet ACS or ISO analytical standards. Water, a major component of media, not only meets specific resistance criteria (≥ 18 MW/cm), but is also tested for purity by HPLC analysis of organic microcontaminants (analytical methods and specifications available on request).
Microbiological safety
Some media contain human albumin which is supplied by LFB (Fractionation and Biotechnology Laboratory – France)
Each lot is tested by LFB for:
- Anti-HIV antibodies
- Anti-HCV antibodies
- HBs antigen
Quality controls
1. Starting materials
Upon receipt, all starting materials, which are accompanied by a certificate of analysis from the manufacturer, are sampled by quality control for pharmacopeial identification tests. At least one control parameter appearing on the manufacturer's certificate of analysis is tested. The result of our test must conform to the value indicated on the certificate, within the limits of measuring error. If all these criteria are met, the starting material is accepted and declared usable for manufacture.
2. Finished products
Our quality control department checks to make sure that product specifications are within the limits of acceptance. Sterility is tested by an authorized outside laboratory. When the finished product has satisfied all these control tests, it is released.
Traceability
Both starting materials and finished products are traced through our upward and downward computerized tracking system. We have continuous access to the history of all marketed products. Manufacturing documents are kept on file for at least one year after the expiry date of the product. Of course all these measures we take to guarantee product quality go hand in hand with our ISO-9002 certified complete documentation system for procedures, manufacturing protocols, etc.
our catalogue
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