To reply to specific requests of new partners, PFMP/Aquitaine Pharm is building a new production site, ATEX standards, dedicated to anticancer drugs, in solution and freeze dried, opened to outsourcing.
Evolution of the new production site
With an investment of 30 million euros, two 1.000 sq.m. manufacturing suites are being built as well as a control laboratory. Approvals from European, American and Japanese authorities are planned for 2007.
These 2 workshops are designed in partnership with suppliers. All studies have been done as per the AMDEC methodology by taking into account criticity of each equipment. The operation safety is totally guaranteed.
These workshops will manufacture vials in solution and/or freeze dried, from 1-ml to 80-ml.
Production capacity is 30 million vials in solution or 10 million freeze-dried vials per year.
- Formulation and lyophilization of high alcoholic concentration products
- 100 % of the process is under isolator
- Automatic loading and unloading of lyophilizors (CIP / SIP)
- Waste recovery and treatment
Future project :
The next goal of Aquitaine Pharm is to perform aseptic filling of syringes for products with a FDA agreement.
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