ISO 7 Injectable Drug Processing

Injectable drugs must meet high standards of quality, purity and sterility. Our ISO 7 suites allow us to develop injectable drug products that can be terminally sterilized after manufacture. This allows for a high guarantee of product sterility with heat, gamma or e-beam exposure. All injectable drug processing is conducted in our ISO 7, cGMP facility, which has been inspected by both FDA and European Union Quality Personnel.

TERMINAL STERILIZATION VS. ASEPTIC PROCESSING

Terminal sterilization is a convenient, cost-sensitive alternative to aseptic manufacturing. Aseptic manufacturing involves separate sterilization processes for each component of the product being manufactured. As the number of variables increase, so does the chance of product contamination and cost.

With terminal sterilization, only the complete final product is sterilized. This decreases development time and expense.

 

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