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All of our Bioprocess Container manufacturing is completed in a FDA Registered, Class 10,000 Clean Room, adhering to current Good Manufacturing Practices (cGMP’s) and ISO 9001 Standards. A 100% visual inspection on perimeter seals and fitment seal integrity is conducted on all bags prior to irradiation. Leak testing is conducted according to ASTM F2091-01. Our ports are manufactured on site in a Class 100,000 Clean Room. We hold our products to the highest level of quality.
Lonza continually strives to incorporate FDA and other regulatory guidelines in the manufacturing of our products. Our customers can save valuable time in the regulatory submission process by utilizing our records, documents and quality standards as evidence of compliance with current regulatory requirements
- Lonza documents all components, manufacturing processes and test results for both raw materials and the finished product.
- Quality testing includes raw material identification, performance evaluation and complete cGMP traceability.
- Pre-qualified raw materials are tested by NIR as a confirmation of vendor certification.
- Computerized weigh stations use bar coding to identify cleared chemicals and add them to the chemistry batch record.
- Formula expansions and actual chemical weights are recorded, ensuring accurate preparation, documentation and cGMP traceability.
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