When performing a GMP application, one needs to comply to Good Manufacturing Practice Guideline for Pharmaceutical Products, Main Principles. These guidelines call out that a high level of sanitation and hygiene should be practiced in every aspect of the manufacture of pharmaceutical products. Production equipment should not present any hazard to the products.
To answer GMP compliant production, the biotherapeutic market has been rapidly adopting single-use BioProcess Container (BPC) technologies to reduce risk and improve operational efficiencies. For more than 20 years, Thermo Fisher Scientific has pioneered single-use technologies for this industry. Our products have been proven to be robust and scalable from lab scale-up to cGMP production applications.
The Thermo Scientific™ CentriPAK™ BioProcess Container is a next generation centrifuge container providing a single-use, sterilized, closed system for cell culture separations.