- Quality Testing
- Documented Traceability
- Dual-site cGMP Manufacturing
This Trypsin is modified as follows:
|• EDTA||• Phenol Red|
The complete formulation is available.
Gibco® Trypsin solutions are tested for pH, osmolality, sterility and performance. In addition, prior to manufacturing, the raw materials are verified for e-beam irradiation and tested for endotoxin, PPV, PCV 1/2, mycoplasma, bacterial, fungal and viral contamination, as well as multiple activity assays, ash analysis and moisture analysis.
Life Technologies can provide detailed documentation to meet your regulatory needs. Gibco® Trypsin information available includes lot traceability, animal origin certificates, lot analyses, irradiation certificates, a viral inactivation summary, and supply chain transparency.
cGMP Manufacturing and Quality System
For supply chain continuity, Life Technologies manufactures Gibco® Trypsin at two separate facilities located in Grand Island, NY and Scotland, UK. Both sites are compliant with cGMP manufacturing requirements, are certified to ISO 13485, and are registered with the FDA as medical device manufacturers. In addition, the New York facility has ISO 9001 certification.
Concentrated forms of trypsin can be aseptically diluted to 1x using a balanced salt solution without calcium and magnesium.