- Quality Testing
- Documented Traceability
- Dual-site cGMP Manufacturing
This Trypsin is modified as follows:
|• Phenol Red||• EDTA|
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
Gibco® Trypsin is manufactured at a cGMP compliant facility, located in Grand Island, New York. The facility is registered with the FDA as a medical device manufacturer and is certified to ISO 13485 and ISO 9001 standards. For supply chain continuity, Life Technologies offers a comparable Gibco® Trypsin solution made in our Scotland facility (25050-014). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.