- Quality Testing
- Documented Traceability
- Dual-site cGMP Manufacturing
This Trypsin is modified as follows:
| With | Without |
| • Phenol Red | • EDTA |
The complete formulation is available.
Quality Testing
Gibco® Trypsin solutions are tested for pH, osmolality, sterility and performance. In addition, prior to manufacturing, the raw materials are tested for endotoxin, Mycoplasma, bacterial, fungal and viral contamination, as well as multiple activity assays, ash analysis and moisture analysis.
Documented Traceability
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 Paisley, Scotland, UK. The facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard. For supply chain continuity, Life Technologies offers an identical Gibco® Trypsin solution made in our Grand Island, New York facility (15050-065). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 and ISO 9001 standards.