Corgenix is located in Broomfield, Colorado, a community in the metro Denver area. The facility has been an FDA-registered Class BSL-2 facility since it was founded in 1990. Corgenix is certified to ISO 13485 and is in full compliance with both the European IVDD for CE marking products and the Canadian standard CMDCAS.
Our facility is split into dedicated sections. Over 32,000 sq. ft. are devoted to IVD diagnostic test-related activities, and over 12,000 sq. ft. are BSL-2 laboratory space and controlled environmental areas for production. The areas that make up the latter space are designed and designated for a multitude of projects, including:
- Incoming component and raw material testing and qualification
- General reagent formulation and preparation
- In-process production
- Project requiring a cold and ambient storage area
- Assay and component production
- Final product assembly, including packaging and labeling
- Final product testing
Corgenix is capable of preparing and producing materials in both a manual and automated production format, depending on the size and complexity of the product. The facility can handle small production lots up to lot sizes in excess of 8,000 units per lot. The production area houses state-of-the-art production technologies, including a fully-automated filling and packaging line, large lot lyophilization capabilities, and an environmentally-controlled production room.
Corgenix facility ensures the protection of all fixed assets and production areas with an advanced security system, which includes:
- Access Control: Full, unapproved access coverage, including entry alarms, glass breakage monitors, and infrared sensors, as well as security cards, which control access to entrances, laboratories, and other critical areas.
- Video Monitoring: The facility has around-the-clock video monitoring of all entrances and laboratories.
- Critical Condition Monitoring: Temperatures for critical equipment are monitored at all times. Ultralow freezers have automatic liquid nitrogen backup, while freezers and refrigerators have redundant compressors, which automatically activate in the event of a primary system malfunction.
Corgenix employs a secure offsite, co-hosted data network system with redundant replication. This ensures maximum data protection for all software, critical data storage, and maintenance.