2020 FDA Refrigeration
Chamber Mapping And Qualification Services
The FDA has specific requirements around commissioning, qualification, and validation of refrigerators and other environmental chambers that control temperature and humidity. The FDA’s CGMPs govern the qualification of chambers that hold raw materials, analytical samples, process intermediates, and bulk/final product. A documented validation, along with ongoing validation maintenance, is not optional – it is required for compliance.
Kymanox is a leading expert in these requirements, which include robust temperature mapping, calibration, procedural controls, and Good Documentation Practices. We have a dedicated team with the latest data logging equipment and industry-best templates for validation planning, risk assessments, Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs). We offer rapid, turnkey professional services for all chamber types including, but not limited to, refrigerators, freezers, ultra-low freezers, incubators, ovens, autoclaves, and warehouses.
Installation Qualification Services include:
- Preparation of Documentation (e.g. Standard Operating Procedures, Preventative Maintenance, Drawings, Manuals, and Qualification Protocol)
- Calibration Record of Devices Used in IQ
- Equipment Identification (e.g., Make, Model, Instrumentation Listing)
Operational Qualification Services include:
- Alarm Testing (e.g., low temperature, high temperature, etc.)
- Open Door Testing
- Power Loss and Recovery Testing
- Empty Chamber Temperature Mapping