Temperature Mapping:
A risk-based approach to document temperature distribution in storage facilities
GDP compliant, End-to End-solution, GMP compliant document package
BACKGROUND
Need for increased storage capacity in API storage freezer room.
Storage racks needed to be implemented to optimally use vertically higher storage locations without interrupting proper air flow.
Need to map temperature in new upper locations of freezer room with product present.
Need to perform seasonal mapping during summer conditions (hot ambient temperatures).
Enhanced compliance level for temperature mapping was needed.
Need to use temperature loggers with better data resolution and analysis possibility.
Benefit
Optimized placement of storage racks with increased storage capacity and proper air flow.
Storage locations with temperature excursions identified (and hence could be avoided).
Permanent temperature probes were relocated to new hot and cold spots.
Temperature mapping with high level of GDP compliance was performed.
Enhanced data resolution using sensitive and robust temperature loggers.
Services
Project Management of storage racks implementation
Temperature mapping.
Coordination with client staff: user representatives, technical specialists, QA and others.
Provision of loggers and identification of mapping locations with rationales for each location.
Temperature mapping in compliance with regulatory requirements and client SOPs.
Root cause identification, correction and prevention (CAPA).
Complete GMP documentation (mapping protocol, report and deviations) delivered using client templates – all the way through QA approval.
contact for this case
Anders Helmer Nielsen
Mobile: +45 5099 8328
Email: ahn@amgroup.dk
