Temperature Mapping for Storage Environments
We provide precise temperature mapping for pharmaceutical warehouses, refrigerators, and freezers to ensure GMP storage compliance. Our mapping protocols help manufacturers maintain consistent conditions, safeguarding product integrity and regulatory readiness.
Thorough Cold Storage Temperature Mapping
We perform temperature and humidity mapping studies for refrigerators, freezers, and pharmaceutical warehouses. These studies confirm uniform environmental conditions and provide documented evidence for GMP storage compliance.
Detailed Mapping Studies
Using both wired and wireless validation equipment, we design mapping protocols that capture real-time performance across worst-case scenarios. This includes identifying hot and cold spots, seasonal variability, and system recovery after door openings or power interruptions.
Regulatory Compliance and Documentation
Our reports meet FDA and EU GMP expectations, with complete data sets, risk assessments, and validation summaries. Each report is formatted to integrate into your quality management system and support audits or regulatory inspections.
1. Planning & Alignment
We define study scope, risk categories, and regulatory expectations, tailoring protocols to FDA and EU GMP storage compliance.
2. Commissioning
CTUs are checked for proper installation, calibration, and functionality before mapping begins.
3. Risk Assessment
Storage conditions are reviewed to determine sensor density, placement, and worst-case scenarios.
4. Qualification (IQ/OQ/PQ)
Mapping studies are executed under baseline, seasonal, and worst-case load conditions.
Our Process
FAQS
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