TEMPERATURE MAPPING STUDY OF COLD CHAMBERS, INCUBATORS, WAREHOUSES, TRANSPORT VALIDATION, STABILITY CHAMBERS & REFRIGERATORS FOR PHARMACEUTICAL INDUSTRY

The pharmaceutical industry places a lot of importance on the temperature mapping study of cold chambers, incubators, warehouses, transport validation, stability chambers, and refrigerators for the pharmaceutical industry. The majority of medications should be kept between 2 and 8 degrees Celsius, while those should be kept between 15 and 25 degrees Celsius. The therapeutic effects of the medication will gradually deteriorate if the temperature is raised over certain limits. Transportation is done in refrigerated vehicles, while storage is done in warehouses, cold rooms, or refrigerators. In order to determine whether the temperature inside such a facility is consistently maintained between the target temperature, an entire series of studies is conducted to examine the temperature distribution in a warehouse, cold room, refrigerator, van, or reefer truck.

1. SOP for Procedure for Operation and Cleaning of Walk in Type Incubator
2. Risk Assessment for Computer System of Stability Chamber
3. Risk Assessment Annexure -1 (Before Qualification)
4. Risk Assessment Annexure -2 (After Qualification)
5. Installation Qualification for Computer System of Stability Chamber
6. Operational Qualification for Computer System of Stability Chamber
7. System Requirement Specification for Computer System of Stability Chamber
8. Traceability Matrix for Computer System
9. Validation Plan for Computer System of Stability Chamber
10. Validation Summary Report
11. Transport Validation Protocol‘
12. Transport Validation Report
13. Temperature Mapping Protocol for Cold Chamber
14. Temperature Mapping Report for Cold Chamber
15. Temperature Mapping Protocol for Refrigerator
16. Temperature Mapping Report for Refrigerator
17. Temperature Mapping Protocol for BOD Incubator
18. Temperature Mapping Report for BOD Incubator
19. Temperature Mapping Protocol for Laboratory Incubator
20. Temperature Mapping Report for Laboratory Incubator
21. Temperature Mapping for Fill Bin Hold
22. Temperature Mapping Protocol for Cooling Incubator
23. Temperature Mapping Report for Cooling Incubator
24. Temperature Mapping for FG Store
25. Temperature mapping PPM Store
26. Temperature mapping RM Quarantine
27. Temperature mapping Tablet Quarantine
28. Temperature mapping Under Test & Approved RM Store Area
29. Transit Study Protocol cum Report
30. Protocol for Temperature Mapping of Softgel Dispensed Materials
31. Protocol for Temperature Mapping of Ointment Dispensed RM Hold Area