Temperature Mapping Project

The company entrusted the project to the S4BT Equipment & Facilities Qualification Team.

To achieve the objective, the S4BT Team divided the project into the following phases:

1. Inspection. During which S4BT Consultants undertook the following activities:

• a tour inside the warehouse and the temperature-controlled environments in order to identify critical issues in terms of temperature (thermal bridges, openings, glass surfaces, etc.)
• analysis of existing documentation (SOPs of use and management of temperature and/or humidity controlled areas, maintenance and calibration plans, calibration certificates, layout with the positioning of measurement chains
  installed for continuous monitoring of thermo-hygrometric conditions)
• analysis of the system for monitoring and controlling thermohygrometric conditions

2. Drafting of mapping protocols.

Based on the information obtained during the inspection, the S4BT Team prepared mapping protocols containing:

• a detailed description of the warehouse and/or temperature-controlled rooms being mapped
• purposes of mapping and other related activities
• The rationale and/or risk analysis identifying the critical points in terms of temperature (the points at which the data-loggers were positioned)
• a detailed description of all tests to be performed (documentation verification, procedure verification, positioning, programming and calibration of measurement chains used for mapping and where applicable recovery time and door opening tests)

• summarise all tasks performed including any deviations identified during testing
• highlight the critical elements (cold spots and hot spots) in terms of temperature identified during the mapping period
• certify – in the event of a positive outcome of the mapping activity – the suitability of the temperature controlled warehouse and/or area for use as a storage site for pharmaceutical products.