PROJECTS

Temperature Mapping Project

Client: leading company in the logistics sector

Sector: Pharmaceutical industry

Objective: to ensure the maintenance of the correct thermo-hygrometric conditions necessary to guarantee the quality and effectiveness of pharmaceutical products

Project

The client company is a leader in the logistics sector, especially in the pharmaceutical sector.

The company needed to perform temperature mapping of warehouses, cold rooms and/or other environments.

The aim is to demonstrate the capability of monitoring and control systems to ensure the maintenance throughout the year of correct thermo-hygrometric conditions necessary
to guarantee the quality and efficacy of the pharmaceutical products stored there.

Our contribution

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)

3. Data recording and analysis.

Once the mapping period was completed, the S4BT Team recorded and analysed the data collected by the
individual measurement chains

4. Drafting of the final report. The purpose of the final report was to:

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.

Result

Preserving the quality, integrity and efficacy of pharmaceuticals plays a crucial role in all phases of the life cycle, from production to distribution.

The temperature mapping activity ensured full compliance with the regulations and the respective guidelines and met all the needs and expectations of the customer.

The documentation produced also allowed the company to successfully pass inspection by regulatory agencies and customers, thereby increasing its visibility.