Good Practice Guide: Controlled Temperature Chamber Mapping & Monitoring

Author(s): Arrighi, Luca; Bender, Denise; Bradley, Mike; Daniel, Paul; Glauser, Geoffrey; Harber, Paul; Haycocks, Nicholas; Leinhauser, Randolph; Flores, Elizabeth Martinez, CPIP; McMenamin, Matthew; Moss, Derek; Newton, Mark; Saxton, Brian W.; Vezina, Jean; Weaver, Christopher B.; Zemler, Mark

The ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring provides industry good manufacturing practices for the temperature mapping of controlled temperature chambers, along with development of test acceptance criteria and a risk-based approach to practices for periodic review of system performance. The approach described is consistent with that described in the ISPE Good Practice Guide: Cold Chain Management.

Guidance is provided on Controlled Temperature Chambers used to store raw material, work in progress, or finished product, and which operate under current Good Manufacturing Practices (cGMPs). A Controlled Temperature Chamber is defined as a system, unit, equipment, or room in which the environmental conditions (usually temperature) of a chamber are controlled, maintained, and regulated to meet specific user requirements.

Types of Controlled Temperature Chambers considered by this guide include:

• Purchased Commercial Off the Shelf (COTS) items (such as freezers, refrigerators, and incubators)
• Warm rooms designed to maintain consistent temperatures
• Ovens, and custom built units, such as controlled room temperature environments, e.g., warehouses, walk-in cold rooms and freezers. Freezers can be used for short to long term preservation of pharmaceutical and biopharmaceutical materials, e.g.:
  • Active Pharmaceutical Ingredients (APIs)
  • Process intermediates
  • Stability samples
  • Laboratory materials
  • Cell banks

Guidance is provided on the definition of the requirements (producing a user requirements document), design, purchasing, commissioning (including temperature mapping), qualification, and maintenance of controlled temperature chambers operating under cGMPs.

Benefits Provided by ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

There is an increased regulatory interest in cold chain driven by the growing number of products requiring controlled temperature shipping and storage, the complexity of the distribution network for the products and governmental requirements for distribution of vaccines.

This is reflected in the recent revisions to the related regulatory guidance. Utilizing the ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring provides a number of benefits in an area where there is little authoritative guidance, including:

• Provision of industry good manufacturing practices for the temperature mapping of controlled temperature chambers, considering the impact of load, and the use of the data to determine the location and number of monitoring sensors
• Development of test acceptance criteria
• A risk based approach to practices for periodic review of system performance

The paper, Determining the Uncertainties Associated with Mapping, from the National Standards Authority of Ireland/National Metrology Laboratory (NSAI/NML) ( 599 KB), is being provided to accompany the Controlled Temperature Chamber Mapping and Monitoring ISPE Good Practice Guide.