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New ISPE Guide Includes Updated Guidance for Controlled Temperature Chambers

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Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Good Practice Guide: Controlled Temperature Chambers 2nd Edition

“This Guide provides the information of how successful practices are being used today to safely store samples and to meet compliance objectives with regulatory agencies,” said Dean Rainbolt, Technical Applications Manager/ Controlled Temperature Technologies Division, Thermo Fisher Scientific.


NORTH BETHESDA, Md. (PRWEB)

The International Society for Pharmaceutical Engineering (ISPE) announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition). This Guide was written to meet changing industry practices, as global distribution of medicines requiring controlled temperatures has increased in complexity since the first edition of this Guide was published.

This edition is now aligned with the ISPE Baseline® Guide, Volume 5 – Commissioning and Qualification (Second Edition). Revising the Guide provided the opportunity to consider a periodic review based on the risk of failure to maintain uniform temperature and criticality of product stored rather than a standard, one-size-fits-all time span. In addition, the Guide was expanded to include ultra-low freezers, decommissioning a unit, and ocean reefers.

“Whether you are new in the business of storing samples, a university looking for answers for small scale storage or have been doing this for years and are going through the process of benchmarking to assure alignment with the industry, this Guide provides the information and ‘real world’ examples of how successful practices are being used today to safely store samples and to meet compliance objectives with many regulatory agencies,” said Guide Co-Lead Dean Rainbolt, Technical Applications Manager/ Controlled Temperature Technologies Division, Thermo Fisher Scientific. “This Guide will save you time and money by not having to re-invent the wheel and provides a strong starting point to building most any sample storage operation.”

Topics presented include the definition of requirements (producing a user requirements document), design, purchase, commissioning (including temperature mapping), qualification, and maintenance of CTCs used to store and transport raw material, Active Pharmaceutical Ingredient (API), Work in Progress (WIP), and finished product.

In an area with little authoritative guidance, this Guide can provide several benefits, including:

  • Provision of industry good practice for the temperature mapping of CTCs, considering the impact of load, and the use of the data to determine worst-case locations and number of monitoring sensors

  • Development of test acceptance criteria

  • A risk-based approach to periodic review of system performance


Purchase the ISPE Good Practice Guide: Controlled Temperature Chambers (Second Edition) online at ISPE.org/Publications/Guidance-Documents, among ISPE’s other detailed education resources on a variety of industry topics.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000+ Members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

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