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New Guide Helps Ensure Sample Safety in Controlled Temperature Chambers

Dean E. Rainbolt
ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping & Monitoring

ISPE published the 2nd Edition of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring in December. The international team of experts working on the revision felt it was time to update the Guide due to the increasing complexity of global distribution for medicines requiring controlled temperatures.

ISPE Good Practice Guide: Controlled Temperature Chambers 2nd Edition

The new Guide provides guidance on the lifecycle management of GMP controlled temperature chambers from creating a user requirements document to decommissioning a unit. The controlled temperature chambers discussed in this Guide range from purchased commercial off-the-shelf items such as freezers and refrigerated delivery vehicles, to walk-in cold rooms and walk-in freezers, to custom-built units such as warehouses. The risk-based approaches covered include commissioning, temperature mapping, and periodic review, along with examples and sample templates.

  1. Why is it important to commission, qualify, map, and monitor Controlled Temperature Chambers? What are potential ramifications if these activities are not done properly?

    Sample safety should be priority #1. The best way to ensure sample safety is to store samples in a properly commissioned, qualified, and mapped Chamber. Once a chamber is qualified, with the monitoring probe(s) appropriately located within, internal conditions can be monitored to ensure that samples always remain safe and chamber conditions are collected and saved for future reference. Failure to utilize a robust and repeatable qualification procedure or protocol that includes strict documentation practices and qualified monitoring, may lead to failed audits and possibly sample loss.

  2. What are the main updates or changes in the new edition?

    One of the most significant changes included in the new edition is information about improved commissioning and qualification activities which should result in more efficient processes. We updated several examples to reflect current practices around the globe and regulations have been checked to be sure we are current, and the document better aligns with the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition). We also include information about determining the periodic review frequency based on risk of failure to maintain uniform temperature and criticality of product stored

    Additional revisions include: expanded description of freezer types to add ultra-low freezers and duration of storage needs, discussion on how materials of construction may impact cold rooms, descriptions of GxP storage facilities and warehouses, and enhanced descriptions of monitoring systems.

  3. Why should someone in the pharmaceutical industry purchase the Guide? Are there common mistakes companies make that this Guide will help them avoid?

    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 successful practices being used today, right now, to safely store samples and to meet compliance objectives with many regulatory agencies. This guide will help you save time and money by not having to re-invent the wheel and provides you with a strong starting point to building most any sample storage operation.

  4. Are there any key takeaways from this Guide you would like us to highlight?

    Quite a bit of effort was put into the alignment of chapters so the guide flows well from beginning to end. Even though you can quickly go to a chapter topic that is most important to you for a quick reference, the progression of chapters now more than ever reflect the natural progression of activities to consider to be successful at chamber mapping and monitoring.

  5. To your knowledge, is there other guidance like this available?

    Not that I know of. Not in this detail. ISBER does go into some detail regarding storage but it’s for biobanking application mostly.

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