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.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.
Dean E. Rainbolt
Environmental Growth Chambers (EGC)
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