New ISPE Guide for Controlled Temperature Chambers
Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) Now AvailableISPE 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.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
Thermo Fisher Scientific
Topics presented include the definition of requirements (producing a user requirements document), design, purchase, commissioning (including temperature mapping), qualification, and maintenance of Controlled Temperature Chambers used to store and transport raw material, Active Pharmaceutical Ingredient (API), Work in Progress (WIP), and finished product.
Controlled Temperature Chambers Guidance
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
ISPE is committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.
ISPE was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals. The much-needed forum provided by ISPE began with a Membership of engineers in North America. In time, ISPE Membership expanded beyond engineering to include a broad representation from pharmaceutical professionals.
We lead and facilitate the development of next generation process technologies and innovative technical solutions. On matters of regulation, our focus is on those requirements that impact — or will impact — the licensing of facilities, manufacturing processes and operations, and the sustainability of the supply chain over the product lifecycle. ISPE provides a neutral environment where our individual Members and experts belonging to Regulatory Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.