Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Published: December 2021
Pages: 134

Executive Summary

This comprehensive second edition of the ISPE Good Practice Guide: Controlled Temperature Chambers offers updated best practices for the lifecycle management of temperature-controlled chambers, with a focus on GxP compliance. Covering design, qualification, maintenance, and eventual decommissioning, it provides critical guidance to ensure data integrity and product quality in regulated environments.

What You'll Learn

This guide provides detailed recommendations and industry-aligned practices for managing controlled temperature chambers, including:

• Risk-based approaches to specification, design, and qualification
• Integration of Good Engineering Practices (GEP) and Good Documentation Practices (GDP)
• Qualification and calibration strategies for temperature chambers
• Application of temperature mapping guidelines for ongoing monitoring and control
• Methods for lifecycle maintenance and change control
• Criteria for decommissioning and documentation archiving

Who Should Use This Guide

The guide is designed for professionals involved in the design, qualification, and maintenance of controlled environments within pharmaceutical and biopharmaceutical manufacturing, including:

• Engineers and facility managers overseeing temperature-controlled chambers
• Quality assurance and validation professionals
• Regulatory affairs teams responsible for compliance
• Project teams implementing new temperature-controlled systems

New in This Edition

The second edition includes significant updates and new content reflecting evolving regulatory expectations and technological advancements:

• Expanded guidance on implementing risk-based lifecycle approaches
• Updated temperature mapping strategies aligned with current best practices
• Clarified recommendations for calibration and qualification
• Enhanced focus on integration of computerized systems in chamber management

Conclusion

For organizations operating GxP-regulated storage and production facilities, this guide is an essential resource for ensuring the reliability and compliance of temperature-controlled chambers. Its lifecycle approach supports consistent performance and effective risk management.

The paper, Determining the Uncertainties Associated with Mapping, from the National Standards Authority of Ireland/National Metrology Laboratory (NSAI/NML) (Adobe PDF 599 KB), is being provided to accompany this Guide.

Guide Core Team

Michael Bradley

Validation Manager

Neurotech USA

Dean E. Rainbolt

Validation and Qualification Consultant

Environmental Growth Chambers (EGC)

Luca Arrighi

Principal Building Services Engineer - Life Sciences

Wood PLC

Paul Daniel

Sr. GxP Regulatory Expert

Vaisala Inc

Abhishek Garg

IPS

Derek Moss

Validation Engineer II

Fujifilm Diosynth Biotechnologies

Dinora Najera

Lead Software Quality Engineer

Alere

Sarah Pegington-Chow

NHS Blood and Transplant

Nathan Roman

Director / Industry Advisor / Global Brand Ambassador

Ellab

James Swann

Head of Validation

Seqirus

Shadreck Tasiyana

Engineering Manager

Wildlife Medicinal Cannabis (Pvt) Ltd

For the full list of contributors to this Guide see Guidance Document Teams