The Critical Role of Temperature Control in the Life Sciences Industry

The Importance of Temperature Control

Temperature is a fundamental parameter to control, particularly when it comes to food and drug products. These products require storage and transportation within predetermined conditions, for instance, between 2°C and 8°C. The handling, transportation, and storage of these products necessitates measures that decrease the risk of exposure to temperature excursions. According to the FDA, adherence to the Current Good Manufacturing Practices (cGMP) is mandatory to uphold the safety, quality, and efficacy of these products. For temperature-dependent drug products or samples, storage temperature plays a crucial role in maintaining these critical attributes.

Regulations mandate that manufacturers in healthcare industries, pharmaceutical companies, and research laboratories employ equipment, systems, and processes that are current and fit for purpose.

Understanding Controlled Temperature Chambers (CTC)

The Controlled Temperature Chambers (CTC) used to store drug products need to be qualified. Equipment like freezers, refrigerators, incubators, and walk-in cold rooms are commonplace, yet their maintenance and compliance involve complex procedures.

A manufacturing facility or a research laboratory operating in the Health and Life Science Industry must meet regulatory requirements – a task that is far from straightforward. To ensure that products are manufactured and delivered safely under rigorous regulations and standards, it's imperative to find the best way to comply.

Each firm is responsible for selecting suitable equipment used in research and development, manufacturing, or storage to produce, distribute and store quality products in accordance with CGMP.

Key Characteristics of Qualified Equipment

Qualified equipment should exhibit several characteristics, such as:

• Proper maintenance
• Alarm systems
• Absence of excess frost buildup
• Adequate air distribution and organized storage within the chamber
• Sensors for continuous monitoring
• Alarms positioned at the points representing the temperature’s worst-case scenarios
• Calibration as required by a calibration program
• Backup power or alternate storage availability in case of a power failure
• Commercial-grade equipment, not of household type

For those aiming to meet regulatory requirements, regulators emphasize the need to perform temperature mapping on controlled temperature storage units.

Validation: Proving the Process Ensures the End Product

Qualification of storage environments must be undertaken to ensure conditions align with the stability requirements of the products. This qualification is also mandated by international standards to ensure products are always stored and distributed within the specified temperature limits.

To demonstrate that proper environmental conditions and temperature and/or humidity controls are achieved, qualification and/or validation must be carried out.

Temperature Mapping studies should be conducted regularly as part of the equipment installation and operational qualification (IOQ) to verify that the controlled temperature chamber is capable of accurate and repeatable performance.

Temperature Mapping Studies: Equipment Qualification

A properly developed qualification protocol helps ensure the equipment meets all documentation requirements and performs as expected, including successfully carrying out the temperature mapping study.

A reliable validation service provider can assist in determining whether your qualification protocol is sufficient or help you create a protocol to meet your needs.

A protocol generally includes a documented approach to conduct the qualification process, along with the procedure, scope, equipment description, responsibilities, test method, IQ/OQ/PQ test scripts, acceptance criteria, report, and approval.

For better understanding of these concepts, the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) offers guidance on commissioning and qualification, temperature mapping, periodic reviews, and provides examples and sample templates.