How to Qualify an Incubator: A Comprehensive Guide

Before diving into the qualification process, it’s essential to understand the different types of incubators commonly used in laboratories and their specific purposes.

CO2 incubators are typically used for cell culture applications that require controlled CO2 levels, maintaining precise CO2 concentration, temperature, and humidity to create an optimal environment for cell growth.

Bacteriological incubators are designed for the cultivation of bacteria and other microorganisms, providing a stable temperature environment without CO2 control. Other types include BOD (Biochemical Oxygen Demand) incubators, which maintain low temperatures for microbial activity, and shaker incubators, which combine incubation with shaking to promote the growth of cell cultures.

In addition to incubators, stability chambers play a crucial role in stability testing, ensuring that products remain safe and effective throughout their shelf life. These chambers generally come in two sizes: reach-in chambers and walk-in chambers. Reach-in chambers are compact, cost-effective, and suitable for smaller scale stability studies, featuring shelves for sample storage. Walk-in chambers, on the other hand, are larger and designed for extensive sample storage, making them ideal for long-term studies where conditions remain constant. Both types of chambers are essential for maintaining precise control and accuracy in stability testing.

Stability chambers and incubators must undergo qualification at three stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These stages ensure the equipment is correctly installed, operates as intended, and performs reliably under actual conditions.

Installation Qualification (IQ)

During the Installation Qualification stage, it is essential to verify several aspects:

• Correct installation of the chamber and its components: This includes checking that the equipment matches the details on the purchase order, such as model, serial number, and specifications.
• Utility requirements: Ensure that the incubator’s utility requirements meet the manufacturer’s specifications and that the installation site meets the environmental conditions specified by the manufacturer.
• Proper positioning: Verify that the incubator is level and positioned with adequate clearances, as per the manufacturer’s guidelines.
• Instrument calibration: All instruments must be calibrated according to NIST standards with current calibration certificates.

Operational Qualification (OQ)

Operational Qualification involves testing the individual functions of the chamber, including switches, controls, alarms, and doors. Sensor calibration is also checked if not covered during IQ.

Key steps include:

• Alarm testing: Test high and low-temperature alarms by manipulating sensor conditions.
• CO2 conditions: Simulate high and low CO2 conditions to verify the alarm function for CO2 incubators.
• Empty temperature uniformity study: Position at least nine thermocouples throughout the incubator to monitor temperature uniformity, collecting data at regular intervals over a period of at least 24 hours.
• Power failure and door opening study: Conduct a study at the end of the mapping to calculate the average recovery time after door openings or power failures.

Performance Qualification (PQ)

Performance Qualification involves conducting a full-load thermal and humidity mapping using the same sensor configuration as in the empty chamber study for 24 hours. PQ ensures the chamber performs consistently under actual operating conditions. Requalification helps ensure the chamber continues to perform as expected over time. If there are changes in temperature or humidity set points, both empty chamber and full-load studies should be repeated with the new settings.

Initial Qualification and Structured Approach

When acquiring new stability chambers or incubators, the initial qualification can be purchased from the vendor, a validation service provider, or performed internally by the validation team. The qualification process follows a structured approach:

1. Establish operational conditions based on user requirements specifications.
2. Prepare IQ/OQ/PQ protocols with clear acceptance criteria.
3. Perform IQ to verify installation and documentation.
4. Conduct OQ to test all functions and perform empty chamber mapping.
5. Execute PQ to validate performance with a full load and requalify as required.

By following these steps, you ensure that your stability chambers or incubators are properly qualified, thereby maintaining compliance and guaranteeing the integrity of your operations. This systematic approach helps achieve reliable and accurate results, ultimately ensuring the quality and safety of pharmaceutical products.

Despite thorough qualification procedures, several common challenges can arise. Sensor calibration drift is a frequent issue, necessitating regular recalibration to maintain accuracy. Environmental fluctuations, such as changes in room conditions, can also impact incubator performance, requiring stable conditions to ensure optimal operation. Additionally, alarm system malfunctions can pose significant risks, making periodic checks essential to ensure alarms function correctly.

Adhering to relevant industry standards is crucial for ensuring the proper qualification of incubators and stability chambers. Key guidelines include the ISPE Good Practice Guide for Controlled Temperature Chamber Mapping & Monitoring, relevant chapters from the United States Pharmacopeia (USP), and the World Health Organization (WHO) guidelines for storage and handling of biological materials. Additional resources such as Nathan Roman’s “Six Steps to Effective Temperature Mapping” provide detailed insights into temperature mapping procedures and best practices, while Steven Lauver’s “Calibration Program Management” covers the essentials of calibration management.

Properly qualifying an incubator is essential for maintaining accurate and reliable laboratory conditions. By following detailed installation procedures, conducting rigorous operational tests, addressing common challenges, and adhering to industry standards, professionals can ensure that their incubators operate within specified parameters and meet regulatory requirements. This process guarantees the integrity of research and production activities, safeguarding the reliability and reproducibility of experimental results.

At Ellab, we recognize the complexities and challenges that global life science companies face. As your trusted compliance partner, we are dedicated to efficiently managing operational risks, ensuring enhanced control, and delivering greater predictability. Connect with your local team to explore how we can support your compliance needs.