Stability Chamber and Incubator Validation for Temperature-Controlled Solutions
Our experienced technicians perform validation services for various types of critical temperature-controlled units, from stability climatic chambers to simulate extreme environments to laboratory incubators crucial for creating lab-controlled environments, particularly for growing cultures. Transcat’s quality services help to ensure that your equipment meets critical temperature and control specifications before it is used to hold pharmaceuticals, lab samples, or product materials.
Qualifications for Temperature Validation
As part of our validation procedures, we can conduct IQ, OQ, and PQ controlled-temperature testing that fully covers your stability chamber or incubator qualification requirements.
Our Installation Qualification (IQ) services ensure that your unit is installed and operating properly. The IQ can also evaluate the environment where the storage unit is located.
Operational Qualification (OQ) will:
- Test a container’s controls and monitoring features
- Ensure the unit has been calibrated
- Verify applicable alarms associated with the unit
The Performance Qualification (PQ) consists of temperature mapping services.
Data is collected during both an empty state and a loaded state. Additionally, data is collected on temperature recovery following specific events, such as opening doors or power losses.
Transcat gathers temperature mapping results using highly reliable NIST-traceable data loggers and temperature probes.
Faster Cycle Times
- Electronic Routing for Review/Approval
- Instantly route across departments, buildings, and remote locations
- Eliminates delays to ship physical hard-copy records
- Remote worker friendly
- Equipment is qualified and back in service ahead of slower hard-copy processes
Transcat Ireland Services for cGMP Compliance
At Transcat, we can customize testing protocols to cGMP compliance requirements and your quality processing standards. We can also use protocols that have been previously established by your quality department. Our technical experts regularly called on to conduct accurate validations for pharmaceutical, food service and medical industry cold storage. For validation information tailored to your unit, request a quote from Transcat today.