Validation

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Medical refrigerators and freezers are used in many industries to process and hold a variety of materials. In everything from safe storage of vaccines and biomedical products, to maintaining low temperature levels for processing materials in lab freezers, it’s important to ensure these systems are operating correctly. In operable functions within these systems can lead to unsafe materials in the hands of end users.

Similar to ovens and environmental chambers, refrigerators and freezers have a variety of components that need to be maintained or calibrated in order to ensure the system as a whole is operable. This is why it’s important to perform validation as a whole, and within industries such as life sciences, IQ/OQ/PQ protocol requirements are a must.

Cryomed Scientific knows the importance of all the components within medical refrigerators and freezers. Our team is experienced and equipped to perform full freezer validation which includes UKAS calibration of temperature controllers, chart recorders, freezer temperature alarms, temperature uniformity, and more.

For more information about refrigerator and freezer validation or to get a quote for service, fill out our contact form to get in touch with us.

Excellent Customer service is, and always shall be, our focus to reduce downtime to our clients’ equipment.

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Equipment Validation Protocols written and executed for

Fridges

Freezers

ULT Freezers

Liquid Nitrogen Systems

Co2 Incubators

Ovens

Constant temperature stability cabinets

Storage facilities

Water Purification Systems

IQ/OQ/PQ Qualification

Qualifications are a collection of instructions and gathered documentation used in the validation of temperature-controlled units. During validation, we can qualify a freezer by progressively performing the following:

Installation Qualification
Operational Qualification
Performance Qualification

Freezer IQ, OQ, PQ procedures accomplish specific objectives:

IQ determines proper freezer installation
OQ confirms freezer operation within pre-established parameters
PQ provides evidence of consistent, accurate performance

According to MHRA regulations, companies must demonstrate that freezer storage spaces meet temperature requirements. To gain this documentation, a temperature mapping will often be performed, along with the freezer qualifications. Cryomed Scientific brings highly accurate UKAS-calibrated sensors onto your site for Temperature Mapping. We utilize the appropriate number of sensors, based on the size of your cold storage space, to capture and document measurements.