8월 13, 2019 By Johannes Gross (3 minute read)
As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use. It establishes confidence that the equipment in a biorepository is capable of consistently operating within set limits and tolerances, and allows for conduction of tests to be performed on one element or component of the process to be validated against a specified outcome.
Now that we have a better understanding of the difference between Qualification and Validation, let’s expand our knowledge of the four equipment qualification stages.
The four qualification stages help determine if the process being tested is capable of operating in its specific environment. They include:
Design Qualification (DQ)
As part of freezer design qualification it is important to assess freezer capabilities such as temperature range, size, capacity and power needs, ease of use and, of course, manufacturer warranty and support. This qualification element helps us outline why each particular freezer is selected for use.
It is essential to utilize a freezer which is manufactured of high quality and with suitable material; this requirement can be evaluated under this qualification. The freezer construction materials should not present any hazard to the biological product being stored within. It should also not react with the materials or product or absorb any substance in the product or material. For example some freezers have plastic liners, and some plastic contains plasticizers that may leach onto products. Therefore, it is essential to evaluate such attributes and ensure that the product should not absorb anything from the equipment nor react with it. It is the qualification stage where user requirements should be considered when deciding on the specific design of a system or equipment.
Installation Qualification (IQ)
This qualification testing element focuses on specific information surrounding freezer placement and receipt at its site of operation. The testing details should focus around the condition of the freezer on arrival, assess for expected electrical specifications such as correct voltage, amperage and to see if the equipment is correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges and other components. Measuring, control and indicating devices should be calibrated against appropriate national or international standards, which are traceable. Make sure to include and capture details such as the ones listed below where possible:
Operational Qualification (OQ)
This qualification testing element should focus on testing specific manufacturer claims such as:
This qualification stage verifies that the equipment operates consistently within established tolerances over the defined operating ranges (mostly temperature). This stage of the qualification can also be utilized to test critical variables encompassing upper and lower operating limits and circumstances (i.e. “worst case conditions”), while challenging the equipment functionally to verify compliance with manufacturer’s specifications and end – user defined requirements if any.
Performance Qualification (PQ)
In today’s world we have more freezers which allow us various programmable options for temperature, thus it is critical we assess the specified temperature curves. Performance qualification is where we look to see if the freezer being tested is performing consistently. We also verify that the equipment performs according to design specifications and user defined requirements in a reliable and reproducible manner under normal production conditions.
Throughout the four stages of equipment qualification there is a common theme—quality! It is imperative that the equipment used to store your precious material is qualified by standards that will not have a negative impact on the material. By implementing the four stages of equipment qualification, you can take the necessary steps to educate yourself on important items to consider prior to purchasing a freezer and storing your valuable material.
To learn more about maintaining temperature throughout logistical activities, download my eBook Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics.
Johannes joined Fisher Clinical in 2013 as Director, Quality and Regulatory Affairs. Prior to joining Fisher Clinical, Johannes was the Sr. Director, Program Management (PMO) at QIAGEN. Johannes has over 30 years of commercial diagnostics and pharma experience.