An explanation of the different types of validation qualification in the context of autoclave sterilizers.
What is IQ/OQ/PQ and how is it relevant to your autoclave?
Validation of a new steam sterilizer is required to verify that the unit is capable of delivering the tasks and performing to the parameters set out in the original URS. For example, in the heavily regulated Pharmaceutical industry, accuracy and repeatability are imperative to both research and production.
Why do I need an installation qualification or operational qualification for a laboratory sterilizer?
By validating an autoclave with IQ/OQ/PQ it benchmarks the installation, operation and performance of the autoclave from the design specifications and manufacturer recommendations. By following the validated processes, it ensures the desired outcome is always met, i.e. sterilization of the load placed in the autoclave chamber.
IQ stands for Installation Qualification
Installation Qualification of an autoclave is to determine the supplied unit meets the manufacturer’s specification (FS). This can be as simple as identifying key tasks in the manufacture, or providing a fully comprehensive package of every step of the manufacturing process. This will prepare the way for a successful operational qualification of the sterilization equipment. Procedures to do with maintenance, cleaning and calibration can be part of the Installation Qualification. These are usually referred to as Standard Operating Procedures, also known as SOPs.
OQ - Operational Qualification
Operational Qualification for an autoclave is an essential step during the development of a defined sterilization process. OQ can be explained simply as a series of tests that ensure the autoclave will operate within specified limits or parameters consistently and repeatedly, always giving the same outcome. For example, maintaining a specified temperature value for a predetermined amount of time to achieve sterilization. If there are any deviations from this the equipment engineers will determine and rectify the cause of the problem.
PQ - Performance Qualification
Performance Qualification is what determines how effective the sterilizer is to sterilize the loads specified in the customers URS. In production manufacturing terms it is typically used to establish if the sterilizer performs to the same parameters set in OQ but with the loads added. PQ would normally set out the types of loads to be sterilized, the time and temperature and how the sterilizer must be loaded if the performance is to be repeated cycle after cycle.
Where PQ is required, it should be carried out by both the equipment manufacturer and the end user. Astell can provide multi-point (12 Pen) validation by one of our fully trained validation engineers in accordance with UKAS 17025:2005 standards.
IQ/OQ option for Astell autoclaves
Astell is able to offer full IQ/OQ/PQ Validation packages including:
- User Requirement Specification (URS)
- Design Specification / Technical quotation (DS)
- IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification)
- Document package including all required information
- PQ will need to be developed together with the customer once exact loads are identified.
The IQ/OQ/PQ option can be specified on any Astell circular or square section autoclave. The IQ documentation includes as a minimum details of calibration equipment, an order acknowledgement, PED (Pressure Equipment Directive) compliance, a Declaration of Conformity, FAT (Factory Acceptance Test), a drawing schedule, ISO 9001:2015 certification, pressure vessel specification and door safety checks. The OQ documentation includes an Automatic Control Test sheet (per cycle) and Chamber Temperature Distribution (per cycle).
Specifying IQ/OQ with your next autoclave will give you peace of mind, as it establishes documented evidence that shows a high degree of assurance that the sterilisation process will be performed consistently. It can be especially valuable where a custom built autoclave is requested. Astell have the experience and knowledge to help a customer spec. the equipment they need and write protocols to exact customer specifications. For more information please Contact us.
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