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IQ/OQ/PQ AUTOCLAVE VALIDATION SERVICES

An explanation of the different types of validation qualification in the context it ensures the desired outcome is always met, i.e. sterilization of the load
of autoclave sterilizers. placed in the autoclave chamber.

What is IQ/OQ/PQ and how is it relevant to your autoclave?

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

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