Astell Scientific™ IQ/OQ Documentation Service

Description

• 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.
• In the heavily regulated pharmaceutical industry, accuracy and repeatability are imperative to both research and production.
• Validating an autoclave with IQ/OQ/PQ benchmarks the installation, operation and performance of the autoclave from the design specifications and manufacturer recommendations.
• The IQ/OQ 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 and ISO 13485:2012 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 sterilization process will be performed consistently.
• IQ/OQ can be especially valuable where a custom built autoclave is requested. Astell™ has 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.