Autoclave Validation and Qualification
We offer comprehensive autoclave validation services to ensure compliance with UK, EU, USA, and other International Standards for steam sterilisation. We also offer development testing for autoclaves to maximise equipment efficiency, reliability, and compliance.
As a professional provider of validation and qualification services for the pharmaceutical industry, BPV understands the critical importance of ensuring that your manufacturing, laboratory, and medical autoclaves operate safely and reliably whilst maintaining peak performance levels.
To benefit from a flexible, cost-effective, and hassle-free solution, get in touch with us today to learn more about BPV’s autoclave validation services and how they can be tailored to your specific project requirements.
Design Qualification (DQ)
Our design qualification services provide you with documented verification that the design of a new autoclave is suitable for its intended purpose, based on your requirements, ensuring all necessary options and specifications are considered. This crucial step helps you to avoid costly complications and ensures your autoclave suits your specific needs.
In the EU, design qualification is a mandatory requirement under Annex 15, emphasising the importance of DQ in ensuring the design of facilities, systems, and equipment aligns with GMP principles and provides a solid foundation for consistent product quality and performance.
Installation Qualification (IQ)
Installation qualification is a key component in autoclave validation and is often the first stage of validation after receiving a new autoclave on site. During this stage, we rigorously verify that the autoclave has been installed correctly, according to the approved design specifications and manufacturer recommendations.
This comprehensive review includes examining engineering drawings, inspecting all components, and reviewing the necessary certifications to confirm the system is installed correctly against pre-defined criteria. At this stage, materials of construction, accuracy of documentation, placement, wiring, piping are reviewed. Importantly, we also collect and review the supplier’s operating procedures and maintenance requirements, allowing for detailed schedules to be developed for maintenance, calibration, and validation.
Operational Qualification (OQ)
BPV offers autoclave operational qualifications, providing documented evidence that your autoclave operates as intended across the anticipated operating ranges. Operational qualification involves tests conducted without the product, developed from the knowledge of processes, systems, and equipment, to ensure the system functions as designed.
Where possible, all electrical, mechanical, pneumatic, hydraulic, or other components are tested to verify correct operation. Safety switches, alarms, and other safety or protective devices are also tested. In some cases, upper and lower operating limits and general automated processes are confirmed. Successful operational qualification completion enables finalising standard operating procedures, cleaning procedures, operator training, and preventative maintenance requirements.