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Autoclave Qualification and Autoclave Validation Services

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.

We offer comprehensive autoclave qualification services to ensure compliance with UK, EU, USA, and other International Standards for steam sterilisation while maximising equipment efficiency and reliability.

BPV provides Autoclave validation services

Design Qualification (DQ)

Design Qualification (DQ): We assist in providing you with a documented verification that the design of a new autoclave is suitable for the intended purpose based on your autoclave requirements, ensuring that all necessary options and specifications are considered. This crucial step helps you avoid costly complications and ensures your autoclave is suitable for your specific needs.
In the context of the European Union, Design Qualification is a mandatory requirement under Annex 15. This regulation emphasises the importance of DQ in ensuring that the design of facilities, systems, and equipment aligns with Good Manufacturing Practice (GMP) principles and provides a solid foundation for consistent product quality and performance.

Installation Qualification (IQ)

Installation Qualification (IQ): We rigorously verify that the autoclave has been installed according to the approved design specifications and manufacturer recommendations.
This comprehensive review includes examining engineering drawings, inspecting all components, and obtaining necessary certifications to confirm the system is installed correctly. 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 specialises in Autoclave Operational Qualification (OQ), the documented verification process ensuring your autoclave operates as intended across the anticipated operating ranges. It Involves tests without the product, developed from the knowledge of processes, systems and equipment, to ensure the system functions as designed.
All electrical, mechanical, pneumatic, hydraulic, or other components are tested, where possible, to verify correct operation. Safety switches, alarms, and other safety or protective devices are also tested. In some cases, upper and lower operating limits are confirmed, as well as general automated processes.
Successful OQ completion enables the finalisation of standard operating procedures, cleaning procedures, operator training, and preventative maintenance requirements. Trust our expertise to document and verify that your autoclave performs as intended through the anticipated operating ranges.

BPV provides autoclave qualification services

Performance Qualification (PQ)

Performance Qualification (PQ): PQ tests the autoclave’s performance under real and worst-case conditions with the product. We check if the specified process requirements are met, considering factors such as temperature distribution and loading configurations. Tests are carried out in a suitable number of repetitions to demonstrate that consistent results are achieved. This step is essential to demonstrate the reproducibility of the sterilisation process.

Development Testing

Development Testing: In addition to autoclave qualification services, we offer development testing to optimise sterilisation parameters, cycle efficiency, and regulatory compliance. Our custom protocols are designed to evaluate autoclave performance across various operating conditions, helping you establish the optimal combination of temperature, pressure, and exposure time for your specific products and packaging materials. Trust our expertise to optimise your systems and ensure seamless operation.
Development testing can include: Setup of air detectors, induced leak rate valves, Bowie Dick cycle parameters, Porous/Fluids/Combination cycle development, Chamber cold spot mapping, Wet load/superheat investigation, steam quality testing and development.

BPV also provides protocol writing services, offering clear roadmaps for autoclave validation projects. We can customise protocols or work with your existing documents to streamline the validation process.

We use trusted equipment such as the Kaye Validator 2000 for a calibration for thermal validation. They are available for hire (please click here to see more). Establishing a regular validation schedule with BPV, we ensure that your autoclave equipment is consistently performing at its best and complies with manufacturer and industry specifications.
When changes occur, such as alterations to process parameters or components, we recommend re-validation to assess their impact on the overall process. This ensures that the autoclave continues to adhere to the established parameters and maintains its validated status.

BPV helps life science companies ensure that their autoclaves are properly validated, maintained, and operated in compliance with regulatory standards, such as those set by the FDA, EMA, and MHRA.

Choose BPV as your trusted UK validation service provider for autoclave qualification and thermal compliance. Our expertise and commitment to excellence will help you achieve regulatory compliance and maintain the highest standards in sterilisation.

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