Autoclave Validation Services

Performance Qualification (PQ)

Performance qualification tests the autoclave’s performance under worst case conditions with the product and is the final stage in autoclave validation. During this stage, we check if the specified process requirements are met, assessing various factors such as temperature distribution, Biological Indicator (BI) kill, 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. Successful completion of PQ allows the finalisation of standard operating and cleaning procedures and operator training.

Autoclave Development Testing

In addition to autoclave validation services, we also 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.

Development testing can include:

• Setup of air detectors and induced leak rate valves;
• Bowie dick cycle parameters;
• Porous, fluids, or combination cycle development;
• Cycle development for packaging integrity;
• Cold spot mapping;
• Wet load or superheat investigation; and
• 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 thermal validation. They are available for hire (please click here to see more). By establishing a regular validation schedule with BPV, we will collect evidence to ensure that that your autoclave 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.

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

Autoclave validation is carried out by using chemical and biological indicators to confirm that an autoclave is functioning correctly and is consistently achieving the desired level of sterilisation. It involves a series of tests and documentation which ultimately verifies that an autoclave meets the required performance and regulatory standards.

Our autoclave validation services are essential for any businesses operating in highly regulated environments such as pharmaceuticals, biotechnology, healthcare, medical device manufacturing, and food production. If your operations rely on sterilisation to meet compliance standards or ensure product safety, professional autoclave validation is vital for your business. To ensure your sterilisation processes meet industry and regulatory standards, reach out to us today. Our expert team is ready to support your autoclave validation needs.

Product Safety

In pharmaceuticals, biotechnology, and healthcare settings, reliable sterilisation is crucial for patient safety and infection prevention. Autoclave validation is key here, as it confirms the safety and efficacy of products.

Compliance and Risk Management

Meeting regulatory requirements through validation reduces the risk of penalties and legal issues, ensuring that the autoclave is operating in accordance with industry standards.

Efficiency

Our experienced autoclave validation experts can help with streamlining your validation process by providing customised solutions, efficient methodologies, and regulatory expertise, saving you time and resources.

Cost Savings

By optimising equipment performance and preventing unexpected errors or breakdowns, autoclave cycle development and subsequent validation can lead to significant cost savings in the long run.

Arranging our autoclave validation services is an easy and straightforward process tailored to meet your regulatory and operational needs. Our expert team is here to guide you through each step, from project scoping to execution. We work closely with you to ensure full compliance, data integrity, and time efficiency.

To take advantage of our team’s expertise in autoclave validation, contact our friendly team to schedule a consultation to define your scope, timelines, and deliverables based on your business and regulatory objectives.

Bio Products Validation Ltd (BPV) was established to offer the best level of validation services within the UK and Ireland life science industry. With a dedicated team of validation engineers and consultants, BPV’s team has provided services to the life science industry since 2005. Sterilisation is one of our specialist areas, led by our sterilisation subject matter expert (SME) who has extensive experience of validation testing in this area.

As a company, our engineers have over 100 years of combined experience working on a variety of validation projects, small and large, across the pharmaceutical and life science sectors.

We understand that every company’s needs are different, so we will work with you to achieve your desired goals and outcomes efficiently.

Our experienced validation engineers can reduce your project timelines and overall costs by streamlining your processes and we can quickly scale our resources to meet your changing demands. BPV is a trusted name in the industry; our team is fully versed in cGMP and GxP regulations and boasts an unwavering commitment to excellence and customer satisfaction which truly sets us apart.