EQUIPMENT VALIDATION SERVICES

As specialist equipment validation services providers, our expert team is widely experienced in validating equipment used in manufacturing processes to ensure it meets all necessary regulations and safety levels, while also achieving optimal performance.

We can provide comprehensive validation services on all types of manufacturing and laboratory equipment. With some equipment, we can also complete commissioning, qualification, and validation (CQV) services.

Equipment Validation Services can include:

Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ); these are the critical components that guarantee the safety, reliability and consistency of the equipment.

Our UK validation service consultants and validation engineers will validate and determine whether new instruments or equipment are installed correctly and perform according to the specified requirements. These qualification checks ensure that manufacturing equipment delivers consistent results and meets regulatory standards.

To benefit from a flexible, cost-effective, and hassle-free solution, get in touch with us today to learn more about BPV’s equipment validation services and how they can be tailored to your specific project requirements.

Installation Qualification (IQ)

We follow rigorous Installation Qualification (IQ) protocols to confirm and document that equipment is correctly installed and complies with the approved design and manufacturer’s recommendation. Our stringent IQ validation service evaluates many areas, including verification using engineering drawings to confirm the correct installation of equipment and pipework; calibration; verification of the materials of construction; utilities; accuracy of documentation; placement; and standard operating procedures (SOP).

Operational Qualification (OQ)

Our Operational Qualification (OQ) testing ensures that manufacturing equipment operates as intended and within approved operating ranges. Operational Qualification involves tests without the product where any electrical/ mechanical/ pneumatic/ hydraulic components are assessed to verify correct operation. In this stage, safety switches, alarms and other safety and protective devices are tested. In some cases, upper and lower operating limits are confirmed, and general automated processes are tested.

Performance Qualification (PQ)

Bio Products Validation Limited offers Performance Qualification (PQ) services, where we verify and document that the equipment can perform reliably and effectively in the intended use, based on the approved process method and product specification. Our PQ includes tests using production materials, qualified substitutes or simulated products/ items proven to have equivalent behaviour under normal operating conditions with worst-case batch sizes/conditions. During this stage, worst-case load sizes for products are determined alongside tests covering the whole operating range. Units or processes are tested in their intended use with their intended routine challenges.
Tests are carried out over a suitable number of repetitions to demonstrate consistent results, which may involve product sampling.

At BPV, we ensure that all equipment meets industry standards and regulatory requirements. We take pride in delivering top-quality services to our clients to ensure their equipment is safe, effective and compliant.

Provider of CQV and Equipment Validation Services in the UK

Example Equipment Types Validated by Our Services

Autoclave Validation

We provide autoclave commissioning, qualification, and validation (CQV) for all types of autoclaves, whether they are primarily porous, fluids, or combination systems. Autoclave validation is essential as it provides robust sterilisation of items to ensure the safety of patients who are receiving treatment with the final product.

Autoclave services can include:

Autoclave Commissioning
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Development testing
Protocol writing or development

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 and superheat investigation, and steam quality testing.

Freeze Dryer / Lyophiliser Validation

We provide commissioning, qualification, and validation (CQV) to all models of freeze dryers. Freeze dryer validation is essential as it guarantees that the lyophiliser operates within predefined parameters and maintains the product’s quality, stability, and efficacy by removing the liquid content using a sublimation process. This enables manufacturers to mitigate the risks associated with product degradation or contamination which could lead to regulatory non-compliance, financial loss, and negative impacts on patient health.

Lyophiliser validation services can include:

Lyophiliser Commissioning
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Development Testing
Protocol Writing or Development

Our validation services can cover validation for CIP, SIP, and the lyophilisation process, calibration, shelf mapping, and condenser capacity mapping.

Development testing can include the optimisation and development of clean-in-place, steam-in-place, and lyophilisation processes.

Depyrogenation Ovens and Tunnels Validation

We provide qualification of all types of depyrogenation systems, including ovens and tunnels, whether they are used for sterilisation or depyrogenation purposes. Qualification of depyrogenation ovens and tunnels is essential as it provides robust sterilisation and depyrogenation of items to ensure the safety of patients who are receiving treatment with the final product.

Depyrogenation system services can include:

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Development Testing
Protocol Writing or Development

Development testing may involve infeed, belt speed, primary heat zone, secondary heat zone, cooling zone, and baffle adjustment or delay development.

Controlled Temperature Unit Validation

BPV provides temperature mapping services and validation for all temperature-controlled equipment and facilities including warehouses, stability cabinets, fridges and freezers, cold rooms, CO2 freezers, LN2 freezers, incubators, ovens, and humidity chambers. Temperature mapping is essential for complying with GMP and GDP regulations and involves assessing and monitoring the storage and handling spaces to meet specified temperature, humidity, and gas environment requirements.

Thermal validation services can include:

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Development Testing
Protocol Writing or Development

Development testing can include fitting temperature barriers if required.

BPV offers validation consulting services in the UK and to Life Science companies in Ireland. BPV consultants are able to make VMP, validation reports and provide validation protocols.

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Benefits of Equipment Validation Services

Quality and Consistency

Our equipment validation services confirm that your equipment performs within specified parameters, leading to consistent product quality and reducing variability and defects.

Compliance and Risk Mitigation

By demonstrating that your equipment is adherent to industry standards and regulatory requirements, your organisation minimises its risk of non-compliance penalties, recalls, and safety incidents.

Cost Savings

By preventing errors, reducing downtime, and optimising your use of resources, our equipment validation services can result in significant cost savings for your organisation.

Industries and Applications

At BPV, we offer expert equipment validation services across a wide range of industries including pharmaceuticals, biotechnology, medical devices, healthcare, food and drinks, and chemicals. We are experienced in ensuring machinery meets UK and international regulations, working to safeguard the quality, safety, and efficiency of your operations.

Across every sector, our aim is to help you to stay compliant, minimise downtime, and optimise the performance of your equipment through precise, reliable validation, tailored to your project’s specific requirements.

How To Arrange Our Equipment Validation Services

Arranging our equipment 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 equipment validation, contact our friendly team to schedule a consultation to define your scope, timelines, and deliverables based on your business and regulatory objectives.

Why Choose BPV?

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.

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.

Frequently Asked Questions (FAQs)

What industries does BPV Limited serve?

We serve clients in pharmaceuticals, biotechnology, medical devices, healthcare, and life sciences manufacturing.

Where is BPV Limited based?

We are headquartered in the UK, with services available throughout the UK and across the EU.

Does BPV offer field-based validation services?

Our engineers travel to client sites across the UK and EU for on-site validation.

Does BPV provide documentation support?

According to your preferences, we can deliver full validation documentation, including protocols, reports, risk assessments, and SOPs.

Can BPV handle multi-site validation projects?

We have the capacity and experience to manage multi-site and cross-border validation projects.

What sets BPV apart from other validation companies?

What truly sets us apart is our ability to work innovatively with our clients and go above and beyond to solve our clients’ problems. We do not only identify areas requiring improvement, but we use our engineering knowledge and experience to offer effective solutions to those areas. As standard, we offer a tailored, SME-led approach, fast turnaround times, and full regulatory compliance.

How do I arrange your services?

You can contact us via our website, by phone, or by email to schedule a consultation or to request a quote.