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EQUIPMENT VALIDATION SERVICES

Bio Products Validation Limited are a specialist validation services provider in validating equipment used in manufacturing processes to ensure it meets all necessary regulations while also achieving optimal performance and safety levels.

We can provide complete CQV services (Commissioning, Qualification, and Validation) on all types of manufacturing and laboratory equipment.

To ensure that devices and products are safe and effective to use, it is essential to have a robust quality assurance system in place.  Equipment Validation Services can include: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ); these are the critical components that guarantee the reliability and consistency of the equipment.

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

As a provider of UK life science validation services, our team tests that every piece of equipment is installed correctly, and configured according to the manufacturer’s standards.

We follow a rigorous Installation Qualification (IQ) process to validate equipment and confirm that it is correctly installed and complies with the approved design and manufacturer’s recommendation. Our stringent IQ validation services 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).

Our pharma validation service expertise covers Operational Qualification (OQ) testing, ensuring 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, as well as the testing of general automated processes.

BioProducts Validation Limited, an equipment validation provider, offers Performance Qualification (PQ) services, where we verify and document the equipment’s performance to ensure that it can perform reliably and effectively in the intended use, based on the approved process method and product specification. Our PQ elements 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 are obtained and this 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 reliable.

Provider of CQV and Equipment Validation Services in the UK

Autoclave Validation

BPV provides autoclave commissioning, qualification and validation (CQV) for all types of autoclave whether they be 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/superheat investigation, Steam quality testing and development.

Freeze Dryer / Lyophiliser Validation

BPV provides commissioning, qualification and validation (CQV) to all models of freeze dryer.

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.

Through this process manufacturers can mitigate risks associated with product degradation or contamination, which could lead to regulatory non-compliance, financial loss, and negative impacts on patient health.

Lyophiliser services can include:

  • Lyophiliser Commissioning

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Development testing

  • Protocol writing or development

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/or depyrogenation of items to ensure the safety of patients that 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 can include: infeed, belt speed, primary heat zone/secondary heat zone/cooling zone, baffle adjustment/delay development.

Controlled Temperature Units/Warehouses/Stores

BPV provides temperature mapping and validation for all temperature-controlled equipment and facilities including: Warehouses, Stability Cabinets, Fridges/Freezers, Cold Rooms, CO2 Freezers, LN2 Freezers, Incubators, Ovens, Humidity Chambers and more.

Temperature mapping is essential for complying with GMP and GDP regulations. It involves assessing and monitoring the storage and handling spaces to ensure they 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.

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