EQUIPMENT VALIDATION SERVICES

Bio Products Validation Limited are a specialist validation services provider 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, and with some equipment, complete CQV services (Commissioning, Qualification, and Validation). Equipment Validation Services can include: Installation Qualification (IQ), Operational Qualification (OQ), and 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 assembled correctly and perform according to the specified requirements. These qualification checks ensure that manufacturing equipment delivers consistent results and meets quality standards.

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 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 validation 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 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/delay development.

Controlled Temperature Units/Warehouses/Stores

BPV provides temperature mapping services 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 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.