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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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