Validation Consultancy & Training

Paragon V offer validation consultancy and training where we are able to share our experience and offer practical solutions for the following

  • Validation lifecycle training

  • Application of risk based approach to validation

  • System impact assessment

  • FMEA

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Capital Projects

Paragon V offers the following support for large and small projects for clients and vendors

  • Validation project lead

  • Vendor representative where vendor knowledge of the validation lifecycle is limited

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Gap Analysis & Remediation

Paragon V offer support for Gap analysis and remediation where the validation lifecycle process needs to be reviewed.

  • Audit preparation

  • Responses

  • Remediation

  • Implementation

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Qualification & Requalification

We specialise in Commissioning and Qualification across the Validation Lifecycle incorporating:

  • Assisting with URS / Vendor selection

  • FMEA

  • Validation Master Plan /  Validation Plans

  • Design Qualification (DQ)

  • Requirements Traceability Matrix (RTM)

  • Factory Acceptance Testing (FAT)

  • Site Acceptance Testing (SAT)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Cycle Development

  • Performance Qualification (PQ)

  • Process Performance Qualification (PPQ)

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Paragon V specialise in the following areas

Controlled Storage / Distribution Environments

  • Controlled Storage Environments (CSE’s)
    • Fridges
    • Freezers
    • Incubators
    • Walk In Cold Rooms
    • Warehouses / Controlled Ambient Storage
    • Liquid Nitrogen Cryogenic Freezing
  • Temperature Controlled Distribution
    • Controlled Road Freight
    • Controlled Sea Freight
    • Active Sir Freight
    • Passive Air Freight
    • Cold Chain (2°C to 8°C)
    • Controlled Ambient (15°C to 25°C)
    • Frozen (-20°C and -40°C)
    • Cryo Shipping (Liquid Nitrogen)

Sanitisation, Sterilisation and Depyrogenation

  • Steam Sterilisation
    • Autoclave (Porous and Fluid Loads)
    • Steam In Place
    • Steam Out of Place
  • Depyrogenation
    • Tunnel Steriliser
    • Depyrogenation Oven
  • Vaporised Hydrogen Peroxide (VHP)
  • Gamma Irradiation
  • Sterile and non-sterile pharma & biopharma
    • Vial
    • Pre-Filled Syringe
    • Tubes
    • Ampoules
    • Blister Packaging
    • Cryo Vials
    • Media Simulations
    • Upstream equipment
    • Downstream equipment
  • Cleanroom Facilities including HVAC
    • Design
    • Airflow Visualisation
    • Installation and Operation Qualification
    • In Use Performance Qualification
    • On-Going Environmental Monitoring regime

We also have experience and offer support in the following Life Science Applications:

  • Utilities
    • WFI / Purified Water
    • Clean Steam
    • Process Gases (CO2, Nitrogen, Process Compressed Air)
  • Various Formulation / Product types:
    • Solid Dose
    • Liquid
    • Granule
    • Powder
    • Semi Solid (Ointment)
    • Paste
    • Tablets
  • Medical Devices
  • Lyophilisation
  • Cleaning Validation
    • Clean In Place (CIP)
    • Clean Out of Place (COP)
    • Parts Washer
  • Secondary Packaging
  • Inspection Vision Systems
  • Process Performance Qualification (PPQ/CPV)
  • Mixing Studies – Disposable and Fixed Systems
  • Computer Systems Validation (CSV)
  • Laboratory Equipment
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