Our services
We support projects of any size, from a single piece of equipment to a full facility build, and we work with manufacturers and with the equipment and software suppliers who serve them.
Commissioning, qualification and validation
We cover the full validation lifecycle:
- URS preparation and vendor selection
- Risk assessment and FMEA
- Validation master plans, validation plans and C&Q plans
- Design qualification (DQ)
- Requirements traceability matrix (RTM)
- Factory and site acceptance testing (FAT / SAT)
- Installation, operational and performance qualification (IQ / OQ / PQ)
- Cycle development
- Process performance qualification (PPQ / CPV)
- Periodic review and maintenance of the validated state
Capital projects and technology transfer
- CQV strategy, planning and resource estimates
- Validation project lead
- Vendor representative where the supplier’s knowledge of the validation lifecycle is limited
- Asset relocation and decommissioning with a risk-based approach
Computerised systems and data integrity
- Computerised systems validation (GAMP 5 Second Edition, EU GMP Annex 11, 21 CFR Part 11)
- Monitoring systems (BMS / EMS) and process control system qualification
- Digital validation implementation, including Kneat Gx
Gap analysis and remediation
- Audit and inspection preparation
- Responses to observations
- Remediation planning and implementation
Consultancy and training
- Validation lifecycle training
- Applying a risk-based approach to validation
- System impact assessment
- SOP suites and validation policies
Specialist areas
Sterilisation, sanitisation and depyrogenation
- Steam sterilisation: autoclaves (porous and fluid loads), steam in place, steam out of place
- Depyrogenation: tunnel sterilisers and ovens
- Vaporised hydrogen peroxide (VHP)
- Gamma irradiation
Cleanrooms and HVAC
- Design input and qualification
- Airflow visualisation
- Installation, operational and in-use performance qualification
- Environmental monitoring programmes
Sterile and non-sterile manufacturing
- Vials, pre-filled syringes, ampoules, tubes, cryo vials and blister packaging
- Media simulations
- Upstream and downstream equipment
- Lyophilisation
- Solid dose, liquids, powders, granules, semi-solids and pastes
- Inspection vision systems and secondary packaging
- Mixing studies for single-use and fixed systems
Controlled storage and distribution
- Fridges, freezers, incubators, walk-in cold rooms and warehouses
- Liquid nitrogen cryogenic storage
- Temperature-controlled road, sea and air freight (active and passive)
- Cold chain (2°C to 8°C), controlled ambient (15°C to 25°C), frozen (−20°C and −40°C) and cryo shipping
Utilities
- WFI and purified water
- Clean steam
- Process gases (CO2, nitrogen, compressed air)
Cleaning validation
- Clean in place (CIP) and clean out of place (COP)
- Parts washers
Also
- Medical devices and IVDs (ISO 13485)
- Laboratory equipment