Services

We are experienced with:

Packaging, filling and capping machines
Clean rooms and Heating, Ventilation and Air Conditioning (HVAC) systems
Water for Injection (WFI) systems
Purified Water systems
Compressed Air systems
Nitrogen systems
Lyophilisers
Blister packers and cartoners
Cartridge filling lines
Vial filling lines
Depyrogenation tunnels
Clean steam generation and distribution
Cold rooms
Autoclaves
Fermenters
Vessels CIP/SIP

Our qualifications:

Calibration and Measurement in the Pharmaceutical Industry.
Pharmaceutical GMP
GMP Awareness
How to write GMP documents
Yearly and Revalidation Testing of Transportable Steam Sterilizers for Unwrapped Instruments and Utensils, STM1 – HTM 2010, City and Guilds Certified.
Testing Large Porous Load Sterilizers, STM2 – HTM 2010, City and Guilds Certified.
Yearly and Revalidation Testing Large Porous Load Sterilizers, STM3 – HTM 2010, City and Guilds Certified.

Validation

PQ execution for the manufacture of Biopharmaceutical manufacturing processes in a new secondary manufacturing facility and involved with the PQ process validation of the packaging line.
PQ and Requalification execution carried out on the following: Parts Washers, Autoclaves, Vial washers, sterilizing tunnel, stopper washer, freeze dryer Automatic Loading and Unloading System, Filling machine.
Continuing revalidation work for particle monitoring of isolators, laminar flow units and Air Handling Units carried out to ISO 14644.
Commissioning and Qualification of new fill/finish facilities.

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Documentation

Preparation and review of validation protocols and reports.
Generation of planned and unplanned deviations, as well as incident reports and change controls.
Generation and execution of many varied URS, SOP, DQ, IQ, OQ, IOQ, PQ and Revalidation/Requalification protocols and reports.
Production of VMP, Gap Analysis, Risk Assessments and Impact Assessments.
Experienced raising CAPA’s, UER’s and closing out general discrepancies.

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