We support pharmaceutical manufacturers with validation and qualification services across the lifecycle of their facilities, utilities, equipment and computerised systems, from commissioning and qualification to operation, periodic requalification and remediation.
Our work is aligned to the requirements of regulators such as WHO-GMP, USFDA, EMA, MHRA, ANVISA, TGA and CDSCO, and we supply validation and monitoring instruments from global OEMs as an authorised channel partner.
Thermal Validation
Autoclave, steam-in-place, lyophilizer and depyrogenation tunnel validation, steam quality testing, and temperature mapping of warehouses, cold rooms and stability chambers.
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Commissioning, Qualification & Validation
Science- and risk-based CQV of process equipment, HVAC and water systems, other utilities and facilities, from FAT and SAT through DQ, IQ, OQ and PQ.
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Clean Room Validation
ISO 14644-1 classification at rest and in operation, filter integrity (PAO), air velocity and recovery tests, 360 degree smoke studies of sterile areas, and compressed air and nitrogen testing.
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Computer System Validation & Data Integrity
GAMP 5 validation of laboratory and manufacturing computerised systems, with 21 CFR Part 11 and EU GMP Annex 11 assessments, data integrity audits and remediation.
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Bio-Decontamination
Hydrogen peroxide fogging of cleanrooms and aseptic enclosures, for example after a shutdown, maintenance or refurbishment, or when monitoring shows high viable counts.
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Instruments we supply as an authorised channel partner of global OEMs, and data loggers we design and manufacture.
Thermal Validation Systems
Kaye AVS validators and ValProbe RT wireless loggers for autoclave, steam-in-place, lyophilizer and stability chamber studies, with calibration references and accessories.
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Cleanroom Monitoring
Particle counters, microbial samplers and real-time monitoring for classified areas, liquid particle counters for USP 788, and aerosol photometers for filter integrity tests.
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Biodecontamination
Phileas airborne surface disinfection systems and biocides, also available as a rental validation service with protocol, SOP and summary report.
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Tracer Particle Generator
Foggers, diffuser manifolds and neutrally buoyant solution for the in-situ airflow pattern studies expected by FDA, PIC/S, EMA and WHO.
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Process Analytical Tools (PAT)
MicroNIR spectrometers and a real-time particle analyser for in-line and at-line monitoring of batch and continuous processes.
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Data Loggers & FacilityOne
Wired and wireless data loggers with FacilityOne for cleanrooms, pressure cascades, cold rooms, stability chambers, warehouses and QC laboratories.
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Isolator Glove Testers
Glove testing devices for isolators and RABS, including fully automatic glove integrity testers.
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