From commissioning a new build Cleanroom to service, maintenance, testing & validation of existing controlled environments, the Guardtech Service Department support ongoing compliance in all cGMP & ISO14644 classified cleanrooms.

ISO14644:1-15 Validation: Airborne Particle Counts, Airflow Volume Measurements, Pressure Differential Testing, Temperature, Humidity & Lux Level Recording, ISO Certification and Full Validation Report.

Environment Qualification: Design Qualification (DQ) conducted by in-house Design Team, Installation Qualification (IQ) and Operational Qualification (OQ) conducted by the Services Department.

Facility Decontamination: Builders Cleans, Pre-Validation Cleans, Biocidal / Sporicidal Cleans. Range of contract options: Annual, Quarterly, Monthly, Weekly or Daily. Cleanliness Verification tests conducted and full reporting.

Maintenance: Service Visits and Maintenance Contracts for Cleanroom plant including Filtration, HVAC, Compressed Air, Extraction and other Mechanical Services.

All work conducted is followed by detailed reporting in line with ISO14644-1:2015 standards and cGMP guidelines ensuring client facilities are audit ready and compliant with the requirements of regulatory bodies.

Cleanroom Cleaning

Offering a range of one off post-build or pre-validation cleans, to quarterly, monthly, weekly or daily cleans the Guardtech Critical Control Team are specialised in restoring control to critical environments and supporting clients in maintaining complaint facilities.

  • POST-CONSTRUCTION CLEANS

'Builder's Cleans are conducted post construction projects and prior to validation to ensure the removal of visible dust, fibres and large particulate. This can include full coverage of the cleanrooms structure, equipment, furniture and extend as far as ductwork or plenum cleaning.

  • CONTAMINATION CLEANS

Guardtech 'Deep Cleans' utilise biocidal or sporicidal agents to drastically reduce the presence of bio-burden, spores and bacteria within Cleanrooms. All cleans are supported by a pre-clean contamination assessment and a post-clean efficacy verification stage to demonstrate the effectiveness of the clean. All operators are specially trained and work to extensive SOP's and checklists, all cleans followed by in-depth reporting & verification testing to prove efficacy.

Validation

Guardtech conduct Cleanroom Validation

  • AIR VELOCITY AND VOLUMETRIC FLOW RATE MEASUREMENT

Airflow volume readings shall be taken in accordance with ISO 14644-3 at each supply grille using a calibrated Ballometer set to read cubic meters per hour. Supply volumes from each filter are recorded and used to calculate the volumetric flow rates. Filter integrity testing, filter replacements and Cleanroom re-balancing can also be undertaken if these results are found to be outside of desired specification.

  • ROOM DIFFERENTIAL PRESSURE TESTING

Measurements of the Pressure Differential between cascading areas will be measured in accordance with ISO 14644-3. A calibrated Micro Manometer will be used to measure each room to absolute. Each reading will be recorded, and a pass/fail determined for each reading.

  • AIRBORNE PARTICLE COUNTING

Particle counts are conducted in the cleanroom at bench height. Each sample will be for 1 minute  In accordance with ISO 14644-1. A calibrated Laser Scattering Particle Counter with the flow rate set to 50 Lmin-1and the units of measurement set to m3. 0.5, 1 and 5 µm will be used. All particulate counts shall be recorded, and a pass/fail determined for each reading based on the classification required. All raw data will be attached to the report appendices.

  • TEMPERATURE & HUMIDITY MONITORING

Measurements of the Temperature & Humidity levels are conducted in accordance with ISO 14644-3 using a calibrated Thermal Hygrometer. Tests are conducted in set positions in each room at bench (working) height where equipment or an operator will potentially be sited. The Temperature & Humidity reading for each of the tests shall be recorded and a pass/fail determined for each reading.

  • LIGHT & SOUND LEVEL MEASUREMENT

Measurements of the lighting level are to be conducted in accordance with ISO 14644-3 in each room with a lux meter at bench (working) where equipment or an operator will potentially be sited. The lux level reading for each of the tests shall be recorded and a pass/fail determined for each reading. The same shall be determined for the decibel (db) levels using a sound level meter.

  • FILTER INTEGRITY TESTING

Measurements of the Humidity levels are conducted in accordance with ISO 14644-3 in each room at bench (working) height where equipment or an operator will potentially be sited. The Humidity reading for each of the tests shall be recorded and a pass/fail determined for each reading.

  • PRESSURE & FLOW GAUGE CALIBRATION

Measurements of the Humidity levels are conducted in accordance with ISO 14644-3 in each room at bench (working) height where equipment or an operator will potentially be sited. The Humidity reading for each of the tests shall be recorded and a pass/fail determined for each reading.

Maintenance

Carrying out routine maintenance and repairs nationwide, the Guardtech Service Department support clients with planned servicing, maintenance and emergency call-outs for the following:

  • FILTER REPLACEMENTS

HEPA Filter replacement for terminal connections and fan filter units, all major HEPA filter brands supplied, pre-filter changes, airflow balancing conducted post HEPA replacement if required.

  • HVAC MAINTENANCE, REPAIRS & UPGRADES

Regular service & maintenance contracts for controlled environment air conditioning followed by comprehensive reporting. Engineers equipped with routine maintenance parts and can diagnose faults onsite, undertake repairs and optimise setup for energy efficiency. Guardtech can tie Cleanroom HVAC maintenance in with A/C service contracts for the full facility.

  • COMPRESSORS & GENERATORS

Service, Maintenance & Repair of Air Compressors and Gas Generators, including testing & reporting. Also available for Local Air and Fume Extraction and Ventilation systems.

  • SEPARATIVE DEVICES

Service, Maintenance, Filter Replacement, Testing & Repair of Separative Devices, including Laminar Flow Hoods, LAF Workbenches & LAF Cabinets, Air Showers, Downflow Booths, Fume Hoods & Cupboards and Garment Stockers.

Offering a wide range of contract options, Guardtech support clients in keeping their Cleanroom and Plant operational and can support with contingency planning and facility upgrades to ensure environments are performing at optimal levels and disruption is minimised.