The Commissioning phase begins post-construction and concentrates on qualifying all systems and their functionality.
For a Pharmaceutical application this will form part of the Installation (IQ) and Operational Qualification (OQ).
For all other industries a standard commissioning plan will be drafted and test certificates will be produced alongside a detailed Operational & Maintenance (O&M) manual.
The commissioning plan will cover a series of verification checks on key components, systems and plant – such as:
- Electrical, network
- Other critical utilities
The cleanroom performance will be verified through ISO 14644 validation and associated testing.
- Airflow supply and velocities
- Chilled water flow rates, temperatures and valve set points
- Room temperature and humidity check
- Air on and air off coil temperatures
- Frost protection checks
- Heater loading tests
- Probe calibration, location and offset
- Fan speed, inverter and electrical checks
- System pressure testing
- Continuity testing
- Insulation resistance testing
- Resistance testing (measuring Zs)
- RCD checks
- LAN continuity testing
- BMS Software validation
- Hardware verification and calibration
- Transmitter/probe calibration (UKAS)
- CF21R Part 11 compliance (if required)
- LUX level verification
- Emergency lighting testing
- Pipework pressure & drainage testing
COMPRESSED AIR & GASSES
- Air purity & oil-free test ISO8573-1:2010
- Pressure, micro-organism, moisture testing
- Particulate, airflow, filter integrity testing
- Optional: temperature, KI-discus, velocity
Upon conclusion of all cleanroom builds an ISO 14644 validation is conducted to verify cleanroom performance and adherence to classification guidelines.
The critical testing point is to ensure that the airborne particle counts are in line with the allowable tolerances as set out in ISO 14644-1. All other testing is to provide supporting data to confirm the performance specification of the environment.
Validation testing could include any or all of the following:
- Air velocity and volumetric flow rate measurement
- Room differential pressure testing
- Airborne particle counting
- Temperature & humidity monitoring
- Light & sound level measurement
- Filter integrity testing
- Pressure & flow gauge calibration
- Room recovery rates
- Containment testing
- Airflow visualisation
For all non-cGMP-rated projects, standard commissioning documentation will apply.
A far greater level of detail is required for qualification of cGMP facilities, following strict protocols and defined standards.
This portfolio of documentation includes the compilation and execution of a Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ).
These documents are produced as a call and response to the User Requirement Specification (URS) and aim to objectively answer all requests with supporting evidence.
Detailed and comprehensive documentation is produced to aid the design process and support cGMP compliance.
This information is compiled in response to the client brief and provides a contractual framework, a fully developed scope of works and a defined performance specification.
- Master Room Specification: Excel documentation that captures specific parameters pertaining to the design
- Functional Design Specification: Outline of the design concept for all structural, mechanical and electrical systems
- Design Qualification (DQ): For all cGMP projects a full design qualification can be produced in response to the URS outlining compliance to the brief whilst initiating a framework for the later commissioning stages of Installation Qualification (IQ) and Operational Qualification (OQ).
The Guardtech Group Decontamination Team are specialists in restoring control to critical environments and supporting clients in maintaining compliant facilities. Performing to GMP standards, all operators are specially trained and work to extensive SOPs and checklists.
Our packages include:
- Builders’ cleans, Pre-validation cleans & Biocidal/Sporicidal cleans
- Microbiological/Bioburden Testing with TSA & SDA plates
- Pre-clean and post-clean contact plate testing
- Certified to work at height (IPAF PAL card holders)
- Cleanliness verification tests conducted – with full reporting
- Bespoke cleaning programmes
- Comprehensive multi-stage cleaning as and when required
Guardtech Group Case Study Guardtech Group Validation Case Study
Discover the process undertaken by the Guardtech Service Department for a CleanCube Maxi Validation as part of an Operational Qualification (OQ).