The ongoing operation and maintenance of your controlled environment is of paramount importance, therefore ensuring a Cleanroom Service Plan is in place to adequately facilitate this should form part of the strategy of implementation.
The Guardtech Group can provide a full turnkey offering with their in-house Service Department.
WHAT DO GUARDTECH CLEANROOMS HAVE TO OFFER?
- CITB-trained engineers and mechanical and electrical specialists
- Consolidate all utilities and plant maintenance to as few visits as possible
- Selection of all plant and equipment will take into consideration ongoing maintenance and associated costs
- Energy efficiency and warranty conditions are balanced to achieve the best value solution for your application
- Service contracts can also include emergency call-out rates to ensure a rapid response for any potential future issues
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
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
DECONTAMINATION TEAM TESTIMONIALS
Susi Osborne, Manufacturing Director at Emergex Vaccines, said: “Thank you to the Decon Team for their work on our Level 4 – Intense Facility. This first clean also involved in-house training and Sarah and Lee helped enormously by doing the pre-reads prior to coming on site, meaning that we could start straight away on practical training.
“Their professional approach was fantastic. When I went into the cleanroom I had to smile – the facility was sparkling. They put everything back where it belonged and really showed how much care they were taking of our facility. They make such a great team – so hard working, great sense of humour and just willing to be so flexible. It was a pleasure to work with them. I really feel I have the A Team now to do our important, major cleans.”
Ann Mason, Deputy Production Manager of Pharmacy Technical Services at Derriford Hospital, said: “Right from the first Deep Clean conducted by Lee Burton and Sarah Mayes – in our NHS aseptic suite – we have not looked back. They are very efficient and great people to work with. They carry out microbial monitoring and particle counts, which saves us time and ensures we get back up and running as soon as possible. We greatly appreciate the work the Guardtech Group’s Decontamination Team do for us.”
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).
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