Arranging regular cleanroom validation is an essential part of running an industrial cleanroom. The frequency of inspections will depend on the type of application, for instance whether the facility is needed for manufacturing of pharmaceutical products or micro-electronic components – but, whatever the type of use, full regulatory compliance is essential.
Having to close down your operation while validation takes place can be disruptive and can be seen as an “overhead” in terms of costs. Fortunately, however, the disruption and the cost can both be minimised, depending on which cleanroom services contractor you choose to carry out the validation and the approach they take.
Why Cleanroom Validation Matters
If you are responsible for running a cleanroom, whether in a research, industrial or pharmaceutical setting, then organising validation is an inescapable requirement. This must be carried out to ensure your facility is performing as intended and that you are meeting all relevant regulations, including MHRA and GMP compliance.
Routine cleanroom monitoring is needed as well as regular inspections and certification. If this is not carried out often enough, then you risk failing to meet your statutory obligations. If levels of contamination rise as a result, then there are risks to the safety of workers in the cleanroom.
There is also the risk of production being contaminated, including sensitive items such as cells, tissues and medicines processed in a cleanroom setting. This in turn could potentially damage the safety of recipients of the end product. Any of these eventualities could have devastating costs in both human and financial terms.
Cleanroom Validation by Tecomak
Fortunately, if you rely on an expert provider like Tecomak to provide cleanroom testing and maintenance, it is possible to be sure that your facility is operating as it should, and giving the right level of protection to both staff and the sensitive items being handled.
A number of different technical skills are needed to perform a full cleanroom validation. This includes the ability to carry out HEPA filter services, including DOP testing. Engineers also need to be able to test any cabinets present, and to carry out a whole range of tests designed to ensure the room is performing as it did when built. These include airflow visualisation and measurement, monitoring the level of particles, differential pressure testing and testing the temperature, humidity, lighting and noise levels in the area.
Tecomak’s team of engineers are fully qualified to carry out all cleanroom performance tests, so we can offer a testing regime specifically geared to the needs of your site. We are able to validate cleanrooms to all current standards applying not only in the UK but worldwide.
Saving Both Time and Money
As well as assuring you that your cleanroom is up to standard, choosing Tecomak as your cleanroom maintenance, testing and validation contractor can help to keep both costs and loss of operational time to a minimum.
All Skills Under One roof – Our team can carry out all necessary tests in one visit and are able to fix the majority of issues on the spot, from replacing filters to putting right both electrical and mechanical faults. This range of expertise minimises any downtime, since you don’t have to call out separate contractors to carry out different aspects of the work, incurring callout costs for different trades and multiple lab shutdowns.
Maintenance to a high standard – If a cleanroom is properly maintained to a high standard, this minimises the chance of breakdowns, which means less disruption to schedules and fewer repair costs. By ensuring that planned maintenance and validation visits are carried out at optimum intervals, you can avoid the far greater costs of losing production for a longer period. At Tecomak, we ensure that cleanroom certification visits are quick and easy to carry out, by constantly keeping the facility in good condition to help avoid breakdowns of equipment.
Contracts – Arranging a contract for cleanroom validation means you are able to budget for costs well in advance. It also means you can save on costs by being offered services such as archiving of records, rather than having to carry this out yourself. Tecomak also keeps an asset database and sends out reminders of when visits are due.
If you are running a large establishment with multiple cleanrooms, critical ventilation systems, cabinets and other equipment, then our archiving, assets and reminders service alone could save significant administration costs. We also offer ongoing support to our regular customers, giving you confidence that if there is a problem then we will visit quickly to put it right.
Cleanroom Validation – Get in touch for details of our comprehensive testing, maintenance and certification services, designed to suit your needs.