Maintaining high standards: The importance of cleanroom maintenance

Joe Shackley, marketing manager at Guardtech Group, outlines the importance of regular cleanroom maintenance for medical device manufacturers along with insight from the company’s experts.

They say that ‘if it ain’t broke, don’t fix it’ – but when it comes to cleanrooms and laboratories, sometimes waiting for a problem to arise before you act can have devastating results.

Suffolk-based cleanroom construction specialist the Guardtech Group has been providing controlled environments to the life sciences industry for more than 20 years, meaning and a long history working with the medical device industry and wider life sciences community in cleanroom servicing & maintenance.

The company offers a package of controlled environment solutions, including programmes in Cleanroom Service Plans.

In the past 12 months, they’ve designed and constructed controlled environment solutions for the likes of JEB Technologies, Advanced Medical Solutions, Sherlock Biosciences, Biocomposites and Medical Moulded Products.

New services manager Glen Crisp is a former air conditioning installation engineer and senior manager at Adcock with 30 years’ experience in the industry.

He knows how critical it is for applications in the medical device industry to feel they can entrust the Planned Preventative Maintenance (PPM) of their process rooms, plant, utilities, and devices to specialists.

“Regular servicing and maintenance is vital,” Crisp says. “The risk of a major fault developing diminishes significantly when you have a cleanroom that operates efficiently.

“Our testing helps to spot problems before they cause serious issues. When, for example, you conduct a cleanroom validation, you need to check airflows. If you notice these continue to drop over subsequent validations, you recognise there’s a problem that needs addressing.

“The sooner you’re able to identify these issues the better – especially given that some HEPA filters have an 8-10-week lead time.

“Identifying appropriate spares can be critical – in terms of reducing potential cleanroom downtime to a minimum and therefore saving lost process time, which can be very costly. If that doesn’t put a smile on a client’s face, nothing will!”

It’s evident that any business’ controlled environment is given the regular TLC it needs to continue to operate at peak performance – as anything less could risk product and process and, ultimately, cost time and money, and even risk potentially crippling sanctions.

As well as commissioning new-build cleanrooms, Crisp and compliance manager Chris McGinn lead the Group’s service, maintenance, testing, validation, and decontamination programmes for existing controlled environments.

The Guardtech Group Service Department supports ongoing compliance in all cGMP & ISO14644 classified cleanrooms, ensuring facilities are audit-ready and compliant with regulatory bodies.

They also provide documentation on all their construction projects, including a Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) as part of its Commissioning and Compliance offering.

Compliance manager McGinn adds: “All cleanrooms need regular service and maintenance to ensure they continue to meet standards and function at optimum levels – and it’s recommended that you have at least two programmes per year to go over the necessary checks and processes to confirm that nothing is amiss.

“At Guardtech, we’ve built up an impressive amount of knowledge, resource and expertise to ensure our clients’ cleanrooms get the best support available – we’re here to take away the burden of managing a controlled environment, so clients can focus on delivering the product or service they specialise in.”

The Guardtech Group Service Department’s Testing programme includes filter integrity and separative devices – such as biosafety cabinets and laminar flow benches – as well as Performance Testing, including Temperature, Humidity and Lux levels.

Validation features measurements for Air Velocity, Volumetric Flow Rate and Room Differential Pressure, as well as Particle Counting – all in accordance with ISO 14644-1.

The service & maintenance remit is wide ­– from HVAC, compressor and generator repairs and upgrades to filter replacements, gauge calibration and environmental monitoring (EMS) and Building Management System (BMS) Servicing.

The company also highlights the need for rapid rise door or central vacuum system inspection, process air handling unit filter testing, crane servicing, fall protection systems or transfer hatch servicing.

Services manager Crisp says: “HVAC can often be a really tricky area to deal with. Whether it’s refrigerant leaks, F-gas checks, or ensuring efficient operation conditions – you don’t use want to be using more power than you need to be.

“So, a big part of our offering is to ensure everything is working as it should be – be that compressor checks or ensuring evaporator and condenser coils are clean, confirming that the system is drawing the correct number of amps. And all of these HVAC matters tend to lead directly on to filtration issues.

“That’ll be ensuring the filters in our Fan Filter Units (FFUs) are clean and operating effectively. If things aren’t right, you’re going to be overworking motors and there’s more chance of a breakdown.”

The Group also has a dedicated Decontamination Team on hand to complete its Cleanroom Service Plans.The two most senior members have 30 years’ experience in decontamination, offering tailored cleaning programmes to suit the needs of all applications, following client SOPs and using specific validated chemicals and equipment as and when required.

This includes Builders’, Pre-Validation and Biocidal/Sporicidal cleans through to Hydrogen Peroxide Fogging and Microbiological/bioburden testing with TSA & SDA plates.

Working to GMP standards, the team conduct cleanliness verification tests with full reporting and are certified to work at height (as IPAF PAL card holders).

Crisp continues: “Keeping the cleanroom working within the design specification and keeping spaces as clean as possible is obviously critical in meeting compliance and adhering to the regulations which govern the work our customers conduct in their controlled environments.”

For Crisp, efficient programming is as important as any aspect of a solid overall Cleanroom Service Plan.

“To really keep on top of all the maintenance required in a cleanroom environment, you need to be organised. A lot of goes on in there that needs to be done at certain times – for example, HEPA filter changes need to be co-ordinated with a deep clean and validation afterwards.

“You will often need to plan ahead with the client to schedule in the downtime or programme shutdown to facilitate the cleanroom maintenance that’s required.”