Using cleanroom technology to manufacture PPE

Industry-leading technology – featuring a cleanroom which changes the air up to 20 times an hour – means a global PPE producer is making high-grade medical masks in the UK.

The Canadian-based group Medicom has created a state-of-the-art production facility which the company says is the only one in the UK to use cleanroom technology to manufacture PPE masks.

The highly sterile environment created at the factory in Northampton exceeds the standards required for mask manufacturing. Medicom’s plant is making more than half a billion masks for the NHS through a government contract.

Covering more than 20,000 square feet, the cleanroom sits as an independent structure within the Medicom facility and is specially designed to maximise hygiene. It means the supply of fresh air is highly filtered and ensures that no contaminants enter the manufacturing area.

Doors leading to the cleanroom are all equipped with airlock arrangements. The manufacturing space is positively pressured to 15 Pa (pascal) by a 100% fresh air system. 

Ideal Environment

Medicom strongly believes that all PPE should be created in a cleanroom environment to uphold high standards of manufacturing for clinical products.

For mask production, there are several key benefits – including less wastage, cost reduction, consistent quality, and reliability. Many scientists have pointed out that it is the “chief strategy to combat contamination and particle-induced defects.

High Efficiency Particulate Arrestors (HEPA) trap the smallest of particles that other air filtration systems would simply recirculate into the air. At the same time, a consistent cleanroom condition of 20C and 50% RH (relative humidity) is maintained. 

This ideal environment is achieved using a suite of recirculation air handling units (AHU’s). These units provide cooling and maintain an air exchange rate via filters of up to 20 air changes every hour.

With the air being filtered and changed so often, all airborne contaminants are removed from the manufacturing area. This ensures the production of the highest quality masks in terms of cleanliness, filtration efficiency and biocompatibility.

High Quality

The Northampton factory has created 250 new jobs. Medicom’s managing director in the UK, Hugues Bourgeois, said the company was proud to supply high-quality masks for the NHS using the latest technology.

“Our Northampton cleanroom is a great example of how technology can be used to help the medical profession deal with the continuing challenges of COVID.

“We are proud to be the only company in the UK using a cleanroom for the production of PPE masks. It underlines our commitment to supply products of the highest standards for NHS workers.”

Using official classifications, the Medicom cleanroom currently operates as an ISO 7 and GMP Class B environment to produce medical devices. This goes beyond the necessary requirements set out for mask manufacturing. 

With the use of appropriate grade filters, the facility can operate between ISO 6 and ISO 8 to meet a variety of client requirements for specific production runs, as and when required.

Bourgeois added: “This environment, in addition to ensuring an excellent level of cleanliness, brings ideal working conditions for the production personnel of our Northampton factory.”

Laboratory Tested

Medicom’s FFP3 respiratory masks are made under the internationally renowned Kolmi brand and offer a high level of protection from aerosol generated infection. They have been specially created for use by NHS frontline workers.

The Kolmi Type II R Mask is popular with health professionals and is intended for all medical examinations. The mask has fluid resistant non-woven materials providing a barrier against spray, splatter, and airborne particles.

Tested to the most rigorous standards by the internationally recognised Nelson laboratory, Medicom’s masks consistently outperform industry requirements. All are also checked for their lead content and other toxic materials, such as nanographene.

The masks feature base materials produced by a world-leading manufacturer of non-woven and filter materials for the healthcare sector. Berry Global have a factory in South Wales, ensuring a secure UK supply chain. 

Quality Filters

Berry Global are leaders in advanced non-woven air filtration solutions. Their plant in Aberdare supplies the high-quality filters for Medicom’s masks.

The result means the masks are lightweight and comfortable, while remaining breathable and protective over extended periods of time.

Another benefit of Medicom’s masks is the extended shelf-life of five years, meaning they do not have to be discarded if not used within two years (as is the case with most imported masks).

However, all the technology in the world is not effective if the masks are not worn correctly on the frontline. With this is mind, Medicom is unique in making FFP3 masks in three different sizes (small, medium, and large) and provides bespoke support kits to ensure the masks are fitted in the right way for each individual.

Medicom has worked with four NHS trusts to develop a range of materials and tools to help mask fit testers and users. Support kits contain a template to assess which size of mask is required, as well as a portable video and literature showing how the masks should be put on and removed.

This support helps to streamline the fit testing process for clinicians and ensures valuable time with patients is not lost. The ‘right mask, first time’ approach means the technology used in producing the high-grade masks is as effective as possible on the NHS frontline.