Production Environment

The single most important factor in the manufacturing process for Medical Grade Face Masks is the manufacturing environment itself. To ensure the product continually meets the above requirements we have installed and commissioned an externally validated ISO Class 8 Cleanroom. If you’re interested in sourcing your face masks from us, we would be happy to share a copy of the independent accreditation report from our clean room provider.

What is a cleanroom?

A cleanroom is a controlled environment facility in which all incoming air passes through a series of Hepa filters capable of removing 99.97% of all particles 0.3μ m and larger. The key focus of the cleanroom is to control the Microbial Cleanliness i.e. If we remove 99.97% of particles then we remove a large % of Airborne Organisms.

The whole volume of air in the clean room is replaced with fresh clean air at least 15 times every hour.

Bioburden Test of EN14683

Any masks that are to be certified to EN14683 standard must undergo independent testing. The Microbial Cleanliness test determines the total number of viable microorganisms on the face mask using an extraction method. The total viable aerobic microbial count and fungal enumeration is determined.

Based on the weight of the mask, the results are reported as the total bioburden per gram tested for each mask. For EN 14683, in order to meet the performance requirements of Type IIR, the bioburden of the face mask shall be ≤ 30 cfu/g.

People and GMP

The cleanroom itself does not provide the complete solution. Staff are the single biggest contributor of contamination coming in to a cleanroom if it is not properly controlled.

During their induction, all of our staff undergo an intensive bespoke hygiene training programme developed in conjunction with contamination control experts. This is followed up with regular training sessions delivered in house. We have implemented industry practices for Cleanroom Clothing and standard operating procedures for gowning and de-gowning upon entry to and exit from the cleanroom.

We have 2 stage changing / gowning areas which are also served with Hepa Filtered air. This allows our staff to wash, gown / degown in a clean area and minimise any contamination being introduced to the cleanroom. The second stage of the changing are is known as a Pedestrian Air Lock (PAL). The air pressure in these areas is slightly lower to allow us to maintain the air pressure in the cleanroom itself.

You will notice that all of our staff are gowned head to toe in anti-static PPE which is laundered / replaced on a weekly basis or more frequently if required.

These strict hygiene protocols ensure maximum reduction in contamination by personnel.
No visitors are permitted access to the clean room and can only observe what is going on from outside through the vision panels.

Strict cleaning protocols have been introduced to ensure the production environment is consistently running at the highest possible level. Cleaning protocols include:

ASEPTIC TECHNIQUES

  • Wiping benches / machines / touchpoints with disinfectant / sterile alcohol to defined standards
  • Validated Weekly Cleanroom surface cleaning regimes (surfaces, ceilings, floors and walls) with disinfectants, sporicides and biocides
  • Regularly changing and disposing of all used equipment / PPE
  • Washing hands thoroughly to defined practices
  • No eating or drinking in the cleanroom

Control of Materials

The other area of risk of contamination in a clean room is via production materials. This is why we have

  • a Material Air Lock (MAL) where all raw materials are decontaminated prior to introduction the cleanroom itself.
  • All external packaging is removed and disposed.
  • No wooden pallets are permitted in the clean room.
  • Final packaging in to cardboard boxes takes place in a separate packing area outside the cleanroom to avoid introduction of contamination.

Environmental Monitoring Programme

To ensure we continuously achieve the highest quality of product we have implemented an Environmental Monitoring Program (EMP). This includes but is not limited to:

  • Cleanroom Air Quality by Particle Count for Airborne Quality
  • Collection of data relating to the numbers of microorganisms present on surfaces, in the air and from people
  • Collection of data on product microbial count as per EN14683

If you are a client of North West Medical, we would be happy to share our Environmental Monitoring Results. Every manufacturer is required to do this under the EN14683 standard.

Manufacturing Equipment

Our state of the art manufacturing equipment ensures that the process for manufacturing facemasks is fully automated from start to finish. All equipment is CE Marked for use in the UK / Europe and is fully guarded to ensure the safety of our employees.

We have a full time maintenance crew on every shift to ensure that the machines are maintained to the highest possible level and this ensures that we achieve the maximum possible production levels as well as ensuring that every mask coming off the line meets the strict quality standards that we expect.

Clean Room Production

The whole volume of air in the clean room is replaced with fresh clean air at least 15 times every hour.