Nordell have been enjoying strong growth and had forecast continued growth to the end of the year. When the Covid-19 pandemic struck, it quickly impacted some of our key customer accounts resulting in a decline in our like for like sales. The Nordell leadership quickly considered the options to ensure continued grow and retain jobs. Nordell took the decision to heavily invest and adapt. Working in partnership with a customer in the medical consumables sector we had the confidence to invest, even when market conditions are very challenging and agreed to build a class 7 Cleanroom, which will have been designed, built and commissioned by TCA within 6 weeks. We have purchased 4 new Injection Moulding machines and ancillaries and are currently recruiting 10 new employees in various roles to add to our current 80 strong team. By adapting, we will continue to grow!
Nordell have invested in a new 100m2 Class 7 Cleanroom to meet the significant increase in demand for medical consumables. The cleanroom will house 5 Injection mould presses from 50tn to 120tn and manufacture around the clock.
The cleanroom represents a new venture for Nordell which has been built by specialist cleanroom manufacturer TCA (Total Clean Air) of Redhill, Surrey who completed the build within 3 weeks of starting the build process.
Nordell prepared the site and services to house the cleanroom in the space previously occupied by our toolroom which has now been relocated at our Worthing Factory. TCA built and project managed the build, pulling out the stops to complete the project from design to commissioning in just under 8 weeks. A huge thank you to Phillip Godden, CEO of TCA and his team.
What is a Class 7 Cleanroom?
A Medical Injection Moulding cleanroom is an enclosed zone where airborne particulates and pollutants are maintained at specific levels. The cleanroom is used to filter polluted air as per the requirements of certain industries such as pharmaceuticals, E-liquids, healthcare facilities, as well as science and technology.
Aerosol particles, bacteria, pathogens, chemical vapours, fibrous materials and more are types of pollutants that can hurt the manufacturing process in these industries. TCA’s Medical Injection Moulding Cleanrooms are built to comply with the international organisation for standardisation (ISO) 14644-1: 2015
The ISO 14644-1:2015 compliant Medical Injection Moulding Cleanrooms vary between class 1 and 9. The class of each Cleanrooms can change depending on prevalence and size of air contaminants in the cleanroom. The Class 1 classification is the greatest in the range and it is tested for the lowest frequency and smallest particulate size while the Class 9 classification represents the least in the range and is valued based on a higher frequency and larger air pollutants present in the cleanroom at any given time.
To test Medical Injection Moulding Modular Cleanrooms and classify them, particle counters are used to measure the Particles Per Cubic Metre (PPCM) of the environment by size and quantity. The ISO Class 9 Modular Cleanroom’s PPCM has a semblance with regular atmospheric air but filtration of much larger air contaminants >5 microns is accounted for.
A Class 1 Cleanroom will focus on much smaller air particulates of sizes >0.1 microns and >0.2 microns resulting in a much cleaner air enclosure. Here is an example of this kind of testing requirement.
A Cleanroom that falls in Class 7 (the class Nordell have) will be tested for the presence of an air particulate size of >0.5 microns where the highest particle count should be capped at 352,000.
Medical Injection Moulding Cleanrooms maintain strictly low levels of air particulates through the use of ULPA/HEPA filters. The use of these filters have passed scientific evaluation and are proven to keep out certain amounts and sizes of air particulates from a cleanroom. When non-filtered air goes through Filter Fan Units (FFUs), a positive pressure area is introduced and maintained in the clean air environment. This positive pressure helps maintain the controlled level of clean air by preventing contaminated air from entering back into the cleanroom through perforated openings.
Pollution-free manufacturing is fostered through the mechanism of the aforementioned type of Medical Injection Moulding cleanroom as it only allows the air that passes through the filtration unit to enter the internal space.
Deploying a Medical Injection Moulding cleanroom solution is the first stage of producing a clean environment for production and it substantially lessens the risk of product contamination. The second steps that should be taken in mitigating contamination are measures that will avoid cleanroom personnel from bringing in pollutants. This can be achieved through the proper use of PPE for cleanrooms such as hair nets, overshoes, and gowning. This move will see to it that certain numbers of contaminants like dust and fibres do not enter the cleanroom and disrupt research/production. Medical Injection Moulding Cleanroom operators must undergo training in the reduction of contamination to prevent the introduction of microbial/foreign materials into the production area.
We are looking forward to starting production and giving our support to the medical sector in the fight against the Covid-19 pandemic.