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. Our Medical Injection Moulding Modular Cleanrooms are built to comply with the international organisation for standardisation (ISO) 14644-1: 2015. Our expert team and dedicated clean room is perfect for your contract or sub contract clean room injection moulding, extrusion, plastics or other manufacturing processes.
If you are interested in how Nordell can help improve your manufacturing or provide expert plastics manufacturing then get in touch below.
More about our Clean Room
The ISO 14644-1:2015 compliant Medical Injection Moulding Modular 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.
A Modular Cleanroom that falls in Class 7 (the class we are specifying) 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. Modifications will have to be put in place if the Medical Injection Moulding Cleanroom does not meet the requirements for this classification.
Medical Injection Moulding Modular 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.
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 have recently built a 100m2 Cleanroom in our Worthing HQ, housing 5 Injection mould presses from 50tn to 120tn, with full capability to manufacture around the clock.
The cleanroom represents a new venture for Nordell which has been built by specialist cleanroom manufacturer Total Clean Air of Redhill, Surrey who completed the build within 3 weeks of starting the build process.
We are looking forward to starting production and giving our further support to the medical sector, not just with the Covid-19 pandemic but for medical consumables further forward. If you are interested in how Nordell can help improve your manufacturing or provide expert plastics manufacturing then get in touch below.