Wayne Matthews, sales manager at Tecman Speciality Materials, outlines what should be considered before embarking on a clean manufacturing process.
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Manufacturers are facing a tough trading environment. They regularly walk a tightrope to keep costs down and satisfy demanding specifications, and are currently doing so in a highly challenging, inflationary context. Finding and selecting a manufacturing partner that has the required capabilities to produce quality, high volume components within budget is a difficult task, but one that has become even more important.
Whilst many manufacturers know what they’re looking for in a supply partner, plenty are unsure when it comes to specifications relating to clean, sterile, and hygienic manufacturing processes. To determine which capabilities are needed for a project, and to avoid over-spec, it is worth taking time to assess which is most appropriate to your needs.
It can be useful to start with a few basic questions to help clarify project requirements. These can help tease out which manufacturing processes and capabilities would be suitable for a particular product. For example, is the end-product going inside a patient or will it pose an infection risk? And does the product need to be kept sterile throughout the whole process? This is not an exhaustive list but can be a good place from which to start assessing different options.
Many people know what a cleanroom entails but it’s a little trickier when it comes to CMPs because they refer to a set of processes that sometimes vary from manufacturer to manufacturer, but can broadly be understood to involve:
- The careful handling and segregation of raw materials to prevent the contamination of a material during the manufacturing process.
- The limiting of exposure time when processing sensitive materials to reduce the opportunity for contaminants to come into contact with the parts.
- The semi-automation of processing to reduce the number of times the materials are handled by an operator.
- The wearing of PPE and protective clothing by those involved to prevent contamination between people and parts.
CMPs are suitable for many manufacturers, products and applications that require a degree of quality control, hygienic production, and traceability – some examples of which we have worked on include chemical indicator strips used in diagnostic devices and the production of airtight gaskets for use in bone cement mixing devices. These processes signify a risk adverse approach to manufacturing that still ensures a high degree of quality and safety, but without the price tag that can sometimes accompany cleanroom manufacturing.
Expertise is key in this field.
If you are unsure of the regulatory framework for your intended product, or which facilities would meet these requirements, you should seek regulatory advice.
Once you are clear on this, selecting a supplier who has the manufacturing expertise and experience to understand how your vision maps onto technical requirements will enable you to understand which method is best suited to your budget and specification.
You may already be on the right track, but you could be overcomplicating and overpricing a straightforward project.
