How cleanroom training reduced contamination risks for a medical device manufacturer

The client

Schultz Medical is a UK manufacturer of medical instruments. Their hysteroscopy sheaths are manufactured in an ISO 14644:2015 validated cleanroom as they are used to allow physicians and surgeons to insert hysteroscopes into bodily cavities. With a large contract to fulfil for the NHS, Schultz Medical wanted to be sure that their cleanroom procedures were appropriate to control contamination effectively. This need for a truly repeatable environment and process led them to search for a training provider that offered certified and in-depth cleanroom training.

The course

Connect 2 Cleanrooms delivered a CPD accredited cleanroom training course at Schultz Medical’s manufacturing plant in Southport. Through a mix of practical and theory sessions, the course content covered everything the company needed to know about running an effective cleanroom. From gowning and hand hygiene to cleaning and particle size.

Theory sessions covered the size of particles controlled by cleanrooms, reinforcing to Schultz Medical why regular particle counts are an important part of their Quality Management System.

Practical sessions included cleaning demonstrations to highlight how areas can be missed if insufficient methods are used. A UV lamp provided a memorable visual demonstration of effective cleaning and the techniques required to achieve it.

The changes

Behaving in a way that controls submicron particles—invisible to the naked eye—requires discipline. Following the training, the staff at Schultz Medical are now more aware of potential contamination threats and how to prevent them from harming their product.

The Operations Manager at Schultz Medical attended the training. He says, “the training was fantastic. It touched on everything we need to consider for cleanroom production. We were concerned that if things weren’t done right there would be a risk of contamination, but now we understand it better, the risk of contamination is very slim. When considering what a contamination event would cost the business, it is well worth the investment in training.”

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