TSC manufactures medical device components and has recently expanded onto a new site to accommodate a growing demand for its product. TSC uses a cleanroom during production of its devices so it is able to meet the requirements of the Medical Device Directive, so the company began looking for a cleanroom solution to meet its needs.
TSC was first introduced to Connect 2 Cleanrooms at the MEDTEC 3C Exhibition at the NEC, where Connect 2 Cleanrooms was exhibiting its modular cleanroom solutions. TSC spoke with the Managing Director and a project engineer and was impressed by the short lead time and speed of installation offered by the modular approach to contamination control, as this meant the company would quickly be able to capitalise on its investment.
As TSC manufactures medical device components, it needs to be sure that its cleanroom solution is working at optimum effectiveness at all times. It was therefore very interested in the Closed-Loop Control System that Connect 2 Cleanrooms has developed. The system continuously reads particle counts and pressure, as well as managing the speed of the HEPA filtration to ensure the cleanroom is always running at its required ISO classification.
The Control System also records all the data in a choice of parameter, such as shift times or batch production, which is then downloadable via the user friendly ECO-1 Control Panel. The system is designed to save users the expense and time of recording the data manually and is particularly of use to companies who are required to provide audit data to customers or regulatory bodies.
TSC dealt with Connect 2 Cleanrooms’ engineers right the way through the process, so when discussing their requirements they found they were able to have knowledgeable and practical discourse on the best way to approach the project. A 3D CAD drawing of the cleanroom also helped TSC to visualise how the 243m2 (13.5m x 18m) cleanroom would physically fit into the space they had available and gave peace of mind that the cleanroom would be the solution they required. They were also able to extend the height of the cleanroom to 3.2m to allow for their machinery and tooling.
Cleanroom air conditioning units were built into the room for the purpose of comfort cooling. The integrated system gave TSC the peace of mind that the air being produced works in synergy with the 20 HEPA filters, which are working to create an ISO Class 8 environment with 39 air changes per hour.
TSC opted for a hardwall cleanroom, with clear PeTG wall panels that allow a high level of natural light to filter into the cleanroom and created a light and open working environment for production staff. TSC’s logo was manifested on the clear hardwall panels, giving them the opportunity to emphasise their brand to visitors. A goods transfer area was integrated into the room with antistatic softwall strips to allow easy product transfer.
The installation and commissioning of the cleanroom followed the time schedule agreed and took a small team of experienced and qualified engineers four days to complete. Upon completion a full validation of the cleanroom took place; the validation report was described by TSC as “very thorough” and gave TSC exactly what was needed to meet the regulatory requirements of the Medical Device Directive.
To furnish the new cleanroom TSC took advantage of Connect 2 Cleanrooms consumables division, cleanroomshop.com, which was able to manufacture and deliver 18 bespoke stainless steel tables within two weeks from the order date and also supplied chairs and anti-fatigue mats to aid operators’ comfort.
“I would be very happy to recommend Connect 2 Cleanrooms as I was impressed with their quality of service, build quality and performance. They have produced a nice and light environment for production staff to work in,” commented a TSC spokesman.
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