CLEANROOMS
JOSHUA HASTON, TERRITORY ACCOUNT MANAGER AT CONNECT 2 CLEANROOMS EXPLAINS HOW CLEANROOMS CAN SUPPORT THE ACHIEVEMENT OF GREATER DEGREES OF ACCURACY TO RELIABLY REPEAT THE PRODUCTION OF MICRO PARTS.
Creating a repeatable environment
FOR MICROMOULDING
F
or injection moulders, upgrading plastics manufacturing with a cleanroom to gain access to medical markets is a common move and a natural progression pathway. Cleanroom providers typically provide ISO 14644-1:2015 class 7 cleanrooms for such occasions. Having a class 5 cleanroom installed, however, brings additional benefits. MICROMOULDING Biplas Medical — a technical injection moulder in South Wales — had an ISO class 7 cleanroom installed when it introduced clean production in 2018. Earlier this year, the company took cleanroom production to another level when it needed an ISO class 5 cleanroom to house a micro-injection moulding machine to facilitate an Innovate UK grant project. Biplas Medical had joined a European consortium to develop a cancer diagnostics device, which, as it turned out, is produced using the smallest moulding ever made. The larger parts produced by the micromoulding machine for a different project weigh approximately 3–4 g. By comparison, the parts required for the Innovate UK grant project weigh less than 0.1 g. These parts are so small that quality control (QC) inspection requires a microscope and camera. The cleanroom ISO standard (146441:2015) dictates there can be no more than 10,200 particles of size 0.3 µm per m³ of air within an ISO class 5 cleanroom.1 To give an idea of scale, human hair has an average diameter of 100 µm and smoke particles are 1 µm. Achieving a microscopic level of environmental control is critical when producing micro parts as any contaminants would completely stop the products from working. Since investing in the ISO class 5 cleanroom, Biplas has received micromoulding contracts for dentistry components and a two-shot biotechnology component that separates fluids and cells as they pass through the product. Both parts cannot be produced in conditions any higher than ISO class 5.
14
W W W. M E D I C A L P L A S T I C S N E W S . C O M
