Optimold Limited, the sister company to mould manufacturer Microsystems (UK) Limited, is a contract manufacturer producing injection moulded components for medical devices, such as auto-injectors, asthma inhalers, drug delivery and blood diagnostics for both hospital and laboratory use. Over the past decade, C2C has supported Optimold with modular cleanrooms to facilitate growth in the medical device market.
Growing clean production in line with demand
When Optimold won its first contract for medical device parts back in 2011, one machine out of the five they had at the time needed to be enclosed in an ISO Class 8 cleanroom. C2C installed a localised modular cleanroom to house an individual machine. Over the years, as contracts grew or new work was won, more machines were upgraded with a cleanroom. Having the cleanrooms on castors means they can be wheeled away from the machine to give access to change tooling easily.
Optimold now has 13 injection moulding machines, of which seven are enclosed in modular cleanrooms. The modular cleanrooms create a clean environment to prevent contamination issues and, when combined with the controls put in place, they manage contamination well within the requirements of customers’ AQL criteria.
As Optimold have several injection moulding machines in the same white room area, the external room is temperature-controlled. Each cleanroom features a ceiling-mounted HEPA fan filter unit that intakes air from the controlled surrounding environment. This keeps the temperature at acceptable limits within the cleanrooms.
There is one unit, however, where a small amount of secondary work on components is performed within the cleanroom by an operator. Here comfort cooling is supplied to the cleanroom by a localised air conditioning unit. This unit supplies the cooled air to the fan filter unit, to provide terminal HEPA filtration and ISO compliance.
This case study was first published on our UK website.