During the manufacturing process of medical devices it is important that contaminants are absent, which is why cleanrooms are used. In addition to reducing the safety and effectiveness of the medical devices, contamination in a cleanroom could lead to a shutdown, resulting in the loss of significant amounts of money and time.
Cleanrooms are especially important in the manufacturing process of plastic products that are becoming more prominent in medical devices. Impurities can cause defects in the products, which in turn can cause problems in the medical devices. Therefore, it is imperative that organisations have policies and procedures in place to maintain the environmental integrity of a cleanroom.
Successful cleanroom monitoring allows you to observe and control optimum conditions and maintain a consistent environment for your practices. Cleanroom monitoring using particle counting equipment for particle count testing, is the only way companies can ensure they are consistently meeting the air quality parameters set by ISO 14644-1.
Key trends identified through Regular Monitoring
Formed in 2015, Medical Moulding Products (MMP), an injection moulding company specialising in the production of medical products. They now operate 4 cleanrooms, two of which are ISO Class 7 and two which are ISO Class 5. It is imperative the parts they supply to their customers are as clean as possible and by monitoring their cleanrooms on a weekly basis ensures that the environment in which they work meets that requirement.
MMP have dedicated cleanrooms for creating medically clean plastic mouldings and they set very high standards, to ensure that their plastic mouldings are as clean as possible, before being packed and delivered to their customer base.All their cleanrooms are compliant to ISO 14644-1 and the standard requires regular testing to ensure the rooms remain compliant. MMP test cleanrooms weekly with a calibrated particle counter and record and monitor the results in-line with their risk assessment and monitoring plan.
In addition they have external validation every six months and leave our cleanrooms on 24 hours a day, 365 days a year in order to maintain the cleanest possible environment.
Following the purchase of their particle counter from Cleanroomshop.com, Peter Lucas, Director, MMP stated ‘Having considered several options, we purchased the Met One two channel handheld particle counter (part of the Cleanroomshop.com range) because it fitted well with the size of the particles we needed to monitor, as well as being extremely simple to use and competitively priced’
With their weekly monitoring MMP are now able to ensure they meet the class they are working to and enable them to spot any trends that need their attention before any problems arise. Following the introduction of the Met One particle counter they have established what effects their air quality adversely and have introduced procedures to maintain low counts, which would have been impossible without these regular checks.
Ensure your Particle Counter Complies though regular Calibration
Particle counter accuracy is essential in maintaining a quality environmental monitoring system. With such an important part to play in product quality and ensuring overall product safety, especially in the pharmaceutical, biotech and medical device industries, particle counter accuracy is critical.
Properly servicing and calibrating your particle counter provides you with confidence in the data you rely on, minimising inaccurate measurements and reducing variations between different units. Cleanroomshop.com provides an ongoing particle counter calibration service for all units, providing peace of mind that your unit remains ISO 21050-4 compliant.
Cleanroomshop.com offers a full range of particle counters for your cleanroom monitoring process including Particles Plus, Airy and Beckman.