ERIE, Pa. (April 1, 2020): The need for medical manufacturers to develop internal testing for bio-contamination is paramount, especially in the wake of novel infectious diseases, such as the most recent COVID-19 outbreak.
Earlier in 2020, Plastikos and Plastikos Medical implemented its formal system, in full compliance with ISO 14698-1 and ISO 14698-2. This system is dedicated to test for bio-contamination, and evaluate microbiological data for Medical OEM customers who request this level of bio-contamination control in support of their life-saving and
life-sustaining products.
Medical devices are currently molded within multiple ISO-7 certified cleanrooms at Plastikos and Plastikos Medical that meet the ISO-13485 manufacturing standards. Additionally, the development of this bio-contamination testing strategy significantly increases the specific level of bioburden confidence afforded to Plastikos’ & Plastikos Medical’s medical device OEM customers.
- ISO 14698-1: Includes the general principles and methods of bio-contamination control.
- ISO 14698-2: Covers the complete evaluation and interpretation of the biocontamination data.
By obtaining reliable bio-contamination data from multiple sampling locations throughout the cleanrooms, especially in ‘risk zones’, Plastikos’ & Plastikos Medical’s test results provide a comprehensive bacterial & fungal analysis and a heightened accuracy in relation to cultured results as well as the documentation of trending data over time.
Joe Day, Plastikos’ Quality Manager, further commented regarding the enhanced capabilities afforded by the bioburden testing procedure: “Adding a level of bio-contamination control to our already proven and certified cleanroom capabilities affords our customers with a level of confidence that few other custom medical molders & medical manufacturers provide. Knowing that our products meet stringent bioburden limits directly increases our customers’ ability to ensure that they are providing a safer finished product to all of their end consumers.”
This rigorous level of bioburden testing has traditionally been completed by the medical device OEM’s throughout the assembly of a medical device to verify bio-contamination levels prior to the sterilization process. By providing the enhanced bioburden capability to identify any microbial activity in-house, Plastikos & Plastikos Medical can now quantifiably increase the confidence that its manufactured parts meet the medical customer’s bioburden requirements, so that they can move forward with their own downstream assembly, sterilization, and packaging processes.
Ultimately, Plastikos’ & Plastikos Medical’s in-house bioburden testing compliance yields a significantly increased level of risk mitigation (i.e. significantly lower risk) to the Medical Device OEM, to the downstream supply chain, and to the finished medical device.
