The operation of advanced cleanroom facilities is a crucial component of the medical device assembly process and has a critical role in ensuring the quality, safety and success of medical devices.
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If disposable medical devices are not assembled in the correct controlled environment, there is the risk of elevated microbiological contamination and of harm to those using the products and, ultimately, to patients. Failure to ensure the appropriate level of cleanliness could also have serious consequences for the product manufacturer. Cleanrooms are therefore a critical component of the medical device assembly process
Why cleanrooms are a critical component of the medical device assembly process
Cleanrooms are controlled environments in which particle count and microbiological levels can be controlled, using filters and cleaning respectively. This ensures that the bioburden count is reduced as much as possible and that microbiological contamination levels are not elevated during the manufacturing process.
Thereafter, once a medical device has been assembled in a cleanroom, it is inserted into its final packaging and sterilised. This sterilisation protects against live microbiological contamination, such as presence of potentially harmful endotoxins, and is carried out in a separate specialist facility.
The regulations that govern cleanroom operation in medical device assembly
There are two principal regulations that govern the operation of cleanrooms in relation to the assembly of medical devices. Compliance with these regulations is imperative.
The ISO 14644 family of international standards governs aspects relating to the setting up, operation and testing of cleanrooms. In addition, parts 1 and 2 of the ISO 14698 international standard cover the control of bio-contamination in relation to cleanrooms.
Cleanrooms and the benefits of a contract medical device manufacturer
The operation of advanced cleanroom facilities with regard to the assembly of medical devices requires the use of the latest technology and strict compliance with regulations. To achieve this standard of operation and this compliance, a wide range of specific skills, equipment and processes must be practised, used and followed. An expert and experienced contract manufacturer of disposable medical devices will have them all in place.
What cleanroom standards to look for in a medical device assembly partner
With regard to what to look for in a contract manufacturer of disposable medical devices, when it comes to cleanroom infrastructure and standards, you should choose a partner that has extensive advanced facilities and rigorously manages sterilisation processes in strict accordance with the relevant regulations, including regular independent cleanroom testing.
For example, Meridian Medical has multiple advanced cleanrooms, including three class-7 facilities. These state-of-the-art cleanrooms are fully equipped for medical device manufacturing and assembly, including catheter assembly, gluing, pouching, sealing, skiving, tip forming and radio-frequency and ultrasonic welding.
In addition, Meridian Medical operates a class-8 mould shop cleanroom that is set up for the injection moulding of plastic components and a class-7 tube cutting cleanroom. All of these facilities are designed for the manufacture and assembly of products to the highest standards.
Cleanrooms, medical device assembly and your contract manufacturing partner
The importance of cleanroom facilities and processes to a medical device manufacturer, and to the hospital staff who use its products and patients, cannot be overstated. Using a contract manufacturer with advanced cleanroom facilities and comprehensive cleanroom protocols ensures that the highest standards of quality are consistently maintained, that hospital staff and patient health is constantly assured and that brand and reputation are fully protected.
Meridian Medical is an established and experienced contract medical equipment manufacturer, specialising in a wide range of medical device design, development and supply services.
To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.