CLEAN ROOM ASSEMBLY
Clean Room Medical Assembly
The production that takes place within a clean room is known as clean room medical assembly. Pharmaceutical and medical device manufacturing frequently necessitates the use of clean room medical assembly. Contamination during the assembly process could have a negative impact on the finished product. To understand more about our services, continue reading.
Delivering quality results in Class 6 & 7 cleanrooms
Arrow Medical offers a complete medical manufacturing resource. This extends from engineering support for prototype design and pre-production, to production planning and engineering, right up to volume unit production.
Arrow Medical maintains several Class 6 and 7 clean room assembly facilities for the assembly of single use devices and other Class 2 and Class 3 products for use in airway management, anaesthetic, emergency and cardiac treatments, with certificated compliance to BS EN ISO14644-1:2015
These facilities support Arrow Medical’s production of laryngeal masks and allied products, including many different types of tubing sets, to a high and consistent standard to meet the needs of a global market.
Arrow Medical’s cleanrooms are designed for quality assembly of advanced devices as well as precision moulded polymers and metal components.
Arrow Medical facilities are fully qualified for delivery straight to the customer. This includes components, sub-assemblies and complete products, fully assembled and packaged ready for use in clinical environments.
Complete facilities are provided for:
- Assembly of medical devices
- Injection moulding
- Packaging ready for sterilisation using gamma or ETO methods
These rooms can accommodate ancillary and component processes, such as silicone moulding, gluing and bonding, depending upon the customer’s requirements. All processes meet ISO 13485:2016 and other relevant standards, including FDA GMP.
As an Investor in People, Arrow Medical maintains stringent training standards.
The operations are regularly assessed to ensure all biological standards are maintained.
This is supported by both careful selection and staff training throughout the business from supplier selection to delivery to the sterile logistics chain.
Contact Us Now
For further information, please contact us today by dropping your information and queries on our enquiry form or alternatively, you may contact us through email or phone.