Cleanroom Services
Redditch Medical has the capability to prepare Medical Devices within our ISO 7 cleanroom facilities. Our experienced team offer a confidential, high quality and efficient service for all your cleanroom service needs. Dependent on each Customers’ needs, our Contract Manufacturing Service can incorporate: -
- Aqueous Ultrasonic Cleaning
- Cleaning Validation
- Component Assembly
- Packaging and label design
- Full packaging selection and sourcing
- Peel Pouch Packing
- Blister Packing
- Packaging integrity testing & monitoring
- Packaging Validation inc. accelerated aging testing
- Control of sterilisation and sterilisation validation (Gamma Irradiation, ETO and Gas Plasma carried out in partnership with approved suppliers)
- Routine sterilisation dose audits
Working with Redditch Medical, our Customers can take advantage of both low and high-volume production as part of a complete or partial service. We have vast experience qualifying and accepting product specifications, making Redditch Medical an ideal partner for product release. Furthermore over 80% of product manufactured by Redditch Medical is exported; we off a complete supply and logistic solution with finished medical device shipped to the Customer ready for industry use.
Redditch Medical’s Cleanroom Service division is certified to ISO 13485: 2016. We are compliant with the FDA’s 21 CFR 820, registration number 8043734. Our experience with technical authorship allows us to provide effective Quality Assurance advice to assist our Customers who require documentation for their technical dossiers and Quality Management System for Class I, IIa, IIb and III Medical Devices in European and other international countries.
