We specialise in high and low volume production runs and in-house developed medical device packaging solutions.
- High and low volume production in order to meet the requirements of any project.
- Loading of Tyvek, Foil or Paper medical peel pouches and sachets to then be sealed with our comprehensive range of pouch sealing equipment.
- Loading of Thermoformed blisters which are then sealed with either Tyvek Foil or Paper Lids.
- Tyvek Foil or Paper Blister Lids to be sealed to loaded blisters using one of our numerous Nelipak SH-BT1 Analogue Sealers.
- Procedure Packs - Everything required to carry out a routine procedure in one ergonomical package.
Our packaging solutions are supported by:
- Microbiology of products, including; Bio-burden testing, Sterility testing and Endotoxin testing.
- Two seperate Class 7 Cleanrooms, both over 115m².
- Environment monitoring, including; particle counts, active sampling, traditional settle plates, contact plates and result trending.
- Validatable cleaning processes, including Ultrasonic and Plasma.
- CE Marking support from our experienced Quality Assurance Team.
- Additional operations including; Cleaning, sub-assembly, and labelling.
- The management of outsourced Sterilisation processes including Irradiation and Ethylene Oxide.
- Protocol development and validation - please see Quality Assurance.
- In-house Seal Integrity Testing via tensile strength or dye penetrant inspection.
As well as medical device packaging, we offer an in-house label service including:
- Label Design, Printing and Origination.
- Management of outsourced solutions, such as multi-coloured labels, tamper labels and large quantity orders.
- Label proofing protocol.
- We comply with FDA's new UDI System. The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human and machine readable form. This will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
© Wesley Coe (Cambridge) Ltd, Gas lane, Ely, Cambs, CB7 4GH, UK.
Company Registration Number - 00502988