Andel Plastics

intelligent engineering

Clean Room

Our Class 7 Cleanroom working to ISO13485 Quality standard, gives us a unique ability to manufacture, assemble and package medical devices, through to sterilisation.

Our in-house Class 7 cleanroom was purpose built and validated in January 2016.  We are accredited to the ISO13485:2003 Quality Standard for Medical Devices.

Adding to our existing capabilities, this means we can provide our Healthcare providers and customers with a complete service of component design, mould tool manufacture, injection moulding, cleanroom inspection and packaging. 

In addition to this our expertise in post-operative assembly means we can also offer assembly and packaging of medical devices. This gives our customers confidence that each device has been manufactured, assembled and packaged under one roof with all the traceability and cost effectiveness that this provides to the ISO13485 Standard.

Our Medical capabilites include putting together single use procedure packs, with all the instruments and consumables that a Surgeon would need for a specific surgical procedure.  Packaged in a cleanroom environment into Tyvek or foil pouches and labelled with full batch traceability.  Labelling can be customer specific with patient labels for easy completion of batch paperwork on patients records. 

Please contact us to discuss any Cleanroom requirements and let us work with you to provide the best service.

Our capabilities in the Medical Industry

  • Design for medical component
  • Medical Plastic Component manufacture
  • Medical Device Assembly
  • Cleanroom assembly services
  • Surgical Procedure packing services
  • Healthcare packing services
  • ISO13485:2003
Medical device assembly
Winners of the 2015 Plastics Industry Awards

Winners of the 2015 Plastics Industry Awards

UKAS Management Systems

Class 7 Cleanroom

Class 7 Cleanroom