Cleanroom Services
Andel’s in-house Class 7 Cleanroom, gives us a unique ability to manufacture, assemble and package medical devices, ready for sterilisation.
Adding to our existing capabilities, this means we can provide our customers with a complete service of component design, mould tool manufacture, injection moulding, followed by cleanroom inspection, assembly and packaging.
This complete manufacturing solution gives our customers confidence that each device or procedure pack has been manufactured, assembled and packaged under one roof. Offering full the traceability and cost effectiveness that this provides.
We follows the strictest routine quality control processes to the ISO13485 requirements are followed throughout the process. *
Our Cleanroom capabilities also include putting together single use instruments and procedure packs. These are packaged in our cleanroom into Tyvek or foil pouches and labelled with full batch traceability.
Labelling can be customer specific with separate patient piggy back 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.
*ISO13485 requirements are followed, however the certification approval process is ongoing.
- Design for medical component
- Medical Plastic Component manufacture
- Medical Device Assembly
- Cleanroom assembly services
- Surgical Procedure packing services
- Single use instruments
- Medical moulding
