Service Packages > Level Three

[Photo: Ultrasonic Clean and Passivate][Photo: Assembly][Photo: Wash & Disinfect][Photo: Packing][Photo: Sterilisation][Photo: Documentation & shipping]
Our 3,700sq metre facility incorporates a cleanroom specified to operate at ISO Class 7 (10,000) level (incorporating level 5 zones).

Level Three

Our level three service package includes the following:

  • Assembly (optional)
  • Wash & disinfect
  • Packing
  • Sterilisation
  • Documentation & shipping
 

Assembly (optional)

We've got the skilled personnel and automated technologies to undertake a huge range of assembly applications, from small batches of hand-assembled products to large-scale assembly. Better still, we're able to customise our assembly services around each individual client's requirements according to key issues like timescale, budget, traceability and desired levels of cleanliness and purity.

 

Wash and disinfect

We're able to undertake the washing and thermal disinfection of medical devices, including a final rinse cycle using reverse osmosis (RO) water (which eliminates impurities, bacteria and endotoxins).

This fully automated and validated process is carried out in compliance with current HTM protocols (including HTM 2030 and 01-05), and in line with HTM ‘best practice' guidelines. Disinfection via heat, coupled with a final rinse cycle using RO water with no trace of contaminants whatsoever, guarantees the absolute cleanliness of devices prior to packing.

To our knowledge, at the time of writing we're the UK's only sub-contract packer with the on-site facilities needed to achieve these standards.

 

Packing

Our Sheffield facility has everything we need to fulfill a broad range of packing requirements, including the expertise to help devise the perfect solution in the first place. As well as both low and high-volume packing, we're able to offer cost-efficient solutions embracing peel pouches, paper/film packs, paper/paper packs, blister packs, semi-rigid blister packs, 4-side seal packs and thermoformed packs. Naturally, our packaging solutions are built around the customer's specific requirements in terms of volume, deadlines, traceability, sterilisation levels and overall cost.

 

Sterilisation

Thanks to our own reputation within the industry, over the years we've been able to forge lasting partnerships with a number of ISO accredited companies that we trust to undertake sterilisation on our behalf. Typically our clients ask us to arrange either gamma irradiation, ethylene oxide or steam sterilisation, although we're always happy to share our expertise and advise them on the merits of different methods and technologies. We're also happy to direct clients on the validation of sterilisation and packaging.

 

Documentation and shipping

We know that details matter. That's why we always go the extra mile to make sure all release paperwork, including sterilisation certification, is clearly and accurately completed. For transportation and delivery we're able to handle everything from single parcels to multi-pallet shipments, and we use trusted couriers or hauliers to make sure consignments arrive on time, every time.

 
 
Our work conforms to: ISO Class 7 (incorporating Class 5 zones), ISO 13485:2003, ISO 9001:2008