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Packaging (Cleanroom Packaging)


Philosophy

As part of our supply chain concept we offer as an extra service the cleanroom packaging of orthopaedic and dental implants and instruments including their labelling, allowing us to react flexibly and rapidly to our customer's requirements.
cleanroom-packaging at DOT
Technology

DOT has two clean rooms on her disposal with a total area of 100 m², classified and qualified according to accepted international standards (ISO 14644, class 8, particle counts of less than 3,5 million/m³).

In accordance with our strict hygiene standards, we monitor our processes on a regular basis, including the defined environmental conditions for production, as well as the requirements for the water used.

Prior to cleanroom packaging, the implants and instruments are mechanically washed and disinfected in accordance with Robert Koch Institute standards. Subsequently the products are then delivered to the cleanroom for packaging. All processes are carried out using validated procedures.

Range of Packaging Services

Sterile Packaging
Blister‑Packaging:
DOT has validated blister-sealing machines for sterile packaging under cleanroom conditions at her disposal. Products can be boxed and labelled in accordance with individual customer needs.

Pouch Packaging:
Our validated vacuum- sealing machines are especially designed for sterile packaging of healthcare products under cleanroom conditions. The products are vacuum packed in PA and PE bags. A protective gas can also be added if desired. The bags can then be boxed and labelled as well. All sealing is subjected to a regular process monitoring.

Packaging & Services - PDF: 300 KB

Non sterile Packaging
Non sterile serial packaging:
The non sterile serial packaging covers the packaging of implants and instruments in PE pouches, including inline printing using any layout desired. Various counts of roll bags can be packaged. These bags can also be supplied perforated, thus allowing for easy separation (an ideal solution for packaging in sets).

Shrink wrapping:
Boxed products can be shrink- wrapped, with tear-open strips if desired.

Laminar flow packaging:
We also provide microbe- reduced packaging using a laminar flow box.

DOT GmbH
Charles-Darwin-Ring 1a
18059 Rostock l Germany

Phone: +49 381- 4 03 35-0
Fax: +49 381- 4 03 35-99



 

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