Packaging (Cleanroom Packaging)
Philosophy
As part of our supply chain concept we offer as an extra service the cleanroom packaging of orthopedic and dental implants and instruments including their labelling, allowing us to react flexibly and rapidly to our customer's requirements.
Technology
DOT has two cleanrooms on her disposal with a total area of 200 m², classified and qualified according to accepted international standards (ISO 14644, class 7 or C according to GMP Annex 1). 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.
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.
Our 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 medical devices under cleanroom conditions. The products are vacuum packed in PA and PE pouches. A protective gas can also be added if desired. The pouches can then be boxed and labelled as well. All sealing is subjected to a regular process monitoring.
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 medical devices under cleanroom conditions. The products are vacuum packed in PA and PE pouches. A protective gas can also be added if desired. The pouches can then be boxed and labelled as well. All sealing is subjected to a regular process monitoring.
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 pouches can be packaged. These pouches 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.
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 pouches can be packaged. These pouches 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.
