Primary packaging in the clean room.

Primary packaging in the clean room.

The packaging must guarantee the intended functionality and sterility of the medical devices up to the storage expiry date. Blister packs, peelable pouches and ampoules (with or without outer packaging) are usually used for this purpose. The washed and dried medical devices undergo primary packaging in the ISO Class 7 clean room, using the latest equipment and trained personnel. Continuous training, detailed SOP's (Standard Operating Procedures) and documented in-process controls ensure that these requirements are maintained at all times, and are traceable. 

Finishing and final packaging.
Prepared medical devices that have already undergone primary packaging are inspected, transferred from the clean room and finished to form sales-ready packages (e.g. with instructions for use, patient labels, etc.). This stage includes placing within cardboard boxes, coding as well as shrink-wrapping, as required. The finished packages are then palletised in sterile boxes in accordance with a loading plan, protected against unwanted interference during transportation and transferred for sterilisation. This usually represents the end of the service; the sales-ready packages are then ready for the customer to distribute.