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Packaging

Secure packaging guaranteeing integrity, ergonomics and compliance

Packaging designed to secure your products until their final destination

The objective of conditioning is to protect the product, to ensure a sterile barrier, to ensure a good ergonomics for the end user.

We ensure custom packaging of your products via blister packaging, lidding, bagging, assembly and boxing.

The device must be placed in a blister to avoid its X-Y-Z movements.

There robustness of the blister may depend on the thickness of the film used: we can go up to 1.5 mm film thickness. The latter can be reduced by stretching which is done to obtain the shape. The deeper the part and the steeper the sides, the lower the thickness will be in these areas.

In some cases, the blister will be put in another blister:

  • Primary packaging: in contact with the device
  • Secondary packaging: external to receive the first blister

Validation of the robustness of the packaging is ensured by transport tests.

Sterilisation requirements and controlled environment

Sterilisation occurs after packaging. Therefore the device must be packaged and closed in a bacteria-tight manner, i.e. the blister must be thermally sealed with a lid before undergoing radiation or exposure to ETO (Ethylene Oxide) gas.

To guarantee the tightness over time of the delivered product and therefore sterility, certain conditions must be met which must be demonstrated at the time of audits.

For sterilisation to be effective, the dose, the exposure of the pallet, or the cardboard containing the devices must be largely sufficient to kill all the bacteria. It is the sterilisation validation process that allows these parameters to be validated.

But this validation depends on the quality and nature of the bacteria, molds, and other living organisms present with the device and the packaging before its watertight closure. To guarantee a low and controlled level of this level of bacteria, the entire chain of the manufacturing process must be carried out in clean – white rooms, that is to say in a filtered atmosphere, cleaned regularly and the staff equipped with suitable and clean protection.

If this is not the case, the products must be cleaned and disinfected before being packaged.