Packaging and Assembly

Customized. User-friendly. Safe.

Good, safe and user-friendly packaging is essential for medical devices. When selecting the right packaging, the nature of the products to be packed, the requirements of the user, structural conditions and transport logistics play a crucial role. User and environmental friendliness as well as safety aspects are to be treated equally.

Cendres+Métaux offers the following services in the field of packaging and assembly:

  • Transport packaging
  • Final packaging (sterile)
  • Product handling: our four degrees of cleanliness
  • Assembly

Do you have questions on the topic of packaging and assembly or do you require additional information? Do not hesitate to contact us.


Transport Packaging

Safely from clean room to clean room.

Good transport packaging is the basis for the safe arrival of your products. Based on our infrastructure, we have defined four cleanliness categories at Cendres+Métaux and can thus offer the ideal packaging solution corresponding to the requirements for product cleanliness. For example, we can arrange direct and safe shipment to your clean room upon request. The CLEAN TRAY blister carriers we use are manufactured under clean room conditions, can be sealed dust-proof and are ecological. This example of transport packaging meets the requirements of our cleanliness category 4 and is also suitable for direct removal in the clean room for final assembly.


↑ Back to overview

Final Packaging

Customized options, safe application.

When selecting the right packaging, the materials, user-friendly product removal, attractive design and logistics play a decisive role. We can offer you standardized and customized packaging solutions, take effects on product design into account and organize the supply chain so that you can call off ready-to-market products from us.

The specification sheets serves to record the customer's wishes and to derive the resulting necessary requirements. In addition, it is an important element of the product master file which is required to obtain successful certification.

We would be pleased to support you in preparing your packaging specifications. We take the following aspects into account for the concept:

  • Product overview
  • Product processing corresponding to our cleanliness groups
  • Assembly and placement
  • Bacteria-proof sealing
  • Labeling and traceability
  • Suitability for the intended sterilization process
  • Easy and safe handling during transport and storage
  • Ensuring function and sterility of the medical device up to use
  • Option of aseptic removal

Different designs can be realized with various, widely-accepted materials. Whether single or double, flexible, semi-rigid or rigid, we are bound to find the right type of packaging among the many options, depending on your wishes and regulatory requirements:

  • Blisters
  • Peel bags
  • See-through bags
  • Tube bags
  • Trays
  • Capsules and tubes
  • Cartons

Labeling and traceability not only serves the purpose of selling a medical device. It must be identifiable from manufacturing through to the patient records.

The applicable standards and the requirements of the authorities, which can vary considerably from country to country, must be taken into account. Cendres+Métaux have been involved for decades in these issues and can therefore offer sound advice in the field of labeling medical devices.

Our service in the area of labeling:

  • Patient labels
  • Labels for blisters, bags, cartons
  • Direct printing on packaging medium
  • Instructions for use

A number of tests must be passed to ensure that medical devices arrive on the market sterile and suitable for storage. To be observed and tested are the selected packaging components, the suitable cleaning system, the packaging environment, validated seams and suitable sterilization processes. Customized or with existing standards - we would be pleased to accompany your products from the idea to realization.

↑ Back to overview

Product Handling

Our four cleanliness categories.

We recommend different product handling, depending on the risk class of your medical device and depending on the quality requirements your product should meet when delivered. Overall, we offer you four different cleanliness categories (CC 1-4):

Product handling in cleanliness category 1 means:

  • No microbiological requirements.
  • The products are free from process operating materials immediately after washing in accordance with state-of-the-art technology.
  • Further processing under normal, unprotected atmosphere (recontamination cannot be excluded).

Product handling in cleanliness category 2 means:

  • No microbiological requirements.
  • The products are free from process operating materials immediately after washing in accordance with state-of-the-art technology.
  • Packaging in normal unprotected atmosphere.

Product handling in cleanliness group 3 means:

  • No microbiological requirements
  • The products are free from process operating materials after washing in accordance with state-of-the-art technology
  • Packaging under controlled protected atmosphere equivalent to clean room class ISO 8 (GMP class C)

Product handling in cleanliness category 4 means:

  • Product-specific microbiological requirements or sterile
  • The products are free from process operating materials after washing in accordance with state-of-the-art technology
  • Packaging under controlled protected atmosphere clean room class ISO 8 (GMP class C)
↑ Back to overview

Assembly

Straightforward and complex assemblies in clean rooms.

Assembly rounds off our services in the field of packaging. We offer both straightforward as well as complex assemblies including product-specific testing. This also includes engineering services, for example, the set-up of testing mechanisms. Test methods and set-ups suitable for clean rooms can be conceived and manufactured in-house owing to our extensive manufacturing competence. To ensure guaranteed traceability, we exclusively employ qualified, trained personnel as well as exclusively controlled processes.

Our service in the area of assembly includes:

  • Straightforward assemblies, for example, resin pressing on dental abutments
  • Complex assemblies with various assembly parts and elaborate work steps
  • Tests suitable for clean rooms depending on the cleanliness category chosen
↑ Back to overview