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primary packaging for medical devices

Do your medical devices need primary packaging designed and produced in the same environment as the part?

Cemiplast develops and produces primary packaging for medical devices in Switzerland, directly in an ISO 7 cleanroom. Regulatory constraints are built in from the part design stage.

Primary packaging for medical devices built into product development

Primary packaging development is one of the key steps Cemiplast handles. It sits alongside part design, prototype pre-production, industrial phasing and process validation. Integrating it early avoids compliance gaps between the part and its primary packaging.

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validated ISO 7 cleanrooms
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certification covering processes and products
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Production of primary packaging for medical devices in a controlled environment

Cemiplast’s ISO 7 cleanrooms make it possible to produce and package the part in a controlled environment. There is no break in the chain between moulding and primary packaging, a critical point for sterile or single-use medical devices.

The material and geometry of the primary packaging are defined jointly with the client. They depend on the chosen sterilisation method and the target shelf life, in line with ISO 13485 requirements.

Designing primary packaging for medical devices at the same time as the part also simplifies process validation. Cemiplast can then handle secondary packaging, to deliver a ready-to-distribute product.

Primary packaging materials for medical devices

Material choice suited to the sterilisation method and the target shelf life.

Technical specifications of primary packaging for medical devices

Certification

ISO 13485

Cleanrooms

ISO 7

Location

Saint-Imier, Suisse

Presse d'injection plastique en salle blanche ISO 7 pour dispositifs médicaux, dispositifs dentaires, micro-pièces techniques, IQ OQ PQ, industrialisation, production, assemblage, conditionnement, contrôles, conception et développement de pièces plastiques, conception de packaging primaire, atelier de Saint-Imier en Suisse

How we work with you

Initial discussion

Initial literature search and assessment of the patentability of the idea, to frame the project.

Design and development

Part design, taking into account the functional, economic and regulatory constraints of the project.

Prototyping

Prototype pre-production, to validate the material choice and feasibility before industrialisation.

Industrial phasing and production

Industrial phasing then production of the moulded parts, with assembly depending on the project.

Packaging and validation

Packaging development, packaging management and process validation.

They trust us

Medical device manufacturers entrust Cemiplast with the joint design of the part and its primary packaging.

Frequently asked questions about primary packaging for medical devices

Does Cemiplast design primary packaging for medical devices in Switzerland?

Yes. Cemiplast designs and produces primary packaging for medical devices directly in an ISO 7 cleanroom. The packaging stays consistent with the moulded part and ISO 13485 requirements.

Can primary packaging be produced in the same environment as the part?

Yes. Cemiplast’s ISO 7 cleanrooms combine moulding and primary packaging in the same controlled environment.

Does the sterilisation method affect the choice of primary packaging material?

Yes, the material and geometry of the primary packaging are defined with the client according to the sterilisation method and the target shelf life.

Why design the primary packaging at the same time as the part?

Designing both together avoids compliance gaps between the part and its primary packaging. It also simplifies process validation.

Can Cemiplast also handle secondary packaging?

Yes. Cemiplast handles secondary packaging in addition to production and primary packaging, to deliver a ready-to-distribute product.

Discuss your primary packaging