Validation of packaging, cleaning, and sterilisation processes for medical devices
The choice of the right packaging system and the selection of the appropriate materials are of significant importance for medical device development. In addition to the specific nature of the medical device in question, the intended sterilisation method, intended packaging, intended use, shelf-life, expiration date, transport and storage must also be considered.
Our experts can support you in cleaning, assembly, packaging and sterilisation of medical devices. We can provide prefabricated blisters and pouches, however we can also provide a custom-made design to meet your customised needs. Whether you will need 20 or 100.000 products packaged and sterilised, we have the capability to upscale with in-line packaging equipment. This way we can meet any requirement, and it allows us to grow alongside your business needs.
Our services
Packaging designs
- Blister design (using 3D CAD model)
- Label design (conform ISO 15223-1)
- Carton development
In house packaging production in ISO class 7 clean rooms
- Hard blister packaging (PETG, APET, PC film)
- Soft blister packaging (OPA/PE, Tyvek®, medical grade paper)
- Peel pouches packaging (OPA/PE, PET/PE, Tyvek®, medical paper)
- Packaging of sealing lids (Tyvek®, medical paper, aluminum) for hard blisters
- Digital color printing on Tyvek® and medical paper
Cleaning of chemical, biological, and particulate contaminants
- Washing and disinfection machine
- Ultrasonic bath
- Immersion bath
- Wipe disinfection
- Plasma cleaning
Cleaning validation medical devices
Our experts develop personalised cleaning strategies. The pre-processing steps will be analysed, to identify potential sources of contamination, and based on this risk assessment, a personalised cleaning process and cleaning validation strategy will be designed for your product.
- Bioburden
- Endotoxins
- Cytotoxicity test
- Biocompatibility tests
Assembly
- Gluing, pressing, coating, ultrasonic welding, functional tests, measuring, control etc.
- Assembly of products according to customer specifications in ISO class 7 clean rooms
- ESD workstation for assembly of electronic components
Engineering
- Development of e.g. cleaning carriers and assembly aids
- Further developments for the manufacturing process e.g. lamination of foils and filling processes
Packaging of medical devices
- Hard/soft blisters and pouches in standard and individual dimensions
- In-line production, packaging, and labeling
- State-of-the-art qualified machinery and equipment with validated processes
- Filling of powders, liquids, and melts
- Cartoning in folding boxes and shipping cartons
- Shrink wrapping of folding boxes in foil
- Marking of products by digital color printing on sealing lids or labels
Sterilisation medical devices (conform ISO 11137 and ISO 11135)
- Ethylene oxide (EO)
- Gamma radiation
- Steam (increased lead time)
Packaging validation medical devices
- Real-time & Accelerated aging study (conform DIN EN 868-5, DIN EN 868-2, ASTM F1140, ASTM F88/F88M, ASTM F1929, ASTM F3039, ASTM F1980)
- Packaging testing
- Visual inspection conform ASTM F1886
- Seal strength conform DIN EN 868-5 and/or ASTM F88/F88M
- Dye test conform ASTM F1929, ASTM F3039
- Burst test conform ASTM F1140
- Microbiological barrier properties test conform DIN EN 58953-6
- Bubble test conform ASTM F2096
Transport simulation and testing
- Testing strategy for the simulation transportation process (conform ASTM D4169 DC13 with preconditioning according to ASTM D4332).
Documentation
- The documents are provided in English by default. Other languages can be accommodated in consultation.
If you would like to discuss your project and needs with our Business Development Manager Anja Kroon or request a quotation, feel free to contact us.
If you would like more information about our Medical Device testing capabilities, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/
