Packaging (Materials & Design)

The packaging is the first thing the user sees when coming into contact with your product. It must be easy to open and to remove the product according to the function.

At Eurofins Sterile Packaging, we understand that packaging is an integral part of a medical device with key importance for both the manufacturer and the user. It serves as a sterile barrier system and fulfils other elementary functions: the packaging ensures that your product is ready for use for the specified shelf life. Together with the customer, we define the requirements for the packaging system and develop an optimal and product-related solution. In addition to the various packaging solutions for sterile protection or outer packaging through to the cardboard packaging, we also take into account the requirements for the relevant labelling obligations.

Packaging Design:

Blister design:

Along with standard blisters for product packaging and transport blisters, we offer customised, tailor-made blister concepts.

Based on your product’s 3D-data, your wishes, and your requirements for e.g. product removal, we first design a 3D-CAD model. Afterwards we design the appropriate tools. Design, functionality, and security are just as much our concerns as cost, sterilisation, transport safety, and the timely and flexible implementation of your wishes.

Label Design:

Our labelling department supports you in designing labels, according to ISO 15223-1. We prepare a master label according to your exact specifications, to ensure smooth and reliable processing routines.

Here, we can also incorporate UDI requirements and advise you in choosing suitable placement sites for unambiguous international article numbers, such as GS1 and HIBC.  We can also execute barcodes, data matrix codes, and customer-specific fonts and company logos.

Design of sales packaging:

Our packaging of ready-to-sell medical products is completed by means of suitable folding boxes or dispenser cartons, as well as individual shipping cartons for your sales unit. Appearance, ease of handling, and safety during transport all play important roles here. If you wish, we can assume responsibility for developing the appropriate solutions together with our suppliers. In case of printed folding boxes, we will provide you a punching line for the design according to your requirements. Procurement of folding boxes is also part of our service.

Production of packaging materials:

In order to have a flexible and adaptive approach, we manufacture in-house packaging for medical products, such as rigid and soft blisters and pouches, according to international standards. Preservation of the sterility of these packaging materials is documented for a period of at least 5 years.

We offer the following types of packaging (manufactured in ISO Class 7 clean-rooms):

• Four-edge sealed bags
• Rigid blister (PETG, APET, PC-film)
• Soft blister (OPA/PE, Tyvek®, medical-grade paper)
• Peel pouches (OPA/PE, PET/PE, Tyvek®, medical-grade paper)
• Assembly of sealing lids (Tyvek®, medical-grade paper, Alu) for rigid blister
• Digital colour printing on Tyvek® and medical-grade paper
• Individual sterile barriers
• Label printing

Materials used:

• GAG-PET / G-PET /
• PE or PA composite films
• Coated and uncoated Tyvek
• Aluminium composite films
• Coated and uncoated medical grade paper

3dpac:

The 3dpac is a blister system developed by Eurofins Sterile Packaging for optimal position fixing of sensitive products within the sterile barrier.

The 3dpac comprises of 3 components:

• Outer sterile barrier (secondary blister)
• Inner sterile barrier (primary blister)
• Fixing inlay. Your medical device is embedded within a thermally custom-shaped fixing inlay in the primary blister in a stable position. The fixing inlay is produced thermally during the packaging process. The moulding for this occurs when the product is already within the blister. That is why the inlay always encloses the product like a second skin and provides uncompromising safety. When removing the product, the user first removes the fixing inlay from the packaging. The actual medical device is easily accessible and intact within the primary blister.

The innovative blister design shows its particular strengths in products with a large number of variants in terms of sizes and geometries, as well as relatively small batch sizes.

In conclusion, Eurofins Sterile Packaging proposes:

• Rigid / soft blister and pouches in standard sizes and custom sizes
• In-line production, packaging, and labelling
• Ultra-modern, qualified machines and installations with validated processes
• Filling of powders, fluids, and melts
• Boxing in folding boxes and shipping containers
• Shrink-wrapping of folding boxes in plastic film
• Labelling of products via digital colour printing on sealing lids or labels

Sourcing/procurement of packaging materials:

As part of our service, we not only procure the needed packaging components, such as cartons, package inserts, and user instructions, we also take care of providing product components. We have an extensive network of suppliers, including injection molders and metal processors, who are familiar with the medical products industry. They can therefore provide you with the appropriate help, should you need it. We also arrange for the refining of medical products or their components by means of surface treatments, for example, such as anodising and etching.