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A medical product packaging primer

Medical packaging material and converting selection practices are important in satisfying customers and regulation

Hp 20246 Fabrico Intelli Dent Packaging
Packaging plays a significant role in the U.S. medical market's growth and can impact product success and failure, yet it's sometimes the first place a manufacturer will look to cut costs.

However, one packaging-related recall can have a negative impact on business for a medical OEM or contract manufacturer. Receiving a letter from the U.S. Food and Drug Administration, especially if it is a Class 1 recall due to poor seals, pinholes, tears, and or other packaging defects, emphasizes the importance of building quality into every package. As medical device OEMs and contract manufacturers look to improve efficiencies and reduce manufacturing costs, it is important to investigate new processes and materials without sacrificing quality in the end package.

Quality begins in the design phase, with a package design that will meet all specifications and can be consistently manufactured to meet quality and cost requirements. Selecting the right materials, adhesives, and packaging processes will all affect the success of a product package. Testing materials, adhesives, and processes is critical for ensuring that all the components are suitable for the application.

In selecting the right converting partner, manufacturers should look for:
• Numerous materials, adhesives, and manufacturing capabilities
• Extensive medical packaging experience
• A commitment to a team approach to improving design and solving materials and manufacturing challenges
• Compliance with ISO, FDA, and other relevant standards
• Commitment to quality throughout the organization

Keeping up with packaging materials advances

Materials for medical packaging are constantly changing to meet market needs. Currently, the marketplace is minimizing packaging materials and costs by using thinner and less-expensive materials. Medical device manufacturers want to work with converters who know about these materials and can determine if the materials will have the required strength and durability for an application.

Most medical packaging includes some combination of materials, such as single or multi-ply laminated materials, that provide specific characteristics such as improved barrier or performance. The material may combine paper and film, including DuPont Tyvek®, and foils.

Where the medical package is designed for impermeability and low moisture vapor transmission rate (MVTR), multilayer films that combine two polymers are often used. Polyethylene terephthalate (PET) is an example of such a combination film. Polypropylene and polyester are also popular substrates for high-barrier films.

Where permeability is desirable, for example in wound care products, polyurethane and thermoplastic elastomers have good "breathability" or MVTR characteristics. In addition, nonwoven composites are also being developed for these applications.

Manufacturers also want a converting partner who is familiar with EN ISO 11607 on packaging for sterilized medical devices where porous materials are used and must provide an adequate microbial barrier to assure the integrity of the sterile barrier system and product safety. The medical industry is expressing a strong interest in anti-microbial materials to counter healthcare-acquired infections (HAI).

At the same time as anti-microbial safety is a major concern, manufacturers are also looking for materials that are recyclable. Some packaging that was previously considered disposable is now being looked at for re-sterilization. This will require more durable materials that can stand up to the rigors of multiple sterilization processes.

To be able to see the medical device, materials may combine advanced barrier capabilities in a clear format - what-you-see-is-what-you-get in a medical application.

Adhesives for medical packaging

A converter will also be knowledgeable about advanced adhesives for medical packaging. Adhesives are used both in the construction of the medical package and also in the manufacture of films for medical packaging. They can be liquid or tape, with pressure-sensitive adhesive (PSA) tape a favorite for sealing medical packaging to prevent theft or contamination.

Adhesive characteristics for laminating films include bond strength, heat and chemical resistance, and barrier properties. Laminate adhesives can include acrylic polymers and copolymers, natural and synthetic rubber, vinyl acetate/vinyl chloride copolymers, and polyvinylidene chloride. Films using these adhesives typically exhibit low permeability.

In high-permeability films, adhesives can include acrylic, silicone, polyvinyl ether, polyvinylpyrrolidone, and polyurethane.

In addition, for those medical devices that will have a stick-to-skin application, manufacturers will be looking for adhesives that exhibit low trauma, skin-friendly characteristics, for example, silicone or acrylic PSAs.

Medical packaging process capabilities

From identification and selection of the appropriate materials and adhesives, to slitting, layering, laminating, precision die-cutting, and packaging of the finished product, an experienced medical converter provides the design, prototyping, testing, and manufacturing knowledge required for success.

Medical contract manufacturers and OEMs are looking for converters to provide:
• Precision die-cutting, multilayer laminating, and slitting to tight tolerances
• Cleanroom capabilities for both converting and assembly
• Access to medical-grade adhesives
• Testing capabilities

An experienced converter selects from servo-driven rotary die-cutting, CNC die-cutting, laser die-cutting, and water jet cutting to meet the complex specifications of medical packaging components. For example, a servo-driven rotary die-cutter can maintain tight tolerances ranging from 0.015 in. to +/-0.005 in., at speeds up to 500 fpm, and is ideal for the complex, multilayer die-cutting and lamination that a medical device package might require.

For complex foam tape die-cutting, water jet technology provides clean edges with no distortion. Laser die-cutting, kiss-cutting, slitting, and laminating can also be used in converting for medical packaging.

Capabilities also include Class 10,000 cleanroom facilities for medical packaging that requires cleanroom converting and assembly.

Testing before manufacturing
A fully equipped test laboratory ensures that customer materials meet designed-in specifications before they move to the factory floor, often eliminating the need to test materials at the customer's facility. A converter's test lab should offer:
• Accurate and precise part dimension measurement and verification
• Adhesive/release liner to determine converting properties and high speed application characteristics
• Strength measurement to ensure that material meets application requirements;
• Static shear testing to measure the cohesive strength of the adhesive to withstand a fixed load over time
• Material weight measurement to determine adhesive coating weight
• Microscopic imaging to determine differences between adhesive and material over time
• Dielectric testing to determine a material's electrical insulation properties
• Resistance and voltage testing to provide a complete profile of the electrical properties of an adhesive

Testing can help the converter and manufacturer predict the performance of a package in the field. By testing for tensile strength, puncture force, abrasion resistance, and other packaging characteristics, the OEM or contract manufacturer can explore alternatives before even investing in a prototype.

Expert advice

An experienced converter will have invaluable suggestions to make at every turn in the medical packaging development process. For example, in a healthcare packaging application, use of an ultrasonic welding process was suggested for an anti-microbial material, resulting in a much sturdier package. In another example, cold seal adhesive was used for packaging to keep adhesion at a minimum during processing, but allow for a strong, durable seal when finally assembled.
The converter can also provide printing capabilities that include:
• Package printing
• Tamper-resistant and tamper-evident labeling
• Bar-code serialization and labeling

Certifications and registrations

A medical converter will be aware of and meet medical packaging specifications and requirements. In addition to EN ISO 11607, these could include:
• FDA compliance and Current Good Manufacturing Practice (CGMP) standards
• ISO 13485 certification
• ISO: 9001

Summary

Successful medical packaging balances the need for manufacturing efficiency and cost savings, with compliance and regulations, and the characteristics of the materials and adhesives being considered. Working with an experienced medical converter can greatly improve the development and manufacture of medical packaging.

--Article supplied by Fabrico, a Kennesaw, GA-based firm that provides conversion of flexible materials.
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