Package Material Specifications & Your Suppliers
Medical device packaging materials are highly regulated to ensure that the device packaged is safe and effective for the intended use. For the majority of devices, packaging materials are biocompatible, allow for sterilization, and provide an adequate microbial barrier. Compliance with these requirements is ultimately the responsibility of the healthcare manufacturer. However, material manufacturers/converters have the onus of providing safe and effective packaging. The key to ensuring safe and effective components is a thorough supplier assessment and clearly specified material requirements. The ability to meet these specified requirements is important when evaluating suppliers.
The requirements in the material specification should be achievable and acceptable to suppliers. They should adequately describe the quality, characteristics, dimensions, design, materials, performance, and any other features necessary to assure receipt of the item. Specifications should reflect design or performance requirements as well as quality and reliability.
It has been a practice within the industry to include in the specification all the properties listed in the supplier's technical product data sheet and allowable tolerances. Many of the properties listed in these technical data may not be needed for some packaging systems. For instance, water-vapor transmission, thickness, or impact resistance may be the key properties in some materials, while tensile and elongation in either machine direction may not matter. When testing for incoming material acceptance indicates the results are beyond the tolerances specified, then rejections must be enforced.
The technical data sheet properties are good guidelines for comparing like or different materials when selecting the best properties for the package. Once the material has been selected and qualified, the properties and requirements documented in the specification should ensure receipt of the correct material and ensure that the supplier's process is still in control. Typically, a supplier will monitor, test or measure certain properties in its processes. Healthcare manufacturers may not have the capability to test or measure many of these. However, properties, such as thickness, dimensions, porosity, coat weight, and others, can be measured and will most likely provide information regarding whether or not the processes are in control.
Caution should be used when applying tolerances to physical properties. Tolerances on the technical data sheet incorporated into the specification should be confirmed by the supplier with capability studies. Do not simply apply industry averages or standards. The supplier's process will have a certain capability. If that capability is acceptable for the manufacture and use of the packaging material, that determines the tolerances that should be used. Once that capability has been established, any deviations in the future will indicate that the supplier’s processes are no longer adequate.
The specification should be agreed to by both supplier and purchaser. This agreement should not only be for the specified requirements, but also for the methods used to measure or assess those requirements. For example, seal strength measurement may be set up on the apparatus in several different ways. Additionally, attribute aesthetics that detract from appearance on visual inspection should not use the terms "free of" or "none," but they should be agreed upon as appropriate for the material used.
Typical content of a material specification may include:
- Material identification
- Physical properties
- Application requirements, if required
- Appearance (cleanliness and aesthetics)
- Size, shape, style, or dimensions to include in drawings
- Printing or decoration requirements
- Packaging and package markings
- Supplementary requirements
Material or component identification should be specified by its generic name and composition. Caution should be taken in the use of trade names and should be used only if there is no other substitution available. The use of generic names and compositions allows for alternate suppliers. Application requirements may be how the material will be used, or any environmental compatibility considerations. Often healthcare components will go into a clean-room environment, thus requiring them to be packed into double poly bags. The specification should state specific information needed on the shipper-case labels for identification. Supplementary requirements may include the ability to trace raw materials used to produce each lot of material; how changes to materials, processes or sources of supply will be handled; any storage or shelf life requirements; and requirements for GMP systems.
Obviously, with so many different material types and components that make up healthcare packaging, there are numerous specification formats. Vrabel provides several examples in Medical Device Packaging Handbook.1 Other examples are ASTM International Standards F99 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials and F2559 Standard Guide for Writing a Specification for Sterilizable Peel Pouches.
- William S. Vrabel, "Chapter 2 Package Specifications" in Max Sherman, ed., Medical Device Packaging Handbook, 2nd ed., rev. & expanded (New York, 1998), pp. 41-47.
Hal Miller, President, PACE Solutions