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"Writing a Preformed Sterile Barrier System Specification"

What should be included when drafting a specification for a preformed sterile barrier system (i.e. pouch or header bag) that will contain a medical device?

Last Updated On September 4, 2019

Consult your package manufacturer for guidance on the elements that should be contained in a preformed sterile barrier system specification. You may also choose to consult the Guide for Design and Evaluation of Primary Packaging for Medical Products, SPMC011 or ASTM F2097. This guide provides direction regarding topics to be considered and typical test methods used when evaluating flexible packages.

Typical elements of a preformed flexible package specification include:

  • Materials To Be Used — Materials should be based on sterilization, transportation and shelf life requirements, as well as characteristics of the device, such as size and shape.
  • Dimensions of the Package — For drawings illustrating commonly measured dimensions and tolerances, see the Standard Specification for Dimensional Tolerances of Sterilizable Pouches, SPMC 10. Critical dimensions should be indicated. Both SPMC 012 and ASTM F2203 provide valuable information on linear measurement techniques and precision that can be utilized in developing a specification.
  • Seal Strength — The specified value should represent what the package needs to meet the challenges of both shipping and storage conditions as well as ease of opening considerations. Specify both the seal strength value required and the method used to measure it.

There are a number of ways of evaluating seal strength. Peel strength (SPMC 006 or ASTM F88), is the preferred method for specifying seal strength. To improve reproducibility, techniques such as direction of peel, tail orientation, and test speed should be indicated. Internal pressurization, (SPMC 003, F1140, F2054), is more commonly used for in process vigilance testing.

  • Seal Integrity — A statement may be included which requires that seals be continuous, without voids or breaks. Visual seal inspection methods such as SPMC 008 or ASTM F1886 are frequently used for seal evaluation.
  • Aesthetic Requirements — Generally, unacceptable levels of loose or embedded particulates or other defects are defined per unit area.
  • Printing — Print color(s), artwork placement and copy should be specified. It is important to keep in mind the attributes of the package materials when designing the print. For example, certain font sizes or styles may be inappropriate for specific substrates.
  • Packing — Examples of these requirements are package maximum weight, labeling, bundle count and closure, and cartons lined with poly bags.

Before finalizing the specification, it is important to review it with your packaging supplier, as they can suggest upgrades or modifications that best combine the capabilities of the sterile barrier system making process with anticipated conditions of sterile barrier use.