Significance and Use
This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.
The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1—Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.
Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
All categories must be considered for applicability.
The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
Test Description and Applicability (see Table 1):
Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.
Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “R&D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not readily available at a medical packaging or device manufacturing facility.
Package Compliance: Routine Monitoring of Adherence to Specifications—This is referred to as “Compliance Testing” in Table 1. Testing during this phase must be rapid, inexpensive, and readily implemented in a manufacturing environment. The objective is not to develop design data, but to ensure that the design specifications are being met. These test methods do not necessarily make direct measurements of critical values, but detect variations in material, process, or product that are indicative of all critical characteristics.
It is important to note that no individual test method is entirely predictive of final package performance. Filled packages must be evaluated under conditions of use.
Once the design of the package and/or packaging materials has been determined, it may be appropriate to create a package and/or material specification. Guides F99 or F2559 may provide useful guidance.
Scope
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.
