|Complying with EU Packaging Regulations Using ASTM International Standards |
by Patrick J. Nolan
The European Union has specific requirements for products entering its communities. These requirements are most commonly promulgated through material specifications and performance requirements that become regulations through government directives and laws. There are myriad standards sponsored by quasi-government agencies, industry associations, and voluntary standards-writing organizations, and it is these documents that may be written into or referenced in directives and laws, and to which compliance may be a requirement.
The global economy and the importance of open and free trade between countries have amplified the consequences of requiring multiple standards for the same performance parameter. To reduce these consequences, more harmonization of standards is taking place. Although each community has its own unique applications and environments in which products must perform, there are many applications where standards are global and harmonization is essential.
This article will discuss where ASTM International standards related to packaging materials, components, performance and systems can be used to comply with the European Union Directives and laws.
Complying with Standards
Generally speaking, most standards are used on a voluntary basis. That is, their use is based on derived economic, competitive or commercial advantages. So, how do standards become incorporated into Directives and laws? When a regulatory body such as the European Union (EU) or U.S. federal agency develops regulations and reference standards to which a product or process must conform, it has essentially made the standard part of the law or Directive. Because government is generally not in the business of developing product and performance specifications, it must rely on the private sector to develop the standards by which it will ensure fair competition and public safety. In the medical device industry, the U.S. Federal Food, Drug, and Cosmetic Act was enacted to eliminate the misbranding of medical devices. Through subsequent legislation, the U.S. Food and Drug Administration was given significant additional authority concerning the regulation of medical devices. These laws were then the framework for the issuance of more detailed regulations that created specific requirements for compliance to the law. Likewise, the European Union, with the adoption of the Common Market, developed Directives to which all entities interacting with the EU would be compelled to comply. For the medical device industry, the Directive is the Medical Device Directive.
In the United States, laws are developed through legislation and are vague mandates. The federal agency in question then writes regulations interpreting how the law will be enforced. European Directives are legislative instruments developed by member states that replace individual national regulations and obligate member states to introduce them into their own laws. Once compliance with all applicable Directives has been verified for a product, that product can be legally placed on the market of any EU member country. (1) The details of complying with the laws/directives are commonly incorporated in standards that the regulatory agency references in their documents. These standards may be written by ASTM International or the International Organization for Standardization (ISO) (to name the two most common organizations).
Challenges and potential barriers to international commerce exist when the regulatory burden to doing business on a global basis is very high due to the requirement for compliance to multiple regulations and standards. This occurs specifically when an EU Directive requires the use of an ISO standard but does not allow the use of other equivalent standards to meet the essential requirements of the Directive. There are many instances where using an equivalent or technically superior standard will provide all of the information required to verify compliance to the Directive. However, to do business internationally there may be a burden to use both ISO and ASTM standards to meet the international and national regulations.
The EU Medical Device Directive
The EUs Council Directive Concerning Medical Devices, also known as the Medical Device Directive, or MDD, as published in the European Economic Commission in 1993, lists the essential requirements for devices and packages; all medical devices sold on the European free market must meet the specifics of this directive, which overrides all national regulations. The essential requirements for medical devices and packages are found in Annex I of the MDD. General requirements for ensuring that the characteristics of the medical device are not altered or adversely affected during their intended use as a result of transport and storage are found in Section 5. There are more specific requirements for infection and microbial contamination as it relates to packaging found in Section 8. It is incumbent upon the medical device manufacturer to conform to all of the sections of the essential requirements, not just the packaging requirements.
The classic example of how ASTM International standards are used to comply with an EU Directive is demonstrated by reviewing the ISO standard 11607, Packaging for Terminally Sterilized Medical Devices.
This ISO standard, first approved in 1997 by the international community, and since revised in 2000, has become essential to the development and validation of a package system for a terminally sterilized medical device. The standard provides the guidance for selecting materials, designing and validating the manufacturing process, and validating the final package design. Compliance with this standard and other European standards ensures compliance with the packaging provisions of the MDD essential requirements. The FDA has recognized this standard for product reviews in its 1997 Guidance for Recognition and Use of Consensus Standards: Availability.
This ISO standard specifies the basic attributes that materials must have for use in packaging for terminally sterile medical devices. In addition, it provides the producer or manufacturer the guidance to conduct a formal qualification and validation of the packaging operations. There must be a documented process validation program that demonstrates the efficacy and reproducibility of all sterilization and packaging processes, to ensure the package integrity at the point of end-use.
Finally, the ISO standard provides a series of recommended tests and criteria to evaluate the performance of the complete package under all of the stresses and hazards inherent in the packaging and distribution process. To reduce the compliance burden on industry, and since there were few published standards available when the ISO standard was created, ASTM Subcommittee F02.60 on Medical Device Packaging, part of Committee F02 on Flexible Barrier Materials, set out on a course of action to develop and standardize all test methods and practices applicable for conformance to the ISO requirements. (2)
These ASTM tests include the following types.
D 3078, Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission;
F 1886, Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection;
F 1929, Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration; and
F 2096, Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test).
Tests performed using these standards provide a means of validating package integrity by detecting gross breaches in the package materials and/or seals. Package integrity testing is accomplished through the use of internal pressure, dye penetration, gas sensing devices, vacuum pressure, and visual inspection. These standards explicitly meet the requirements of the ISO 11607 Section 7.4 for Physical Testing for Sterile Package Integrity, which states that, The manufacturer shall demonstrate the integrity of the sterile package by testing the package. This can be accomplished by physical tests.
D 903, Test Method for Peel or Stripping Strength of Adhesive Bonds;
D 1140, Test Methods for Amount of Material in Soils Finer Than the No. 200 (75-µm) Sieve; and
F 88, Test Method for Seal Strength of Flexible Barrier Materials.
Tests performed using these methods provide a means of validating package strength and seal closure properties. Package seal strength can be accomplished by using standard test methods such as tensile testing a portion of the seal or pressurizing the entire package to a point of failure (burst). These standards explicitly meet the requirements of the ISO 11607 Section 7.3 on Seal/Closure Evaluation.
Distribution, Storage and Aging (Shelf Life)
D 4169, Practice for Performance Testing of Shipping Containers and Systems; and
F 1980, Guide for Accelerated Aging of Sterile Medical Device Packages.
ISO 11607 requires that The manufacturer shall demonstrate that, under the rigors of distribution, storage, and aging, the integrity of the final package is maintained at least for the claimed shelf life of the medical device under storage conditions specified by the manufacturer, as long as the package is undamaged or unopened. Further, Section 7.5.1 of the ISO standard states, The performance of the package in providing adequate protection to the medical device through the handling, distribution, and storage shall be evaluated. These two standards are included in Annex B of ISO 11607 as examples of standards that could be used to evaluate package performance for this provision.
All of these ASTM standards can be used to meet the essential requirements of the Directive; since the FDA has approved the ISO standard in its guidance document, testing the medical device packaging to the ASTM standards meets the requirements for both regulatory bodies. For example, where ISO 11607 states that the properties of the closure or seal of the package shall be evaluated, the ASTM standard that may be used to meet that requirement is ASTM F 2096, as this standard meets or exceeds any other existing ISO standard that is specific to determining that package attribute. To determine the packages ability to withstand the transport and distribution environment, the ISO standard specifically references in ASTM D 4169, Appendix B, as a laboratory test that will satisfy this requirement. So, this arrangement of reciprocally referencing standards of international reputation is essential to harmonization of the global economy.
The Packaging and Packaging Waste Directive
As discussed previously in this article, the EU Directives encompass all aspects of commerce in the European Union and standards are developed to measure properties and determine performance of products and services. This encompasses the management of packaging and packaging waste as well, and is done in the EU through the essential requirements contained in the Directive 94/62/EC, also known as the Packaging and Packaging Waste Directive, or PPWD. Article 9 of the PPWD requires all packaging placed on the EU market to comply with the three essential requirements set forth in Annex II. They are:
1. Source reduction (qualitative prevention).
2. Minimum presence of hazardous substances.
3. Recovery, reuse, and recycling.
The standards-writing body of the EU, the European Committee for Standardization (CEN), has developed some of the standards that would provide the means for compliance to the three essential requirements. In theory, companies that adequately demonstrate compliance with an existing CEN standard or, in its absence, a national standard, may automatically presume that the product complies with the essential requirements of the PPWD. (3)
According to Annex II, Section 1 of the essential requirements, the packaging users shall demonstrate that they systematically compared different packaging options and chose one which minimizes the weight and the environmental effects of the life-cycle of the packaging, whilst maintaining the necessary level of safety, hygiene, and acceptance of the packed product and for the consumer. ASTM standards developed in Committee D10 on Packaging such as D 4169 could be used to demonstrate the optimum level of packaging to be used to protect the product through the rigors of the shipping and handling environment, whilst maintaining the necessary level of safety, hygiene, and acceptance of the packed product and for the consumer. Another ASTM standard for determining the fragility of products can be used to compare different packaging options in order to choose the one that optimizes the package for performance and provides minimal environmental effects. Standards of this type have not been fully developed within CEN therefore the ASTM standards can be used to demonstrate compliance to this essential requirement. Using the PPWD and D 4169 in tandem can optimize the package design so that only the minimum quantity of packaging materials is used to transport the product to the consumer. This could be used by a company as the basis for the decisions taken on choosing the packaging type for their product by demonstrating that packaging options were evaluated.
ASTM standards provide an alternative source for compliance to international regulations. The primary advantage of ASTM standards is the expertise brought to the table during the standards development process and ASTMs transparent, open, voluntary process itself. More and more international expertise is being contributed to the ASTM standards-writing process, blurring the lines between standards-writing organizations. Governments worldwide are recognizing this superior level of expertise and using ASTM standards to streamline the regulatory process and improve the quality of life for their citizens. //
1 Underwriters Laboratories, Inc. General Overview of EU Directives (www.ul.com/ hazloc/union.html).
2 Miller, Hal, Healthcare Packaging; ASTM Standards and the Bottom Line, ASTM International Business Link, Summer 2004, page 6.
3 Baughan, J.S., Frekko, M., Demonstrating Compliance with the EU Packaging and Packaging Waste Directive, World Trade Executive, 2004, PackagingLaw.com
ANSI/AAMI/ISO 11607:2000, Packaging for terminally sterilized medical devices, AAMI, 2003 ISBN 1-57020-086-6
FDA Modernization Act of 1997: Guidance for the Recognition and Use of Consensus Standards; Availability.
Copyright 2004, ASTM International