// May 19, 2016

Developing Quality Standards for Metal Packaging Used in Drug Products

Standards for Metal Packaging

Desmond Hunt, Ph.D., USP’s Senior Scientific Liaison, provides insight into packaging systems for drugs and how USP standards can support quality in this field. Dr. Hunt works closely with USP’s Expert Committee on Packaging and Distribution—the volunteer experts who serve as key decision-makers in the USP standards-setting process.

What types of “metal packaging systems” are used in the pharmaceutical industry?

A metal packaging system was first used to package pharmaceutical products in the early 1900s due to its lightness and its impermeability to light and moisture. Today, the typical pharmaceutical packaging and delivery systems that utilize metal components include aerosol generators, blister packs, canisters, collapsible tubes, drums, gas cylinders, implants, overwraps, sharps and seals.

What are some quality concerns that drug product manufacturers might have regarding metal packaging systems?

Some quality concerns might include container-product incompatibility, in particular:

  • Extractables and Leachables
  • Biocompatibility
  • Material Corrosion/Oxidation

How can USP help?

Currently there are no Compendial standards for metal materials and packaging/delivery system components used in their construction. However, there are Compendial standards for other drug contact packaging materials.

In recent years, USP has taken on a major effort to expand and revise chapters related to drug contact packaging materials. This has resulted in significant changes in Compendial standards for glass, plastic and elastomeric packaging materials that contact drugs, in addition to the development of several USP general chapters on glass and plastic evaluation and extractables and leachables assessment. In continuing this effort, USP will initiate the development of a new general chapter that addresses baseline requirements for metals materials and packaging/delivery system components.

A webinar was held on April 6, 2016 to obtain stakeholder feedback on a range of topics.  An area of emphasis was on what quality attributes should be included in the new chapter.  The following list was discussed:

  • Elemental composition
  • Processing residues
  • Chemical resistance – corrosion, oxidation
  • Conductivity – electrical, thermal
  • Ferromagnetic properties
  • Biological reactivity
  • Sterilizability
  • Bioburden/endotoxins
  • Particulates

Other discussion topics where:

  • How is the composition of metal containers verified?
  • What coatings are typically used for metal containers?
  • Which properties (chemical, physical and biological) are considered essential?
  • What tests are commonly used to measure container quality?

As USP moves forward to the development of the  new chapter for metals materials and packaging/delivery system components, we are seeking additional stakeholder feedback on what quality attributes should be included in the chapter and responses to the aforementioned questions.

We encourage interested parties to contribute to the development of the new USP general chapter for metal packaging systems by contacting Dr. Desmond Hunt at dgh@usp.org