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Pharmaceutical Packaging: Basics and Testing Methods

Monday, August 9, 2021

There are few industries more heavily scrutinized than healthcare, so it should be no surprise that the packaging intended for pharmaceutical products are extensively vetted to ensure standards for safety are upheld. While a significant range exists for pharmaceutical products, especially pertaining to chemical composition and related storage requirements, there are some universal considerations that are made when selecting the appropriate packaging type for a new drug.

Regulations and Common Package Types

The U.S. Food and Drug Administration has regulations specific to pharmaceutical packaging which states that packaging must:

  • Provide protection against environmental conditions (i.e., light, moisture, oxygen, and temperature changes)
  • Not react with the product
  • Not impart odor or taste to the product
  • Be non-toxic
  • Be approved by the FDA
  • Meet tamper-resistance requirements, wherever applicable

These regulations apply to the primary packaging systems used for pharmaceutical products, although the barrier properties for each package type ranges depending on factors such as intended storage conditions and the relative sensitivity of medicines to degradation through external environmental change.

The pharmaceutical industry employs a variety of packaging solutions to meet the specifications required by each individual drug, but common packaging types include:

  • Ampoules
  • Blister Packs
  • Bottles
  • Vials
  • Sachets

The above represent a wide variety of packaging types, each utilizing packaging materials and closures commonly found within the pharmaceutical industry. Glass, plastic, metal, paper-based materials, as well as films, foils, and laminates, are all employed to meet product-specific needs and ensure that safety standards are met.

Permeation and Other Package Testing

Pharmaceutical products are frequently exposed to external conditions that, if not protected by an appropriate barrier, would degrade, or possibly change a product at a chemical level. The permeation of water vapor and oxygen can be particularly problematic when a drug is sensitive to hydrolysis and/or oxidation. This problem may be exacerbated by consumer storage habits, such as a medicine cabinet within a room where frequent showers alter both humidity and temperature.

A key component to preventing packaging design overhauls, or even shipping a flawed packaging system to customers, is ensuring that appropriate packaging materials are chosen from the outset when bringing pharmaceuticals to market. While the FDA requires stability testing for drug packages, these tests offer overgenerous, blanket pass/fail results rather than pinpointing small differences in permeation that may affect final drug stability.

For pharmaceutical companies seeking assurance beyond FDA required USP and stability testing, AMETEK MOCON’s WVTR (water vapor transmission rate) permeation analyzers are consistent with ASTM F1249 and can aid with early barrier assessment. There is no conflict between WVTR testing and gravimetric testing, but early WVTR permeation testing can guarantee the absolute success of the stability test while offering an overall assessment of barrier effectiveness.

Interested in Learning More?

In addition to WVTR permeation analyzers, like the AQUATRAN 3 and PERMATRAN-W 3/34, AMETEK MOCON offers OTR (oxygen transmission rate) permeation analyzers through its extensive line of OX-TRAN® permeation instruments.

Beyond permeation, AMETEK MOCON offers a variety of solutions for efficient leak, seal, and burst testing of packages for total package integrity. The Lippke® VC1400 leak tester, recently released with a refreshed design compared to prior models, is package leak detector which finds even the smallest leaks in blister packages, glass vials and other flexible, rigid and semi-rigid packages. This instrument automates the methylene blue dye test and bubble emission test (ASTM D3078), guaranteeing optimal reproducibility.