Pharmaceutical Package Testing
Keystone Compliance creates an accurate test plan to eliminate expensive over-testing. Additionally, our team strives to give our customers more time and energy on product development instead of testing. Thus, Keystone provides the peace of mind that all of your needs will be met.
Summary of Pharmaceutical Package Testing
Pharmaceuticals are the chemical drugs used by the medical industry for the treatment and prevention of illness. These drugs can often be costly and in some cases fragile. Companies should not have to worry about losing their product due to ineffective packaging.
Pharmaceutical packaging ranges widely depending on the chemical makeup of the drug or vaccine. Packages should be able to withstand the stresses of manufacturing, storage, transportation, and distribution.
As an internationally accredited laboratory with extensive experience in package testing, Keystone is the best laboratory to partner with for all of your pharmaceutical package testing needs.
Why is Pharmaceutical Package Testing and Compliance Important?
Manufacturing, distribution, and transportation are the areas that pharmaceuticals experience the most stress. The distribution channel can be tough on the packaging. From drops, shakes, and temperature variations, it is imperative that a package is able to maintain its integrity throughout the process.
Pre-conditioning and conditioning tests are common types of testing for changes in temperature and humidity. Exposing the package to these types of environmental stresses allows the lab to check the effects on the integrity of the package. Should the package warp or deteriorate due to the simulated stresses, it should still maintain sterility and the ability to protect the product inside.
Additionally, dealing with pharmaceutical packages, sterility is an important component of distributing pharmaceutical products. The seal on the packaging must be composed in such a way that it will not break and result in a breach of sterility.
Regardless of the specific type of package, it is important for the drug or vaccine to reach its destination ready to be administered to those who need it.
Common Pharmaceutical Package Testing Types
The accelerated aging packaging test is the process of introducing temperature and humidity to expedite the deterioration of materials. Oftentimes, a sterile barrier system has an expiration date because sterility can no longer be guaranteed. Over time, the adhesive materials or cohesive bonds that maintain sterility begin to degrade and the package is compromised.
For more information on Accelerated Aging, please visit the links:
Gross Leakage / Dye Penetration
ASTM F2096, known as the Bubble Test, measures the material integrity of the package. This test consists of submerging the package under water and increasing the internal pressure of the package. Dye penetration package testing is useful for measuring the effectiveness of package seals for a complete seal that will keep the drug sterile under stressful conditions.
ASTM F88 only tests a portion of the seal. This test measures the force required to separate a test strip of material containing the seal. ASTM F88 also identifies the mode of specimen failure.
ASTM F2824 tests the force required to separate the entire lid from a container. This test differs from ASTM F88. ASTM F2824 uses an angle of 45 degrees to determine the maximum forces required to separate the lid. However, other angles of pull may be acceptable.
Pharmaceuticals that have a short shelf life may require Thermal or Cold Chain Packaging to maintain a regulated temperature. These pharmaceutical packages must endure precise temperatures ranging from 2 degrees Celsius to 10 degrees Celsius.
ASTM F2825 is used for the climatic stressing of overnight or two-day delivery systems of a single parcel. The ASTM F2825 testing procedure does not cover refrigerated, frozen food storage, or cryogenic storage conditions.
NSF/ANSI 456 defines criteria for units used to store vaccines. This type of testing consists of refrigerators, freezers, and combination units. Maintaining critical refrigeration and freezer temperatures for vaccines, such as SARS-CoV-2, has created a unique class of storage devices compared to traditional residential and commercial refrigeration units.
Expert Laboratory Pharmaceutical Package Testing
At Keystone, we test to make sure specific package regulations are met. We also ensure that the pharmaceuticals reach their destination safely and are ready to be administered. Below is a list of the most common tests that can be used specifically for pharmaceuticals.
- ASTM D4169
- ASTM D4332
- ASTM D642
- ASTM D6653
- ASTM F88
- ASTM F1980
- ASTM F2054
- ASTM F2096
- ISO 11607
- ISTA Series 3
- ISTA 7D
- ISTA 7E
- NSF/ANSI 456
Pharmaceutical companies partner with us for package testing because of our high-quality work. We take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion.