Pharmaceuticals are the chemical drugs used by the medical industry for 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. Packages should be able to withstand the stresses of manufacturing, storage, transportation, and distribution.
Manufacturing, distribution, and transportation are the areas that pharmaceuticals experience the most stresses. The distribution channel can be tough on packaging. From drops, shakes, and temperature variations, it is imperative that a package is able to maintain its integrity throughout the process.
As an ISO 17025 accredited laboratory with extensive experience in package testing, Keystone is the best laboratory to partner with for all of your pharmaceutical package testing needs.
Package sterility is an important component of distributing pharmaceutical products. The seal on packaging must be composed in such a way that it will not break and result in a breach of sterility.
Over time, package seals can degrade. ASTM F1980 is designed to test the effects of aging on package seals.
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. When doing this, any holes in the packaging or seal will release air and result in bubbles. The test is very useful for measuring the effectiveness of package seals for a complete seal that will keep the drug sterile under stressful conditions.
Pharmaceuticals that have a short shelf life may require Thermal or Cold Chain Packaging to maintain a regulated temperature. Other pharmaceuticals are packaged for sterilization. Keystone has the resources and equipment to test for changes in environmental conditions. 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 allow 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. Regardless of the specific type of package, it is important for the drug to reach its destination ready to be administered to those who need it.
Expert Pharmaceutical Package Testing
As an ISTA and ISO 17025 certified lab, we realize the importance of pharmaceutical package testing. Meeting the standard requirements can be difficult. We understand the challenges and guide companies through the process.
At Keystone Compliance, we test to make sure specific package regulations are met and 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 D5276
- ASTM D5487
- ASTM D880
- ASTM D6055
- ASTM D6179
- ASTM D3580
- ASTM D951
- ASTM D4169
- ASTM D999
- ASTM D5112
- ASTM D4728
- ASTM D4332
- ASTM D642
- ASTM D6653
- ASTM D5331
- ISTA Series 1
- ISTA Series 2
- ISTA Series 3
- ISTA 7D
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. Our customers appreciate the transparency and experience that we bring to every test.
Request a quote to receive testing services customized to your specific needs. We look forward to working with you!