Q&A: Blister Pack Integrity Testing with Mike Kelly
Smithers expert Mike Kelly supervises our new physical and functional medical device testing laboratory in Akron, Ohio. In this brief Q&A, Mike shares his expertise on the importance and process of blister pack integrity testing.
What is blister integrity testing?
Many everyday and prescription drugs are transported and delivered in a blister pack that contains a single dose per individually sealed cavity. A blister pack for pills or capsules is typically made up of pre-formed plastic, an aluminum, or plastic seal. Blister integrity testing assesses the function and durability of this packaging system, including its ability to protect the drug product and the process of removing the drug product from the package.Why is blister integrity testing important?
The safety of the end user and the family is the most important thing. Pills and capsules are specifically engineered to deliver an exact dose of the drug product to the end user. If the dose is altered, it can compromise care and treatment or lead to complications. A blister pack should protect the pill from any damage or breakage that would alter the dose.Additionally, blister integrity testing can measure child safety of the blister pack. You don’t want a curious little one gaining access to a pill or capsule when they shouldn’t.
How is the test conducted?
The testing can be done manually or with a machine. Machine testing can quantitatively measure the force required to peel off or break the seal on the package. Manual testing calls for a mixed population of testers representing different genders and ages removing the pills by hand and qualitatively analyzing the process and the results.We work directly with our clients to determine their goals for the test and develop a testing method that meets the needs of their product or application.
What are you looking for while testing?
We look for a few things.- The strength of the seal and the amount of force needed to open it. The seal needs to be durable enough to protect the pill in transit and keep a child from getting into it but not so tough that an average adult can’t remove the pill when they need it.
- The ability to open the blister pack and remove the pill without damaging it.
- The integrity of the pill itself once it has been removed. We look to see if the pill is broken or crushed or if the pill has any chips, scratches, pinholes, dents, or other damage.
Where is this test conducted?
Smithers offers blister pack integrity testing at our new laboratory in Akron, Ohio and at our original physical and functional testing laboratory in the UK. Our global experts can support pharmaceutical companies throughout the development and distribution process. We offer:- Pharmaceutical development services
- Extractables and leachables studies as well as other analytical services
- Physical and functional testing of medical devices
- Primary pack, packaging, and distribution testing for medical devices and pharmaceutical products
