Determining the Resid ual Seal Force (RSF)
MECHANICAL TESTING OF MEDICAL VIALS
Parenteral products such as injectable medications and vaccines are commonly packaged in glass vials. These vials must maintain a robust seal between the glass vial and the elastomeric closure to prevent product contamination and leakage. Residual Seal Force (RSF) is an evaluation of the quality of this seal.
The glass vials subjected to RSF evaluation are used exclusively within the healthcare industry. A perfect example of the importance of RSF testing is the COVID-19 vaccine: some of the vaccines need to be stored at extremely cold temperatures in order to remain effective. Extremely cold temperatures can cause elastomeric materials to contract, which could cause the vial seals to leak. RSF testing can be performed at the full range of possible temperatures to assist manufacturers in evaluating raw materials and assembly processes. This verification is critical in ensuring that products can withstand travel and storage before being administered to the patient.
"Residual s eal force" refers to the force that the elastomeric seal is placing on the aluminum cap of the vial. This force measurement indicates the security of the vial closure. The seal consists of a rubber stopper and an aluminum cap that is crimped onto the vial with an initial force. Over time, this force declines due to the relaxation behavior of rubber, a decay of the force imposed by the cap, and various processing procedures.Determining the Residual Seal Force
The United States Pharmacopeia (USP) outlines standards for the determination of Container Closure Integrity (CCI), a measure of the ability of a container to prevent leakage through non-destructive means. Many studies have shown a correlation between residual seal force values and the CCI performance of the container, prompting many vial manufacturers to adopt RSF testing into their quality program. Residual seal force results can also be correlated to the capping and crimping process, helping manufacturers optimize their cap application settings to maximize CCI.
Instron 6800 Series Universal Testing Systems provide unparalleled accuracy and reliability. Built on a patent-pending Operator Protect system architecture with an all-new Smart-Close Air Kit and Collision Mitigation features, the 6800 Series makes materials testing simpler, smarter, and safer than ever before.
Bluehill Universal Software is built from the ground-up for touch interaction and an intuitive user experience. Discover simpler and smarter testing with features such as pre-loaded test methods, QuickTest in seconds, enhanced data exporting: and Instron Connect – a new feature that provides a direct communication link to Service. Users of previous versions of software such as Bluehill 2 and Bluehill 3 can easily upgrade to the newest version of Bluehill.