Capping Optimization and Residual Seal Force

Often performed in conjunction with helium leak or vacuum decay testing, WL offers in-house parenteral vial capping and residual seal force testing of parenteral package systems.

A Genesis Westcapper RW50 housed at Whitehouse Labs is operated onsite by Genesis staff to apply closures at a range of compressive forces. When used in conjunction with leak test methods such as helium mass spectrometry or vacuum decay, an optimal range of residual seal force values may be determined that correlate to a reduced risk of leakage resulting from improper capping force.

Residual seal force is not a leak test, but is an indirect measure of the compressive force exerted by the stopper on the vial’s land surface.  A slow, constant rate of strain is applied to the top of a capped vial and the resistance to compression is monitored and reported. An appropriate amount of compressive force is required to ensure a quality seal. Vials capped at an insufficient force may leak from the sealing surface.  On the other hand, vials capped at an excessive force may experience cracking and bulging, also risking the integrity of the closure system.

This type of testing is of value to clients aiming to establish optimal sealing parameters or those who wish to implement a sampling procedure during product production.

Whitehouse Laboratories operates a “Container Testing Center of Excellence”. The entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs.


Brandon Zurawlow
Associate Director, CCIT
Direct: 908-823-9300
wlccit@amriglobal.com
 


Justine Young
Associate Director
Direct: 908-823-9300
wlccit@amriglobal.com


Container Closure Integrity
Testing (CCIT) Brochure