The pharmaceutical industry continues to bring breakthroughs in the field of new vaccines and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
Container closure integrity is over and above a quality feature. Container closure integrity determines the safeness of the drug product at the time of use. The selection of the right CCI inspection methodology holds up to the quality standards endorsed by the pharmaceutical manufacturers. Any negligence of CCI is taken seriously by the regulatory bodies. The guidance documents stand by the deterministic, reliable test methods for measuring the industry-wide quality standards.
PTI, the global leader in package quality testing equipment provides rapid deployment of inspection solutions for fill-finish validation and pharmaceutical container quality testing. Our proven technologies are backed by 35+ years of engineering expertise and experience. Leading technologies include vacuum decay and MicroCurrent HVLD for container closure integrity testing. All solutions include Data integrity 21 CFR part 11 compliance and system validation.