Get more pharma manufacturing insight with our FREE newsletter sign me up

FEATURED ARTICLES

  • CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors

    Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package lifecycle stage, an approach where combination products will highlight the pitfalls.

WHITE PAPERS & CASE STUDIES

PRODUCTS & SERVICES

Used Safeline metal detector, model PHARMXSR4V1/26X22, module serial# 32625, serial# 13123.

The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.

Unused Seidenader inspection system, type V90-AVSB/60-LR semi automatic inspection units, L-R orientation, currently set up for syringe inspection, with Sortec feeding system, 460 volt, Seidenader serial#, 117066

Unused Seidenader inspection system, with (2) type V90-AVSB/60 Seidenader semi automatic inspection units, (1) L-R unit, (1) R-L unit, currently set up for syringe inspection, with Sortec feeding system, 460 volt, Seidenader serial #'s, 11706A, 11706B.

There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.

There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.

Pfeiffer Vacuum applications are Ideal for medical device and medical package leak testing. Unlike pressure decay, we offer a faster, more accurate test as well as direct measurement capabilities that are not volume sensitive.

Container Closure Integrity Testing of Pouches is common across many industries.