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.
Seal-Sensor™ utilizes ultrasound technology that provides non-contact seal inspection solutions for offline laboratory use and high speed 100% online applications. Seal-Sensor is a very rapid, reliable method that provides an instant reading of seal presence and quality.
Seal-Scan™ inspection systems evaluate and analyze seal integrity with precision and repeatability. This leading edge technology offers the unique ability to pinpoint invisible defects while identifying good and bad seals.
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.
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