Packaging Inspection Solutions

PK Series


Product Description

A complete range of products that covers all nominal production throughput/speed of production lines. Each Machine is designed for Non-Invasive, Non-Destructive Integrity Testing of diverse types of Pharmaceutical Containers and Contents. It is conceived for 100 % in-line testing at high production speed. Testing is fast, reliable and repeatable, giving consistent results and allowing for full batch control without altering the container or content features.

Vacuum Decay or Pressure Decay Methods allow to reach full compliance with current cGMP international regulations.
High class mechanical design and automation solutions fit for the purpose to perform, ease service and avoid downtime.
Equipment has full capability to be integrated into Industry 4.0 environment with Electronic Batch Record management or Manufacturing Execution Systems.

Main Features and Benefits

  • Improved functionality of the testing chamber group
  • Multiple format, content type and sizes machine
  • Container application: Ampoules, Vials, Bottles (glass + plastic), Cartridges, Blow Fill Seal, Syringes, Injection Devices, Flowpacks, Pouches, and Testing Using Pucks
  • High quality handling system, comprising State of the art electronic actuators and motor inverters
  • Optimal testing results are achieved at nominal speed and also in case of speed reductions and increases
  • High machine installation flexibility, by means of rotating tables or other systems like tray loading
  • The network connection allows machine database production data exchange and download, also remotely, to the Line/Laboratory Supervisor for data management and control
  • Production, test and alarms reports are printable either local or network printer
  • Statistical Process Control is conceived to give full support to the quality system, maintenance and process control staff
  • PLC manages all Machine actuation commands and D.C.U. manages Leak Testing Data elaboration
  • Automatic head exclusion allows any testing chamber to be excluded from the leak testing process
  • Equipment test method complies with:
  • FDA Guidance for Industry “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”
  • United States Pharmacopoeia General Chapter «1207» “Packaging Integrity Evaluation”
  • EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
  • PDA Technical Report No. 27 “Pharmaceutical Package Integrity”


Related Video

PK V In line Container Closure Integrity Testing Machine

.embed-container { position: relative; padding-bottom: 56.25%; height: 0; overflow: hidden; max-width: 100%; } .embed-container iframe, .embed-container object, .embed-container embed { position: absolute; top: 0; left: 0; width: 100%; height: 100%; }

Request further information on this product

    Additional Product Model Imagery

    Connect with STEQ America

    © 2024 STEQ America LLC. All Rights Reserved. Privacy Policy | Sitemap | Site Credits.