Inspection Capabilities: Oxygen/Moisture/Carbon Dioxide level, Absolute Pressure value
Can be fitted with multiple laser heads depending upon production-line speeds
Fast, reliable and repeatable results
HMI real-time display of statistics and raw data
Maximum accessibility of electrical and mechanical component for easy maintenance
Connections to Active Directory and VPN router for machine remote access
Computer-based automated measurement system: data acquisition, processing, and decision making.
Validation package guarantees complete and efficient regulatory compliance
Full batch control testing: fast, reliable and repeatable
MES (Manufacturing Execution System connection) allows remote machine data exchange & download
Headspace Gas Analysis (HGA) inspection process based on Tunable Diode Laser Absorption Spectroscopy (TDLAS) method to accurately quantify gaseous concentration levels. Diode laser beam transmitted through headspace region of the container and reflected back towards the receiver. LVA 600 sensors measure the laser beam absorption related to target gas concentration.
Equipment test method refers to:
EU GMP Annex 1 Manufacture of Sterile Medicinal Products, section 123: “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period”
Testing method in conformity with provisions of USP- United States Pharmacopeia - General Chapter <1207> “Package Integrity Evaluation – Sterile Products” (USP 39-NF34): Laser-Based Gas Analysis is listed among the Deterministic Leak Test Technologies
Software designed to comply with FDA 21 CFR Part 11 and EU Annex 11
Standard containers set supplied for easy calibration and verification