Laser EXP Headspace Gas Analyzer

Pharmaceuticals

A headspace gas analyzer designed and validated to demonstrate compliance with worldwide regulations. Uses a precise laser to perform 100%, non-invasive, non-destructive testing using TDLAS for quick, accurate, repeatable measurement of gas composition in the headspace of pharmaceutical products. Suitable for testing glass vials from 2R to 100R which contain liquid, powder, and lyophilized content.

Vials

Tech specifications

Highlights

Reliable, accurate CCIT results provide quality control of pharmaceutical products and process control of your production line
Validation made easy, with complete documentation for effortless demonstration of regulatory compliance
TDLAS test method delivers accurate, reliable, repeatable HGA results
Efficient design optimizes production floor space without sacrificing capabilities

Technical Features

Technology: Container Closure Integrity Testing by Headspace Gas Analysis with TDLAS (Tunable Diode Laser Absorption Spectroscopy)
Laser Specifications: Class 1 according to IEC 60825-1, 760 nm wavelength
Precision and Accuracy: For 2R vials at 150 cpm, typical precision: 0.1%, typical accuracy: 0.5%
Compliance: Laser IP Classification IP64, CE-marked according to EMC 2014/30/EU; Machine compliant with EC 2006/42 and Low Voltage Directive 2014/35/EU
Applications: Measures 0 - 100% oxygen concentration in glass vials from 2R to 100R containing liquid, powder, or lyophilized products

Additional Benefits

Full validation performed by ISO-9001-certified Bonfiglioli Engineering to get you online quickly, with complete documentation to certify your compliance with regulations
Customizable and intuitive HMI with real-time display of statistics and raw data
Ewon connection and advanced alerts for easy troubleshooting and problem solving
System supports remote connectivity, enabling MES connection for in-house data collection and analysis and facilitating remote support from Bonfiglioli Engineering
Can be integrated into production line or positioned separately for post-quarantine testing
Designed with fewer moving parts to be simpler to operate and maintain than other HGA inspection machines

Technology

TDLAS (tunable diode laser absorption spectroscopy) is the only non-destructive HGA method, enabling 100% testing of valuable pharmaceutical products.
TDLAS involves transmitting a laser beam through the headspace of a sealed container onto a receiver. The receiver measures the absorption of the laser, indicating the composition of the headspace atmosphere including details such as oxygen concentration, humidity, and pressure. If analysis detects anything outside the desired atmosphere for the product being tested, the container is rejected.
The Laser EXP analyzer features a Class 1, 760 nm wavelength laser, and uses TDLAS to perform quick, accurate, repeatable HGA.

Quality Assurance

Full validation performed by ISO-9001-certified Bonfiglioli Engineering, with complete documentation to certify compliance with a host of regional and worldwide regulations
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