HEADSPACE GAS ANALYSIS is a laser-based, non-destructive and fully automatic inspection method for sealed packages. It allows for measuring oxygen concentration, carbon dioxide, residual moisture content and absolute pressure value. Its purpose is to verify the headspace conditions and their maintenance to confirm stability and sterility in filled and finished parenteral packages.

Monitoring the maintenance of container headspace conditions is needed for sterile drugs such as oxygen sensitive liquid products and lyophilized or powdered products; any modification in the headspace pressure, moisture or oxygen level may result in the degradation of the active drug, as well as in the reduction of drug potency and product shelf life. Traditional headspace analysis methods include testing by means of a probe, generally performed on samples at regular intervals during the production cycle: a destructive, time consuming and unrepeatable procedure, which prompts the issue of disposing of destroyed products and leaves with no timely feedback on the filling process. Each time out of specification conditions are detected on a sample container, the entire batch is to be rejected, making it most difficult to assess if it is random package closure integrity failure or systematic process unwanted deviation. BONFIG, instead, offers a non-destructive, more deterministic and reliable procedure.

For oxygen detection, the laser beam is reflected by a golden mirror towards the receiver allowing a double passage of the headspace target. Double Path system significantly increases the signal strength and makes Etalon Effect negligible by means of a small tilt.

The laser system performance is practically insensitive to environmental factors such as oxygen presence thanks to its electronic design. Therefore, when performing headspace level analysis, there is no need for purging the surroundings of the container under inspection with nitrogen.

Since height & width of laser absorption signals are measured and compared to preset values (Standard Containers) during each cycle, a reference pack is not required in operation. If the measured parameters are not within acceptable ranges, the equipment automatically signals it.

Specific requirements for sterile drugs packaged under full or partial vacuum are covered by 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”. The testing method conforms to provisions expressed in United State Pharmacopeia, USP General Chapter <1207> “Package Integrity Evaluation – Sterile Products” (USP 39-NF34):

Laser-Based Gas Analysis is listed among the Deterministic Leak Test Technologies. Validations and qualifications are easy to perform by means of advanced protocols and documentation.

A Tunable Diode Laser Absorption Spectroscopy (TDLAS) based sensor is the core of the inspection system installed in our unit, a spectroscopic method allowing the detection and quantification of gaseous components concentration. The principle underlying the TDLAS measurement is based on the Beer-Lambert Law, stating that light transmitted through a given sample at a particular wavelength is a function of the concentration of the substance that is absorbing the incident light.

A diode laser beam, at a wavelength optimized for the measurement of a particular gas species, is transmitted through the headspace region of the container and received by a detector after passing through the container itself.

Oxygen level monitoring is obtained with a light source tuning at a wavelength of 760 nm, while carbon dioxide at 2000 nm and wavelength of 1400 nm is employed to obtain measurements of residual moisture level and absolute pressure.

The inspection time of BONFIG systems is shorter compared to the ones currently available on the market: this results in a better test performance either more accurate or faster.

Please contact our representatives to learn more about our current Headspace Gas Analysis solutions by calling 800-829-5741.

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