Gasporox AutoMAP™ Pharma in-line testing for film-packaged parenterals

Inspection technology specialist Gasporox AB has introduced its AutoMAP™ Pharma as the world’s first non-destructive and non-invasive headspace analyzer for parenteral products packaged in transparent plastic film, such as IV bags.

AutoMAP™ Pharma is based on laser assisted spectroscopy technology, which allows it to replace destructive headspace gas testing technologies, even on inspection of primary and secondary bags, without any specific adaptations and without requiring any product specific parameters.

AutoMAP™ Pharma is a highly versatile in-line solution that allows pharma manufacturers to increase their cGMP compliance in parenteral production, supporting regulations set in ANNEX 1 of the EU GMP guide revised in 2022.

Meeting in-line inspection challenge

The new product meets a long standing need in the pharmaceutical industry to ensure drug integrity and stable shelf life by preventing the ingress of oxygen or non-sterile media into the drug containers.

Today many parenterals use modified atmosphere packaging (MAP) in which gas composition in the headspace is altered by means of nitrogen purging. The updated EU-Annex 1 “Manufacture of Sterile Medicinal Products” explicitly focuses on the product quality of Small Volume Parenterals (SVP) and Large Volume Parenterals (LVP). Current testing methods for LVP bags and pouches are largely based on destructive methods typically using electrochemical sensors with high maintenance demands on maintenance. Lack of real time in-line inspection capability has meant testing carried out on statistical, rather than the deterministic base favoured in current protocols.

The market needs  good inspection tools that are easy to integrate into the production lines and that are reliable and can provide analyzed data in real-time.

Innovative technology

AutoMAP™ Pharma applies Gasporox patented Tunable Diode Laser Spectroscopy (TDLAS) technology to close this gap, extending laser-based headspace analysis (HSA) from the testing of rigid parenteral vials, ampoules, etc., to flexible packaging formats like bags or trays.

In HSA, laser light is sent through the gas filled volume of the container and measures the gas concentration with a high accuracy and precision. Pharmaceutical application has demonstrated the capability of providing a high quality HSA measurement on packaged product, even when contained in secondary bag.

The GASPOROX AutoMAP™ Pharma is developed for non-destructive headspace analysis placed directly on existing conveyor belt or integrated into a packaging machine, meeting the need for high speed automated inspection of thermally sealed parenterals.

Developed in the Gasporox Innovation Center, AutoMAP™ extends use of TDLAS to all different sizes of IV bags, regardless of content. The applicability on very small headspace volumes removes the limitations seen with destructive methods. The new system thus provides an efficient solution for production inspection that ensures product safety and regulatory fulfillment while also reducing waste.

AutoMAP™ features and benefits

The GASPOROX AutoMAP™ Pharma uses a highly sensitive laser sensor that offers exceptional performance and precision in measuring zero to 100% oxygen headspace content on variety of flexible containers packaged in transparent film materials in modified atmosphere, such as large volume parenterals (LVP) and small volume parenterals (SVP).

A vacuum pickup clamps the film surface to the sensor module to allow the laser beam to be directed into the headspace of the package, allowing TDLAS measure the concentration of oxygen present, with full testing cycle taking around one second per item.

The robust sensor module is designed for long service life, low maintenance, compact footprint and easy integration into existing production lines, compatible with many system interfaces.

AutoMAP™ Pharma’s measurement is parameter-free, requires no consumables is completely safe for the eyes, and can be easily adjusted to different package sizes.

With its ability to perform 100% headspace inspection of thermally sealed parenterals, AutoMAP™ Pharma has emerged as a suitable tool to replace manual package testing.

Resources

Click on AutoMAP™ Pharma Headspace Analysis of MAP for 100% Testing to learn more.
Click on AutoMAP™ Product Sheet to download technical details.
Click on AutoMAP™ in action to view video.