LineArch

Non-destructive in-line headspace analysis measures gas concentration inside sealed pharmaceutical containers without opening or damaging them. The method analyzes the headspace gas through the container using laser spectroscopy while the product moves along the production line. This allows manufacturers to verify oxygen levels, moisture, or internal pressure in real time without interrupting production. Non-destructive testing enables 100% inspection of containers and supports container closure integrity testing (CCIT) programs used to detect leaks or gas ingress during manufacturing.

One of the most widely used technologies for non-destructive headspace inspection is Tunable Diode Laser Absorption Spectroscopy (TDLAS). This technique sends laser light through the container headspace and analyzes how specific gases absorb the light to determine their concentration.

We implement this technology in the LineArch™ in-line inspection platform. The system measures oxygen and water vapor inside sealed containers while they move along the production line, enabling continuous monitoring of headspace conditions without opening or sampling the product.

In-line laser headspace analysis uses tunable diode lasers that emit light at wavelengths absorbed by specific gases. When the laser passes through the headspace of a sealed container, oxygen or water vapor molecules absorb part of the light. The system analyzes the absorption pattern to determine gas concentration.

Because the measurement is optical and contactless, the container remains intact and production does not need to stop. This makes the method suitable for in-line quality control in pharmaceutical manufacturing environments.

Yes.

In-line headspace inspection systems based on Tunable Diode Laser Absorption Spectroscopy (TDLAS), such as LineArch™, can measure different gas parameters that indicate container integrity.

LineArch™ in different variations can measure oxygen concentration from 0 - 100% and can also measure internal pressure and water vapor partial pressure within total pressures of 10 - 1050 mbar.

Leak detection is based on detecting differences between the internal package conditions and the surrounding atmosphere:

• If the oxygen concentration inside the package differs from ambient air, oxygen measurements can reveal leaks through gas exchange.
• If the internal pressure differs from the surrounding atmosphere, pressure measurements can reveal leaks through pressure equalization.

Both measurement approaches can be used to detect leaks or verify headspace conditions using the same in-line system. Oxygen and pressure measurements are performed separately, but each parameter independently provides information about container integrity.

In-line headspace inspection systems can support a wide range of pharmaceutical containers depending on configuration.

The LineArch™ platform supports two sensor configurations. VialArch™ is designed for small and medium containers such as vials from 2R to 100R diameter, including tubular glass, molded glass, plastic, and amber containers. BottleArch™ extends inspection capability to larger pharmaceutical containers up to 105 mm diameter, including large volume parenteral bottles.

The laser-based measurement works with transparent and semi-opaque glass containers and does not require container-specific calibration.

The LineArch™ platform is designed for parameter-free operation during container format changes. The system automatically handles different container diameters within the supported range without requiring manual recalibration.

In VialArch™ configuration the system supports vial sizes from 2R to 100R, while BottleArch™ supports bottles up to 105 mm diameter. Self-calibrating operation eliminates the need for daily calibration procedures, simplifying operation and reducing maintenance requirements in production environments.

In-line headspace oxygen measurement using TDLAS technology provides high precision during full-speed production.

LineArch™ typically achieves 0.1 - 0.2% oxygen precision at conveyor speeds of 300 mm/s. The system measures oxygen concentration across the full 0 - 100% range with typical accuracy of ±0.4% O₂. This performance enables reliable detection of abnormal headspace conditions or gas ingress without interrupting the production line.

In-line headspace inspection systems are designed to connect directly to existing packaging or inspection equipment. The LineArch™ platform uses standard industrial interfaces including Serial RS422, USB communication, and digital I/O (0–24 V) connections for interaction with line controllers.

The system is housed in an IP-rated stainless steel and anodized aluminum structure suitable for GMP manufacturing environments. Installation typically involves positioning the unit alongside the conveyor line and connecting power and communication interfaces

Laser-based headspace inspection systems use low-power tunable diode lasers that are designed for safe operation in industrial environments. The lasers used in LineArch™ are operator safe and do not require special protective barriers or operator safety measures beyond standard industrial equipment requirements.

The system complies with EMC Directive 2014/30/EU and Low Voltage Directive 2014/35/EU, ensuring safe operation in regulated pharmaceutical manufacturing facilities.

Deterministic headspace measurement methods such as TDLAS support regulatory expectations for container closure integrity testing. The technology provides quantitative measurement data that can be used for validation and documentation.

In-line headspace analysis systems such as LineArch™ support testing strategies aligned with USP <1207> deterministic testing principles and EU GMP Annex 1 requirements for sterile manufacturing. Consistent measurement performance and calibration-free operation simplify validation activities and long-term compliance verification.