Lab Testing Equipment: Frequently Asked Questions (FAQ)

The NEO Series is WILCO’s range of lab testing equipment designed to support both early-stage development and quality control in commercial manufacturing. Its strength lies in the ability to seamlessly transfer test methods from R&D to production, helping reduce risks and accelerate time to market.

The NEO DPX is part of WILCO’s next-generation benchtop inspection systems: compact, intuitive, and built for advanced container closure integrity (CCI) testing. Specifically designed for small volume parenterals (SVPs), it combines three differential pressure methods in one device, delivering high sensitivity and flexibility across various container types and sizes.

Equipped with the MAVIS user interface, the NEO DPX offers a highly user-friendly experience with customizable widgets, operator guidance, and an LED status bar for instant visual feedback. It’s also built for smart integration, featuring a PLC system that connects easily to MES and SCADA environments.

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The NEO HSX is WILCO’s latest lab testing system for non-destructive headspace analysis of small volume parenterals (SVPs). Using Tunable Diode Laser Absorption Spectroscopy (TDLAS), it measures gas concentrations, such as oxygen and carbon dioxide, directly in the headspace of vials, syringes, ampoules, and other sterile containers.

Available in two versions, the NEO HSX DUO features two different laser heads for expanded testing capabilities, while the HSX ONE includes a single laser head. The latest laser technology ensures lower standard deviation, making the system suitable for accurate measurements.

Part of the NEO Series, the HSX combines high sensitivity with user-friendly operation and flexible design, delivering precision and performance in a compact, modern setup.

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Yes. The NEO Series can be equipped with robotic automation to streamline container closure integrity (CCI) testing for small-volume parenterals. A collaborative robot (cobot) handles sample transfer, reducing manual workload and increasing throughput, especially useful for larger batch sizes.

The automation is fully integrated into the NEO user interface, ensuring smooth operation, intuitive control, and consistent test accuracy.

Find out more: Lab testing equipment | WILCO AG

For reliable and non-destructive testing of small volume parenterals (SVPs), WILCO’s NEO DPX and NEO HSX systems offer highly specialized solutions.

• The NEO DPX is ideal for container closure integrity (CCI) testing. It combines three differential pressure methods in one compact unit, offering high sensitivity across a variety of container types.
• The NEO HSX is designed for headspace analysis using Tunable Diode Laser Absorption Spectroscopy (TDLAS)
• It accurately measures oxygen and carbon dioxide levels and absolute pressure in the headspace of vials, ampoules, and syringes — without damaging the packaging.

Both systems are compact, easy to use, and compatible with automation, making them excellent choices for R&D and quality control in pharmaceutical environments.

The 3-in-1 Tester refers to the compact benchtop system NEO DPX that combines three container closure integrity testing (CCIT) methods in one device: Vacuum Decay, Pressure Decay, and the optional LFC Method®.

The LFC Method® is a vacuum-based test performed at lowest pressure, offering enhanced sensitivity for liquid based drug products that are evaporable. By integrating these three methods, the system can handle a wide range of packaging types and product formats — delivering precise leak rate of down to 5.0 × 10⁻⁴ mbar·L/s.

Vacuum Decay is a deterministic, non-destructive leak detection method used in container closure integrity testing (CCIT). After sealing the test chamber around the container, the system evacuates air to reach a predefined vacuum level. If there's a leak, air or gas escapes from the container into the chamber, causing a measurable drop in vacuum.

This method is especially effective for lyophilized or powdered products in rigid containers and for testing vial closures (cap/crimp systems) or pouches.

Pressure Decay is a deterministic, non-destructive method used to test the integrity of container closures. During the test, the chamber surrounding the container is filled with sterile air at a set pressure. If there’s a leak, air will flow into the container, causing the pressure in the chamber to drop, this change is measured to detect leakage.

This method is widely used due to its flexibility and suitability for containers like vials and ampoules in different sizes.

The LFC Method® (Liquid Filled Container) is WILCO’s advanced vacuum decay technique designed specifically for testing liquid-filled containers such as vials, BFS ampoules and bottles, syringes, auto-injectors, cartridges or IV bags.

Like other differential pressure methods, it measures gas exchange between the container and test chamber. However, the LFC Method® operates at a deep vacuum level, which causes any liquid that enters the vacuum chamber through a leak to vaporize. This requires specialized sensors - developed by WILCO - to detect even the smallest pressure changes with high precision.

This method is optimized to detect leaks both in the headspace and through the liquid phase. Because vaporization significantly affects the pressure differential, even leaks hidden by liquid are reliably identified.

Note: Vaporization varies depending on the properties of the liquid, so WILCO offers laboratory testing to evaluate leak detection effectiveness for specific products.

Laser-based Headspace Analysis (HSA) is a non-destructive technique used to measure gas concentrations and absolute pressure levels inside pharmaceutical packaging, including vials, ampoules, syringes, and flexible containers like IV bags and pouches. It uses Tunable Diode Laser Absorption Spectroscopy (TDLAS) to deliver precise, real-time results.

Headspace (the gas space inside sterile packaging) is a critical quality attribute defined by USP <1207>. For oxygen-sensitive products, measuring residual oxygen levels ensures product safety and efficacy. Monitoring these critical process parameters over time also helps assess container integrity and product stability.

The NEO HSX ONE is a desktop headspace gas analyzer equipped with a single laser, either for oxygen (O₂) or carbon dioxide (CO₂) measurement. It can inspect vials (1–100 ml), ampoules (1–20 ml), and syringes (0.5–10 ml) manually or with robotic support.

The NEO HSX DUO features both O₂ and CO₂ lasers for simultaneous gas analysis, covering the same container sizes and inspection options.

Absolutely. The NEO HSX supports both applications. When used with the Bombing Station, leak detection capabilities are further enhanced.

Vacuum decay is not the universal standard but is preferred for certain applications — especially powder or lyophilized products — where only air is used to detect leaks. It's often more efficient for these product types.

Yes. Pressure decay can be applied across a wide range of products. However, the test cycle tends to be slightly longer. When suitable, vacuum decay is faster and typically preferred.

Vacuum decay can shorten test cycles by around 10%, making it ideal for powder or non-toxic products. Pressure decay is more universally applicable but slower in comparison.

Our systems can detect leaks down to 5.0 × 10⁻⁴ mbar·L/s. By adding the bombing method, leaks down to 0.01µ can be detected.

Yes, the NEO DPX system is designed to prevent stopper movement, ensuring reliable container closure integrity during testing.

Yes. There is a special product holder available for the NEO HSX in order to secure a measurement of the gas concentration in the headspace even if the vial is filled up to the shoulder.

Yes. All test time parameters can be adjusted in the “Parametrization” mode to fit specific testing requirements.

Format changes can typically be completed within minutes, minimizing downtime. For the NEO DPX you need to have the corresponding test chambers. In the NEO HSX you can adjust the product size in the product holder.

Large volume parenterals (LVP) like BFS bottles, IV bags or pouches can be tested with up to 3 differential methods with our W07 DPX. It offers even more flexibility in terms of testable packaging sizes and types and is equipped with the same user interface (MAVIS) as on the NEO series. 

The primary requirement is an annual calibration to maintain testing accuracy and system reliability.

Up to 10 user access levels can be configured in MAVIS. WILCO provides preconfigured roles such as Operator, Maintenance, Supervisor, and Administrator. Additional roles, like Operator+, Setter, Maintenance+, Manager, and Engineer, can be created but are not preconfigured by default.

Yes, the report layout can be configured. Users can upload a custom logo and define machine identification to personalize reports.

Yes, users can define custom names for PDF reports during the export process.

Reports can be exported as non-editable PDF files or image formats via Ethernet or USB. Batch data can also be exported in .xls or .csv format for further analysis. A printer can be connected (optional) for hardcopy reports.

Yes. The system is fully compliant with 21 CFR Part 11 and supports integration with other software environments.

User access is managed through the MAVIS operating system, which includes built-in user and recipe management, access control, and logging—fully aligned with 21 CFR Part 11 compliance.

Yes. The NEO platform is designed to be modular and scalable, making upgrades and feature additions straightforward.

Yes. Both models support printer connections for hardcopy report generation.