Enhancing Drug Lab Testing Precision

Container Closure Integrity Testing ensures the sterility and integrity of packaging for sterile pharmaceuticals. While the Differential Pressure methods are based on a gas exchange between the test chamber and the sample, the Headspace Analysis concentrates on the measurement of O_2, H₂O or CO₂ in the headspace of the sample.

Differential pressure technology enables the quantitative determination of leakage without the need for a modified headspace or liquid conductivity. This highly sensitive method ensures that the entire product—whether liquid or lyophilized—can be tested without impacting its integrity. Applicable across a wide range of product types, including alcohol-based formulations, and adaptable to various container sizes, this versatile approach meets diverse testing requirements. Additionally, the combination of multiple pressure-based methods further enhances its range of applications, making it an invaluable tool in comprehensive quality assurance.

Based on Tunable Diode Laser Absorption Spectroscopy (TDLAS), headspace analysis non-destructively measures gas concentrations like oxygen (O₂), carbon dioxide (CO₂), and water vapor (H₂O) in various packaging types, including vials, ampoules, syringes, IV bags, and pouches. By using infrared single-line absorption spectroscopy, this method delivers precise results proportional to gas concentration levels. It supports applications like shelf life studies, stability validation, and leak detection, setting new industry standards with its 4th generation laser technology and seamless integration capabilities. By adding the bombing method, the gas ingress can be significantly accelerated.

The NEO DPX and NEO HSX address industry challenges head-on by implementing these two testing methods.

• Cost-Effective Testing: The NEO DPX eliminates the need for multiple machines by offering three testing methods in one. Similarly, the NEO HSX DUO reduces costs with its 2-in-1 dual laser capability.
• Regulatory Readiness: With deterministic methods and compliance with 21 CFR part 11, these systems simplify meeting FDA and EMA requirements.
• Enhanced Accuracy: Sensitivity and precision metrics ensure high-quality results, minimizing errors and improving batch consistency.

What sets the NEO DPX and NEO HSX apart from other lab equipment available on the market? Their multifunctionality. While many systems on the market are designed for single-method testing, the NEO DPX combines three methods, and the NEO HSX DUO measures O₂ and CO₂ simultaneously. This not only saves time but also reduces equipment costs for labs.

Moreover, both systems offer user-centric designs, compact footprints, and minimal training requirements, making them ideal for busy lab environments.

If you're looking for more in-depth information or have specific questions about our products and services, request a data sheet or get in touch with us - whether you're evaluating options for a project or need precise product data. We are looking forward to hearing from you.