Small-scale inspection of parenterals

With the increase in the development and manufacturing of drugs being produced in smaller batch sizes, the inspection process needs to be adjusted as part of the overall manufacturing and automation strategy. WILCO has developed novel inspection solutions for the automatic inspection of small-scale productions of sterile pharmaceuticals.

World's first dual-laser Headspace Analyzer driving the holistic CCIT approach

WILCO is presenting its cutting-edge Headspace analysis equipment – the NEO HSX DUO. It is designed for tasks related to non-destructive integrity testing and process control. It can be used for the testing of various pharmaceutical primary packaging materials and product types requiring compliance with USP 1207 and Annex 1 regulations. The NEO HSX DUO is the first Headspace Analyzer capable of testing two gases (O₂ and CO₂) simultaneously, saving space, time and cost, while increasing the range of applications.

Novel method for inspection of aseptic process simulation samples (Media Fill)

Traditionally, microbial growth within pharmaceutical containers is visually inspected by manual turbidity checks. However, this process is time consuming and does not provide operator independent results. As an alternative, WILCO, in cooperation with leading pharmaceutical companies, developed a data-driven approach: Growth of different bacteria species can be monitored by measuring the change of CO₂ concentration in headspace over time. Those changes in CO₂ concentration can be linked to microbial growth and thus allow an automated, data-driven and reproducible inspection process.

Non-destructive leak testing method by CO₂ ingress (Bombing)

Bombing allows to detect leaks down to 0.2 µm and is a valid non-destructive alternative to dye ingress method and helium leak test. It also allows 100% control with in-line application of up to 600 test samples per minute. For the CO₂ ingress method, a container is exposed to a pressurized environment containing a high percentage of CO₂. In the event of a leak, CO₂ enters the headspace and can then be measured. WILCO presents its latest applications and solutions for this novel at approach at INTERPACK 2023.

Leak testing of fusion sealed containers such as Blow-Fill-Seal and IV-Bags

With the release of the Annex 1 requirements about leak testing of fusion sealed containers are increased by authorities. WILCO presents multiple solutions for the semi-automated and fully automated inspection of those packages and helps develop and validate the corresponding test method.

Solution Design Process helps to comply with Annex 1

WILCO develops inspection solutions for lab and production environments in close collaboration with the customers. In order to meet expectations, reduce time to production as well as overall cost, WILCO follows a structured and risk-based approach in five phases. The solution design process can be experienced at INTERPACK along with other services supporting the development and validation of inspection processes and equipment.