Sepha to demo latest innovations at Pack Expo 2022
Sepha is excited to announce its participation at Pack Expo International, that will be held in McCormick Place, Chicago from 23 – 26th October 2022. The Sepha booth (W-14019) will be part of the Healthcare Packaging Pavilion, located in the West Building. With 90,000 square feet of exhibits, the Healthcare Packaging Pavilion is like a life sciences packaging show within PACK EXPO International, the place to be for companies that are manufacturing pharmaceuticals, biologics, nutraceuticals and medical devices.
Quality, Integrity & Reliability
Taking centre stage will be the two key products from the leak testing range, the VisionScan 3D and Multi-Q HD. Both systems are non-destructive and reliable quality control system to test the integrity of pharmaceutical packaging including blister packs and parenterals. They utilize ASTM standard test methods and are in line with USP 1207 guidelines that prefer deterministic methods. They also can form part of a 21 CFR Part 11 compliant environment.
- VisionScan 3D – Blister Pack Leak Detection
The VisionScan 3D is a blister leak test solution that takes non-destructive leak testing to a new level. The next generation machine is built around a new and patented 3D measurement technique to test the integrity of pharmaceutical blister packs. The 3D technology is used in combination with differential pressure and vacuum and enables the machine to detect leaks in individual blister pockets as low as 5μm (pack and material dependent). The new technology can be applied to all foil types, matt or gloss. Different text patterns can be tested with one test method, making it ideal for production lines with multiple language print variations. The system is designed to allow for easy calibration, quick set up times and a streamlined validation process across different foil types. Watch VisionScan 3D video.
- Multi-Q HD – Container Closure Integrity Testing
The Sepha Multi-Q HD is a non-destructive, deterministic and reliable Container Closure Integrity (CCI) test system developed to detect leaks down to 1μm in parenteral containers. CCI testing is critical for parenteral applications as they often contain drugs that have a short shelf life and are highly sensitive to oxygen or moisture; even the smallest defect can affect sterility and efficacy of the drug. As the content is injected directly into the tissue or bloodstream, any compromised container can jeopardise patient safety. These applications often have a lower Maximum Allowable Leakage Limits (MALL) and require a higher level of sensitivity to demonstrate CCI. The Multi-Q HD has been developed to reach this sensitivity and offers a reliable solution down to 1μm. Watch Multi-Q HD video.
Digitalisation & Flexibility in Blister Packaging
In addition, Sepha will also bring its latest development the EZ Blister+. Demand for small batches of pharmaceuticals and medical devices has exploded in recent years, and businesses are often struggling to accommodate increasingly frequent requests for low volumes on their high-speed blister lines. However, most bench-top machines are not intended for commercial production, and although capable of fulfilling small orders, do not have the necessary software architecture for demonstrating 21 CFR Part 11 compliance. The EZ Blister+ answers calls from larger pharmaceutical manufacturers and Contract Manufacturing Organisations (CMOs) for a small-scale blister packaging machine with 21 CFR Part 11 capabilities.
- EZ Blister+ 21 CFR Part 11
The EZ Blister+ is a small blister pack machine that meets the need for electronic data storage capabilities and digital connectivity. It provides the same proven blister packaging performance, but with added software capabilities that enable the creation of electronic signatures, batch reports, audit trails and other electronic documentation. The EZ Blister+ offers a 3-in-1 manufacturing process including forming, sealing and perforating/cutting. Watch EZ Blister+ video.
- EZ Blister+ 21 CFR Part 11
Book a demo
If you are planning to attend the show and would like to book a demo in advance, or maybe discuss your requirements in more detail, why not book a meeting with our sales team:
🎫Get your free ticket
To see how our range of innovative solutions and equipment can improve quality assurance procedures, reduce manufacturing costs and enable you to meet regulatory requirements visit us at Pack Expo 2022, in the Healthcare Packaging Pavilion, Booth W-14019.
For your free ticket, register here.