Sepha showcases leak detection technology for blister packaging

At Pack Expo International 2022, Sepha will showcase its latest packaging and leak test innovations, including the VisionScan 3D, the Multi-Q HD and the EZ  Blister+.

Key highlights:

• Sepha will showcase its VisionScan 3D technology - in combination with differential pressure and vacuum - used to detect leaks and test the integrity of blister packs.
• Multi-Q HD will also be exhibited – a non-destructive, deterministic and reliable Container Closure Integrity (CCI) test system - developed to detect leaks down to 1μm in parenteral containers.
• To meet demand for CMOs, Sepha will demonstrate its EZ Blister+ 21 CFR Part 11 – a small blister pack machine with added software capabilities that enable electronic documentation.

Pack Expo International will be the first time that many of Sepha’s North American customers have the chance to see these new technologies on display together, as the company debuts its own dedicated booth themed around quality, integrity and reliability.

For over 40 years Sepha has provided the pharmaceutical, medical device and healthcare industries with solutions to accurately detect leaks in packaging, recover high-value products from rejected blister packs and create high-quality blister packs. These specialised, high-quality machines enable pharmaceutical manufacturers to improve quality assurance procedures, reduce manufacturing costs and meet regulatory requirements.

Unveiling the latest innovations

Taking centre stage will be Sepha’s two key products from the leak testing range, the VisionScan 3D and Multi-Q HD. Both are non-destructive and reliable quality control systems to test the integrity of pharmaceutical packaging including blister packs and parenterals. They are in line with American Society for Testing and Materials (ASTM) standard test methods and United States Pharmacopeial Convention (USP) 1207 guidelines that prefer deterministic methods. They also can form part of a 21 Code of Federal Regulations (CFR) Part 11 compliant environment.

• VisionScan 3D – a blister leak test solution that is built around a new 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.

• Multi-Q HD – 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.

In addition, Sepha will also bring its latest development the EZ Blister+ that has been developed to answer calls from larger pharmaceutical manufacturers and Contract Manufacturing Organisations (CMOs) for a small-scale blister packaging machine with 21 CFR Part 11 capabilities. With the demand for small batches of pharmaceuticals and medical devices, manufacturers are increasingly unable to accommodate requests for low volumes on their high-speed blister lines. Most current benchtop 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.

• EZ Blister+ 21 CFR Part 11 – 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.

Pack Expo 2022

The Sepha booth will be part of the Healthcare Packaging Pavilion, located in the West Building. With 70,000 square feet of exhibits, the Healthcare Packaging Pavilion will be the central hub for solutions targeted to the life sciences industry such as pharmaceuticals, biologics, nutraceuticals and medical devices.

Paul Smith, managing director of Sepha, says: “This is the first time that our customers in North America will have the chance to see all three of our machines together, in person, and to do it at such an iconic event such as Pack Expo is very exciting for us at Sepha. The show not only brings together the latest and most innovative technologies available on the market, but also everyone involved in the pharmaceutical packaging industry. We’re really looking forward to finally meeting with everyone in person to gain more insight into their packaging and leak testing requirements.

"Our expert team will be on hand to give live demonstrations and show how Sepha’s solutions can help solve industry wide problems.”

To see the innovative technologies in person, stop by Sepha’s booth in the West Hall.