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Sepha’s New EZ Blister+ Enables 21 CFR Part 11 Compliant Micro-Batches

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Sepha, the Northern Ireland-based manufacturer of pharmaceutical packaging and equipment, has developed a new compact small-batch blister packaging machine with full traceability and electronic data storage capabilities. The EZ Blister+ meets increased demand for 21 CFR Part 11 compliant micro-batches throughout the blister production lifecycle, from R&D right through to commercial production. 

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. Demand for small batches of pharmaceuticals and medical devices has exploded in recent years, and these businesses are struggling to accommodate increasingly frequent requests for low volumes on their high-speed blister lines.

Manufacturers have historically relied on lab-scale blister packaging machines to produce small quantities of drugs and medical devices for samples or clinical trials. 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. Therefore, manufacturers are left with no choice but to use their high-speed lines, which cannot be justified in terms of line clearance and changeover times.

The result of 12 months of R&D, the EZ Blister+ bridges this gap, providing a 21 CFR Part 11-ready system for producing small batches with electronic signatures and documentation. The machine is an intelligent evolution of the EZ Blister, Sepha’s flagship low volume blister packaging solution. 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 Structured Query Language (SQL) database system at the core of the EZ Blister+ powers a host of applications on the machine, from recipe creation and management to reporting, as well as facilitating integration with factory networks and Management Execution Systems (MES).

Paul Smith, Managing Director of Sepha, says: “The message that we are getting loud and clear is that pharmaceutical manufacturers want electronic record keeping functionality and digital connectivity from all of their packaging equipment – not just their highly automated, high-speed lines. They are looking to create digital eco-systems in which all systems are connected and centrally controlled, so that when the auditors come knocking, they can easily show compliance.  At the same time, the trend towards small batches is gaining momentum as drugs become more specialised and personalised. These two trends converge in the EZ Blister+, which we believe to be the first micro-batch blister packaging machine to offer 21 CFR Part 11 functionality.”

He continues: “Our R&D team has digitised the EZ Blister machine, elevating it to a highly intelligent system that can record all data that is necessary for traceability purposes and connect with a company’s network so site personnel can have full visibility of what is going on during blister production.”

The EZ Blister+ employs proven forming, sealing and cutting techniques to ensure packs are of the same quality and integrity as those produced on large blister packaging lines. Blister trays or cards are thermoformed or coldformed according to the exact specification of the product, sealed with pre-cut pieces of lidding material using knurled or flat heated sealing plates, then cut and perforated using a precision die-cutter. Tablets, capsules, ampoules and other products can all be packaged on this compact, versatile system.