Sepha has developed a new compact small-batch blister packaging machine with full traceability and electronic data storage capabilities.

The Northern Ireland-based manufacturer of pharmaceutical packaging and equipment has launched the EZ Blister+,  which employs 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.

Sepha said the new machine caters for demands from larger pharmaceutical manufacturers and Contract Manufacturing Organisations (CMOs) – 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.

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.

Paul Smith, managing director of Sepha, said: “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.”

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