Blister packaging of medications , a revolutionary concept in the reading, packaging and distribution of pharmaceuticals is witnessing a number of innovations in its machinery as well as as in allied software.
New products unveiled by leading packaging machinery manufacturer, Sepha Ltd and Aras®, leading provider of enterprise open source Product Lifecycle Management (PLM) software solutions is a testimony to this.
In order to meet the rising demand from India, China and South America for an affordable, mobile blister packaging machine for clinical trial use ,Sepha Ltd has launched a new, mobile blister packing machine EZ Blister II. It is a flexible short-run blister-packing solution at minimal cost.
EZ Blister II enables labs requiring short runs of high quality blister packs to choose from a range of technical options and combine these with extensive standard features, creating a final product that is tailored to their exact commercial and production requirements. Options such as nitrogen purge, Teflon coated forming plates, pressure boosters and batch coding enable blister packs to be produced from difficult to form materials, such as Aclar, while maintaining full traceability over drugs in clinical trials.
According to a spokesperson of the company “With fast set-up and minimal operator training required, EZ Blister II offers pharmaceutical research and clinical trial companies a lab scale blister packing machine that combines the flexibility, technology and cost savings that they need in an increasingly competitive market. In a global industry where cost of ownership is vital, the ability to customize, tool and tailor the EZBII to exact customer specification means that the commercial and technology needs of our customers can be balanced.”
Sepha has been serving the needs of the global pharmaceutical blister packing and leak testing markets for over 30 years now and is already doing business with many of the world’s top pharmaceutical manufacturers including Boots, Bayer and Wyeth. It has been designing and building machines in Northern Ireland since 1980 and exports them to over 60 countries worldwide.
In recent years the company has become increasingly involved in developing more sophisticated and complex blister pack designs such as those that incorporate different products and packs where different doses have to be highlighted and separated.
Price was identified as a possible cause of the low conversion rate, prompting Sepha to perform a cost reduction exercise on the EZ Blister. The mechanism from the original machine has been retained but is now housed in a smaller, more affordable package.
The tabletop version of EZ Blister II is around 25 to 30 per cent cheaper than the original model. With stainless steel housing the EZ Blister II costs 10 per cent less than the original version.
While making these changes Sepha has retained the core components. For instance, EZ Blister II is capable of batch coding blister packs to allow for traceability of drugs in clinical trials.
Sepha has also included nitrogen purge to extend the shelf-life of the drug, Teflon plates to allow for easy removal of the pack, and pressure boosters to improve the sealing process
EZ Blister II is more economical for batches up to 20,000 units, making it suitable for low volume specialist products and clinical trials. Changeover takes two minutes, reducing down-time, and it is current good manufacturing practice (cGMP) compliant. Cleaning takes five minutes.
Uhlmann is marketing the Blister Express Center 300 as a low-cost but high-performance line that will appeal to the many pharmaceutical manufacturers who are producing shorter runs of increasingly customised products.
According to the spokesperson medicines are increasingly being customized to suit regional and target group needs. For globally operating pharmaceutical companies, generics manufacturers and contract packagers this means that the volumes of packaging batches are decreasing.
The machine can handle blister sizes of up to 95x145mm and carton formats of up to 115x90x150mm, producing up to 300 blister packs and 150 cartons every minute. In addition, an operator can complete a changeover on the 8m-long machine alone in around 20 minutes.
In the meanwhile Aras®, leading provider of enterprise open source Product Lifecycle Management (PLM) software solutions recently announced that the Deutsche Blisterunion (DBU), an association of blister pharmacies, regional operating blister centres and industrial companies providing blister packaging of drugs for the individual patient, has selected the Aras PLM software suite to automate and streamline its document control and product release process and eliminate the use of paper documents completely.
Aras will drive the entire document control and release process for the production of patient-individual blister packs. The Aras Innovator Signature Connector, developed by Aras partner DataSquare, will enable DBU to document the release process with a qualified electronic signature, saving time, eliminating paper-based forms and manual entry, and ensuring that all protocols are digitally signed and archived in a legally secure and compliant manner.