Demand for small batches of pharmaceuticals and medical devices has exploded in recent years, owing to a number of factors, including the rise of personalized medicines and orphan drugs and the industry need to produce small batches economically. This has led to larger pharmaceutical manufacturers and CMOs (Contract Manufacturing Organisations) struggling to accommodate occasional low volumes on their high-speed production lines.
Sepha has introduced the new service in response to this challenge amid increasing calls for support from its larger pharmaceutical customers.
“Customers were looking to us for support with small runs. Some were having to halt 24/7 high speed blister lines to produce a few hundred sample packs. This is not what these lines were designed for and cannot be justified in terms of line clearance and changeover times. Sepha, on the other hand, is ideally placed to take on small runs, as we have all the know-how we have built up over the years with our laboratory-scale EZ Blister packaging projects, consisting of design, manufacture, process parameter optimization and analysis,” explains Paul Smith, Managing Director of Sepha.
He continues: “We believe we have something unique in the marketplace. We have a breadth of experience – spanning pharmaceutical packaging equipment, leak testing, deblistering and packaging design – that is unrivalled in the small volume contract packaging space. In the last 40 years we have partnered hundreds of pharmaceutical companies across the globe and have brought to market over a thousand different blister designs. This new service brings all these strands of our experience together in an exciting offer that will support our customers’ product quality, time to market and pack integrity ambitions.”
Sepha’s contract packaging division will operate from a new packaging facility in Belfast. Housing a range of dedicated blister packaging equipment, it will be able to accommodate the gamut of small-batch packaging projects, from cold-form and thermoform blisters to MAP packs, trays for medical devices, and temperature and humidity controlled packaging.
Sepha will also draw on over 30 years of design experience to offer a holistic blister packaging development service, complete with QA and non-destructive leak testing. Encompassing material selection, tooling design and 3D prototyping, the full-service offering will be particularly attractive to manufacturers looking to test or compare different materials and designs on a pilot scale.
The new contract packaging service is geared towards companies looking to outsource anything from 100 up to 10,000 packs per week, either as one-off runs or longer-term contracts. These might be packs for use in stability studies, multiple formats for patient compliance testing or marketing samples, for example. Multi-national pharmaceutical manufacturers wanting to focus on drug development and outsource the packaging of solid dose tablets, capsules and medical devices will be the main beneficiaries. Sepha is also keen to work with larger CMOs, for whom small or ad-hoc contracts are not always viable.
“We see ourselves working in partnership rather than in competition with large CMOs. We will nurture customers during the low volume, early life cycle stage, then, when a few hundred or thousand blisters becomes a few million, we will work closely with their chosen CMO to ensure a smooth transition into large scale production,” explains Smith.
Whilst the UK & Ireland and Western Europe will be Sepha’s primary target market, the service will be accessible to manufacturers and CMOs across the globe, thanks to strategic partnerships with specialist providers of temperature-controlled logistics with full track & trace.