Biopharma Business

Jonathan Gardiner, packaging technologist at CDMO Almac looks at how packaging can become more efficient.

The old adage, move with the times, or get left behind, applies to most industries, and the pharmaceutical industry is no exception. Pharma is constantly evolving, whether it’s to meet the requirements placed upon it by the regulators or as a result of changes in the approach to research and development, as well as the economic factors at play.

Almac recognises that in order to be a market leader and maintain a competitive advantage, we need to utilise the most current techniques and strategies and continue to invest in new technologies and equipment, in turn allowing us to become more efficient and maintain our reputation as one of the world’s leading CDMOs.

We have seen a significant increase in the number of our clients filing orphan/niche products, and the requirements to develop paediatric doses, has led to a reduction in batch sizes and a requirement for CDMOs, like ourselves, to develop more flexible packaging solutions, to meet these requirements.

In Europe there is a tendency to favour a blister presentation, for solid oral forms, as opposed to bottles, which are more prevalent in the US. Therefore, as a European based CDMO, a significant portion of our business is manufacturing and packaging tablets and capsules, into various blister formats. Producing hundreds of kilos of pre-printed blister lidding, to satisfy the requirement for multiple languages, to support the multiple European markets, when the volume demand for some of those markets is in the hundreds of units, is clearly not efficient.

Almac sought to address this inefficiency with the acquisition of a Hapa Blisterjet Printer. This is a single colour, fully digital, ultra violet piezo inkjet printing system, used for printing both blank and pre-printed blisters. This printer is capable of printing on multiple surfaces which includes aluminium foil, paper-backed foil, PVC and Tyvek. By packaging the tablets or capsules into unprinted blisters and off-line printing those blank blisters, through the Hapa unit, it allows us to process batches at a larger, more efficient, scale. It also facilitates just-in-time production and eliminates the requirement to hold large amounts of inventory of both printed material and finished goods. This solution is, and will be, of significant value to those companies launching orphan and niche blistered drug products into EU and ROW markets, many of which Almac already supports.

In line with EU Paediatric Regulations (EC1901/2006 and EC1902/2006), one of our US clients implemented its Paediatric Investigation Plan (PIP) and developed and launched an age appropriate formulation, to meet infant patient needs, with Pharma Services manufacturing the paediatric granules, primary packing into stickpack sachets and then into wallet cards.

To facilitate the packaging of these paediatric dosage forms, investment was made in Merz Stickpack technology, with the acquisition of an SBL-50 stick sachet packaging line. This packaging machine is a vertically operating, fully automatic forming, filling and sealing machine for the production of very small tubular bags, also known as Stickpacks. The SBL-50 stickpack technology is a fully automated machine capable of filling 80 stickpacks per minute. This technology not only meets the stickpack presentation needs of our current clients but has also the capacity to process new paediatric drug products (powders, granules and minitabs), that require this specialist packaging.

Another recent expansion included the installation of a new Noack 623 blister line, with a custom designed desiccant feeder. The line was sited in a room with a de-humidification system fitted to an air handling unit, giving us the ability to bring the room humidity down to as low as 20%, enabling us to pack humidity sensitive drug products.

Almac are currently assessing additional investments to ensure we stay at the forefront of the latest packaging technologies, to drive efficiency, flexibility and competiveness.

Among the options being considered are additional blister printing capabilities from Hapa:

The Hapa 237 roll to roll, 3 colour flexo offline foil printing system is a UV flexographic offline foil printing system. An alternative option is the Hapa 237 hybrid roll to roll, UV flexo / UV DOD foil printing system. Both of these systems are designed to print roll fed material and rewind it so that it can be used on a remotely positioned packaging machine.

The Hapa 800 WebJet DOD piexo inkjet digital Drop On Demand digital printing system is designed to print roll fed material in single or multi-colour application. This system would be configured to be installed on an existing blister packaging line.

Any of these systems provide additional flexibility and control to the packager and allows us to address complex packaging challenges associated with innovative drug products. It also provides our partners with the option to address modest country-specific market volumes.