Almac invests in humidity controlled blister packaging
Meeting the requirements of the two clients, the expansion included suite modifications for processing humidity sensitive drug products; installation of a new Noack 623 blister line, a custom designed desiccant feeder and an off-line Hapa Blister-Jet printer.
David Downey, VP of business development, told Outsourcing-Pharma.com that the two Japanese products, which will be launched next year in the EU, need the new humidity controlled blister packaging suite and are “small volume products that need product-specific small blister runs that are either very inefficient or you run the blisters off with a blind background and then you pass them down…to apply the information on the back of the blisters, which is a really neat solution for a relatively small product volume.”
“Now we’re doing validation runs for registration batches and stability work to be ready for next year,” Downey said.
The Noack blister line offers more flexibility for processing larger blister sizes and multi-product blister formats, and can be configured to process both thermoform and coldform materials, with maximum blister sizes of 220mm x 155mm. The line facilitated the integration of a bespoke desiccant feeder that cuts, picks and places reel-fed desiccant wafers into blister pockets.
Downey further explained: “With solid oral dose products, they’re normally pretty robust, and it’s unusual to have sort of a really high level of humidity control for these products but both of these products are going into capsules and as soon as the capsules are filled, because of the API, it’s very sensitive…and it’s multiplied by the fact that they’re Japanese, they themselves are sensitive to the presentation of the product.”
James MacKenzie, Commercial Director at Hapa added, “As order sizes continue to fall, the business case for late stage customisation continues to grow. The addition of the Blister-Jet to Almac’s portfolio extends their capability to provide rapid and efficient late stage customisation of bulk-packed blisters.”
Thesolution will add value to companies launching orphan and niche blistered drug products into EU and ROW markets, many of which Almac already support, Downey added.
Cold Chain Expansion
In addition to the humidity-controlled blister packaging suite, Almac also recently doubled its cold-room labelling capacity at sites in the UK, Pennsylvania and North Carolina.
The amount of biologics we’re handling both on the clinical and commercial side, a lot of it’s 2-8 degree Celsius product so really the more of that that’s coming in, the more we may have to store,” Downey told us. In the UK space, he noted that the company “already had a couple of thousand palette spaces in 2-8°C but we’re continuing to have to expand it. That’s the largest cold chain facility in the local area. We have another monoclonal antibody that has to be stored at -70 degree centigrade.”
