Sachet Line Provides a Strategic Solution
Almac Pharma Services has been processing and packaging up to 20 million sachets per year of a laxative product sold in Ireland and the United Kingdom. When the product license holder wanted to increase output to more than one hundred million sachets per year to expand throughout Europe, the global contract services company decided an expansion was in order. “Demand for our client’s product was outstripping what we could supply,” says David Downey, vice president of commercial operations, Almac Pharma Services. “We had to work as quickly as we could to build and validate a new facility with the required equipment to meet forecasted demand increases.”
|MediSeal provided a sachet filler and a cartoning system that work together to support production of several million sachets per year.|
Almac Pharma Services, with its client partner, invested £2 million at its headquarters in Craigavon, United Kingdom, adding a new 5500-sq-ft facility. The facility features blending suites to accommodate 2.5-ton batches along with a sachet filling and carton packaging line. The facility is expected to produce more than 120 million sachets per annum, split across various packed formats.
“This investment has allowed our client to quickly meet growing demand for one of their key future products,” explained Geoff Sloan, vice president, manufacturing operations, Almac Pharma Services, in a press release. “Utilizing Almac’s technical and project management expertise to deliver a complex engineering solution to an aggressive project timeline will assist our client in securing the market for this strongly performing product.”
MediSeal provided the sachet filling and cartoning line. “The project started out with standard models in mind, but the nature of the product demanded a certain degree of customization, including special product handling and tooling,” explains Andrew Longworth, responsible for MediSeal sales in the United Kingdom and Ireland. “Priorities included filling speed and accuracy and an automatic connection to a cartoner.”
Almac Pharma Services has extensive experience in terms of building and expanding machinery for its own use, but its existing sachet line could not handle such a significant increase in capacity. “Almac has multidisciplinary strengths, including equipment build, modification, and maintenance,” says Sloan. “Having this engineering team in house gives us confidence and shortens our timelines.”
In terms of manufacturing and packaging the laxative product, “we understood our existing process very well. The knowledge was here—we just needed to scale up production,” says Downey. “We had nine months in which to build the whole infrastructure, including the facility itself, and it was a big project to manage.”
|Almac's new facility to support sachet production features clean processing suites. Shown is a new blender for powdered products.|
Adds Sloan: “We raised our User Requirement Specification (URS) to detail critical requirements and discussed them with a range of equipment suppliers. MediSeal was one of the few companies offering to run a trial, which was a big bonus for us. This, coupled with our established relationship, determined MediSeal to be the best fit for Almac Pharma Services. And we were confident in their ability to meet our requirements within the tight timeframe.”
Trials were held at MediSeal’s facility using Almac’s client’s product on the MediSeal LA Edge-Seal Sachet Machine to confirm the accuracy and output. Available with a range of dosaging systems, the vertical machines are compact in construction and can be cleaned and changed over quickly. Platen-sealing tools are mounted on quick-tensioning devices. Servo-motor-driven modules can be programmed by users, and different printing and coding systems can be integrated. Sachets can be transferred via vacuum to a discharge conveyor or a cartoning system. In Almac’s case, the company sought a direct connection to a cartoner, so MediSeal’s solutions for cartoners were evaluated. Almac required a cartoner that could be rapidly and frequently changed between different formats. In particular, the cartoner needed to accommodate a wide range of sachet stack heights. For these reasons, the extended pitch version of the MediSeal P1600 cartoner was selected for connection to the sachet machine.
MediSeal was given an aggressive timeline, reports Longworth. An order was placed in August 2009, and the factory acceptance test was scheduled for February 2010.
“We all had to carefully dovetail our schedules and work cooperatively,” explains Longworth. “The facility had to be built as the machinery was built.”
|Close up of the MediSeal LA Edge-Seal Sachet Machine.|
Given the heat-sensitive nature of the product, MediSeal needed to include machine design features that insulated the product from high heat during sealing. “The product itself is difficult to handle,” says Longworth. “This was a critical aspect of the project.”
“The line also minimizes the amount of manual product handling,” Downey adds.
MediSeal also added 100% electronic verification (optical character verification). “We needed to ensure printing accuracy of labeling data for each market,” says Sloan. “Filling could also be electronically verified, but we have documented product dosing accuracy to within +/-1 %.”
The system is also ready for item serialization. “As a separate, on-going project, we have been working to ensure our equipment is ready for serialization when our clients need it to be,” explains Pauline Glenholmes, business project manager, Almac Pharma Services.
“The new line is also ready for clean in place (CIP) processes if needed,” she adds.
While MediSeal was building new equipment, Almac “had to keep existing equipment running 24/6,” Downey says. “We planned to run both processes in parallel and then scale up the new line. We always planned to keep the existing line for redundancy and for some commercial volumes.”
|Image courtesy of MediSeal.|
MediSeal developed equipment to meet GMP requirements and provided a validation package for GAMP compliance, explains Longworth. “It is helpful to have this document on our desk,” says Sloan. “The detailed documentation helps meet EU and U.S. requirements.”
From a business perspective, this project had wider implications. In addition to meeting its client’s needs, Almac sought to further position itself as a provider of rapid solutions.
“We don’t just provide services, but also “value added” solutions,” says Downey. “Rather than have a customer go to another service provider for additional capacity, we established a cost-effective plan that provided a quick and dedicated solution. It provided a strategic solution, rather than just a tactical one.”