Blister Packaging Line Positions New Facility for Flexibility
Pharmaceutical and biotech contract company Almac Pharma Services has installed a high-speed blister line at its new 100,000-sq-ft packaging facility in Audubon, PA. The UPS4 blister line provided by Uhlmann Packaging will package solid oral dose products, using a range of materials such as PVC, PVC/PVDC, Aclar, and Alu/Alu. The line will feature an integrated C2206 cartoner, offering an output of up to 12,000 blisters per hour in a wide range of blister sizes.
Investing more than $10 million, Almac’s new U.S. facility will offer commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets, and hospital unit-dose formats along with secondary labeling and packaging of biopharmaceutical presentations such as vials and ampoules.
Blister packaging will be central to its services. “For the EU and international markets, blister packaging formats have been the preferred packaging solutions, however, we are witnessing a movement in the U.S. market away from bottle formats and into blister formats to address issues of patient compliance, brand awareness, combination packs, etc.,” explains David Downey, vice president of commercial operations for Almac Pharma Services. “Almac is, therefore, well placed to provide their expertise to our U.S. client partners for this packaging format.”
For its blister operations, Almac sought flexibility. “Our User Requirement Specification detailed all our critical requirements including the capability to process both large blister formats while at the same time achieving high-speed outputs with small blister formats,” explains Downey. “The ability to package multi-product blisters was also an important requirement.”
Almac selected the UPS4 blistering line because it can process both coldform and thermoformed packaging materials in a range of blister sizes. “The line is capable of both multi-product blister processing and online blister printing (both flexographic and digital) addressing the need for enhanced patient compliance, while ensuring flexibility of supply,” Downey adds.
According to Dirk Corsten, managing director for Uhlmann, the UPS4 also supports digital printing with OCV/OCR inspection and full product inspection; is track-and-trace ready; and employs a completely new generation of blister reject verification.
Almac and Uhlmann partnered with Hapa, which provided a hybrid printing system providing a 100% verified print capable of coding the individual product cavities.
“Coupled with the Uhlmann VisioRead system, Almac will be certain that all printed information is accurate, legible, and grades to an acceptable level,” says Corsten. “Compliance is a key driver.”
Almac believes such printing will appeal to pharmaceutical companies. “Utilizing two different printing technologies ensures flexibility for our U.S. clients,” says Downey. “The Hapa 237 Hybrid is a modular UV printing system that combines the economic features of flexo technology and the flexibility of the fully digital drop-on-demand (DOD) printing of variable data such as serialized or market-specific information. The integration of the online print unit means that even hundreds of commercial packs can be processed without the need for expensive small runs on preprinted foils.”
Almac also required flexibility with product feeding, Corsten reports, so the machine was equipped with a universal GMP flood feeder and dedicated product feeder. The machine is equipped with two punch stations; one for larger cards (up to 270 mm × 280 mm) and a second punch for maximum output on smaller card sizes.
The line will also include a Total Quality Control Centre (TQCC) incorporating a checkweigher and integrated print and vision system for auto-rejection of incorrect print/serialization data including 2-D codes.
“As an FDA and EU approved outsourcing provider, quality is key in all our operations,” says Downey. “The TQCC was required as a means to ensure reliable quality and compliant product. The TQCC incorporates a checkweigher and integrated print and vision system for auto-rejection of incorrect print/serialization data including 2-D codes. The TQCC unit is separate to reduce impact on print quality and allow for the addition of future technology for example RFID.”
Corsten says that the TQCC will also support Almac’s future flexibility. “Almac can even bring cartons produced off line, or in larger batches, and mark, verify, and checkweigh them on a stand alone unit,” he explains. “OCS/Wipotec was selected as the supplier because of its previous experience with these systems and its second-to-none industry reputation.”
Almac chose the Uhlmann C2206 cartoner for its high-speed, flexibility, and ability to process large carton sizes (130 × 100 × 200 mm), Downey reports.
The wide format range is possible thanks to a 6-in. pitch and the ability to handle all carton closure types (reverse tuck, hot melt, airplane, 4th panel), Corsten says.
The cartoner employs a rotary booklet feeder and leaflet folder/feeder allowing multiple inserts per carton, he adds. “The system has the capability to insert either patient information as a leaflet or a booklet or both. The leaflet option used is a GUK folder and folds the information leaflet flat to the correct size to allow easy insertion,” says Downey. “Electronic verification ensures the correct component is being selected and inserted.”
Almac’s main challenge with installing the blister packaging line was that the facility itself had to be converted from a clinical packaging site to one that could process commercial volumes, Downey says. “This required significant reconfiguration and construction of processing rooms.”
Because of critical timelines and the size of the blister line, the Uhlmann technology was installed while the blistering processing room was being reconstructed, he adds.
“Uhlmann was selected as Almac’s preferred blister line supplier as it was able to provide us with a versatile, high-spec blistering line to address our U.S. client requirements for high-quality, flexible commercial packaging solutions,” he says.
In addition, Uhlmann’s presence as a local U.S. supplier was a “great benefit to Almac,” says Downey. “Uhlmann has provided valuable support to the Almac team at Audubon, PA. They have supported installation, validation, and commissioning of the blister line alongside providing onsite training for the technical/operational teams. Uhlmann will also provide local support for after-sales activities. The Uhlmann line was purchased with a full training package, and we take very seriously the ability of a supplier to support our operator training needs. The provision of local support and after sales service together with short lead times for engineering spares will be advantageous.”
The blister line will complement the full suite of highly flexible commercial packaging equipment already installed in the new Audubon facility. Supporting high-volume marketed products to niche/orphan drug launches, additional technologies include bottling, walleting, and vial labeling and packaging.
Almac has several products scheduled to be processed on the UPS4 line upon FDA approval in Fall 2012, says Downey. “All products processed on this line will be pharmaceutical products, primarily Rx products,” he adds.
Corsten says that the “UPS4 line’s robust design and inherent flexibility make it well suited for product launches and short runs as well as multiple shift production with high yields and OEE for large SKUs.”