Catalent Pharma Expands Blister Facility In Italy
Published: April 4th, 2012
Catalent Pharma Solutions (www.catalent.com) has announced the completion of the on-going expansion of its facility in Aprilia, Italy. The expansion offers customers a complete turnkey service from product conceptualization to formulation, development, production, and packaging for prescriptions and OTC products.
The improvements—which include enhanced workflows and environments for maintaining high safety standards and cGMP—were recently successfully inspected by the Italian Regulatory Agency for RX and OTC, says Stefano Arena, the site’s general manager.
“Expanding our drug delivery capabilities and expertise reinforces Catalent Aprilia’s position as a leading integrated development and delivery facility in Southern Europe,” Arena says.
The facility manufactures, controls, packages, and releases prescription drugs and OTCs in PVC, PVDC, Polybar, and Triplex blisters on two fully dedicated production lines. Blisters and patient instruction leaflets are packaged in folding boxes with printed master batch number, manufacturing, and expiry dates.
Mandated, peelable Bollini labels are attached to the saleable-unit boxes for product distributed in Italy. The optical or “vignette” Bollini labels, produced by the State Printing Office, incorporate two linear bar codes; one contains the product name and the name of the market authorization owner, the other a serialized number for uniquely identifying product to prevent reimbursement fraud and support traceability.
Three vision systems and a checkweigher are used on the blister lines performing 100% automated inspection. Camera systems check for correctly filled blisters, leaflet presence, and that leaflets and labels are correctly matched, says Alessandro Maselli, director of operations.
Boxed blisters are then cartoned, placed in shippers, labelled, and palletized. “The blistering is performed in a monitored environment fully segregated from secondary packaging to avoid risk of contamination from secondary packaging materials and microbes,” Maselli says.
Arena says the facilty will look to bring more products to the market as the production enhancements help to meet strong demand for Softgel and Vegicap capsules. “In addtion, we see potential further expansion. Customers are increasingly looking for a full service solution for their packaging requirements.”