Almac announced the successful inspection of its new U.S. Commercial Packaging operations located in Audubon, PA, by the U.S. Food and Drug Administration. The inspection took place Jan. 9 and 10, 2013, from which the agency concluded that the site is fully compliant with Good Manufacturing Practices, with no 483 issued.
Commenting on the inspection, Ian Markwell, vice president of quality, said: “We are very pleased with the outcome of our inspection, as it marks the establishment of our U.S. commercial packaging operations with FDA approval for bottle, blister, wallet, and vial labeling and packaging.”
Jim McGibbon, U.S. director of business development, said, “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the U.S. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”
Almac’s first U.S. commercial packaging client, a U.S.-based diversified healthcare company, is an existing long-term client partner of its U.K. operations for both formulation development and contract commercial manufacture services. Initially, Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA-approved commercial facility in the U.K., with final bottle and blister packaging in Audubon.
“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year,” said McGibbon.
The Audubon facility offers primary packaging of solid oral dosage forms to customized secondary labeling and packaging of sterile biopharmaceutical products for both established U.S. products and niche/orphan drug launches.
Almac has also invested more than $3.3 million in the state-of-the-art Uhlmann UPS 4 blister line. It processes solid oral-dose products, providing primary packaging into a range of materials including PVC, PVC/PVDC, Aclar, and alu/alu. Complete with an integrated C2206 cartoner, the line provides an output of up to 12,000 blisters/hr, in a wide 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, whilst ensuring flexibility of supply.
Enhancing product compliance, the line includes a Total Quality Control Centre (TQCC) incorporating a checkweigher and integrated print and vision system for auto-rejection of incorrect print/serialization data, including 2D codes.
Bulk fill bottling line
Also, Almac’s high-speed bulk fill bottling line processes a range of container types including bottles, jars, and tubs. The technology can fill tablets and capsules operating at speeds up to 14,400 bottles/hr. The bottling line uses electronic filling systems with in-line fill sensors to confirm fill-count accuracy, complete with labeling and component code and print verification.
Meanwhile, its 4Vial Labelling Line applies clear and paper self-adhesive labels to a range of rigid cylindrical containers. GMP design and robust construction ensures efficient operation. Infinitely variable speed control allows labelling in excess of 12,000 containers/hr.
The labelling line is fitted with an optical character verification system that allows an automated inspection of batch detail overprinted onto each label. The labeller also has a system that verifies that the labels used are the correct labels by verification of a barcode on each label. There is also a label/no label system that automatically rejects any container that has not been labelled.