Sharp Packaging Solutions has increased its packaging capacity by 30% for its life science customers with a $45 million investment in a new Center of Excellence for specialty/biologic/cold chain packaging at its Penn Am Drive facility in Allentown, Pennsylvania, and in the addition of four new bottling lines within its adjacent 270,000-square foot contract packaging facilities on Keebler Way in Allentown. The Center of Excellence marks Sharp's third expansion within the Allentown campus since 2014.

The investment in this new facility substantially increases Sharp's ability to handle specialty packaging requirements, with room to increase capacity for these products an additional 30%. Qualification and commissioning of the Center of Excellence was completed in April, 2016, and Sharp commenced commercial packaging activities in June.

By consolidating all its specialty and biologic equipment in the new Center of Excellence, Sharp will open up additional packaging capacity for bottling at its Keebler Way facility by September 2016. All bottling lines will be serialization ready, as well as all lines in the Center of Excellence, in advance of industry requirements for meeting track and trace regulations by 2017. Sharp has been providing serialization services since 2008, with over two billion units serialized in six different formats for 35 client programs, from bottle and individual blister to pallets in support of seven international programs. With the addition of the new capabilities at the Center of Excellence, Sharp will be offering serialization at five of its packaging sites, with the intention of adding 4-5 lines per quarter through 2017.

Due to the proximity of the new building to Sharp's current packaging facility with the use of the same management team, processes and procedures, the US Food and Drug Administration is considering a campus approach in their evaluation of Sharp. A new registration with the FDA will not be required for the Penn Drive Center of Excellence.

The only request by the FDA thus far has been to be advised on when the company anticipates the first production for the building. That information will be provided, and the agency will then determine if it will review the building at that time or as part of the company’s next GMP inspection anticipated in late 2016 or early 2017.

Source: Sharp Packaging Services