Injection molding and the assembly of in-house-produced and purchased parts occurs in a Class 100,000 cleanroom. The assembly
process involves manual, semiautomatic, and fully automated operations. In fact, robots extract parts from the molding machines.
Because most parts snap-fit together, adhesive usage is minimal. An automated laser-coding system etches alphanumeric codes
on certain components to provide lot traceability. Pad printers apply logos, which not only identify the product but also
help the patient position the inhaler properly for use. Quality control is stringent. Optical scanners monitor the assembly
sequence, which includes a significant amount of testing to ensure the device will be functional and reliable for the duration
of its recommended one-year usage.
To mitigate the risk of supply disruptions, Nektar and Pfizer wanted more than one contract manufacturer for the inhaler and
selected a European counterpart for West's Tech Group. Bespak plc (Milton Keynes, UK,
http://www.bespak.com/) manufactures the inhaler at a purpose-built facility in Milton Keynes, UK.
"Although they would ordinarily be considered a competitor, we partnered on this project," says Treadaway. "They have the
same molding machines, the same automation, the same molds. In addition, manufacturing processes were developed to ensure
interchangeability plant-to-plant," he adds. In addition, each facility follows the same standards and complies with FDA and
EC regulatory requirements to ensure each inhaler is acceptable for shipment anywhere.
In addition to filling the blisters, Pfizer's Terre Haute plant performs final kitting and distribution tasks. Patient packs
come in a variety of configurations, including a combination pack that includes both 1- and 3-mg doses. An Exubera "CareKit"
consists of one inhaler, a replacement chamber, and two Exubera release units that are individually packaged in sealed, thermoformed
trays. The latter items also are sold separately.
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com
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