Unique packaging options
Some contract packagers offer custom designs, and several vendors have developed proprietary unit-dose delivery systems. One
such system consists of a foam applicator pad backed by a small pouch, which is squeezed to break a frangible inner seal and
release the product into the pad. Suitable for creams, ointments, and lotions, the system is available in 0.5- and 1-g sizes
(DelPouch single-use pack, Catalent).
Another proprietary system is a scored, four-side-sealed pouch that permits one-handed dispensing of creams, gels, pastes,
or lotions. Capable of holding 0.5 to 17 mL, the pouch dispenses the product when the user pushes two of its ends together
to break the score (Snap! single-use pack, Tapemark). The pouch also can be equipped with a flat or pop-up applicator pad
(Snapplicator) and configured to provide a series of doses or to deliver dual-component products.
Custom designs for solid dosage forms include wallet-pack configurations that support patient compliance and impart child-resistant
and senior-friendly features to traditional blisters (Shellpak unit-dose medication packaging, MeadWestvaco, Richmond, VA,
filled by Reed-Lane).
Contract packagers constantly upgrade their operations to meet the ever-changing requirements of their customers. One firm's
strategy involves making plans to expand as soon as an existing bottling, stick pack, or blister-packaging line is running
at 50% capacity. When the line reaches 75% capacity, the expansion plan is activated. "We never want to operate at higher
than 75% capacity so we always have room to grow with our customers," says Dupont. "We never want to be the constraint on
growth. We want to be able to take on a new project or accommodate a surge in demand," he explains.
As a result, the company recently installed a stick-pack system that precisely fills 10 packs at a time with volumes from
180 mg to 3 g at speeds as high as 1000/min (Ropack). The equipment is installed in a Class 100,000 environment with controls
that permit filling under conditions of 30% relative humidity. If needed, a nitrogen flush before sealing can reduce residual
oxygen in the package headspace to less than 2%.
Another firm recently installed two blister lines and built a secondary packaging line in Europe for nasal strips (Catalent).
The lines address growing demand for these packaging formats and products.
Another new installation involves a high-speed pouching machine that forms, fills, and seals four-side-seal pouches (Reed-Lane).
It also produces multiple packs per cycle.
Contract packager needs
Pharmaceutical companies decide not to outsource a function if it requires customized equiment or if outsourcing is perceived
as risky, But brand owners considering contract packaging need to be prepared to provide the information and support needed
for a successful collaboration. It's particularly important to define critical quality attributes early in the process. "Having
that dialogue up front is essential," says Larsen.
Contract packagers also need a clear description of the nature and scope of the project, product samples, drawings, Material
Safety Data Sheet information, primary and secondary packaging material specifications, lot size, forecasts, and special requirements
such as temperature or humidity levels.
Luke says, "Our customer service and project management people go through a detailed checklist." This information sharing
helps ensure that the project proceeds smoothly.
Dupont concludes, "A master service agreement regulates all of our business dealings. The second document we rely on is a
quality agreement that lays out in detail how we manage and report quality."
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, firstname.lastname@example.org