OR WAIT null SECS
Outsourcing packaging functions can save time and money.
Sometimes it makes sense for a pharmaceutical company to outsource the packaging of one or more products. Some contract packaging firms also are contract manufacturers that can make the product as well as package it.
Outsourcing packaging operations can expedite product launches, accommodate surges in demand or volume growth, provide access to packaging formats that are unavailable in house, locate packaging closer to the market where the product will be sold, and reduce the expenses related to installing and running a packaging line.
Most contract packagers also provide other services, including custom designing packages that aid patient compliance, vial labeling, secondary packaging such as cartoning and kitting, cold-chain, ePedigree, and repackaging. Some firms also assemble devices such as syringes, and others offer stability testing, microbiology and chemistry laboratory testing, engineering support, and tooling design and production. Tooling frequently is dedicated to one product and often is owned by the pharmaceutical company rather than the contract packager. Tooling costs may be assumed by one company or shared by both.
In addition to standard bottles or blisters, some contract packagers offer proprietary designs like the unit-dose Snapplicator from Tapemark. (IMAGE IS COURTESY OF TAPEMARK)
Although outsourcing sometimes seems like an obvious solution, selecting the right partner requires considerable effort and can take time (see sidebar "Criteria for selecting a contract packager"). Companies can spend as long as 18 months on the vendor-qualification process. Because many contract packagers that serve the pharmaceutical industry specialize in specific product and package types, the first step is to identify suppliers with the capability and experience to handle the product (e.g., solid dose, liquid, parenteral, or aerosol) as well as the desired package (e.g., bottle, blister, wallet, vial, ampul, pouch, or syringe).
Criteria for selecting a contract packager
One resource that can help identify potential suppliers is the Contract Packaging Association (Naperville, IL). Its website (www.contractpackaging.org) offers advice about choosing and hiring a contract packager and provides a directory of members that's searchable by criteria such as types of products filled, packaging process, and location.
"Quality and reliability are critical in selecting a supplier," says Aileen Ruff, group product manager for commercial packaging at Catalent Pharma Solutions (Somerset, NJ), which handles various product types and package formats. "Suppliers should also have extensive experience operating under the most stringent regulatory requirements [and] a proven record of success delivering products on time to desired specifications."
Like pharmaceutical manufacturers, contract packagers follow current good manufacturing practices (CGMPs). They also are regularly audited by the US Food and Drug Administration, as well as by customers and other organizations. "We have standard operating procedures for everything we do," says Joe Luke, vice-president of sales and marketing at Reed-Lane (Wayne, NJ), which primarily packages solid dosage forms in bottles, travel-size vials, blisters and pouches. To maintain proper control, "all printed materials are kept in a locked area and must be reconciled as part of the final batch record," he says.
"We can't close a master batch record or ship without a final reconciliation," agrees Paul Dupont, director of business development at Ropack (Montréal). His company specializes in stick packs and products that must be packaged in low relative humidity conditions.
Despite stringent adherence to CGMPs, due diligence is crucial when selecting a contract packaging partner. "Visit the contract packager's operation, walk around the plant, meet the people, check out standard operating procedures. You have to feel comfortable with the people," advises Luke.
Companies seeking a contract packager should perform a quality audit and risk assessment. The prospective supplier's history, customer references, and finances should be reviewed.
Personnel also should examine any Form 483 citations describing CGMP compliance deficiencies that FDA inspectors have observed at a given contract packager. "Not having any [recent] 483s is definitely a positive," says Luke. However, the existence of a 483 shouldn't necessarily be a deal breaker. "It's important to know what the 483 was for and how the problem cited was addressed," he explains.
Steve Larsen, national sales manager for Tapemark (West Saint Paul, MN), a contract manufacturer of transdermal patches, agrees that the existence of a 483 shouldn't be a disqualifier. However, "a series of 483s on the same topic should be a concern," he says.
Once due diligence has been completed, lead times vary, but can be as little as four weeks. Project turnaround will take longer if stability tests must be performed, packaging components must be specified and ordered, tooling is needed, or the package configuration or artwork changes after the project gets underway.
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