Bearing Down on Quality

Packaging service providers have focused on package innovation and improved designs, while placing increased emphasis on quality assurance. Information systems are supporting more seamless supply chain integration, as suppliers extend the scope of customer services.
Contract packagers have taken on expanded roles, as pharma companies gravitate to “virtual models” encompassing outsourced services. Traditional pharma core functions such as package design and materials sourcing, tooling, CR/SF testing, and storage and distribution are handed off to third parties offering best-in-class processes.
 
Contract packagers can help fill the void when mergers and layoffs result in excess capacity, offering services across product life cycles, from drug discovery to mature brand management, says Justin Schroeder, director, marketing and business development, Anderson Packaging (Rockford, IL).
 
“Pharma companies are reconciling excess plants and capacity. Some are looking to pull in outside business, while others are looking to do more outsourcing, Schroeder says.
“When the pharmaceutical manufacturer makes a make-versus-buy analysis, as a strategic partner, Anderson is inherently more cost-competitive. Our responsibility is to demonstrate where we can provide value to activities traditionally supported in-house, such as project management, stablity testing, and partnering much earlier in the development process to support early phase clinical development,” Schroeder says.
 
“We have two top twenty pharma firms doing what I would call ‘strategic’ or significant outsourcing with us. For each customer, we are packaging nine or ten different drugs, rather than a single opportunity,” he adds.
For supporting Phase I to IV trials, AndersonBrecon Clinical Services this quarter launched a clinical packaging and distribution facility at Anderson Packaging’s headquarters in Rockford that provides a North American counterpart to AndersonBrecon Clinical Services in Wales.
 
“Now we are packaging, labeling, and managing clinical trial product on both continents. From a distribution perspective, you are shipping out the individual (packages or kits) to where-ever studies are being executed. Facilities and staff on two continents create operational efficiency for our customers. We have the added advantage in comparator sourcing because of our relationship with AmerisourceBergen,” Schroeder says.
 
Growth in global distribution provides opportunities for service providers to enhance partners’ efficiencies and reduce their costs. Late-stage customization (LSC) provides economies of scale that make costs more manageable when companies are shipping small commercial and clinical quantities to emerging markets.
 
Almac Group (Craigavon, Northern Ireland) has added an additional dedicated LSC suite to its commercial facilities. In an EU regional supply strategy, one package is assembled for as many as five markets, with country-specific information applied to a “Blue Box” area as orders are received. LSC provides flexibility to ensure just-in-time delivery as orders are processed immediately, Almac says.
 
The industry has witnessed robust adoption of vision inspection solutions by pharma firms, and suppliers are responding to customers’ dictates for “zero defects” in supplied product.
“All of our bottling and blister lines have vision systems where we are looking for missing, broken, and foreign tablets, and scanning labels to ensure the correct lot and expiry information,” says Joe Luke, VP, sales and marketing, Reed-Lane Inc. (Wayne, NJ).
Contract packager QPSI upgraded inspection of primary and secondary packaging across five plants in adopting Cognex Corp. and Banner Engineering Corp. bar code verification and vision inspection systems.
 
Chesapeake Pharmaceutical and Healthcare Packaging has implemented 100% automated inspection systems, supporting recent deployments of new label and carton printing presses at locations globally.
“We have invested in a number of advanced image verification systems for our pharmaceutical business [that emphasize] our firm commitment to delivering the highest quality products to our customers,” says Simon Tokelove, head of asset management, Chesapeake. At the Chesapeake Leicester, UK, facility, a camera-based system for monitoring carton color and content has been fitted to a new sheet-fed Komori S40 press. Chesapeake plants in Northern Ireland and Belgium have installed the EyeC offline system for print inspection. In Ireland, Chesapeake Westport has installed blank leaflet detectors, complementing existing bar code readers, on folding machines.
 
Advanced Vision Technology’s AVT Print Vision/Helios system is integrated to a newly installed Mark Andy label press at Chesapeake’s Kunshan, China, plant. At the company’s Lexington, NC, facility, the AVT Print Vision/Helios system has been fitted to a rewind station where it augments human inspection of labels, says Troy Turley, market development director, Chesapeake Pharmaceutical and Healthcare Packaging.
 
Inspecting registration and print consistency, the system detects missing copy, type irregularities, and color variations that might be missed in a manual process. “At some point an operator may miss a random defect. The Print Vision/Helios system will catch those potentially critical one-off defects, allowing isolation and removal of the non-conforming materials. Customers need to avoid the risk of defective print that may lead to a recall. They require a more-robust inspection process as a condition for doing business with them,” he adds.
 
For supply-chain visibility, Catalent Pharma Solutions (Somerset, NJ) and Sharp Corp. (Allentown, PA) have joined the TraceLink Network for collaborative supply management. TraceLink network partners are working on technical development of serialization services in preparing for California’s 2015 pedigree and serialization mandate.
 
Meadwestvaco Corp. (Richmond, VA) announced the MWV Exchange, a web-based Open Innovation portal for connecting directly with customers, suppliers, and partners. Portal users—collaborating in a more seamless fashion—will accelerate package development from “concept to commercialization,” MWV said.
 
As medical device manufacturers reach into new markets, device packaging has to protect product exposed for extended durations. Shifts and extremes in temperature, humidity, and pressure variances can stress seals and damage product. Excess moisture inside containers generate mold that may damage devices.
 
Materials companies are lending support services. “The rigors of transportation drive choices in materials and adhesives. We might investigate creep-resistant adhesives or materials that will give you longer shelf life,” says Jane Severin, PhD, director of technology, Oliver-Tolas Healthcare Packaging (Grand Rapids, MI). “We generate a plethora of data in house on shipping environments that we can apply to address likely conditions. In optimizing the primary package, you have to take a systems approach [taking into account climate] and package orientation in intermodel containers,” Severin says.
 
Oliver-Tolas’s on-site service program extends customer technical services with an embedded Oliver-Tolas engineer running a complete validation of the customer’s packaging. Program targets for usage and revenue doubled this year, Severin says.
 
In the area of healthcare system costs, all parties in the medical device supply chain need to communicate on the issue of what constitutes defective packaging, Severin says. “The pressures on cost are mounting every day. As a supplier we look for ways we can reduce cost while maintaining patient safety,” Severin says. Multilevel packaging solutions address multiple requirements. Oliver-Tolas’s Ostasis pouch is reinforced with a Tyvek strip at each end, which enables downgauging or the use of less expensive grades of film. VisiSeal supports visual point-of-use inspection for seal breeches and thwarts reproduction by counterfeiters.
 
“As an industry, we have to get our arms around what is and is not a defect, because a lot of waste is generated and money lost when good packaging is disguarded for perceived defects. As we move into this new healthcare era, who will pick up the cost?” she concludes.