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Survey says validation tops packaging issues

Validation issues, FDA regulations, and personnel skills are key concerns for healthcare professionals responding to an exclusive Packworld.com survey.

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Biological and biopharmaceutical products will offer the most growth potential in the next two to three years. RFID will be the most effective technology to combat counterfeit packaging. Ease of opening and reclosing will be the most important factor in packaging for aging baby boomers.

Those predictions are among the findings of an exclusive healthcare packaging survey conducted recently on Packaging World’s Web site, Packworld.com. Fifty-one percent of the 208 survey respondents were end users/buyers of packaging machinery, materials, or services. Nearly one in five were suppliers or distributors of packaging materials, followed by consultants, machinery vendors, and contract packagers. Only respondents from end users are quoted in this report.

Among these packagers, 44% listed solid-dose pharmaceuticals as the product its company manufactured, followed by liquid pharmaceuticals (41%), medical devices (35%), biopharmaceuticals (18%), lyophylized products (13%), and nutraceuticals (11%). Slightly more than one in four packagers’ companies produced other products, primarily cosmetics. Respondents were able to select all products that their companies manufactured.

Three of the survey’s 15 questions were related to the challenges to meet FDA regulations, package process validation, and concerns about the skills of engineers and other healthcare packaging professionals (see sidebar).

Asked to identify the most important among five healthcare packaging-related issues for their company in the next year or two, 37% of end users cited validation. Counterfeiting and good manufacturing practices (GMPs) each received 17% of the “vote,” followed by FDA regulations at 12%, and outsourcing at 7%. Among the 10% who selected the “other” category, the most frequently mentioned issues were package innovation, and offshore regulations.

Validation challenges

One question asked end users to describe the major challenges companies face with regard to validating packaging processes, equipment, and materials. Here’s a sampling of some of the responses:

• “The major challenges are implementing technology-driven packaging processes, equipment, and materials at an acceptable cost to meet the regulatory demands and quality upgrades,” said a respondent with a firm that makes pharmaceuticals, as well as lyophylized products.

• “We are moving to a global database for all outsourced packaging vendors, [with] access via the Internet, running off our MRP system,” said a medical device manufacturer respondent. “Validation [of] all external locations will provide challenges,” he said. This respondent brought up another challenge: “Bringing on-line new equipment to print directly on pouches and tray lidding versus the current practice of appling labels.”

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