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Packaging 'pain points' reveal frustrations

Validation, regulatory/standards, and cost issues top the list of laments for respondents of recent Healthcare Packaging reader survey.

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In your most pressing packaging project, what are your pain points, asked a late-July online Healthcare Packaging reader survey?

Perhaps the most emotional response: “Getting the organization to spend more money on the packaging to make it 'WOW' the consumer and truly be innovative,” said a manufacturing company respondent. Of course, wowing consumers with innovative packaging requires package design expertise and likely costs some money. Economics and design issues both were identified as pain points by respondents.

A marketing manager at a packaging supplier provided some perspective in the cost analysis, describing it as “finding a balance between price and functionality. Most customers want thinner and less packaging--and want to see a reflectance in cost savings. However, running thinner material leads to more problems in the manufacturing and thus more waste. In actuality, no less packaging material is being used, just less is going on shelves and more to waste.”

“Costs, design, performance, and regulatory compliance” were all grouped together by a supplier respondent in India. “Performance versus cost,” was a challenge noted by a U.S. packaging supplier.

On the design end, a medical device maker respondent listed “developing new packaging designs for projects with shortened timelines,” as a concern. Similarly, “Compressed timelines, late involvement,” was mentioned as an issue by a package designer with a pharmaceutical company.

Several survey takers spoke of validation and compliance challenges. For example, “Regulatory acceptance of product-contact materials,” was expressed by a production and engineering professional with a company in the nutritional/functional food and beverage category.

A couple of the validation matters concerned sterilization. A medical device company CPP brought up several issues with the comment, “sterilization facility change--same sterilization method, how/what to revalidate, justification in change.”

On a related note, one of the most thoughtfully expressed issues came from an engineering and production respondent with a medical device firm. He noted:
“Determining the proper environmental conditioning standard to subject a biologic product to during design verification. ASTM F2825 is the newest one, but even it seems unrealistic considering the temperature jumps from -20°C to 50°C in one hour as part of the conditioning profile. Additionally, FDA 510(k) requirements regarding packaging are vague. Some auditors are still concerned with conducting package aging and distribution testing as one test, instead of two separate tests per ISO 11607.”

Sealing was also identified as a difficulty by several respondents. Among other pain points mentioned were the following:

• Awareness of sustainability outside of packaging
• Reliable data on global machinery production by regions
• Customer acceptance to new packaging material.
• Minimal packaging cost but adequate product protection
• Compatibility of films used in sachets to products
• Packaging line efficiency
• Time delays of shipments due to FDA, etc., holds for cold chain
• Documentation, IQ and OQ, high speed of the machine (number of products per minute)
• The customer not being knowledgeable
• Combination products—large, heavy moisture- and oxygen-sensitive projects
• Decision related to markets/countries where a new package will be introduced
• Preventing materials from slipping within package when shipping.
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