Innovation & Expert Tips

Sealed with Success: Top Tips for Successful Blister Sealing

By Scott C. Garverick, Vice President – Business Development

Pharmaceutical companies count on their contract packagers to provide the fundamentals consistently. Blister sealing is one of those basic but critical fundamentals. Consistently and continually delivering compliant, safe, successful sealing will build trust and provide the invaluable confidence needed in a true partnership between packager and pharmaceutical company.

The following tips can assist you with a more successful bond between pharma company and contract packager.

1. Avoiding the Most Common Sealing Pitfalls

Common sealing risks include insufficient seal area around the blister cavity, inadequate sealing temperature for the materials used, inaccurate seal pressure, and customer surprises, say, a tablet coating or lubricant that can interfere with sealability to film or foil.

How do you avoid these? Start by getting your product team involved at the outset. Vendors, purchasing, package development, manufacturing, customer, and packaging representatives need to understand the blister manufacturing requirements and then define those in the technical transfer document. The packager should go over these with the customer to ensure understanding of how the product contributes to blister seal quality.

Other pitfall prevention methods include: communicating tooling requirements with the tooling manufacturer to ensure adequate seal area between the cavity and the blister card edge (or perforations between sections); determining what sealing temperatures and pressures need to be during the Operational Qualification testing; and testing components for seal integrity, both with and without actual product. Then testing again. And don’t forget to get vendors involved to help you; they are the experts and can often offer free engineering assistance.

2. Validation Compliance and Sealing

Validation, when done correctly, can reduce set-up time, decrease scrap and increase yield because changes in seal quality performance are more easily identified when the process is fully documented through validation.

Validation should include qualifying each combination of film, foil and tooling. Operational Qualification will determine and verify operational ranges to ensure that the blister meets all physical and visual quality attributes. Blister cards should also be leak tested to ensure seal integrity.

Additionally, thermoformer validation establishes documented evidence for packager, pharma company and regulatory agencies that the packager has established the correct equipment, tooling setup and operational parameters that will consistently produce a blister card meeting all quality requirements.

3. The Structural Design Process Behind Blisters

The structural design process begins with discussions and a close, symbiotic working relationship among the Packaging Development team, the Marketing Group, and Quality and Regulatory Departments. Those initial discussions should center on determining the true goal of dispensing the product at the patient level while simultaneously ensuring that marketing and compliance objectives are met.

How the blister card is to be used and how it will be presented to the customer in the final package contributes to the design requirements. For example, will the finished product be for sample or trade? Will it be packaged in a carton, hang tab or fold-over card? Will the seal area requirements mandate a perforation? Is a cold-formed foil needed to protect the product? Is the product light sensitive?

These questions and more will help determine sealing success. Remember, a successful product is one that is not only safe, secure and compliant, but also is used as the therapy dictates and reminds the consumer if he’s taken it or not. Those are the ones that will actually sell more product because they aid patient compliance and desired dosing and health results.

4. Personalizing & Customizing Packages for Consumers

Blister package design must adequately protect the product from degradation over the product’s shelf life while also differentiating the package to help build product branding and increase product stability.

For example, blister cards must be designed to ensure that the film material used will adequately protect the product from moisture, oxygen and other external and environmental factors, while also differentiating the product from competitors by including important information that the consumer will value. The consumer will then remember the product and build faith and trust in the brand.

An innovatively designed package can actually result in significant increase in product net sales for the pharmaceutical company.

Top Tips for Choosing a Contract Packager

By Scott C. Garverick, Vice President – Business Development

When you’re provided with the daunting responsibility of selecting a contract packager for your latest product launch or an existing product, it’s easy to get overwhelmed. After all, a lot rides on proper packaging, safety, compliance, security–not to mention structural design and marketing graphics. Finding just the right contract packager can seem intimidating.

Here are a few tips to help ease you through the selection process of finding the right packager for your project.

Packager Profile & History

Find out what the packager’s strengths are. What’s their specialty? Where are they strong? Make sure they can actually do what they say and they’re not just saying what you want to hear in order to get your business. Are they aligned with your requirements throughout their entire organization? Some packagers focus on big pharma, while others might focus on the niche markets with creative solutions. Bottom line: does their culture fit your needs?

Ask how long the packager has been in business. Is it a true bricks-and-mortar operation or is it a company that intends to subcontract many of the components of your business to others? How complex is their supply chain? You need to know. Make sure the packager offers you full, turn-key solutions, all under one roof and has very tight controls over their supply chain. After all, it’s your product for which they are being held responsible.

Look at the experience of their management group. What do they bring to the table? How long have they been around? You should be partnering with a strong, experienced, capable team – not one that’s a bit green. Also, find out how accessible the top leadership will be. Here’s a quick test: call one of their top executives on a Friday afternoon and see if he or she is able to take your call. If not, how long does it take for your call to be returned?

Look for Value-Adds: Marketing continues to be a pivotal requirement in the selection of a contract packager. Does that contract packager offer the messaging that you require for your product? Ask the packager if they have capability with design, graphics, labels, inserts, cartons, and various print needs. Additionally, ask if the package’s structure will be designed in their own facility or if they intend to ship it out for structural engineering.

Regulatory Capabilities

Ask about FDA audits and how the packager performed. When was their last audit? Are they cGMP compliant? Were there any 483s? If a packager declines to tell you any audit information or claims that it’s proprietary, consider that a concern.

Ask about the breadth of their customer base. Does one customer account for half of their business, or do they work with a variety, like brand and generic pharmaceuticals, OTCs and nutraceuticals? Caution: if the company does mostly nutraceuticals, check into their regulatory status to ensure they are FDA-audited and DEA-registered so that they can handle your pharmaceutical needs.

Does the company measure and regulate its own performance? If the packager isn’t measuring their own performance capabilities, they really don’t have metrics in place to determine for themselves how they are performing, whether it’s quality deviations, delivery rates or something else, so they won’t be self-checking and they won’t be working on continuous improvements.

Project Management

Ask the packager to describe their project management system. You have a right to know who will be managing your project and how it will be managed. Who is the primary person responsible for shepherding your project from beginning to end? Is there a system in place to establish a production plan, examine each project element, and provide consistent and continual communications? You should be treated as a partner, and should expect expert project management coordination.

Find out what kind of turn-around time you should expect. How quickly can this packager turn the project around? Will they have a dedicated line just for your product’s run–and for as long as it’s needed? Look for a commitment to dedicated resources, and ask them to show you how that will work. Equally important: ask the company to demonstrate how they can work within your production budget, and how they intend to stay within budget throughout the life of your project.

Look for dedicated resource availability throughout the project. Depending on how many lots you anticipate running, the packager should be able to tell you whether or not they have the right equipment and tools needed to produce and manage your project.

Determine their flexibility and capacity. How flexible is their production? Do they have several lines to run your product or just one? Ask for success stories and references on product launches. Tell them you’d like to hear about their most successful launches and existing-product case histories and how they handled them.

How do you keep up with the increased need for value-added packaging?

Packaging plays an increasingly important role in the overall pharmaceutical product’s life cycle, from FDA approval to distribution and, ultimately, to consumer preference.    Packaging has a lot resting on its shoulders: brand identity, compliance, cost-effectiveness and product protection, just to name a few.  In addition, there are several main industry trends that push forward the need for value-added packaging.

Adherence Packaging

Meet the CRx Pack™, a patented F=1 Child-Resistant and Senior-Friendly blister packaging solution.

The CRx Pack™ features a Senior-Friendly (SF) design to assist with dosage compliance, while also protecting children via a proprietary Child-Resistant (CR) locking system.

PPS created the CRx Pack™ so that pharmaceutical customers in need of an F=1 compliant packaging could also get a leg up on their competition by working directly with the PPS design team to create a customized package with innovative, one-of-a-kind graphics.

That custom design, combined with proprietary construction, ensures the customer’s solid-dose pharma product captures market attention while holding to stringent CR-SF standards for compliance, safety and security.

This innovative packaging’s carded design maintains semi-manual assembly capabilities to accommodate smaller batch runs, and can easily move from clinical trial runs to automated runs for larger volumes.

“We wanted to make sure that the CRx Pack™ format and packaging dimensions were available in flexible configurations to accommodate monthly regimens as well,” said PPSVice President of Sales Scott Garverick. “At the same time, we needed to incorporate a cost-effective format to support high-speed automated production.”

Smaller formatting sizes are also available for holding one or several tablets.

“Here’s what our customers are telling us,” said PPS President, Reid Lederer. “They want compliance card blister packaging that’s senior friendly, has visual prompts to aid patient compliance, and offers increased stability and shelf-life. They want child-resistant solutions. And they want a low cost of entry along with minimal tooling.

“And rightfully so,” Lederer said. “We were determined to give all of that to them, and that was the impetus behind creating the CRx Pack™.”

Additionally, pharma companies are increasingly expressing the need to communicate critical messages to their own customers.

As part of the package’s customized design, CRx Pack™ offers ample billboarding for marketing messages along with a customizable secondary packaging for value-added appeal. The package offers multiple panels, versatile sizes, economical SBS paperboard construction, and limitless graphics.

All CRx Pack™ primary and secondary packaging is created and completed in one facility to ensure that customers also benefit from accelerated speed to market as well as reduced start-up costs.