New solutions for damage, tampering, and migration are underway.

Struggling with product damage in transit? Need tamper evidence for parenterals? Concerned about extractables and leachables? Two exhibitors at Interphex offered solutions to such on-going concerns. 

DAMAGE

If your glass bottles, vials, or other containers are continuously showing up broken at their destinations, Victor Dixon, President & COO of Rondo-Pak (www.rondo-pak.com), may have a solution. 

Rondo-Pak just debuted a new folding carton called Safepack developed to provide shock and vibration resistance. “The carton has a built-in partition inside that expands all around the product, and it can be configured for more than one unit if needed,” Dixon explains. It also features “autoactuating” cushion flaps on its top and bottom flaps. 

Safepack reportedly can protect against severe impact and provides higher crush resistance than standard cartons, the company reports. “Companies traditionally use materials such as foam, cotton, pillow packaging, or plastic clamshells to provide extra protection,” says Dixon. “Safepack offers an 100% recyclable paperboard alternative that inherently increases the protection of the product while reducing the complexity of the supply chain significantly.” The double-walled carton can be erected with standard cartoning equipment. And the design “doesn’t slow down the line,” adds Rick Leppert, VP of global business development. “Adding other protection features could impact line efficiency.” 

Rondo-Pak can test carton designs during trials on equipment provided by its sister company Mediseal under Körber Medipak Systems North America Inc. And while Safepack could be configured with a longer design to accommodate prefilled syringes, other partitioned protective cartons can be developed to be used with Dividella’s top-loading machines. 

TAMPERING WITH HEAT-SENSITIVE DRUGS

Shrink sleeves are frequently used to provide a tamper-evident overwrap on bottles and vials. Given the use of heat during shrink-sleeve operations, heat-sensitive pharmaceuticals need another solution for tamper evidence.

Schreiner MediPharm (www.schreiner-medipharm.com) offers Flexi-Cap as an alternative. The company custom designs a label specifically for a given vial cap, and then the cap manufacturer forms and incorporates the label into the cap design. “The idea was inspired by caps used in the wine industry,” explains Gene Dul, President of Schreiner MediPharm U.S. 

Schreiner MediPharm is working with machine applicators to make Flexi-Cap use as easy as possible, says Dul. Application involves positioning the film cap over the closed container and applying the label without covering the peel-open tab of an opening strip. Once the strip is opened, the bottom part of the cap, together with the label, remains attached to the container. Any attempt to remove the rest of the cap would destroy the label, the company reports. 

Simply using vial caps with covers isn’t enough to provide tamper evidence, adds Dul. “Caps and crimpers can be purchased by counterfeiters and applied to vials without any evidence,” he says.

Flexi-Cap labeling systems can be developed to suit different container types, forms, and sizes. In addition, the top of the cap could carry bar codes or NFC chips for electronic tracking, and the label could feature holographs, color-shifting inks, void effects, or the machine-readable LaserSecure technology, the company reports.

LEACHABLES AND EXTRACTABLES

Dul of Schreiner Medipharm reports seeing a growing interest in moving away from glass vials and syringes for parenteral drugs, but lingering concerns over introducing the potential for extractables and leachables. 

“A variety of factors – including cost-effectiveness, break resistance, and convenience – explain the rising prominence of plastics in pharmaceutical packaging containers,” says Dul. “However, when compared with glass, plastic containers bring an increased risk of package-to-product migration, meaning that molecules from solvents and other substances contained in inks, adhesives, and film materials could potentially migrate through the packaging over time.”

Dul says that this potential drawback is especially relevant in the case of soft plastics. “For example, eye drops in soft plastic bottles might be contaminated or their effectiveness impaired.”

Schreiner MediPharm offers low-migration label solutions for plastic containers to address the potential downside of such plastics. The company qualified special adhesive systems, materials, and inks to develop the ideal label design for particular plastics.

To help potential users evaluate its low-migration labels, Schreiner MediPharm conducted a study with an independent test laboratory on the migration tendency of various label compositions. 

“The report will help reduce some of the testing needed,” Dul says.