Holographic anti-counterfeiting technology. Among the more intriguing things shown on the Pharma EXPO side of the recent Las Vegas show was a new twist on holographic anti-counterfeiting technology for blisterpacks. Shown at the Romaco booth, the technology was developed in an exclusive partnership between Romaco and a company called NANO 4 U. Based in Germany and Switzerland, NANO 4 U applies a range of technologies in the fight against counterfeiting, including methods developed originally in the business of authenticating banknotes. Romaco says the technology can be integrated into a variety of blister packaging machines. At the Romaco booth, it was integrated into a Romaco Noack blister line 960. The NANO 4 U process uses steel hologram stamps that are created by structuring the surface of the steel using a proprietary micro/nano structuring method. On the Romaco machine, the steel stamps are integrated into an embossing station, so there is no additional material or tooling involved and the hologram stamping takes place as part of the normal blister packaging process. The process can create a hologram logo that changes with viewing angle, or it can be used to create a covert feature that is revealed with a laser pointer showing a reconstructed image.
Alternatives to Barex. When INEOS Barex AG announced in 2014 that it intended to close the Barex plant in Lima, OH—the sole facility producing it—the worldwide pharma industry faced the loss of a staple barrier film. The plant will produce contracted volumes for existing customers through the second quarter of 2016. Several plastics and packaging companies are working to find alternatives and were exhibiting their progress at Pharma EXPO 2015. For instance, Bemis is testing alternatives to Barex for the sealant layer in transdermal patch constructions.
Transdermal patch delivery of drugs is a $25 billion market (2014 estimate from Bemis) and is on its way to being a $40 billion market (2018 estimate from Bemis), with approximately 90 drugs in the pipeline that will utilize patches as the delivery method.
In their presentation entitled Materials Science: Case Study for Rational Design of Transdermal Patch Packaging, Rishabh Jain and Yuan Liu, Research Scientists at Bemis, took to the Pharma EXPO Innovation Stage to present the test results for two alternatives to Barex. They have been named PerfecPharm P616 (CXB Sealant) and PerfecPharm P619 (PET Sealant).
The testing examined chemical resistance, diffusion barrier performance, and ability to resist delamination. Heat sealability was tested for both films, with generally good results.
One of the chemicals tested was nicotine, a tough substance to handle in a transdermal patch. Bemis’ CXB sealant, a blown film, holds up well when tested with nicotine using spectroscopy and solubility modeling.
Bemis scientists have also conducted case studies for transdermal patch performance for both films using Lidocaine, estradiol, and Fentanyl. Bemis marketers emphasize that the company’s technology family covers the full range of transdermal patch packaging options, including paper, foil, child resistant, high chemical resistant, and low drug uptake laminations.
Elsewhere at PACK EXPO Las Vegas, Rollprint exhibited Exponent, a high-barrier, peelable film that can function as an alternative to Barex in chemically sensitive applications, for example in transdermal patches. Exponent extrusion coated sealants also provide excellent water vapor and oxygen barrier. Available in both peelable and weld seal versions, Exponent provides high-barrier clear film options where previous package choices were limited to aluminum foil laminations or glass.
Rollprint representatives emphasized that Exponent materials are suitable for use not only in transdermal patches but also in diagnostic, cosmetic, e-cigarette, and other chemically-sensitive applications requiring exceptional barrier and clarity.
Minimizing risk of API exposure. Presentations at the Pharma EXPO Innovation Stage were excellent sources of information for show attendees, including a presentation by Senior Packaging Engineer Kevin Swartz and Senior Process Engineer Len Pauzer of Integrated Project Services. Titled “Oral Solid Dose Packaging: Assessing, Minimizing, and Monitoring the Risk of API Exposure,” the presentation was focused on Active Pharmaceutical Ingredient manufacturing and what kind of protection needs to be in place for personnel when packaging Oral Solid Dose (OSD) drugs. Key considerations to protect workers included these:
- The movement of paperwork, labels, and sampling in and out of the packaging area can create situations for exposure.
- Product-product contact is a leading cause of particulates in the air, so it’s important to minimize table-to-tablet contact to keep dust to a minimum. Product contact with stainless steel can also lead to particulates in some cases. Using plastics or coating processes may be considered for certain product contact equipment.
- The manufacturer should be involved in the machine design process as a partner. While vendors are experts in the machinery itself, the manufacturers “run it 365 days for 20 years straight, so [they] are the process and product experts,” Pauzer explained.
Swartz and Pauzer say they still come across user requirement specifications that deal only with functionality and not with safety. They hope to bring awareness to the packaging community about personnel exposure hazards.
The contract manufacturing decision. Whether or not to use a CMO can be a nerve-wracking decision for any pharmaceutical manufacturer. In their presentation, “Outsourcing Dilemma: Find the Right CMO to Minimize the Risk and Maximize the Quality of Your Brand,” Christa Myers, Associate/Lead Process Engineer, and Kevin Debbs, Process Specialist at CRB Consulting Engineers, specified important questions and details to look for in CMOs.
“First and foremost, this is about protecting your brand,” explained Myers, adding that it’s not a “touchy feely” decision—manufacturers must make a plan and work through the details to be able to approach upper management with reasons why a CMO is the best for the product or packaging.
Key drivers will be different for each product and process, but the right CMO should demonstrate an ability to handle the production scale and timeline. Myers added that the regulatory history must be researched, but that manufacturers shouldn’t react on the face value, as inspection frequency and the nature of findings should be taken into account.
When visiting the facility, it’s important to perform interviews and look for tells that indicate CMO quality, including:
- Clear procedures
- A well-maintained facility
- Cross-contamination control
- Engaged staff
- Age of processing equipment
Additionally, a CMO’s documentation practices should be looked into. This is a simple thing, but if it’s not being handled appropriately, it may be a bad sign. The right CMO will demonstrate confidence in its ability to provide a service, and show a commitment to your success and to having integrity. Manufacturers must take responsibility and do their homework, as Debbs concluded, “Trust, but verify.”
