Among the chief trends impacting pharmaceutical packaging equipment are biopharmaceuticals and highly potent compounds, which require sophisticated containment systems, personalized medicine, requiring scale flexibility, and serialization requirements for Drug Supply Chain Security Act (DSCSA) compliance.
Generally, the trend toward smaller-sized, very flexible and modular packaging systems is still ongoing, according to Matthias Poslovski, technical sales director at OPTIMA pharma GmbH. “These elaborate processing systems assure that every drop of an existing amount of pharmaceutical product can be transferred into a saleable unit,” he said. “What’s behind this trend is mainly the growing sector of biopharmaceuticals, which are typically characterized by small batch sizes, high potency, sensitivity, that are often toxic and represent high values.”
According to Greg Zaic, president and chief executive officer of Maruho Hatsujyo Innovations, the most important trend impacting business is personalized medicine. “This trend has caused pharma companies to produce smaller volumes of drugs in smaller batch sizes, which requires more frequent changeovers,” he said. “Here, a challenge becomes limiting machine downtime.”
Additionally, with the upcoming DSCSA deadline, serialization efforts are well underway with solutions to address various compliance needs. Michele Leonardi, packaging division sales manager for MG America said, “Serialization is driving most of the current efforts with packaging equipment, and is creating need for more automated packaging lines.”
Keeping pace with the nuances of today’s pharma and biopharma R&D trends is critical for equipment providers. Packaging needs are changing at a fast pace in parallel with the growing demand for biopharmaceuticals, according to Dr. Johannes Rauschnabel, chief pharma expert, Bosch Packaging Technology. “This calls for highly sophisticated equipment, capable of handling complex, extremely sensitive molecules and assuring the highest quality by isolating the operators from the API,” he said. “Apart from isolator and other containment technologies, increasing automation and digitization are supporting the safety of both people and products.
“A focus of new pharmaceutical packaging equipment is on flexibility regarding packaging types and product changeovers, as well as batch sizes. For high production volume medicines, speed, output and efficiency are important features of new equipment, hence, so-called combi machines are highly sought-after.”
In its effort to increase production flexibility for drug manufacturers and contract packers, combined with easy changeovers, Bosch’s new ampoule filling and closing machine platform ALF, offers an increased output of up to 600 ampoules per minute and is also available for vials as a stand-alone version, as well as in a combi version, which processes both vials and ampoules on the same platform.
OPTIMA’s Mr. Poslovski added, “The diversity of packaging and processing technologies is growing, from small sized, sophisticated systems to high output packaging systems that are still in charge of many vaccines, for example. Another area of change is new medication systems, i.e., self-medication, transdermal patches (TDS) and oral film strips (ODF). In terms of packaging and processing technologies, self-medication devices require handling and assembling technologies with low particle emission or particle free. TDS or ODF products are processed with combined converting and packaging processes.”
Additionally, many companies are finding they need flexibility in their manual packing solutions for serialized lines, according to Chris Siegele, serialization specialist for Omega Design Corp. “This flexibility also helps conserve valuable floor space,” he said. “Designing to a smaller footprint is one of the reasons we introduced our LCX Unscrambler, which brings the technology of our rotary pocket bottle unscrambler into a smaller machine.”
Temperamental products, such as packaging injectables and potent compounds, present significant challenges. Because modern drugs are more sensitive, Mr. Zaic of Maruho Hatsujyo Innovations explained, they require improved barrier performance (e.g., light, moisture and oxygen barriers) to protect them from external conditions, and improved product environment within the package (e.g., nitrogen flushing, oxygen scavengers and desiccants).
For small batches, the efficiency in processing depends on fast format changes, but also in short cycle times for sterilization, as well as for the process of freeze drying, according to Mr. Poslovski of OPTIMA. “As many of the new products are highly potent, toxic and not stable, isolator technology and freeze drying are integrated in many pharmaceutical packaging systems,” he said. “Many improvements have already been achieved. The cycle times of isolators has been reduced from several hours or even days to one or two hours, while reaching smallest amounts of residual concentration of H2O2—cycle times are always customer and product specific.”
A new technology called Decojet will lead to further improvements, added Mr. Poslovski. “New developments in the field of controlled ice nucleation will improve the freeze-drying process, in terms of energy and time savings, along with quality improvements of the pharmaceutical product,” he said. “Finally, the flexibility of the filling and packaging machinery has been increased in many ways. New transport systems or disposable systems are examples.”
To help address quicker changeovers and easier adjustments to cover more applications in a single machine, Mr. Siegele at Omega Design Corp. said, “We’ve incorporated adjustable pushers in our bundlers, and developed the adjustable drop chute in our unscramblers to enable quicker changeovers.”
Today’s drug products present various challenges that require advanced capabilities. Adding a layer of complexity to this, are serialization solutions to stay ahead of requirements. Compliance with the DSCSA mandate requires pharma manufacturers to serialize production by Nov. 27, 2017, creating a rush of last-minute requests. Adriano Fusco, marketing director at Antares Vision, said, “Serialization equipment—printers and cameras—is increasingly being integrated within packaging machines at the moment of specification and design. This results in smoother installation and lower cost of introducing serialization to meet looming regulatory deadlines.”
Serialization is a high-priority regulatory subject for pharmaceutical packaging, which goes beyond requiring a data matrix code to be printed on folding cartons. According to Bosch’s Dr. Rauschnabel, “A holistic serialization solution should be able to mass-serialize the packaged product, verify the codes and provide the packaging with tamper-evident labels or security seals. Moreover, the entire process should be consistently controllable and the data accessible at any time. Only this way do manufacturers—and later issuing authorities—have an exact overview of all process steps.
“Against the background of digitization, pharmaceutical serialization is a first step toward an increasing connectivity of production processes, also known as ‘Connected Industry’ or ‘Industry 4.0’. State-of-the-art software solutions should not only be able to manage the allocation of serial numbers through to the last aggregation step. They should also connect single components and third-party equipment, packaging lines, own or third-party IT systems and entire production facilities.”
With the DSCSA deadline looming, where do drug packagers stand with their serialization efforts and what options are available to get up to speed? According to Mr. Fusco, “Antares traditionally has been concentrated on the high end of the market, offering solutions mainly designed for high throughput lines and for highly demanding customers and CMOs. And, for the most part, these customers have planned well and are in good shape to respond to the 2017 mandate. However, many smaller companies are only starting the process now, and run the risk of not meeting the compliance deadline.” That said, Antares has dedicated the last year to designing a number of flexible, quick-to-deploy solutions that meet the needs of such companies. These include stand-alone modules for serialization and off-line serialization systems that can feed several packaging lines.
Mr. Siegele of Omega Design Corp., added, “Pre-stocked, pre-configured equipment is what’s needed to deliver serialization solutions to customers fast. We leveraged our experience, and that of our partners throughout the industry to offer serialization equipment that is ready to satisfy most customers’ needs without hassle.”
At MG America, the company developed new equipment to support serialization applications, including carton coding and verification unit featuring tamper evident seals applicator, according to Michele Leonardi, Packaging Division sales manager for MG America. “One such solution is the ACE-CT400 Coding & Verification Unit, an integrated system for carton serialization,” he said.
Pharma and biopharma firms are not alone in their serialization efforts and can seek support from contract packagers. According to Gaurav Banerjee, serialization subject matter expert at Sharp Packaging Solutions, Sharp’s investment in serialization has been over the past nine years, rather than just the past 12 months. “Our parent company, UDG Healthcare Plc has invested heavily in equipping several dozen packaging lines with serialization capability throughout our commercial packaging network in the U.S., Belgium, and the Netherlands,” he said. “In addition, Sharp has developed multiple teams of dedicated professionals in various disciplines to support the on-going serialization needs of our customer base, such as engineering, IT, technical project management, and computerized systems validation.”
Equipment Capabilities for Today’s Products
The packaging equipment capabilities needed for today’s pharma/biopharma products continue to be very flexible and modular systems to handle very specific needs. Also, working with equipment providers to achieve this has become part of the drug production process for pharma/biopharma.
According to Mr. Poslovski of OPTIMA, “The latest filling and packaging machinery needs to process different types of containers: prefilled syringes, vials and carpules. At the same time, the machinery needs to accommodate different types of filling systems, i.e. time-pressure, peristaltic, rotary pistons and mass flow meter.”
The requirements of pharmaceutical manufacturers for new projects nowadays hardly ever focus on a single machine, according to Dr. Rauschnabel of Bosch. “The trend is toward complete solutions that go far beyond technical or mechanical know-how. In parallel, the roles of drug producers and equipment manufacturers have also changed,” he said. “The supplier has advanced to a partner, who accompanies the entire process with knowledge and technological expertise before, during and after project implementation. The focus in all projects is on pharmaceutical line competence and system integration, providing technology, services, consultancy, and process knowledge from a single source.”
Meeting the needs of today’s pharma/biopharma products increasingly requires flexible packaging solutions. The growth of biopharmaceuticals continues to drive advances in packaging equipment, and greater collaboration among industry and equipment providers is essential to address challenges and deliver enhanced solutions. Finally, whether or not drug manufacturers tackled serialization early on or waited for clarification of requirements, solutions are available to address various compliance issues.