Pharmaceutical Technology, Pharmaceutical Technology, October 2024, Volume 48, Issue 10
Pages: 10–14
Pharmaceutical packaging must advance to adapt to new, complex modalities.
Suitable packaging for pharmaceutical products is a must to ensure the integrity of the products is maintained, which includes making sure the product does not degrade, become contaminated, or get damaged when being transported, for example. The role packaging plays in protecting drug products is important irrespective of dosage form or administration route; however, as the drug molecules themselves become more complex, packaging has also needed to advance.
Age Considerations for Pharmaceutical Packaging Compliance
Keeping up to date with the latest regulatory and pharmacopeial guidelines and revisions is always in the best interest of a pharmaceutical company throughout all aspects of its business. In terms of pharmaceutical packaging, there are important standards and guidelines for companies to follow, not only to ensure the safety and efficacy of the medicines housed within their packaging, but also to protect and assist the patient.
“Compliance trends in the pharmaceutical packaging sector are constantly evolving but CRSF [child-resistant senior-friendly] packaging has long been a major concern,” stresses Olivier Rousseau, CEO, SGD Pharma. “In the United States, over 300 children under the age of 20 are treated in the emergency department every day, and two die as a result of unintentional poisoning (1). And in the European Union, it is the fifth leading cause of accidental death for children and adolescents. Most cases occur within the home, when children gain access to harmful substances that are improperly stored.”
While the ultimate responsibility lies with parents or carers of children to ensure medications are not erroneously consumed, pharmaceutical packaging manufacturers are also being tasked with providing packaging solutions that are child-resistant while also being as user-friendly to adults and senior citizens as possible, Rousseau explains.
“There are numerous mechanisms for child-resistant closures (CRC) on medical packaging, which are primarily categorized into re-closable (bottles) or non-re-closable (blister packs),” Rousseau continues. “In some countries, pharmaceutical and healthcare companies are required by law to produce packaging that is child-resistant, while maintaining accessibility for the consumer.”
For example, Rousseau points out the standard test procedure, published by the International Organization for Standardization, for re-closable child-resistant packaging (2). And, in Europe, he notes, several norms have been introduced that complement the ISO standard.
“Pharmaceutical companies must have certification of child resistance for the for their full solution and the time and cost related to this is significant,” Rousseau stresses. “To streamline this, drug manufacturers can partner with packaging manufacturers that can not only supply innovative, high-quality packaging, but also provide the required certification (ISO 8317:2015 in Europe and 16 CFR [Code of Federal Regulations] 1700.20 in the US).”
“With highly complex biologics and other specialty drugs representing an increasing proportion of the pharmaceutical market, demand for pre-sterilized and ready-to-use (RTU) drug packaging options has increased in recent years; valued at $8.42 billion in 2022 and predicted to reach $14.23 billion by 2031 (1),” says Olivier Rousseau, CEO, SGD Pharma. “As well as this, trends such as personalized treatments in place of blockbuster drugs, increasing regulatory quality and compliance and a move towards self-medication, are changing the way that drugs are administered and therefore manufactured.”
Modern drug packaging
“As the drug pipeline becomes more complex with the rise of biologics and personalized medicine, sterile drug containment and delivery systems have emerged as a great solution,” explains Robert Lindner, global product manager for Bulk and Sterile Solutions at SCHOTT Pharma. “Both prefillable polymer syringes and RTU [ready-to-use] cartridges offer the versatility to handle a wide range of drug formulations. The ability to pre-fill syringes and cartridges in a sterile environment and their compatibility with various drug formulations make them indispensable for biologics and other complex therapies and reduce the risk of contamination.”
Made from either glass or advanced polymers, prefillable syringes are a convenient option for the end user and have become a cornerstone of modern drug packaging, asserts Nina Krautwurst, global product manager for Polymer Solutions at SCHOTT Pharma. “Polymer syringes offer the advantage of being shatterproof, significantly reducing the risk of breakage during handling. This is crucial for maintaining the integrity of sensitive biologics and high-value medications. The design of these syringes has evolved to ensure they are user-friendly and safe, making them ideal for both clinical and at-home use. Their compact and robust nature facilitates easy integration into secondary packaging solutions.”
Additionally, there have been advances made in secondary packaging for prefillable syringes to ensure safe transportation and storage, specifies Krautwurst. “Modern designs focus on maintaining the syringes in optimal condition and ready for use. This includes robust and compact packaging solutions that emphasize safety and compliance,” she says. “The secondary packaging is designed to be user-friendly, facilitating easy handling and reducing the risk of contamination.”
Pharmaceutical companies are moving toward RTU components as preferred solutions to meet the needs of the market and address challenges, concurs Rousseau. “And [pharmaceutical companies] are outsourcing their packaging to trusted experts who offer sterile and RTU options, [which,] in turn, has led pharmaceutical packaging manufacturers to invest in advanced packaging facilities to meet increased demand and ensure effective and timely product delivery,” he adds.
Rousseau also points out that for primary packaging of pharmaceuticals, glass provides significant benefits, including strong chemical and mechanical performance, and sustainability. “Based on the proven success of other RTU glass primary packaging solutions, RTU molded glass vials offer a new choice to pharmaceutical industries in aseptic manufacturing and processing,” he says.
“Molded glass brings its own improved chemical durability and greater mechanical strength, combined with proved industrial platforms for RTU primary packaging as well as state-of-the-art secondary packaging systems, such as trays and nest and tubs used in fill and finish,” Rousseau continues. “Secondary packaging removes glass-to-glass contact, improving the aseptic filling lines of pharmaceutical companies and reducing the risk of failure during drug manufacturing and development. The expansion of the pre-sterilized and RTU market has triggered renewed demand for secondary packaging systems that can easily incorporate RTU offerings.”
For RTU cartridges, particularly prior to the filling stage, secondary packaging developments have focused on sterility and protection, often incorporating sterile barrier systems such as nested tubs or trays, which maintain the integrity and cleanliness of the cartridges during transport and storage, confirms Lindner. “Modern secondary packaging solutions are optimized for automation, reducing manual handling and enhancing efficiency in high-throughput production lines. This [automation] minimizes contamination risks and streamlines the transition to the filling process, reflecting the industry’s focus on maintaining sterility while improving operational efficiency,” he says.
Supporting patient safety
“Patient safety is paramount to pharmaceutical packaging manufacturers,” notes Rousseau. Additionally, it is important for packaging manufacturers, such as SGD Pharma, to ensure all products not only meet all relevant regulatory guidelines to ensure safety but also that any technological advances are also considered to improve the packaging for the patient, he states.
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When looking at glass vials, for example, companies can use an internal siliconization treatment that provides advanced protection for drug products that are sensitive, aggressive, and viscous, Rousseau continues. “A micro-layer of silicone is highly bonded to the internal surface of the glass vials and acts as a barrier coating to provide dual protection: preventing ion leaching from the glass into the drug product as well as blocking drug molecules from penetrating the glass primary packaging. The internal coating enhances the functional performance of the glass vial while safeguarding the integrity of the sensitive therapeutic product to ensure it is preserved when it reaches the patient,” he adds.
“Patient safety has also been supported by the development of an external treatment on the sealing surface of glass vials that protect solid oral drug products from moisture and oxygen though a hermetic seal adhesion of the foil,” Rousseau specifies. “The vials are child-resistant senior-friendly (CRSF) compatible and have tamper-evident closures, both of which help prevent accidental ingestion.”
“Advances in drug packaging have played a crucial role in improving patient safety through several key innovations,” states Krautwurst. “Prefillable polymer syringes have significantly contributed to patient safety by offering features designed to reduce medication errors and improve the administration process. These syringes often come with tamper-evident closures, ensuring that the medication has not been compromised before use.”
Dosing errors are prevented through clear, easy-to-read labeling on the polymer syringes, which provides accurate information about the medication housed within, points out Krautwurst. “The design of these syringes allows for precise dosing, which is particularly important for administering potent biologics, ensuring that patients receive the correct amount of medication,” she says. “Additionally, using advanced polymer materials reduces the risk of contamination and particle generation, enhancing the overall safety profile of the drug.”
Another advancement in packaging, driven by the trend to large-volume subcutaneous injections, is that of specialized containers. These larger cartridges and prefilled syringes “have been developed to handle higher volumes of medication higher volumes of medication while maintaining drug stability and ensure patient comfort during administration,” remarks Lindner.
“Packaging often integrates with wearable devices, autoinjectors, or infusion pumps, enabling patients to self-administer larger doses safely and conveniently outside clinical settings,” adds Lindner. “This reduces the need for frequent hospital visits and allows for more consistent treatment adherence. Innovations in packaging have prioritized sterility and ease of use, essential for patient safety. Sterile packaging minimizes the risk of infection, while user-friendly designs help ensure patients can administer their medications correctly and comfortably. These advancements reflect a strong focus on improving patient outcomes and supporting the unique demands of complex therapies.”
Furthermore, leveraging innovative technologies to make packaging more interactive has the potential to improve overall health outcomes for patients, asserts Lindner. “These innovations can be incorporated into RTU containers’ packaging to give patients instant access to dosing instructions, reminders, and other critical information via their smartphones,” he says. “This enhanced connectivity fosters greater patient engagement and compliance, which is essential for effectively managing chronic conditions.”
Demand for sustainability
While patient safety is obviously critical, other factors that can help make a product appealing to the patient must also not be overlooked. “During recent years, the demand for sustainability has accelerated throughout the packaging industry and has had a particular influence on the pharmaceutical industry,” notes Rousseau. “Consumers are now more environmentally conscious than ever before, and sustainability has become a key factor in their decision-making. In a recent survey (2), FEVE [The European Container Glass Federation] revealed that three out of four European consumers find that purchasing sustainable products makes a difference for our environment.”
Rousseau highlights that “glass is already a highly sustainable packaging material and is [now] 70% less energy intensive than 50 years ago (3). However, in response to growing consumer demand,” he continues, “the glass packaging industry is striving to improve this further, investing around €600 million [US$670 million] each year on updates to manufacturing facilities and steps in the supply chain to improve energy efficiency.”
“Sustainability has become a driving force in the evolution of drug packaging,” confirms Krautwurst. For syringes, polymer materials provide a lightweight option that require less energy to produce and transport than other materials, which can result in a lower carbon footprint, she remarks. Further, high durability of polymer syringes can lead to fewer breakages and hence less waste during handling and transportation, Krautwurst states.
“Drug packaging has also become more sustainable through efforts to reduce its ecological impact, such as using steam-sterilized RTU cartridges. Steam sterilization, which operates with ultrapure water and heat, requires lower energy levels for the same or better microbial kill rates than chemical or radiation-based sterilization techniques, reducing the overall carbon footprint,” says Lindner. “Additionally, steam sterilization does not produce harmful residues or by-products. Further innovations include using eco-friendly materials and designs that minimize waste and energy consumption.”
Along with an increased demand for greener practices from consumers, regulatory pressures and overall industry goals to lower carbon footprints are driving the shift towards sustainability, adds Lindner. “These advancements aim to balance effective sterilization with environmental responsibility, reflecting a broader commitment to sustainability in the pharmaceutical industry,” he concludes.
References
Insight Ace Analytic. Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market Size, Share and Trends Analysis Report by Type of Container (Sterile Cartridges, Sterile Syringes, and Sterile Vials), by Type of Closure (Caps, Plungers, Seals, Stoppers, Tip Caps/Needle Shields), by Material of Fabrication, Region, and Segment Forecasts, 2023-2031. Market Report, Oct. 30, 2023.
FEVE. Sustainability and Climate-Neutral Production. feve.org/glass-industry-positions/sustainability-climate-neutral/ (accessed Aug. 22, 2024).
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