Equipment and Processing Report
Glass remains the most widely used primary packaging material for parenterals, but polymeric materials are an option.
Despite the proliferation of new drug delivery systems for parenteral products, glass vials remain the most widely used primary containers worldwide. This trend is expected to continue for several years, with global demand for glass vials projected to rise to $5.7 billion in 2024 (1).
In fact, borosilicate glass has been the primary packaging choice for parenteral products since its development more than 100 years ago due to its excellent barrier properties, chemical resistance, regulatory acceptance, and broad range of applications served.
But glass is not the only choice, especially for sensitive biotech products, and polymeric materials have captured market share in recent years. Polymeric materials offer light weight, shatter resistance, greater formability, tighter tolerances, strong barrier, and chemical compatibility. As a result, plastic packaging is gaining ground with global demand for plastic parenteral vials forecast to grow 7.7% per year to more than $1.6 billion (13.1 billion units) in 2021 (2).
One popular polymeric option, cyclic olefin copolymer (COC), combines formability, break resistance, and light weight with a glass-like transparency. Other polymers such as cyclo-olefin polymer (COP) and polyethylene naphthalate (PEN) offer similar attributes.
“The physical stability as well as the diverse design options make COC an attractive alternative for some drugs,” explains Tom Van Ginneken, global product manager SCHOTT TopPac at SCHOTT Pharmaceutical Systems, a supplier of glass and plastic packaging for parenteral products. Anna Malori, business development manager at Bormioli Pharma, a producer of pharmaceutical primary packaging both in glass and plastic, agrees and predicts, “Some fields of application for COC will be highly sensitive drugs, biotech drugs and vaccines, and high-value drugs such as oncology treatments.”
With glass and polymers offering advantages and limitations in different scenarios, many factors must be considered to determine the better choice. Commercializing new primary packaging for parenteral products tends to be time-consuming due to the complex regulatory approval procedures that must be followed to adopt a new packaging material. “The regulatory approval process can take years, and that is why each single change in the glass vial configuration may be seen as an obstacle toward the final drug product approval,” explains Malori.
As a result, many producers of glass packaging for parenteral products are leaving glass chemistry unchanged, but they are fine-tuning processes and quality control practices and increasing inspection capabilities to ensure shipment of flawless finished containers.
Malori says: “Each packaging choice should be strictly related to the specific needs and characteristics of the formulation that will be contained inside.” Working in close collaboration, the packaging supplier and drug maker identify the best packaging material and container-closure system for the formulation. Once that decision is finalized, suppliers provide support during the validation process.
Ginneken details the holistic approach: “We consider what we call the three Ps-product, process, and patient. For example, we examine specific requirements for the drug. Does it need a particularly inert packaging? We also look at the process requirements to consider how the product will be integrated into existing manufacturing lines or how to create a low-waste filling process, among others. Lastly, we focus on the patient as we aim to continuously meet the patient’s comfort and needs. Therefore, we study if drug delivery in a home setting is required. If so, the primary packaging must be easy to handle for the patient and work with self-administration devices.”
1. Freedonia, “World Pharmaceutical Packaging Industry Study #3269,” July 2015, p. 73-75.
2. Freedonia, “World Pharmaceutical Packaging Industry Study #3591,” January 2018, p. 66-67.
Hallie Forcinio is Pharmaceutical Technology's packaging editor.