NEXT: Winning Combination: Reducing Particles in RTU Packaging
The global sterile injectable drugs market was valued at approximately USD 369.7 billion in 2017 and is expected to reach around USD 779.9 billion by 2024. Across the industry, there is a shared commitment to ensuring injectable drugs are safe and effective. This includes the expectation that every lot be essentially free from visible particulates, as outlined in various pharmacopeial standards.
While numerous guidance documents support manufacturers in achieving quality and safety standards, there is still no definitive roadmap to eliminating foreign matter entirely. More than a decade after the first PDA/FDA Glass Quality Conference in 2011, product recalls due to visible particulate contamination continue. In some cases, even a single particle has led to entire lots being pulled from the market—resulting in drug shortages and significant commercial impact. At the time of this case study, 123 drugs were listed on the US FDA’s drug shortage list.
Primary packaging remains a leading source of visible particles in parenteral drugs. Ready-to-use (RTU) components, delivered in a nested configuration, help mitigate risks by preventing glass-to-glass contact and reducing defects such as scratches, breakage, and particle contamination. However, secondary packaging materials can introduce additional contamination risks.
This article examines the role of sealing lids as a potential source of particles in RTU containers. By optimizing lid material, adhesive selection, and processing parameters, manufacturers can enhance particle control. In the next section, we will outline five key focus areas for pharma companies and their suppliers to further mitigate particulate risks in injectable drug manufacturing.
While numerous guidance documents support manufacturers in achieving quality and safety standards, there is still no definitive roadmap to eliminating foreign matter entirely. More than a decade after the first PDA/FDA Glass Quality Conference in 2011, product recalls due to visible particulate contamination continue. In some cases, even a single particle has led to entire lots being pulled from the market—resulting in drug shortages and significant commercial impact. At the time of this case study, 123 drugs were listed on the US FDA’s drug shortage list.
Primary packaging remains a leading source of visible particles in parenteral drugs. Ready-to-use (RTU) components, delivered in a nested configuration, help mitigate risks by preventing glass-to-glass contact and reducing defects such as scratches, breakage, and particle contamination. However, secondary packaging materials can introduce additional contamination risks.
This article examines the role of sealing lids as a potential source of particles in RTU containers. By optimizing lid material, adhesive selection, and processing parameters, manufacturers can enhance particle control. In the next section, we will outline five key focus areas for pharma companies and their suppliers to further mitigate particulate risks in injectable drug manufacturing.
