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Standards Development
The document specifies the characteristics of sterile and ready for filling empty polymer vials, for injectable preparations, including the requirements of dimensions, materials, packaging systems and analytical test methods.
Due to the increasing market presence of containers ready for filling and the associated advantages of this product for the pharmaceutical industry, the suppliers of packaging materials started to develop systems for polymer vials. In 2019 a standard was implemented for “Sterile packaged ready for filling glass vials” (ISO 21882). The standard has been successfully adopted by the pharmaceutical industry. There is a need for similar standard(s) for ready for filling polymer vials to address unique container attributes.
Polymer containers have unique properties relative to glass containers, such as resistance to breakage, tighter dimensions (for processing and final use), and different interaction properties with their contents.
Polymer vials are suited for special applications such as radioactive and other hazardous substances. They are lightweight, can be incinerated different to glass containers.
Also other regulatory entities have enclosed polymer containers into their guidelines, and documents recently. As of July 2025, the European Pharmacopoeia (Ph. Eur.) section 3.1. on materials used for the manufacture of containers has been expanded to include new materials such as cyclo-olefin polymers (3.1.16), cyclo-olefin copolymers (3.1.17), and styrene block copolymers (3.1.18). These additions, published in July 2025 and effective from January 2026, aim to standardize analytical procedures and specifications for these widely used polymers in pharmaceutical containers.
Additionally, a new chapter on extractable elements in plastic materials (2.4.35) was adopted in June 2024 to assess elemental impurities, further enhancing the quality control of polymer materials used for containers ([EDQM](https://www.edqm.eu/en/-/new-general-chapter-on-extractable-elements-in-plasticmaterials-for-pharmaceutical-use-2.4.35-adopted)).
A standard on polymer ready-for filling- syringes on dimensions, test procedures and ready-for filling packaging had been established in 2012 (ISO 11040-6). A roll-out to vials is worthwhile. Standard sizes, dimensions, packaging, etc. enable standardization with fill-finish equipment. This can minimize custom tooling needs and timelines and facilitate use of these containers into existing infrastructure.
Packaging should be harmonized between glass RTU containers and polymer containers. Using the same fill and finish equipment as for glass containers is beneficial for all stakeholders. A standard on RTU vials had been established in 2019 (ISO 21882). It is worthwhile adapting existing nests, tubs, trays and bags for plastic vials to this standard. By this concept sterilization/depyrogenization at site as needed for bulk vials at the filling site can be avoided.
For glass vials sterilization today is restricted to EtO. Plastic containers in the proposed RTU format allow for both Gamma- or EtO-sterilization prior to the fill/finish already at the supplier. Introducing a harmonized RTU standard for plastic vials will extend flexibility and scope of applications of primary packaging in the pharma industry.
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