ISO 24166-2:2022

Overview

ISO 24166-2:2022 - "Snap-on bottles for metering pumps - Part 2: Moulded glass" defines the physical and performance requirements for moulded glass snap-on bottles used with metering pumps for medicinal products. The standard specifies shape, dimensions, brimful capacities, material options, performance tests and secondary packaging approaches. It applies to colourless or amber glass containers moulded from borosilicate or soda‑lime‑silica glass and addresses nonsterile, ready‑to‑sterilize and sterile packaging configurations.

Key technical topics and requirements

• Dimensions and tolerances: Detailed neck and body geometries (including options with or without a sealing ring) and brimful capacity values for standard sizes (e.g., 10M, 20M, 30M, 50M, 100M) to ensure reliable snap‑on functionality with metering pumps.
• Material and hydrolytic resistance: Accepted glass types and hydrolytic resistance classes referenced to ISO 719 / ISO 720 and ISO 4802 series to control drug/container interactions.
• Performance requirements:
  • Tightness tests and acceptance criteria to verify snap‑on seal integrity.
  • Vertical force measurement for snap engagement (test method provided in annex).
  • Particulate contamination and chemical requirements for suitability with fill/finish and sterilization processes.
• Sterilization and packaging options: Guidance for packaging as nonsterile, ready to sterilize or terminally sterile, aligned with sterile barrier system and protective packaging principles (references include ISO 11607‑1 and ISO 11607‑2).
• Marking and traceability: Requirements for labelling and marking to support identification and regulatory compliance.
• Informative annexes: Practical test methods and examples (snap‑on considerations, tightness test, inner depth measurement, vertical force test method and example packaging configurations).

Practical applications and who uses this standard

ISO 24166-2:2022 is principally used by:

• Glass bottle manufacturers designing moulded bottles for metering pumps.
• Metering pump and closure system designers to ensure mechanical compatibility and leak‑tight performance.
• Pharmaceutical packagers and fill‑finish operations validating packaging configurations and sterilization workflows.
• Quality, validation and regulatory teams for setting acceptance criteria, test methods and supplier specifications.
• Procurement and specification writers when sourcing primary packaging that meets medicinal product requirements.

Practical benefits include streamlined component interoperability, reduced development rework for pump/bottle assemblies, and clearer validation paths for sterile or ready‑to‑sterilize packaging in regulated environments (cGMP considerations and pharmacopoeial alignment).

Related standards

Key normative references cited in ISO 24166‑2:2022:

• ISO 719, ISO 720, ISO 4802‑1/2 (glass hydrolytic resistance)
• ISO 11607‑1 and ISO 11607‑2 (packaging for terminally sterilized medical devices)
• Relevant cGMP guidance (e.g., ISO 15378 considerations for primary packaging)