ISO 24166-3:2022 PDF

Overview - ISO 24166-3:2022 (Snap‑on bottles for metering pumps - Part 3: Plastic)

ISO 24166-3:2022 defines the shape, dimensions, fill capacities and performance requirements for plastic snap‑on bottles intended for use with metering pumps in medicinal applications. The standard covers material selection, neck finishes (with or without a sealing ring), brimful capacities for standard sizes (e.g., 5P–100P), manufacturing tolerances, packaging options (nonsterile, ready‑to‑sterilize, sterile) and relevant test methods. It is part of the ISO 24166 series and references packaging validation requirements such as ISO 11607‑1/2.

Key topics and technical requirements

• Neck finish and snap‑on geometry: precise neck dimensions and tolerances to ensure a reliable press‑fit between bottle and metering pump; separate specifications for bottles with and without a sealing ring.
• Brimful capacity and dimensions: standardized capacities and dimensional tables (typical sizes 5P, 10P, 15P, 20P, 30P, 50P, 100P) with defined tolerances to support interoperable filling and pump assemblies.
• Materials: selection criteria covering oxygen and water vapour permeability, sterilization compatibility, drug/container interactions, and suitability for Injection Blow Molding (IBM) or Injection Stretch Blow Molding (ISBM).
• Mechanical and physical performance: wall‑thickness requirements and tests such as vertical force resistance and tightness tests (annexes provide measurement methods).
• Packaging and sterilization options: requirements for protective packaging, sterile barrier systems (SBS), foil bags, shipper boxes, and configurations for nonsterile, ready‑to‑sterilize or sterile deliveries.
• Testing and annexes: informative annexes detail snap‑on considerations, tightness tests, inner depth measurement and vertical force measurement technical methods.

Practical applications and who uses this standard

ISO 24166‑3:2022 is intended for organizations involved in the design, manufacture and distribution of primary packaging for liquid medicinal products:

• Plastic bottle manufacturers and mold designers (IBM/ISBM)
• Metering pump and closure system suppliers seeking interoperable interfaces
• Pharmaceutical fill‑finish and packaging engineers standardizing production lines
• Quality, regulatory and sterilization teams ensuring cGMP compliance and sterile barrier validation
• Supply chain and procurement teams specifying packaging for storage and transport

Adoption of this standard helps ensure compatibility between bottles and metering pumps, reduces redesign risk, and supports regulatory expectations for primary packaging used in medicinal products.

Related standards

• ISO 11607‑1 / ISO 11607‑2 - packaging and validation for terminally sterilized medical devices
• ISO 15378 - primary packaging materials for medicinal products (cGMP considerations)
• Other parts of the ISO 24166 series (glass and alternate materials)

Keywords: ISO 24166-3:2022, snap-on bottles, metering pumps, plastic bottles, medical packaging, sterile barrier system, brimful capacity, neck finish, vertical force, IBM, ISBM, cGMP.