ISO 15759:2005

Overview

ISO 15759:2005 specifies dimensional and functional requirements for plastics caps with inserted elastomeric liners used on infusion containers manufactured by the blow–fill–seal (BFS) process. Applicable to caps attached by welding (Form A) or by collar technique (Form B), the standard covers cap and liner geometry, materials guidance, and performance tests for safe packaging and handling of liquid drugs for parenteral delivery.

Key topics and technical requirements

• Scope and designation
  • Covers caps for BFS containers (designated e.g., “Cap ISO 15759‑BFS‑A/B”) and liners (Elastomeric liner ISO 15759).
• Dimensions and tolerances
  • Defined drawings and tolerances for Form A and Form B caps and typical liner geometry; general tolerances per ISO 2768‑1 and ISO 3302‑1.
• Materials
  • Caps: plastics that are physiologically harmless.
  • Liners: meet at least Type II extractables requirements per ISO 8871‑1.
• Physical and functional tests (normative annexes)
  • Leak-resistance (Annex A): no penetrant leakage of the covered piercing area.
  • Opening force (Annex B): lid removal force ≤ 80 N; recorded average and maximum values.
  • Fragmentation / Coring (Annex C): ≤ 7 fragments ≥ 50 µm per 10 piercings.
  • Penetration force (Annex D): individual ≤ 80 N, average ≤ 75 N.
  • Dynamic and static spike‑retention (Annexes E & F): dynamic retention ≥ 15 N; static test shows no leakage and the spike must not fall out during 4 h.
  • Resealability (Annex G): no air escape after re-sealing.
• Other requirements
  • Packaging, storage (per ISO 2230), and marking; biological testing is not prescribed by ISO 15759 but must follow national pharmacopeia or regulatory requirements where applicable.

Applications and who uses it

• Manufacturers of BFS infusion containers, caps and elastomeric liners
• Medical device and pharmaceutical packaging designers and quality engineers
• Regulatory and compliance teams assessing parenteral packaging components
• Suppliers of closures, elastomeric components and piercing spikes

ISO 15759 helps ensure safe administration (parenteral delivery) by specifying reproducible cap/liner performance - critical for leak prevention, contamination control, spike retention and user handling.

Related standards

• ISO 48 (rubber hardness)
• ISO 2230 (storage of rubber parts)
• ISO 2768‑1 (general tolerances)
• ISO 3302‑1 (rubber dimensional tolerances)
• ISO 7500‑1 (verification of testing machines)
• ISO 7864 (sterile hypodermic needles)
• ISO 8871‑1 (elastomeric parts extractables for parenterals)

Keywords: ISO 15759:2005, medical infusion equipment, blow–fill–seal (BFS), plastics caps, elastomeric liner, parenteral packaging, leak-resistance, coring, spike retention.