ISO 8536-6:2016 PDF

Overview

ISO 8536-6:2016 specifies requirements for freeze drying closures for infusion bottles used in lyophilization (freeze-drying) of drugs and biological materials. It covers the shape, dimensions, materials, performance tests and labelling for elastomeric closures intended for use with infusion glass bottles described in ISO 8536-1. The standard applies to single‑use closures (dimensional requirements exclude barrier‑coated closures) and includes normative test methods for fragmentation (coring), spike penetration, sealability and residual moisture.

Key topics and technical requirements

• Scope and designation
  • Defines closure design and how to designate a compliant product (e.g., “Freeze drying closure ISO 8536‑6 - 32”).
• Dimensions and design
  • Shape and dimensional limits are given (see Table 1 and Figure 1 in the standard); spacers and positioning elements are covered to permit sublimation position and final insertion.
• Materials
  • Elastomeric materials must meet the performance requirements in Clause 7 and withstand two steam‑autoclave cycles at (121 ± 2) °C for 30 min without loss of function. Barrier‑type closures are treated separately.
• Physical performance
  • Hardness: ±5 Shore A (or ±5 IRHD if tested per ISO 48).
  • Fragmentation (coring): ≤ 20 fragments ≥ 50 µm per 10 piercings (Annex A).
  • Spike penetration: maximum 80 N, average