ISO 11040-5:2012

Overview

ISO 11040-5:2012 defines requirements for plunger stoppers for injectables used in prefilled syringes (glass barrels, single‑chamber design). The standard specifies shape, dimensions, material, performance, labelling and classification of elastomeric plunger stoppers intended for single use. It aligns with cGMP expectations for primary packaging components and references relevant test methods for physical, chemical and biological performance.

Key topics and technical requirements

• Scope and applicability
  • For plunger stoppers used with glass barrels in accordance with ISO 11040-4.
  • Not applicable to barrier‑coated plunger stoppers; intended for single use only.
• Classification
  • Type PSL: plunger stoppers with snap lid (snap lip).
  • Type PST: plunger stoppers with thread.
• Shape, dimensions and tolerances
  • Detailed dimensional drawings and nominal ranges are given; general tolerances default to Class M3 (ISO 3302-1) unless otherwise specified.
  • Spacers are required to prevent stiction between stoppers; spacer height shall not exceed 0.3 mm.
• Material and sterilization
  • Elastomeric formulation must be the type tested and approved by the end user.
  • Material shall withstand two autoclave cycles at (121 ± 2) °C for 30 minutes without functional impairment; other sterilization methods require validation.
• Physical performance
  • Hardness tolerance: ±5 Shore A (ISO 7619-1) or ±5 IRHD if tested per ISO 48.
• Chemical and biological safety
  • Aqueous extractables limits per ISO 8871-1.
  • Biological requirements and test methods per ISO 8871-4.
• Designation and labelling
  • Standardized designation format (example): Plunger ISO 11040-5 - PSL - 0,5 or Plunger ISO 11040-5 - PST - 1 - lg for long version.

Applications and users

ISO 11040-5 is essential for:

• Pharmaceutical packaging manufacturers and elastomeric component suppliers
• Prefilled syringe and medical device OEMs designing glass‑barrel injectables
• Quality, regulatory and R&D teams validating primary packaging compatibility with drug products
• Contract manufacturers and assemblers specifying stopper shape, thread compatibility and functional acceptance criteria

Using ISO 11040-5 helps ensure compatibility, sterility performance, low extractables and consistent mechanical behavior of plunger stoppers in prefilled syringes-supporting product stability, patient safety and regulatory compliance.

Related standards

• ISO 11040-1 to ISO 11040-6 (other parts of the Prefilled syringes series)
• ISO 11040-4 (Glass barrels for injectables)
• ISO 8871-1, ISO 8871-4 (extractables, biological requirements)
• ISO 7619-1 (hardness testing), ISO 3302-1 (dimensional tolerances)
• ISO 15378 (primary packaging materials - GMP considerations)