Ph. Eur. Monograph on Rubber Closures revised

The revised Ph. Eur. Monograph 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders will become official with Supplement 9.5. It will be implemented on July 1, 2018.

As reported before, the scope of this general chapter has been expanded to include coated closures, bi-layer seals and lubricated closures to reflect better the range of closures on the market. Additionally, more details are provided in the Identification section for greater clarity.
The revision includes the following modifications:

  • Identification A (IR spectrophotometry): the amount of rubber required is described as ‘an appropriate amount’ to allow more flexibility.
  • Identification B (total ash): a precision has been added on how to proceed with samples that are not subjected to steam sterilization; an indication has been added to allow compliance with the limit for a specific rubber type, when a type sample is not available.
  • Solution S: the washing step performed before the preparation of solution S has been deleted; the procedure for the measurement of the temperature during autoclaving has been clarified.
  • Appearance of solution S: limits for nephelometric measurements have been included.
  • Acidity or alkalinity: clarification has been added on when to perform the titration.
  • Extractable zinc: the description of the test solution preparation is now more specific.
  • Self-sealing test: a requirement to use a vial that fits with the closure has been added.

The United States Pharmacopeia (USP) is currently also revising its chapter <381> on elastomeric closures and has recently undertaken an in-depth review of the chapter.

More information can be found on the Pharmeuropa website.

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