25/26 September 2019
Two draft chapters for Ph. Eur 3.2.9 "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders" and 3.2.3 "Sterile plastic containers for human blood and blood components" have been published for comment in Pharmeuropa 28.3. Deadline for comment is September 30, 2016.
The revised general chapter 3.2.9 "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders" includes the addition of coated closures, bi-layer seals and lubricated closures to better reflect the range of closures on the market.
The chapter clarifies that rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders cover all types of rubber closures - including those for vials, sealing disks and plunger stoppers for cartridges, and plunger stoppers, tip caps and needle shields for syringes.
The specifications apply to rubber closures made from rubber of 1 type only, to coated closures, to bi-layer seals and to lubricated closures. Coated closures consist of a bulk of rubber, bearing on its surface or part of its surface a layer of a different polymer. Bi-layer seals are composed of 2 different layers of rubber, 1 of which exhibits a higher level of chemical purity and is intended for contact with a pharmaceutical preparation; the other layer exhibits a higher level of elasticity and is intended to improve self-sealing and fragmentation resistance of the seal. Lubricated rubber closures are closures treated with silicone oil (3.1.8) or other lubricants, for example materials chemically or mechanically bonded to the closures. If closures are lubricated they comply in lubricated state with the requirements as defined in this general chapter.
Additionally, the Identification and Tests sections have been revised correspondingly.
A requirement to use a vial that fits with the closure has been added to the specifications of the Self-sealing test.
The revision of general chapter 3.2.3 "Sterile plastic containers for human blood and blood components" includes the requirement that components of inks, glues or adhesives used for marking or on the labels must not migrate into the contents of the container.
Additionally in the Tests section the use of water for injections R has been replaced by water R (the use of sterilised water for injection is not considered suitable for testing purposes); this change is in accordance with general chapter 126.96.36.199. Materials based on plasticised poly(vinylchloride) for containers for human blood and blood components.
To avoid animal testing, in accordance with EU Directive 2010/63/EU and the policy of the European Pharmacopoeia Commission, the test for pyrogens has been replaced by the test for bacterial endotoxins.
The requirements of the Packaging and Labelling sections have also been revised: Among other modifications/removals the Packaging section has been renamed in "Storage" and the requirements in the Labelling section have been almost completely deleted.
Following your registration on the Pharmeuropa website you can get to the complete drafts of the Ph. Eur. chapters 3.2.9 and 3.2.3.