New structure of Ph. Eur.´s packaging section

As previously announced in our News New Ph. Eur. Structure of Chapter 3 on Materials and Containers, the 10th Edition of the Ph. Eur. contains a new packaging chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes, which was created to group texts on medical devices. The 10th Edition of the Ph. Eur. will become official on 1 January 2020.

Following the modification of the structure of section 3 and the creation of the new chapter 3.3., the numbering of texts has been changed for the 10th Edition. General Chapter 3.3 contains texts, which were previously in chapters 3.1. Materials used for the manufacture of containers and 3.2. Containers:

  • 3.3.1. Materials for containers for human blood and blood components (previously 3.1.1)
  • 3.3.2. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components (previously 3.1.1.1)
  • 3.3.3. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components (previously 3.1.1.2)
  • 3.3.4. Sterile plastic containers for human blood and blood components (previously 3.2.3)
  • 3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components (previously 3.2.4)
  • 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution (previously 3.2.5)
  • 3.3.7. Sets for the transfusion of blood and blood components (previously 3.2.6)
  • 3.3.8. Sterile single-use plastic syringes (previously 3.2.8)

The creation of the new Subsection 3.3 will simplify the distinction between primary packaging and medical devices and consequently clarify the legal status of the texts in the different sections. Following the definition provided in Ph. Eur. General Notices, unlike monographs that are mandatory per se, general texts are provided for information and only become mandatory when applying the monograph in which they are cross-referenced. For example, the dosage form monographs refer to these general texts, therefore making them mandatory. However, the texts on medical devices, until now included in Subsections 3.1 and 3.2, are not systematically associated with monographs and, as a consequence, are not systematically mandatory.

In addition, the test for ethylene oxide in 3.3.7. and 3.3.8. has been revised regarding the GC method. The use of a packed column has been replaced by the use of a capillary column and the use of MS for detection and quantification. The method is considered suitable for cyclo-olefin polymers (COPs) and copolymers (COCs), poly(vinyl chloride) (PVC), and polyurethane (PU).

More information can be found on the Ph. Eur. Homepage.

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