20/21 September 2022
Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing. The comment deadline is 31 July 2022.
The following two draft chapters have been published for comment in Pharmacopeial Forum (PF) 48(3):
The proposal for chapter <382> is based on the chapter version to be official on 1 December 2025. Due to stakeholder comments, a revision is being proposed to clarify the applicability of the spike retention and sealability capacity test. Depending on vial size, neck finish, and product volume, a spiking device is not used or does not fit. The new chapter <383> is proposed based on comments received from the 2019 publication of USP chapter <665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products (the chapter was previously announced to be elaborated with the assigned chapter number <668>).
According to the USP, chapter <383> would apply to cured silicone components such as tubing, gaskets, and O-rings that are used in manufacturing operations for drug substances and drug products, as well as for pharmaceutical packaging materials (e.g. elastomeric closures). Due to the scope of the proposed new chapter, a 5-year delayed implementation is proposed to allow industry adequate time for implementation. The proposal includes testing on biological reactivity according to USP chapter <88> to obtain classification. However, the implantation test is not required for manufacturing and packaging components. Moreover, biological reactivity testing is not required for elastomeric closures used to package oral or topical dosage forms, or for manufacturing components. The test may be performed if a classification is needed (classification usually facilitates communication among suppliers, users, and manufacturers, if a need for classification exists).
The proposed USP monographs on elastomers are available after registration to the Pharmacopeial Forum.