ISO 21881:2019 pdf download

ISO 21881:2019 pdf download.Sterile packaged ready for filling glass cartridges
1 Scope
This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 720, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11138 (all parts), Sterilization of health care products — Biological indicators
ISO 11140 (all parts), Sterilization of health care products — Chemical indicators
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,sterile barrier systems and packaging systems
ISO 11608-3:2012, Needle-based injection systems for medical use — Requirements and test methods —Part 3: Finished containers
ISO 13926-1:2018, Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
5 Process description and requirements
5.1 Washing
5.1.1 Washing is the process intended to reduce particle, lubricant or any other contamination on the bulkware cartridges after converting process steps.
5.1.2 Water used for final rinsing shall meet the specifications of water for injection (WFI) (see USP and/or Ph.Eur).
5.2 Drying
Drying is an optional step to guarantee the absence of rinsing water after washing if heating is not applied. The air shall be filtered using a filter with a pore size of maximum 0,22 µm.
5.3 Lubrication
The inner surface of the cartridges can be lubricated. Limit values of the amount of lubricant and the required glide forces are subject to agreement between the manufacturer and the customer. Lubrication of the inner surface of the cartridges is applied in order to improve gliding properties. This is usually done by siliconization, with silicone emulsion followed by heat treatment.
5.4 Capping and crimping
5.4.1 Cartridges can optionally, upon customer request, be pre-capped with selected rubber formulations. The rubber material that can be in contact with the injectable product shall meet applicable requirements of ISO 8871-1. For additional regional or national requirements of pharmacopoeias, see type I or type II requirements of Ph. Eur. 3.2.9, USP <381>.