GB/T 35510-2017

Active

Determination of released-particle count for closures of butyl rubber

丁基橡胶瓶塞易脱落物的测定

Standard Type
GBT
ICS
11.040.20
CCS
G45
Status
Active
Issue Date
2017-12-29
Implementation
2018-07-01
Centralized Committee
中国石油和化学工业联合会
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies a test method for determining the number of particles that can detach from butyl rubber closures, such as those used for pharmaceutical bottles and vials. It is applied in the healthcare industry to ensure the cleanliness and safety of rubber stoppers, particularly for injectable drug containers, by quantifying particulate contamination that could compromise sterility or patient safety. The test is relevant for quality control in pharmaceutical packaging manufacturing and regulatory compliance.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.