YY/T 1479-2016 in English

VALID

Sterility test method for membrane filters

Issued on:2016-07-29
Implemented on:2017-06-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	YY/T 1479-2016
Document status:	VALID
Title in English:	Sterility test method for membrane filters
Title in Chinese:	薄膜过滤器的无菌试验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-07-29
Implemented on:	2017-06-01
ICS Classification:	11.080.99-Other standards related to sterilization and disinfection
Chinese Classification:	C47-Public medical equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	sterility test method membrane filters introductionthis standard membrane filtration equipment sterility tests sterility testing
Related Topics:	membrane filtration Sterilization membrane membrane standard test bacteria Thin film oxidation test Standard Test Method for Determining the Bacteriostatic Capacity of Membrane Filters for Liquid Filtration membrane filter Sterile three-stage filtration membrane filter Thin film experiment membrane filter membrane filter Sterilizing membrane filtration Membrane film process filter sterilizer Dural filter Membrane sterilization How to use bacterial filter filter bacteria Fully enclosed sterile filter Membrane process Bacterial filter, membrane filtration series Box filter sterile membrane filter Sterile filter leak detection Filters for bacteria collectors Sterility test Sterile filter cup Bacterial filter 8 Sterile Filtration Filter Secondary filtration of sterile products Membrane filter analysis Filter cup c8 membrane filtration Film Tensile Test Method Membrane filter disc Sterility test filter membrane filter membrane Bacteria collector filter Bacteria collector filter Membrane m0.45 Sterile filter membrane Semi-hermetic membrane filter membrane filter Thin film collection membrane filter Aqueous Filtration Membrane Membrane Filter Cup filtration operation sterile Membrane filter sterilization Membrane filter New Sterilizing Filter sterile filter sterile Bacteria filter Bacteria filter Membrane Sterilization bacterial filter non-sterile filter USP Sterility Analytical Method Validation Sterilizing filter location filter mycelium bacteria reduction filtration in English membrane chromatography filtration Filter Membrane Encyclopedia How to use Array 3 filter Research on sterile experimental methods Microfiltration membrane sterilizing filtration system technology Sterility testing process international Sterility testing method for sterile cotton swabs Sterile water preparation methods and processes Phage Filtration Test Method Thin film filter testing standards Medical filtration membrane industry filter pancreas method Membrane filtration sterilization method Medical sterile filtration Microbial membrane filtration methodology Aseptic method verification in positive room Determination method of sterility degree of clean room Sterilization methods for plate filters Microfiltration membrane sterilizing filtration technology Sterile filter acceptance Sterile filter incubator Thin film filter universal How to filter soil bacteria using membrane filters How to preserve bacterial strains using filter paper Sterile weighing method Colloidal filtration method Medical bacterial filter industry Sterilizing filter leaves the factory Carbon filter membrane Stainless steel sterile filter test method

本标准规定了在医疗产品生产、检验或其他处理过程中使用的以及作为最终产品的无菌薄膜过滤器的无菌试验方法。本标准适用于验证无菌检查所用的薄膜过滤器为无菌的试验。

Introduction

This standard provides a method for conducting sterility tests using membrane filtration equipment. It outlines the procedures, materials, and conditions necessary to ensure the accuracy and reliability of sterility testing in pharmaceutical and related industries. The standard specifies the requirements for equipment setup, sample preparation, filtration processes, and post-filtration examination. It also includes guidelines for the interpretation of test results and the documentation of the testing process. The content is structured to support consistent and reproducible testing practices across different laboratories and facilities. The standard covers the essential aspects of sterility testing, ensuring that the methods used are scientifically valid and meet the necessary quality requirements.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: GB 18306-2015 JC/T 2453-2018 GB 50021-2001(2009)

Sample only — not a preview of YY/T 1479-2016