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This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism.

While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction filtration, this test is also to be used by the filter manufacturers to validate a mycoplasma-retentive filter within a manufacturing process and to qualify a filter for a mycoplasma retentive claim.

\r\n

This method may also be used to evaluate mycoplasma retention of any filter intended for that use to determine the degree of removal that filter provides. The test gives mycoplasma retention a standard unit of measure so that different filters can be compared under the same conditions.

\r\n

It is important to note that validation of a drug manufacturing process employing such a filter must be done under applicable process-specific conditions.

Available to download
\r\nFormat: PDF (1 file 793 KB)

Click here to view the digital downloading instruction and Terms of Usage

\n"},{"sequence":"2","tabName":"Table of Contents","text":"

Table of Contents:

Introduction

  • Scope\r\n
  • Normative References\r\n
  • Terms and Definitions\r\n
  • Acronyms and Abbreviations\r\n
  • Mycoplasma Filtration\r\n
  • Summary of mycoplasma challenge testing\r\n
  • Test validity criteria\r\n
  • Summary of test parameters\r\n
  • Method\r\n
  • Material and equipment\r\n
  • Preparation of media and buffer\r\n
  • Preparation of challenge microorganism\r\n
  • Preparation of the challenge suspension\r\n
  • Challenge test apparatus\r\n
  • Reporting results\r\n
  • Test acceptance criteria\r\n
  • Bibliography
\n"}],"shortDescription":"This new standard describes a filter challenge test for standardizing test \r\nparameters across laboratories using 47 mm discs and using A. laidlawii as the \r\ntest organism.
While this standard is primarily to educate users and filter \r\nmanufacturers about best practices for mycoplasma reduction filtration, this \r\ntest is also to be used by the filter manufacturers to validate a \r\nmycoplasma-retentive filter within a manufacturing process and to qualify a \r\nfilter for a mycoplasma retentive claim.\n","freeTechReport":"false","subProducts":[{"productId":"6188","name":"PDA Standard 05-2021","displayName":"PDA Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction (single user digital version)","imageUrl":"https://store.pda.org/ProductImages/60002_cover.jpg.ashx?width=150&height=225&bgcolor=white","prices":[{"price":"180.0000","name":"Government","memberTypeID":"6"},{"price":"180.0000","name":"Member","memberTypeID":"2"},{"price":"325.0000","name":"Non-Member","memberTypeID":"1"}],"by":null,"editedBy":null,"datePublished":"Jul 2021","isbn":null,"productCode":"60002","format":"PDF Single user","inStock":"true","formatType":"Digital","numOfPages":"22","tabs":[{"sequence":"1","tabName":"Description","text":"

This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism.

While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction filtration, this test is also to be used by the filter manufacturers to validate a mycoplasma-retentive filter within a manufacturing process and to qualify a filter for a mycoplasma retentive claim.

\r\n

This method may also be used to evaluate mycoplasma retention of any filter intended for that use to determine the degree of removal that filter provides. The test gives mycoplasma retention a standard unit of measure so that different filters can be compared under the same conditions.

\r\n

It is important to note that validation of a drug manufacturing process employing such a filter must be done under applicable process-specific conditions.

Available to download
\r\nFormat: PDF (1 file 793 KB)

Click here to view the digital downloading instruction and Terms of Usage

\n"},{"sequence":"2","tabName":"Table of Contents","text":"

Table of Contents:

Introduction

  • Scope\r\n
  • Normative References\r\n
  • Terms and Definitions\r\n
  • Acronyms and Abbreviations\r\n
  • Mycoplasma Filtration\r\n
  • Summary of mycoplasma challenge testing\r\n
  • Test validity criteria\r\n
  • Summary of test parameters\r\n
  • Method\r\n
  • Material and equipment\r\n
  • Preparation of media and buffer\r\n
  • Preparation of challenge microorganism\r\n
  • Preparation of the challenge suspension\r\n
  • Challenge test apparatus\r\n
  • Reporting results\r\n
  • Test acceptance criteria\r\n
  • Bibliography
\n"}],"shortDescription":"This new standard describes a filter challenge test for standardizing test \r\nparameters across laboratories using 47 mm discs and using A. laidlawii as the \r\ntest organism.
While this standard is primarily to educate users and filter \r\nmanufacturers about best practices for mycoplasma reduction filtration, this \r\ntest is also to be used by the filter manufacturers to validate a \r\nmycoplasma-retentive filter within a manufacturing process and to qualify a \r\nfilter for a mycoplasma retentive claim.\n","freeTechReport":"false","yourPrice":"325.0000"}],"yourPrice":null,"lowestPrice":"325.0000","lowestPriceFormat":"PDF Single user"}">
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PDA Standard 05-2021:支原体减少过滤器评级的共识方法(单用户数字版本)

PDF单用户
州长价格:180.00美元 会员价格:180.00美元 非会员价格:325.00美元
  • 描述
  • 表的内容

这个新标准描述了一个过滤器挑战测试标准化测试参数的实验室使用47毫米光盘和使用答:laidlawii作为测试生物体。

虽然本标准主要是教育用户和过滤器制造商关于支原体减少过滤的最佳实践,但该测试也用于过滤器制造商在生产过程中验证支原体保留过滤器,并使过滤器符合支原体保留要求。

该方法也可用于评估任何过滤器的支原体保留,以确定该过滤器提供的去除程度。该测试给支原体保留一个标准的测量单位,以便不同的过滤器可以在相同的条件下进行比较。

需要注意的是,使用这种过滤器的药品生产工艺的验证必须在适用的工艺特定条件下进行。

可以下载
格式:PDF(1档案793 KB)

点击这里查看数字下载指令的用法

表的内容:

介绍

  • 范围
  • 引用标准
  • 术语和定义
  • 首字母缩写词和缩写词
  • 支原体过滤
  • 支原体激发试验总结
  • 测试效度标准
  • 试验参数总结
  • 方法
  • 材料和设备
  • 介质和缓冲液的制备
  • 挑战微生物的制备
  • 准备挑战暂停
  • 挑战试验装置
  • 报告结果
  • 测试验收标准
  • 参考书目
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