核黄素测试方法

CIP/COP Validation Test Procedure
在线清洁/离线清洁验证测试程序
by Jon R. Voss
September 1999
In the hopes that sharing a test procedure from our library of ValPro™ procedures will get others to do the same, I submit the following procedure for your use. Let us know what you think!
分享我们实验室的ValProTM测试程序，可以帮助更多的人采用相同的方法做同一件事情，
正因如此，我提交如下的程序供大家使用，让我们看看你们是如何思考的。

Coverage Test-CIP/COP覆盖率测试-在线清洁/离线清洁
Objective:
The objective of this test is to verify that the sprayballs/wands/bars associated with the system are capable of delivering cleaning solutions to all exposed product contact surface areas. Often spray ball coverage testing is performed as part of the final vessel factory acceptance test. Coverage testing may be performed on-site using the actual equipment that will be used to clean the vessel.
目的
该测试的目的是为了确认连接在系统上的喷淋球/喷淋管/喷淋隔栅是否有能力将清洁溶液
喷淋到所有与产品直接接触的暴露表面去。

通常来讲，喷淋球覆盖率测试是作为罐体容器最
终的工厂验收测试的一部分。

覆盖率测试也可在现场使用实际用于清洁容器操作的设备来测
试。

Procedure:
Note: Care must be taken when working around cleaning systems. Solutions containing chemicals at high concentrations and temperatures are used in the normal operation of the system. Good practice is to have the system operator available at all times while this testing is being performed.
程序
注意：在清洁系统周围工作的时候应保持小心。

日常清洁系统的时候会使用含有高浓度和高
温度的化学溶液。

应该有良好的规范来保证操作员在测试的全过程中受到安全提醒和指引。

For vessels with sprayballs/wands/bars that have already been tested (for example as part of FAT), audit the test documentation and verify that the following information is available and has been recorded for each sprayball/wand/bar:
对于已经经过测试的自带喷淋球/喷淋管/喷淋隔栅的容器，应审核测试文件中是否含有以下
信息，而且是否记录了每个喷淋球/喷淋管/喷淋隔栅。

Vessel Identification容器识别
1.2 Sprayball/Wand/Bar Identification喷淋球/喷淋管/喷淋隔栅识别
1.3 Date of Test测试日期
1.4 Test Method (Riboflavin, Salt, Other)测试方法（核黄素，盐，其他物质）
1.5 Feed Solution Pressure or Flow Rate进液压力或流速
2.1
2.4 to 启动清洁循环程序，可能的话尽可能使用最小的压力/流速来模拟最差工况。

2.5 At the completion of the cleaning cycle, inspect the vessel product contact surfaces using an ultraviolet light. Look for traces of fluorescence - indications that the spray ball coverage failed to contact the surface in that location.
在清洁循环完成后，使用紫外灯检视容器与产品直接接触面上是否残留有荧光，这是喷淋球覆盖失败的证明，不能将液体喷淋到该接触面。

2.6 Document the locations of any fluorescence observed
记录下观测到有荧光的任何位置。

.
Acceptance Criteria可接受标准:
1. For vessels with sprayballs/wands/bars that have already been tested, the test reports indicate successful sprayball coverage and contain the following information:
Vessel Identification
Sprayball/Wand/Bar Identification
Date of Test, Test Method (Riboflavin, Salt, Other)
Feed solution pressure or flow rate• Results• Conclusion (Pass/Fail)
对于已经经过测试的自带喷淋球/喷淋管/喷淋隔栅的容器，喷淋覆盖成功的测试报告应包含
如下信息：
容器识别信息
喷淋球/喷淋管/喷淋隔栅的识别信息
测试日期，测试方法（核黄素，盐，其他物质）
进液压力或流速，结果，结论（成功/失败）
For vessels with sprayballs/wands/bars that are tested directly as part of this test, there will be 100% coverage as indicated by the observance of no fluorescence
对于自带喷淋球/喷淋管/喷淋隔栅的容器，直接采用本测试方法测试，应该有100%的覆盖
率，没有可以观测到的荧光显示。

Note: If fluorescence is observed and can not be corrected by modification of the spray ball or cleaning cycle, the system will most likely have to have a manual cleaning step performed in order to effectively clean the area that is not covered by the sprayball/wand/bar.
提示：如果可以观测到荧光并且不能通过喷淋球或者清洁程序的修改来进行改正，这个系统
就很有必要通过人工的清洁步骤来清洁哪些喷淋球/喷淋管/喷淋隔栅不能覆盖到的地方。

Acceptance Criteria Met?可接受标准是否满足？
Yes是____ No否____ Initials/Date签名/日期:____ /____
If No, explain in comments如果不满足，请写注释:
Reviewed By复核人:_______________________ Date日期: __________
Page last updated: 6 March 2009。