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1、 IBWAAPPROVED: K. KISEEFFECTIVE: 4/15/00REVISION: 1Technical GuidanceVALIDATION PROCEDURES效果验证程序STANDARD TESTING PROCEDURE FOR BOTTLE WASHER VALIDATION洗桶机效果验证标准测试程序DOC: 0001.000Draft草案I. PURPOSE目的To validate the Cleaning & Sanitizing capability in returnable container Bottle Washers.验证洗桶机对回收使用容器的清洁和
2、消毒能力。II. DISCUSSION 讨论Standard statistical analysis or pass-fail systems that are used to validate other systems are difficult to apply in assuring the bottle washers will always provide the desired performance because of the broad variability of incoming contaminants and the fact we cannot control
3、this process. This procedure is made more complicated by the fact that we may need to test this piece of equipment through several integrated operating parameters; cleaning and sanitizing 由于我们无法控制回收桶受到的各种各样的污染，标准的统计分析或通过性检验难以保证洗桶机始终能达到期望的清洗效果。我们需要通过经过整合的几个清洁或消毒操作参数来测试这个设备，因此该程序较为复杂。The cleaning sect
4、ion of this validation procedure has undergone a calibration against a washing systems effectiveness of cleaning stubborn residues such as light algae and other soils very difficult to visibly inspect out of the returning bottle float and that also displays the potential to re-grow in the finished p
5、roduct or cause other undesirable quality issues with our customers. This sections acceptance criteria is based on successful removal of these issues. 验证程序的清洗部分，是校验清洗系统去除黏附在回收桶内顽固残余物（例如藻类和泥土）的效果，这些残余物很难通过目测的方法检查出来，它们可能在成品中会重新生长起来或造成其它消费者无法接受的质量问题。这部分的可接受标准是基于有效地去除这些异物。The sanitizing section of this
6、validation procedure has undergone calibration against the systems ability to sanitize and reduce a microbiological population in the bottle resulting from either incoming organisms in the bottle or are added to the bottle from the cleaning section of the washer. The washer design and acceptability
7、criteria should be based on Log Reduction Levels specified by USEPA as well as contact time/chemical concentration requirements specified by USFDA and US State Regulations or as scientifically determined to meet equivalency standards. Additionally, the acceptance criteria should be calibrated agains
8、t sanitizer resistant organisms isolated from returnable bottle float assure that bottles will not negatively impact bottler finished product water quality standards when produced in a non-ozonated environment. This is important to establish due to the lack of control we have in managing ozone resid
9、ual contact time in the bottle and as such, if we depend on ozone in the bottle to sanitize the bottle, we will never successfully manage or consistently maintain industry standards.本验证程序的消毒部分，是校验系统的消毒或减少桶中的有机体或洗桶机冲洗时带入的微生物污染的能力。洗桶机的设计及其可接受标准应基于USEPA（美国环保署）规定的对数减少水平标准，以及达到USEPA和美国国家规范或者其它经科学方法确定等同标准
10、所规定的接触时间、化学品浓度的要求。此外，这个可接受标准应可以通过消毒剂对回收桶中有机体的抑制来校准，以确保不含臭氧的成品水的质量不受负面影响。当我们桶装水中臭氧余量接触时间失去控制时，这对保障产品质量起重要作用；也就是说，如果我们只依靠水中的臭氧来消毒桶的话，永远不能有效地管理或持续地维护行业标准。III. SCOPE 适用范围This procedure applies to the proper operation of bottle washers. This validation effort provides a measure of its performance at the
11、time of the test. Continued acceptable performance depends on regular maintenance, proper setup, continuous adherence to the washer equipments validated operating parameters and like-for-like replacement substitution of key parts, washer chemicals and sanitizer chemicals. 本程序适用于洗桶机的正确操作过程，这个验证方法提供了一
12、个洗桶机性能测试方法。持续可靠的性能表现依赖于定期保养、正确设置、持续不断的校准洗桶设备的操作参数，以及一一对应地更换或替代关键零部件及清洗化学品和消毒化学品。This protocol will work for both single in-line washers where one bottles follows one another single file as well as multiple bottle feeds where many bottles enter the washer at the same time. In the case where the bottl
13、e washer is a single in-feed, 16 bottles will be prepared to measure its efficiency. In the case of multiple bottle feeds, two complete rows of bottles will be tested. 本草案适用于单桶或多桶的洗桶机。如果是单桶洗桶机，需要用16个桶来测试它的有效性。如果是多桶洗桶机，则需用两倍“道数“的桶来测试。“STANDARD SOIL” as described by the Society for Soft Drink Technolo
14、gist and used in the returnable bottle washer industry for years in the 1980s is the procedure we will use today. It is a predefined mixture of Red Clay, Durham Water Putty, Xanthum Gum and water. “标准泥土”采用我们一直沿用的，由软饮料技术学会1980年所指定配方配制的，用于回收桶洗桶机行业的标准泥土。它用红黏土、达拉谟水油灰、黄原胶和水混合拌制而成。 It is not intended for
15、all of the soil to be washed off of the bottles during the process. Some measurable soil remains. This measurable amount allows a quantitative procedure to measure cleaning efficiency under a variety of operating procedures and is used to identify unacceptable spray patterns. The formula and methods
16、 of mixing and applying the Standard Soil Procedure Doc 0001.001 issued 10/31/95. Although there may be some differences in the drying time of soil in the bottles due to local weather or if the bottles are stored on the sides or upright, the procedure requires a standardized minimum drying time of 72 hours but not before soil is firmly attached to bottle walls. 72 hours after the bottles have
