洗桶机效果验证标准测试程序.docVIP

This document is CONFIDENTIAL and not to be copied. DO NOT DISCLOSE TO THE PUBLIC PAGE PAGE 2 OF15 FILE: IBWA WasherVal.DOC IBWA APPROVED: K. KISE EFFECTIVE: 4/15/00 REVISION: 1 Technical Guidance VALIDATION 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: 0001.000 Draft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 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 section 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 product 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 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 accep