口服液瓶清洗干燥后清洗效果确认

xuhuijie152993

口服溶液瓶超声波清洗后干燥，对于瓶子的清洁效果如何确认？除了检测微生物，还有什么好的方法呢？

hhp

灌水轧盖，人工目测灯检可见异物。

xqliu

可见异物

chenjh1911

对比法，见瓶内装纯化水无可见异物！

beiwei5du

不太清楚，提供点信息仅供参考：选自：http://abstracts.aaps.org/Verify/AAPS2016/PosterSubmissions/35T0930.pdf



Development of Bottle Washing Process Validation Methodology in Pharmaceutical Industry
R. Bajracharya, S. Neupane Kathmandu University
Purpose
The objective of this bottle washing process validation is to gather documented evidences of the Bottle Washing Process employed to rinse the empty bottles, be capable of removing traces of dirt(s), if present, from the product contact surfaces of the bottles before the filling and sealing operation.
Methods
The underlying principle by which to demonstrate that the Bottle Washing Process results in washed bottles fit for use is Intentional Soiling with known concentration of quantifying material followed by Washing. The bottles were intentionally soiled with known contaminants and subjected to washing process and washed bottles were examined for the soiled residues. The amount of soiled matter remained in the bottle determine the efficacy of washing process. Quantitative analysis was carried out using highly soluble substance as a soiling agent whereas as insoluble matters mixtures were taken as soiling agent for qualitative analysis. The qualitative tests were carried out which include ability to remove particulate matter by intentionally soiling bottle with water insoluble matter. In addition, microbiological testing were carried out to ensure that water used does not contribute in microbial load during rinse process.
Results
The UV-Spectrophotometric method used in quantitative analysis were validated. The washing process using Gripmatic-24 Head machine capable of removing soiled matter by several folds.Both qualitative and quantitative tests resulted that bottle washing process is effective.In qualitative analysis it was found that insoluble matters were completely washed out. In quantitative analysis, soiled matter was found in the range of 0 to 0.001%. The water used in the plant where experiment carried out doesn't contribute in inducing microbial load.
Conclusion
Validation is the act of demonstrating and documenting to ensure that the process operates effectively.Many companies use automated rinse machine and they rinse the bottles prior to use for oral preparations. Although rinsed the bottles, the process of washing bottle are not validated. The present study provides general idea regarding validation of bottle washing process. The Soiling techniques used in this validation process was found to be effective.

查询资料有看到使用很多种方法的：，
比如Particulate Evaluation Test （polystyrene latex bead aqueous standard solution，活性炭，Duke Particle standard ），Riboflavin Challenge Test，Sulfur Treatment Test, chloride content test(sodium chloride solution)
选自：https://sp-penntech.com/uploads/ ... s-After-Washing.pdf
http://www.gerpac.eu/validation-of-a-rotary-vial-washer-for-terminally-sterilized-product-manufacture-924
https://www.pharmaguideline.com/2015/11/qualification-procedure-for-vial-washing-machine.html

梅苏特厄齐尔

口服液有没有遇到难溶性物质

LCH1

加油啊，哈哈哈哈哈