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首页> 外文期刊>Controlled Environments Magazine >CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM: 2020 Pharma
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CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM: 2020 Pharma

机译：清洁室内外的污染控制：2020年制药

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A conversation with industry experts on the future of cleaning and validation. What will the pharmaceutical industry look like in 2020? Paul Pluta, Associate Professor of Biopharmaceutics, College of Pharmacy at University of Illinois, Chicago and Editor in Chief of the Journal of Validation Technology and the Journal of GXP Compliance, sees a need for immediate change. "You ask where we should be in six years. I'd prefer to consider what we have to do to get to where we ought to be today. For example, when people don't determine their worst case compound or identify the actual residue on the equipment, when people use illogical cleaning agents, when people fill a tank half full of water and a 'scoop' of cleaning agent without controlling concentration, when people say something like: 'I had our people clean the equipment three times today so we'll pass validation'--we have a long way to go. Organizations need to develop a cultural change regarding cleaning. The cleaning process must be respected as a manufacturing process--and not just doing whatever is necessary to get the job done."
机译：与行业专家就清洁和验证的未来进行对话。 2020年制药行业将是什么样？芝加哥伊利诺伊大学药学院生物制药学副教授，验证技术杂志和GXP合规性杂志主编Paul Pluta认为有必要立即进行更改。 “您问六年后我们应该在哪里。我宁愿考虑要达到今天的状态我们必须做些什么。例如，当人们无法确定最坏情况的化合物或确定实际残留物时在设备上，当人们使用不合逻辑的清洁剂时，当人们在装满一半水的水箱中加一勺“清洁剂”而不控制浓度时，人们会说：“我今天让我们的人对设备进行了三次清洁，我们将通过验证”-我们还有很长的路要走。组织需要发展有关清洁的文化变革。清洁过程必须被视为制造过程，而不仅仅是做任何必要的事情来完成工作。”

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