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the environmental qualification of new production areas on a former site",{"rendered":431,"protected":432},"\u003Ch2 class=\"wp-block-heading\" id=\"h-key-challenges-of-our-client\">Key challenges of our client\u003C\u002Fh2>\n\n\n\u003Cp>Our client is a Belgian supplier of buffer solutions for biosciences. They have old and new production areas. The old production areas were experiencing difficulties in managing their environment.\u003C\u002Fp>\n\n\n\n\u003Cp>They therefore wanted to:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>control and ensure the \u003Cstrong>compliance \u003C\u002Fstrong>of the environments to qualify the zones previously faulty during the initial qualifications;\u003C\u002Fli>\n\n\n\n\u003Cli>follow a zone construction \u003Cstrong>process\u003C\u002Fstrong>: from the production of the plans to the commissioning of the zone\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>Our approach consisted in:\u003C\u002Fp>\n\n\n\n\u003Col class=\"wp-block-list\">\n\u003Cli>the drafting of a \u003Cstrong>qualification protocol\u003C\u002Fstrong> for a new zone and an old zone\u003C\u002Fli>\n\n\n\n\u003Cli>the drafting of a \u003Cstrong>procedure \u003C\u002Fstrong>based on the good practices of environmental sampling\u003C\u002Fli>\n\u003C\u002Fol>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"h-how-we-proceeded-on-the-former-site\">How we proceeded on the former site\u003C\u002Fh2>\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Gemba in the production area and brainstorming with the production teams\u003C\u002Fli>\n\n\n\n\u003Cli>Mapping to trace the path of contamination in the area and implementing new procedures\u003C\u002Fli>\n\n\n\n\u003Cli>Weekly monitoring and communication with the teams on environmental trends\u003C\u002Fli>\n\n\n\n\u003Cli>Launching qualifications after the realization of good trends.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"h-our-approach-to-the-new-site\">Our approach to the new site\u003C\u002Fh2>\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Drafting of the risk analysis of the area\u003C\u002Fli>\n\n\n\n\u003Cli>Organization of the cleaning and disinfection of the area\u003C\u002Fli>\n\n\n\n\u003Cli>Environmental qualification at rest and in operation\u003C\u002Fli>\n\n\n\n\u003Cli>Processing of results and writing of reports\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"h-results-at-the-client\">Results at the client\u003C\u002Fh2>\n\n\n\u003Cp>The client moves from intensive monitoring of unclassified areas to routine monitoring which halves the frequency of environmental monitoring.\u003Cbr>As a result, there are fewer environmental samples to be taken per month, less analysis, and therefore less cost.\u003C\u002Fp>\n\n\n\n\u003Cp>Therefore, the customer can use the new production areas once the initial qualification of a new area is validated.\u003C\u002Fp>\n",false,{"rendered":434,"protected":432},"\u003Cp>CBTW addresses the challenge of qualifying new production areas within existing sites for buffer solution 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