{"id":9219,"date":"2022-02-14T18:41:00","date_gmt":"2022-02-14T18:41:00","guid":{"rendered":"https:\/\/cando.golighthouse.com\/en\/?post_type=knowledge-center&#038;p=9219"},"modified":"2022-11-11T18:53:54","modified_gmt":"2022-11-11T18:53:54","slug":"gmps-for-ultrapure-water-in-pharmaceutical-cleanrooms-570","status":"publish","type":"knowledge-center","link":"https:\/\/cando.golighthouse.com\/en\/blog\/gmps-for-ultrapure-water-in-pharmaceutical-cleanrooms-570\/","title":{"rendered":"GMPs For Ultrapure Water In Pharmaceutical Cleanrooms"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9219\" class=\"elementor elementor-9219\" data-elementor-post-type=\"knowledge-center\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-51b669f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"51b669f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-18ab0fc\" data-id=\"18ab0fc\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8e4d372 elementor-widget elementor-widget-text-editor\" data-id=\"8e4d372\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Water is an essential part of everyday life, and certain cleanrooms are no different &#8211; especially in pharmaceuticals. But water is unique apart from other products and process ingredients because ultrapure water is not subject to testing or batch-lot release before use and is drawn from on-demand systems. Additionally, results from water testing are not always available immediately because it requires time for microbiological tests to be performed.<\/p><p>Thus, it is critical that\u00a0<a href=\"https:\/\/cando.golighthouse.com\/en\/blog\/what-is-an-ultrapure-water-system-488\">ultrapure water<\/a>\u00a0is stored and produced correctly.<\/p><p>The World Health Organization (WHO) felt the same way. In 2017, the WHO Expert Committee on Specifications for Pharmaceuticals Preparations (ECSPP) issued a recommendation that the WHO Secretariat gather feedback on if they should update good manufacturing practices (GMPs) on water for injections (WFI). In early 2019, the WHO Secretariat issued a draft guidance that allowed for the production of WFI by different processes than distillation.<\/p><p>Now, we operate under these new guidelines for ultrapure water production and storage. And if you\u2019re using ultrapure water in your pharmaceutical cleanrooms, it is vital you understand these GMPs.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3cbaa3a elementor-widget elementor-widget-image\" data-id=\"3cbaa3a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage2.png\" class=\"attachment-large size-large wp-image-9223\" alt=\"pharmacopoeial\" srcset=\"https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage2.png 975w, https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage2-300x199.png 300w, https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage2-768x509.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60cafa4 elementor-widget elementor-widget-text-editor\" data-id=\"60cafa4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><strong>Pharmacopoeial Specification<\/strong><\/h2><p>A pharmacopoeial is a text that describes drugs, chemicals, and other medicinal preparations. The Food and Drug Administration (FDA) has published the\u00a0<a href=\"https:\/\/www.usp.org\/\">United States Pharmacopeia (USP)<\/a>\u00a0that outlines GMPs and standards for production in the US.<\/p><p>It includes specifications for two forms of water: bulk and dosage. Make sure to choose the appropriate specification for your required marketing authorization to the medicine\u2019s regulatory authority.<\/p><p>\u00a0<\/p><h2><strong><a name=\"_z2ld18eofjnh\"><\/a>Bulk Purified Water<\/strong><\/h2><p>Bulk Purified Water (BWP) needs to meet the pharmacopoeial specifications for purity, both chemical and microbiological. So how do you prepare BPW?<\/p><p><strong>BPW is made from &#8211; at the minimum quality &#8211; drinking water.<\/strong><\/p><p>BPW can also be produced by any qualified purification\u00a0<a href=\"https:\/\/cando.golighthouse.com\/en\/blog\/6-water-purification-methods-for-cleanrooms-569\">process or techniques<\/a>. These include combinations of ion exchange, RO, RO, and electro-deionization (EDI), ultrafiltration, and vapor compression.<\/p><p>When configuring your water purification system or defining your user requirements, consider:<\/p><ul><li>The feedwater\u2019s quality and its change through seasons.<\/li><li>How much water is needed?<\/li><li>The necessary specifications of water quality.<\/li><li>The stages required for the sequence of purification.<\/li><li>The needed energy consumption of your system.<\/li><li>Strategically placed sampling points that avoid contamination.<\/li><li>Your process and documentation of flow, pressure, temperature, conductivity, pH, and total organic carbon.<\/li><\/ul><p>When designing your system, remember certain ambient-temperature systems, such as RO, ion exchange, and ultrafiltration, are extra susceptible to contamination. This is especially true when there is less demand for water. To prevent this microbiological contamination, define sanitization to be conducted at regular intervals. These methods should be validated for each stage of purification. In your documentation of sanitization, you must be able to prove the removal of the agents.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d670476 elementor-widget elementor-widget-image\" data-id=\"d670476\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage3.png\" class=\"attachment-large size-large wp-image-9227\" alt=\"pure water sampling\" srcset=\"https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage3.png 975w, https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage3-300x200.png 300w, https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/water-storage3-768x512.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59bd2f6 elementor-widget elementor-widget-text-editor\" data-id=\"59bd2f6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Additionally, consider the following controls:<\/p><div>\u00a0<\/div><ul><li>The water flow should be maintained at all times to prevent stagnation.<\/li><li>The temperature should be constantly controlled by heat exchangers or a plant room cooling to reduce microbial growth. The guidance value for this is &lt; 25 328 \u00b0C.<\/li><li>The use of ultraviolet disinfection at strategic locations.<\/li><li>The thermal and\/or chemical sanitization of the water-treatment system components periodically.<\/li><\/ul><p>\u00a0<\/p><p>At all times, BPW must be protected from microbial contamination and recontamination. To prevent this, proper alert limits should be in place.<\/p><p>\u00a0<\/p><h2><strong><a name=\"_aed21gr71mt8\"><\/a>Bulk Water For Injections<\/strong><\/h2><p>Bulk Water For Injections (BWFI) is the highest quality of water, although it is NOT sterile and it is NOT in the final dosage form. It should meet all the relevant specifications and requirements for microbiological and chemical purity.<\/p><p>\u00a0<\/p><p>BWFI is a suitable bulk ingredient to be used during formulation. You should use a robust technique for production and consider the following when designing your system:<\/p><ul><li>Feedwater quality. Typically, this is drinking water with additional treatment.<\/li><li>Water quality specifications are required.<\/li><li>Water quantity needed.<\/li><li>The appropriate URS, qualification, and validation for your components.<\/li><li>Generator size or variables controls to prevent broken-up cycling.<\/li><li>Dump and blow-down functions.<\/li><li>Cool-down venting in an attempt to avoid contamination.<\/li><\/ul><p>\u00a0<\/p><p>This form of water can be prepared by distillation as the final purification step, but other techniques such as deionization, electro deionization, nanofiltration, ultrafiltration, water softening, descaling, pre-filtration and degasification, ultraviolet 381 treatment, and other techniques, can be used in connection with either a single or double pass RO system.<\/p><p>As always, ensure to set the appropriate limits to avoid contamination, which BFWI should always be protected from.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5179d48 elementor-widget elementor-widget-image\" data-id=\"5179d48\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"530\" src=\"https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/pure_water.png\" class=\"attachment-large size-large wp-image-9232\" alt=\"\" srcset=\"https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/pure_water.png 975w, https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/pure_water-300x199.png 300w, https:\/\/cando.golighthouse.com\/en\/wp-content\/uploads\/2022\/11\/pure_water-768x509.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a314cf5 elementor-widget elementor-widget-text-editor\" data-id=\"a314cf5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Additionally, consider the following controls:<\/p><ul><li>The water flow should be maintained at all times to prevent stagnation.<\/li><li>The temperature should be constantly controlled by heat exchangers or a plant room cooling to reduce microbial growth. The guidance value for this is &lt; 25 328 \u00b0C.<\/li><li>The use of ultraviolet disinfection at strategic locations.<\/li><li>The thermal and\/or chemical sanitization of the water-treatment system components periodically.<\/li><\/ul><p>At all times, BPW must be protected from microbial contamination and recontamination. To prevent this, proper alert limits should be in place.<\/p><h2><strong><a name=\"_aed21gr71mt8\"><\/a>Bulk Water For Injections<\/strong><\/h2><p>Bulk Water For Injections (BWFI) is the highest quality of water, although it is NOT sterile and it is NOT in the final dosage form. It should meet all the relevant specifications and requirements for microbiological and chemical purity.<\/p><p>BWFI is a suitable bulk ingredient to be used during formulation. You should use a robust technique for production and consider the following when designing your system:<\/p><ul><li>Feedwater quality. Typically, this is drinking water with additional treatment.<\/li><li>Water quality specifications are required.<\/li><li>Water quantity needed.<\/li><li>The appropriate URS, qualification, and validation for your components.<\/li><li>Generator size or variables controls to prevent broken-up cycling.<\/li><li>Dump and blow-down functions.<\/li><li>Cool-down venting in an attempt to avoid contamination.<\/li><\/ul><p>This form of water can be prepared by distillation as the final purification step, but other techniques such as deionization, electro deionization, nanofiltration, ultrafiltration, water softening, descaling, pre-filtration and degasification, ultraviolet 381 treatment, and other techniques, can be used in connection with either a single or double pass RO system.<\/p><p>As always, ensure to set the appropriate limits to avoid contamination, which BFWI should always be protected from.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":9220,"template":"","kc_format":[63],"kc_topics":[67,70],"class_list":["post-9219","knowledge-center","type-knowledge-center","status-publish","has-post-thumbnail","hentry","kc_format-blog","kc_topics-best-practices","kc_topics-industry-knowledge"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.5 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GMPs For Ultrapure Water In Pharmaceutical Cleanrooms - Lighthouse Worldwide Solutions<\/title>\n<meta name=\"description\" content=\"Water is an essential part of everyday life, and certain cleanrooms are no different - especially in pharmaceuticals. 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