{"id":133843,"date":"2025-09-30T10:29:13","date_gmt":"2025-09-30T08:29:13","guid":{"rendered":"https:\/\/obera.fr\/our-advice\/pharmaceutical-industry-controlling-dust-and-exposure-during-hpapi-weighing-and-transfer\/"},"modified":"2025-12-31T15:06:18","modified_gmt":"2025-12-31T13:06:18","slug":"pharmaceutical-industry-controlling-dust-and-exposure-during-hpapi-weighing-and-transfer","status":"publish","type":"post","link":"https:\/\/obera.fr\/en\/pharmaceutical-industry\/pharmaceutical-industry-controlling-dust-and-exposure-during-hpapi-weighing-and-transfer\/","title":{"rendered":"Pharmaceutical Industry: Controlling Dust and Exposure during HPAPI Weighing and Transfer"},"content":{"rendered":"\n<p>The rise of HPAPI (Highly Potent Active Pharmaceutical Ingredients) is profoundly transforming <strong>pharmaceutical production practices<\/strong>. These molecules (cytotoxic, hormonal, anticancer, antiviral) exhibit high therapeutic activity, but also pose a <a href=\"https:\/\/obera.fr\/en\/our-tips\/substances-cmr-risque-exposition-au-travail-quelle-reglementation-prevention\/\">significant toxicological risk<\/a> to personnel and the environment.<\/p>\n\n<h2 class=\"wp-block-heading\">Challenges and Field Issues<\/h2>\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p>Powder weighing and transfer steps are particularly critical: even small quantities can <strong>generate airborne concentrations<\/strong> exceeding occupational exposure limits (OELs).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Consequences of Inadequate Control:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>operator exposure (respiratory pathologies, systemic effects);<\/li>\n\n\n\n<li>cross-contamination of other products or batches;<\/li>\n\n\n\n<li>quality deviations, leading to batch recalls;<\/li>\n\n\n\n<li>shutdowns or penalties in case of GMP\/EHS non-compliance.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Audits in HPAPI Weighing Workshops Highlight:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>resuspension during unloading, sieving, or transfer;<\/li>\n\n\n\n<li>leaks at seals, hoppers, valves, and containers;<\/li>\n\n\n\n<li>heavy maintenance (filter clogging, surface cleaning) which extends downtime;<\/li>\n\n\n\n<li>containment difficulties during batch changes and manual operations.<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-1024x1024.webp\" alt=\"pharmaceutical industry\" class=\"wp-image-129371\" srcset=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-1024x1024.webp 1024w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-300x300.webp 300w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-150x150.webp 150w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique-768x768.webp 768w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/industrie-pharmaceutique.webp 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n<p>Conventional methods (simple general ventilation or remote capture) are insufficient to <strong>ensure particle levels<\/strong> comply with targeted OELs (&lt; 1 \u03bcg\/m3 or even &lt; 0.1 \u03bcg\/m3 depending on the OEB).<\/p>\n\n<h2 class=\"wp-block-heading\">Limitations of Traditional Practices<\/h2>\n\n<h3 class=\"wp-block-heading\">Some Units Continue to Rely on:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>dilution ventilation (HVAC) without direct capture;<\/li>\n\n\n\n<li>open hoods or simple booths with clogged or poorly positioned filters;<\/li>\n\n\n\n<li>filters not regularly tested, or even of a class lower than H13.<\/li>\n<\/ul>\n\n<p>These solutions do not allow for achieving low OELs, and <strong>expose operators during dynamic phases<\/strong> (drum opening, weighing, transfer).<\/p>\n\n<h2 class=\"wp-block-heading\">The OberA Solution: the ePURBOX BRS (ATEX)<\/h2>\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h3 class=\"wp-block-heading\">Source Capture, Maximum Proximity<\/h3>\n\n\n\n<p>One of the basic principles of <strong>contamination control<\/strong> is to capture dust at its emission source. The fact that the EpurBox BRS can be positioned very close to the weighing point (or hopper) limits resuspension, reduces dispersion in the workshop, and decreases the load on other <strong>ventilation systems<\/strong>. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Flexibility for Multi-Product or Pilot Use<\/h3>\n\n\n\n<p>In sites that use multiple molecules or are in the development\/pilot phase, it can be impractical to <strong>install a fixed system<\/strong> for each weighing point. The EpurBox BRS allows for &#8220;on-demand&#8221; use: it is brought in when the operation is underway, then moved. This limits <strong>fixed investments,<\/strong> increases agility, and reduces risk areas.  <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Ensuring Safety for Manual Operations<\/h3>\n\n\n\n<p>During manual tasks such as drum opening, dosing, or funnel transfer, the EpurBox BRS can be positioned to <strong>capture dust flows<\/strong> emitted during these manipulations, reducing the operator&#8217;s occasional exposure.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-1024x1024.png\" alt=\"epurbox brs visual\" class=\"wp-image-129394\" srcset=\"https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-1024x1024.png 1024w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-300x300.png 300w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-150x150.png 150w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs-768x768.png 768w, https:\/\/obera.fr\/wp-content\/uploads\/2025\/09\/visuel-epurbox-brs.png 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/obera.fr\/en\/produits\/caissons-mobiles-aspiration\/epurbox-atex\/\">View the ePURBOX BRS datasheet<\/a><\/div>\n<\/div>\n\n<h3 class=\"wp-block-heading\">ATEX Compliance in Combustible Dust Environments<\/h3>\n\n<p>ATEX certified, the EpurBox BRS is suitable for classified areas (e.g., Zone 22 for dust). This allows pharmaceutical sites that <strong>handle powders<\/strong> that are potentially combustible (organic excipients, sugars, lactose, etc.) to use it without compromising their safety zoning. <\/p>\n\n<h3 class=\"wp-block-heading\">Ease of Qualification and Operation<\/h3>\n\n<p>Should a filter change be necessary, the casing can be isolated\/depressurized, limiting emissions.<\/p>\n\n<p>The casing allows for <strong>documenting its performance<\/strong> (flow rates, pressures, filtration efficiency) within the framework of IQ\/OQ\/PQ.<\/p>\n\n<p>Differential pressure monitoring, alarms, and planned maintenance ensure controlled operation.<\/p>\n\n<h2 class=\"wp-block-heading\">Implementation Scenario: Typical Use Case<\/h2>\n\n<h3 class=\"wp-block-heading\">Consider a Practical Example:<\/h3>\n\n<ul class=\"wp-block-list\">\n<li>A pharmaceutical site needs to weigh an HPAPI with OEB = 4 (target OEL ~ 1 \u03bcg\/m3) in a pilot lab. <\/li>\n\n\n\n<li>The EpurBox BRS is positioned next to the balance, with an arm or a <strong>suction nozzle directed towards the weighing area<\/strong>. <\/li>\n\n\n\n<li>The machine operates, powders slightly escape during deposition or transfer: the EpurBox extracts locally, returning the filtered air to the workshop or to a dedicated exhaust. <\/li>\n\n\n\n<li>During operation, differential pressure is monitored: if the filter clogs, an alert is triggered for change\/cleaning. <\/li>\n\n\n\n<li>After use, the EpurBox can be moved to another line or stored in standby.<\/li>\n<\/ul>\n\n<p>With this device, the <strong>workshop avoids installing fixed hoods<\/strong> around each workstation and has a high-performance mobile containment tool.<\/p>\n\n<p>To discover our products and together envision THE solution adapted to your spaces, contact our teams. We will assist you in choosing the <strong>most suitable devices<\/strong> for your constraints and objectives. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The increasing prevalence of HPAPI (Highly Potent Active Pharmaceutical Ingredients) is profoundly transforming pharmaceutical production practices.<\/p>\n","protected":false},"author":13,"featured_media":83737,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"none","_seopress_titles_title":"Pharmaceutical Industry: Controlling HPAPI Exposure","_seopress_titles_desc":"HPAPIs are revolutionizing the pharmaceutical industry. Discover the impacts of these potent active ingredients and how to control the major toxicological risk. 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