{"id":3921,"date":"2025-07-24T10:49:39","date_gmt":"2025-07-24T08:49:39","guid":{"rendered":"https:\/\/torsaglobal.com\/caso-estudio\/environmental-control-in-cleanrooms-and-cold-storage-how-alcura-ensures-gxp-compliance-with-the-borea-system\/"},"modified":"2025-07-24T11:49:51","modified_gmt":"2025-07-24T09:49:51","slug":"environmental-control-in-cleanrooms-and-cold-storage-how-alcura-ensures-gxp-compliance-with-the-borea-system","status":"publish","type":"casos-de-exito","link":"https:\/\/torsaglobal.com\/en\/case-study\/environmental-control-in-cleanrooms-and-cold-storage-how-alcura-ensures-gxp-compliance-with-the-borea-system\/","title":{"rendered":"Environmental control in cleanrooms and cold storage: how Alcura ensures GxP compliance with the Borea system"},"content":{"rendered":"\n

Alcura,<\/strong><\/a> a company belonging to Cencora,<\/strong><\/a> is a leading provider of specialised management for clinical trial medications in controlled environments.
From its facilities in Viladecans, it delivers essential services such as the storage and distribution of clinical trial drugs<\/strong> and the re-labelling of pharmaceutical products in cleanrooms<\/strong>, operating under strict regulations that require full batch traceability and continuous environmental condition control.<\/p>\n\n

In this context, ensuring that temperature, humidity, and pressure<\/strong> remain within validated ranges is not just a matter of quality\u2014it’s a regulatory requirement.
To achieve this, Alcura<\/strong> relies on the Borea<\/strong> real-time monitoring system<\/strong>, developed by Torsa,<\/strong> as a comprehensive solution for environmental supervision across all its critical areas.<\/p>\n\n

<\/div>\n\n

Environmental monitoring in cleanrooms: traceability and continuous control<\/h2>\n\n

A key part of Alcura\u2019s operations takes place in classified cleanrooms<\/strong>, where clinical trial medications are re-labelled. In these areas, maintaining constant conditions of temperature, relative humidity, and differential pressure<\/strong> is essential to prevent cross-contamination and ensure product stability.<\/p>\n\n

With the Borea<\/strong> system, Alcura<\/strong> has implemented a continuous environmental monitoring<\/strong> model that enables:<\/p>\n\n

    \n
  • Real-time monitoring of all environmental parameters from any device.<\/li>\n\n\n\n
  • Immediate alerts in case of any deviation.<\/li>\n\n\n\n
  • Access to historical data with full traceability and automatic records in compliance with GMP<\/strong> (Good Manufacturing Practices)<\/em> requirements.<\/li>\n\n\n\n
  • Generation of auditable reports in seconds, ready for inspections or regulatory audits.<\/li>\n<\/ul>\n\n

    This solution eliminates manual processes, reduces the risk of human error, and enables the quality team to make decisions based on reliable, real-time information.<\/p>\n\n

    <\/div>\n\n

    Monitoring of temperature and humidity in cold rooms and ultra-low freezers<\/h2>\n\n

    Alcura<\/strong> manages various storage environments designed to maintain the stability of highly sensitive products.
    From refrigerated chambers operating between 2 and 8\u202f\u00b0C<\/strong>, to freezing areas at \u201320\u202f\u00b0C and \u201380\u202f\u00b0C<\/strong>, and cryogenic tanks at \u2013196\u202f\u00b0C<\/strong>\u2014each environment requires precise control to preserve the integrity of the medication.
    The Borea<\/strong> system enables reliable monitoring across all these temperature ranges, adapting to the specific requirements of each area without compromising traceability or accuracy.<\/p>\n\n

    In all these environments, thermal stability is critical to preserving the efficacy of the medications<\/strong>\u2014many of which are biological and cannot tolerate sudden temperature fluctuations.
    Borea<\/strong> provides tailored monitoring for each type of chamber, using high-precision, certified, and calibratable sensors that transmit real-time data to the .torsacloud<\/strong> cloud platform.<\/p>\n\n

    This allows Alcura<\/strong> to:<\/p>\n\n

      \n
    • Comply with Good Distribution Practice<\/strong> (GDP<\/strong>) and Good Manufacturing Practice (GMP) regulations<\/strong>.<\/li>\n\n\n\n
    • Detect any incident without relying on manual rounds or periodic checks.<\/li>\n\n\n\n
    • Automatically document the entire environmental custody chain of the product.<\/li>\n<\/ul>\n\n

      In addition, the system integrates with contingency and safety protocols: even in the event of power or network failures, the devices store data locally and synchronize it once the connection is restored.<\/p>\n\n

      \"Alcura's<\/figure>\n\n
      <\/div>\n\n

      Over 50 control points and a single centralized management panel<\/h2>\n\n

      One of the main challenges in this type of facility is the volume and complexity of the control points. Alcura has deployed more than 50 Borea monitoring devices<\/strong>, all connected to a single digital platform. From there, the quality team can:<\/p>\n\n

        \n
      • View the status of all monitored areas from a single dashboard.<\/li>\n\n\n\n
      • Filter by zone, parameter, or alarm status.<\/li>\n\n\n\n
      • Download and automate customized reports by period, area, or sensor.<\/li>\n\n\n\n
      • Quickly audit any detected event or deviation.<\/li>\n<\/ul>\n\n

        This centralized and scalable<\/strong> approach allows Alcura to optimize resources, reduce validation times, and improve its responsiveness to incidents\u2014ultimately ensuring patient safety.<\/p>\n\n

        <\/div>\n\n

        GxP compliance ensured with a validatable and calibratable system<\/h2>\n\n

        The entire system has been designed in accordance with ALCOA+<\/strong> principles and Annex 11 of the GMP<\/strong>. Borea<\/strong> complies with GxP<\/strong> requirements and can be validated under the current regulatory framework, following the guidelines set out in GAMP 5.0, 2nd Edition<\/strong>.<\/p>\n\n

        All installed sensors are included in a periodic calibration plan, and the system records every adjustment or technical intervention with full traceability. This facilitates validation in regulated environments and ensures compliance without disrupting the normal operation of the facilities.<\/p>\n\n

        For Alcura<\/strong>, this represents a tangible competitive advantage: not only can they demonstrate environmental control of their processes, but they can also do so with immediate documentary evidence<\/strong>\u2014reducing administrative burden and minimizing the risk of non-compliance.<\/p>\n\n

        <\/div>\n\n
        \n

        Testimonial \u2013 Anna Par\u00e9s, GDP Responsible at Alcura:<\/strong><\/p>\n\n\n\n

        \u201cThe solution provided by TORSA fits perfectly with the complexities of Alcura\u2019s operations. Our work involves equipment that requires very diverse temperature ranges, as well as different measurement needs, including temperature, humidity, and pressure. In addition, we face high demands in meeting the quality standards of our products.\u201d<\/p>\n\n\n\n

        \u201cThanks to the real-time monitoring of these factors provided by the Borea system, we have accurate and up-to-date information on what is happening in our facilities and equipment. We greatly value TORSA\u2019s efforts to align with our specific needs and requirements. Communication has been highly effective, and we are fully satisfied with the speed and thoroughness of their responses to any issue. This has enabled us to receive effective solutions to our demands. We also appreciate their ongoing commitment to improving the platform through regular updates.\u201d<\/p>\n\n\n\n

        <\/div>\n<\/blockquote>\n\n

        Reliable technology for seamless pharmaceutical logistics<\/h2>\n\n

        The implementation of the Borea<\/strong> system has enabled Alcura<\/strong> to consolidate a safe, efficient, and fully traceable pharmaceutical logistics<\/strong> model\u2014aligned with the demands of its operations and the expectations of the sector.<\/p>\n\n

        Today, the company operates with the confidence that every medication stored, handled, or distributed maintains its required storage conditions at all times, and that any deviation will be immediately detected, recorded, and corrected. \n \n \n \n \n \n \n \n \n<\/p>\n\n

        A reliable technology, developed through experience, that becomes part of the daily routine of a team committed to what truly matters: ensuring every treatment reaches the patient in optimal conditions and with full guarantees.
        If your organisation also needs to ensure environmental control in critical areas and comply with GxP<\/strong> standards, the Borea<\/strong> system can help.<\/p>\n\n

        <\/div>\n\n

        “The information contained in this press release reflects Alcura\u2019s experience with the Borea system within the scope of its current operations. Compliance with GxP and GDP regulations is based on internal validation processes and available technical documentation. For more information, please contact Alcura\u2019s Quality or Regulatory Compliance department”.<\/p>\n\n

        <\/p>\n","protected":false},"excerpt":{"rendered":"

        Alcura ensures GxP compliance in cleanrooms and cold storage facilities thanks to Torsa\u2019s Borea system. Real-time monitoring of temperature, humidity, and pressure guarantees traceability, instant alerts, and continuous control. A reliable, validatable solution for critical environments in the pharmaceutical sector.<\/p>\n","protected":false},"featured_media":3919,"template":"","categorias-casos-de-exito":[54],"class_list":["post-3921","casos-de-exito","type-casos-de-exito","status-publish","has-post-thumbnail","hentry","categorias-casos-de-exito-health-en"],"yoast_head":"\nEnvironmental control in cleanrooms with Torsa\u2019s Borea system<\/title>\n<meta name=\"description\" content=\"Environmental control in cleanrooms with Borea: Alcura ensures traceability and GxP compliance through real-time monitoring.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/torsaglobal.com\/en\/case-study\/environmental-control-in-cleanrooms-and-cold-storage-how-alcura-ensures-gxp-compliance-with-the-borea-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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