Autonomous Pathogen Detection for Pharmaceutical
At Kraken Sense, we redefine the landscape of pharmaceutical manufacturing by prioritizing early detection and real-time monitoring of pathogens. Our innovative KRAKEN™ device offers unparalleled capabilities, seamlessly integrating data, enabling swift response, and adhering to Quality by Design (QbD) principles.
As bioprocessing involves cultivating microbes such as E. coli to produce pharmaceutical products, these operations run an inherent risk of contamination. Since the manufacturing environment is designed to be conducive to microbial growth, with favourable temperature, dissolved oxygen, and pH conditions, fermentations are highly susceptible to bacterial contamination.
Often, contamination isn’t detected until after the medium has entered the bioreactor, requiring the whole batch to be discarded and the bioreactor to be disinfected. However, if the source of contamination is not identified and treated immediately, contamination may spread throughout the facility, causing substantial loss of product.
Our autonomous pathogen detection systems can prevent these issues from arising by providing real-time contamination results. The KRAKEN™ can be installed at multiple points in the bioprocessing system to continuously monitor for pathogens and immediately recognize potential sources of contamination. With live updates, the contaminated media can be discarded before it even enters the bioreactor, preserving the integrity of the batch and reducing the possibility of widespread contamination.
Embrace the Future of Pharmaceutical Quality Assurance
The KRAKEN™ represents more than just a device; it signifies a shift towards proactive, data-driven, and real-time quality assurance. Join Kraken Sense in transforming pharmaceutical manufacturing with early detection, seamless data integration, real-time monitoring, and a commitment to Quality by Design.
IMPROVE Traceability
AUTOMATE Sampling
SCHEDULE Ahead
REDUCE Silos
Kraken Sense pioneers a transformative approach to streamline operations and fortify quality assurance.
Our innovative solutions revolve around enhancing traceability, automating sampling processes, and enabling proactive scheduling. By championing improved traceability, we empower organizations to seamlessly track and monitor critical data points throughout the manufacturing journey, ensuring transparency and compliance. With automated sampling, we revolutionize the collection process, leveraging cutting-edge technology to increase accuracy and efficiency while mitigating human error. The ability to schedule tests ahead not only optimizes resource allocation but also facilitates predictive analysis, empowering proactive decision-making. Additionally, we champion the dismantling of organizational silos, fostering a collaborative environment where data flows seamlessly across departments, fostering synergy and efficiency.
Our Difference
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The KRAKEN™ heralds a new era of early detection within pharmaceutical manufacturing. Leveraging real-time qPCR technology and autonomous sampling, our device swiftly identifies a spectrum of biological and chemical entities with an exceptional low LOD of 1 copy/mL. This early detection ensures proactive responses, safeguarding product quality and patient safety.
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Say goodbye to siloed data. With the KRAKEN™, data integration becomes intuitive and comprehensive. Our secure dashboard allows seamless sharing of reports across your organization. Easily track sample timestamps and locations at the click of a button, enabling swift decision-making and efficient tracking throughout the manufacturing process.
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Experience the power of real-time monitoring with our KRAKEN™ platform. Remote sampling, analysis, and scheduling empower users to make informed decisions instantaneously. Monitor critical parameters and respond in real-time to ensure consistent quality, all through an intuitive and user-friendly interface.
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Our technology embodies the principles of Quality by Design (QbD), championing a comprehensive approach to quality assurance. The KRAKEN™ system is meticulously crafted to fortify each stage of the pharmaceutical manufacturing process with inherent quality. By proactively identifying critical quality attributes, it enables early intervention and process optimization, ensuring steadfast quality control without compromising flexibility or innovation.
Target Sensors
Delve into our expansive sensor library meticulously crafted for precision in pharmaceutical settings. From E. coli and Salmonella to other critical pathogens and molecules prevalent in pharmaceutical environments, our sensors ensure heightened accuracy and specificity. In addition, our array of physical sensors includes pH, temperature, dissolved oxygen, conductivity, and redox potential sensors. Specifically designed for pharmaceutical manufacturing environments, these sensors ensure unparalleled precision and specificity in monitoring crucial parameters and contaminants, safeguarding the integrity and quality of manufacturing processes.
Need a custom solution? Our specialized R&D unit comprising adept scientists and engineers can engineer a customized sensor tailored precisely to address your pharmaceutical-specific requirements within a span of six weeks. The dedicated Kraken Sense team collaborates intimately with your organization, offering tailored project design and device customization to align with your distinct needs and specific case scenarios.
View our brochure!
Unleash the power of state-of-the-art technology in pharmaceutical water analysis, utility monitoring, and municipal testing through our comprehensive brochure. Explore the unparalleled capabilities of our groundbreaking device, the KRAKEN, meticulously engineered to offer unparalleled precision and rapid detection of an extensive array of contaminants crucial in pharmaceutical manufacturing. View our brochure now to uncover how our pioneering technology reshapes and elevates the paradigm of testing solutions within the pharmaceutical industry
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In many cases, analysis can take as little as 60 minutes. Time varies based on the sample type and the target. Speak with our team today for a more accurate estimation based on your personal needs.
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Yes, the KRAKEN™ system is meticulously engineered to seamlessly integrate into established pharmaceutical manufacturing setups and production facilities. Its adaptable design facilitates flexible installation, allowing integration across diverse stages of the manufacturing process, from laboratory to production floor.
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Our system ensures secure data transmission and integration, reducing organizational silos by offering a comprehensive encrypted cloud-based dashboard. This allows for seamless traceability and real-time monitoring across the manufacturing spectrum.
Frequently asked questions
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The Kraken™ offers a measurement range as sensitive as 1 copy/ml, ensuring precision in detecting even minute concentrations. It performs reliably within the range of 1 to 10 copies/ml, maintaining accuracy across a broad spectrum of measurements.
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No, the KRAKEN device does not cultivate or enrich samples. Our methodology circumvents the need for these processes. Instead, the device efficiently filters and concentrates the sample, utilizing custom-optimized reagents for precise results. This approach ensures reliable detection, achieving exceptional sensitivity, often detecting as low as 1 copy/mL without the requirement for enrichment. By omitting the enrichment step, our technology supports on-site deployment without necessitating a dedicated BSL-2 laboratory setup. This ensures both safety and efficiency in real-time testing scenarios within bioprocessing environments.
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Our technology is engineered to enhance QbD principles by enabling proactive identification of critical quality attributes, facilitating early intervention, and process optimization.
