Meeting the requirements of biopharmaceutical processes

Self-calibrating temperature measurement technology can minimize the risk of incorrect measurements and improve process safety and regulatory compliance (FDA) in pharmaceutical applications with continuous process verification (GMP). Automated documentation helps effortlessly build a repeatable, traceable record database for audits and regulatory authorities.

• The self-calibrating hygienic iTHERM TrustSens TM371 lowers risk and drives automation in regulated processes with fully automated process documentation and built-in memory for 350 calibration events.

• The Heartbeat Technology offers full instrument diagnostics, monitoring and verification, effectively eliminating the risk of undetected non-conformities.

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For a system or component to be ASME BPE-compliant, adherence to all applicable parts of the standard is required. The stringent requirements of BPE often mean that only devices specifically designed according to standard can achieve full compliance. Endress+Hauser offers a complete portfolio of instruments that are designed and manufactured according to ASME BPE, such as:

• Promass P 100 Coriolis flowmeter is an ASME BPE-compliant specialist with an ultra-compact transmitter. It delivers total performance on the smallest footprint. They are designed for applications in sterile environments where space is a premium.

• Digital oxygen sensor Memosens COS22E Memosens 2.0 hygienic, amperometric oxygen sensor for the food and life sciences industries

• Absolute and gauge pressure Cerabar PMP51 Digital pressure transmitter with welded metal sensor for measurement in gases, steam or liquids

• Vibronic Point level detection Liquiphant FTL50H Compact vibration point level switch for liquids predominantly in the food and life sciences industry

• Sanitary digital thermometer iTHERM TM411, a hygienic temperature measurement instrument for optimum product quality, process safety, and efficiency

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Single-use instrumentation must offer equivalent reliability and measurement accuracy as their reusable counterparts while still providing key attributes such as minimized hold-up volume, an ergonomic design, no required calibration, and the ability to optimize costs. Endress+Hauser has risen to the challenge, collaborating with leading technology providers to extend our portfolio with an equivalent single-use offering for upstream and downstream process applications.

• Raman Rxn-46 probe connection to BioPAT® Spectro for Ambr® 15 and Ambr® 250 by Sartorius

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Raman spectroscopy is an ideal solution for fast and non-destructive measurement. Our Raman solutions can monitor several parameters simultaneously with one single probe installed directly in-line. The complete upstream package enables real-time and optimized control of the process leading to reduced time between batches, limited risk of contamination and increased yield.

• Kaiser Raman Rxn analyzer  is designed for use in analytical laboratories with model transfer capabilities.

• Raman Rxn-10 probe with Raman optic system for single use, a bioprocess probe with sterile, disposable fittings for single-use bioreactors.

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