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The unique and innovative K-Patents Pharma compact refractometer PR-43-PC system consists of a compact refractometer and a graphical user interface. The Pharma refractometer PR-43-PC is designed to meet pharmaceutical industry standards and guidelines including PAT, GMP, CIP/SIP, 21 CFR Part 11 and validation.
The PR-43-PC has a measurement range of 0 to 100 Brix and provides an Ethernet or 4–20 mA output signal proportional to the temperature-compensated concentration value for real-time process control. The user can choose between a rugged, multichannel, industrial computer or a compact light-weight user interface. The PR-43-PC Refractometer has a built-in web server with an instrument homepage. The homepage enables the configuration, monitoring, verification and diagnosis of the refractometer via an Ethernet connection. Every PR-43-PC Refractometer also generates an mA output signal for control purposes. The PR-43-PC refractometer needs no recalibration or regular maintenance. Furthermore, the calibration of each refractometer can be verified using standard refractive index liquids and a built-in verification procedure.
Validation often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices (GMPs) and other regulatory requirements. K-Patents provides a validation procedure and equipment that help the user to prove the suitability of the refractometer for its designated function. These include an optional laboratory test cuvette for easy off-line testing of drug samples in the laboratory.
Pharma compliance
The K-Patents Pharma PR-43-P is an ideal in-line process instrument for pharmaceutical processing and for the Process analytical technology (PAT) framework, because:
•It provides a modern process and endpoint tool for the real-time monitoring and control of liquid concentration or density.
•It has FDA 21 CFR Part 11 compliant electronic data capture and storage technology.
•Full IQ/OQ documentation is available for the fulfillment of the equipment qualification.
•The K-Patents PR-43-P is a scalable solution, from the early lab scale testing stages to full-scale process production.
•The K-Patents PR-43-P comes with pharma grade materials, material traceability documentation and controls: ◦Steel parts are made of 316L stainless steel
◦Product contact surface finishes are electropolished and the surface roughness is Ra 0.4μm (15μ inch)
◦USP Class VI Elastomers are tested for materials’ biocompability and toxigology safety
◦No animal derived ingredients (ADI) are used in processing or machining
•The K-Patents PR-43-P is Sanitary 3-A approved and EHEDG (European Hygienic Equipment Design Group) Type EL Class I certified.
Platform four (P4) Refractometer
The introduction of a unique new Process Refractometer Technology Platform Four (4) brings improved levels of performance and a choice of user interfaces that fits best for various needs of applications.
Platform four also emphasizes the ongoing shift toward the use of Ethernet, and the concept of software Apps that add significant new possibilities to combine, refine and use measurement data in various industrial control and automation applications. The PR-43 Refractometer has a built-in web server with an instrument homepage. The homepage allows for configuring, monitoring, verifying and diagnosing the refractometer via the Ethernet connection. Every PR-43 Refractometer also provides an mA output signal for control purposes.
The Pharma refractometer PR-43-PC is factory-calibrated to measure Brix and temperature in standard units. Each refractometer has identical calibration. For this reason, the refractometers can be freely interchanged without optical recalibration or parameter changes. The refractometer does not require any recalibration or regular maintenance. Furthermore, the calibration of each refractometer can be verified using standard refractive index liquids and a built-in verification procedure.
Multichannel user interface MI
The Multichannel user interface MI provides the highest level of industrial computing, intelligence and sophisticated features as well as environmental protection.
•High-performance, industrial computing system
•Expandable system and connectivity for up to four (4) PR-43-P refractometers and eight (8) I/O modules
•Environmentally sealed IP67, NEMA 6, rugged 316 stainless steel enclosure that withstands the corrosive cleaning agents and frequent washes in food and beverage processing plants. In addition, the stainless steel enclosure has superior hygienic qualities and bacteria and germs have difficulty growing on it. Also for demanding field and outdoor conditions (-40−50°C, -40−122°F)
•Prism wash diagnostics and control
•Trend display that shows one or two graphs over a selected period of time.
•Embedded measurement apps: The apps are small programs that give different types of measurement data and functionality.
•Modules, e.g. mA-output and mA-input module
•10” graphical touchscreen color display
•21 CFR 11 compliant user identification and management, electronic data records and data-logging, event log/audit trail.
Compact user interface CI
•Single device connectivity
•Local and/or remote display and access
•Light-weight, aluminum enclosure for control room conditions and epoxy coated IP65, NEMA 4 enclosure with polycarbonate display shield for field conditions
•Trend display
•10” graphical touchscreen color display.
Refractometer PR-43-PC
•Universal calibration of each sensor: All sensors are freely interchangeable.
•Full measurement range Refractive Index (nD) 1.3200 – 1.5300, which corresponds to 0-100 Brix.
•Sanitary 3-A approved and EHEDG certified to meet the highest hygiene requirements of food production.
•Withstands CIP and SIP processes and cleaning and rinsing of facilities.
•Completely digital system: particles and bubbles do not affect operation or accuracy.
•Patented CORE-optics: no drift, no re-calibration, no mechanical adjustments.
•PR-43-PC Refractometer has a built-in web server with an instrument homepage. The homepage allows for configuring, monitoring, verifying and diagnosing the refractometer via an Ethernet connection.
•Effective heat transfer and isolation using Teflon® and ceramics in the refractometer provide safe operation also in higher process temperatures (max. 130 °C/266 °F).
•Fast process temperature measurement by built-in Pt1000 and automatic temperature compensation.
•Easy on-site instrument verification within users’ own quality assurance system and standard Refractive Index liquids.
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