Vaisala K-PATENTS® Pharma Refractometer PR-23-AC

These include PAT, GMP, CIP/SIP, 21 CFR Part 11 and validation. The ability to understand and continuously control Refractive Index nD contributes significantly to the development of effective drugs and efficient manufacturing processes.

Vaisala K-PATENTS® Pharma Refractometer PR-23-AC fulfills the pharmaceutical drug production regulations for process wetted part materials, sealing, and surface roughness. No animal originated media are used in the machining and polishing processes.

Each sensor is provided with a calibration certificate comparing a set of standard liquids to the actual sensor output. Therefore, the calibration and accuracy can be routinely verified with the traceable standard Refractive Index liquids.

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.

Features
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/Conc.
Meets 3A Sanitary Standard and tested for CIP cleanability according to EHEDG.
Withstands CIP cleaning.
Completely digital system: particles and bubbles do not affect operation or accuracy.
CORE-optics: no drift, no re-calibration, no mechanical adjustments.
Includes an Ethernet communication solution for data-logging. Together with the user's own procedural and administrative user controls this facilitates electronic data records for FDA 21 CFR Part 11 adherence.
Effective heat transfer and isolation using Teflon® and ceramics in the sensor 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.
Calibration and accuracy traceability with easy on-site instrument verification using standard Refractive Index liquids.
ATEX approved for Zone II, area classification EX II 3 G EEx nA II T4.
ATEX approved for Zones 0 and 1, area classification ATEX II 1G Ex ia IIC T4 (only Intrinsically safe PR-23-AC-IA with single sensor transmitter STR).
FM approved for Class I, Div. 2, Groups A, B, C and D, T6.
CSA certified for Class I, Div. 2, Groups A, B, C and D, T4.
cCSAus certified for Electrical Safety, Sensor: Class I, Pollution Deg. 3; Transmitter: Class I, Pollution Deg. 2; Installation Cat. II.
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Key Benefits

100 % pharmaceutical compliance
The Vaisala K-PATENTS® Pharma Refractometer PR-23-AC supports PAT framework, has FDA 21 CFR Part 11 compliant electronic data capture and storage technology. Materials used are pharma grade, with traceability documentation and controls. Sanitary 3-A approved.
Fully scalable solution
The system is fully scalable from the early lab-scale testing stages to full-scale process production.
Built-in instrument verification
The PR-23-AC Refractometer has a built-in features to enable configuration, monitoring, verification and diagnosis of the refractometer. The PR-23-AC Refractometer needs no recalibration or regular maintenance. The calibration of each refractometer can be verified using certified and N.I.S.T. traceble refractive index liquids and a built-in verification procedure.

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