The unique and innovative Vaisala 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. Vaisala 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.

Vaisala K-Patents Process Refractometer PR-23 meets the pharmaceutical industry standards and guidelines. 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. Vaisala 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.

Key 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.

• Patented 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.

Vaisala K-Patents Sanitary Compact Refractometer PR-23-AC provides accurate means for measuring Brix and liquid concentrations in hygienic installations and in small pipe line sizes of 2.5 inch and smaller.

The PR-23-AC sensor is installed in the pipe bend. It is angle mounted in the outer corner of the pipe bend directly or through a flow cell, a Sanitary clamp or a Varivent® connection. This way the best flow conditions and self-cleaning effect can be achieved.

The measurement range covers 0-100 Brix. The accuracy is ± 0.1 Brix and the measurement is automatically temperature compensated. Low and high concentration alarms can be configured. Because of the digital sensing technology, even large amounts of suspended solids, bubbles or color changes do not affect the measurement or the accuracy.

Each sensor is provided with a calibration certificate comparing a set of standard liquids to the actual sensor output. The calibration and accuracy can be verified on-site with the certified Refractive Index liquids and Vaisala documented procedure.

Key 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.

• Meets 3A Sanitary Standard and tested for CIP cleanability according to EHEDG.

• Withstands CIP cleaning.

• Dual connectivity: one transmitter can operate two sensors. A second sensor can be easily integrated later.

• Completely digital system: particles and bubbles do not affect operation or accuracy.

• Patented CORE-optics: no drift, no re-calibration, no mechanical adjustments.

• Ethernet connection and remote panel for data-logging and remote operation.

• 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.

• Easy on-site instrument verification within users' own quality assurance system with standard Refractive Index liquids.