Vaisala K-PATENTS® Pharma Refractometer PR-43-PC

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 conc% or 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.
 

Features
Universal calibration of each refractometer: All refractometers are freely interchangeable.
Full Refractive Index (nD) 1.3200 – 1.5300 measurement range , which corresponds to 0-100 Brix.
Sanitary 3-A approved to meet the highest hygiene requirements.
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.
+ Show more

Key Benefits

Pharmaceutical compliance
The Vaisala K-PATENTS Pharma Compact Refractometer PR-43-PC supports PAT framework, has FDA 21 CFR Part 11 compliant electronic data capture and storage technology. Materials used are pharma grade, including product contact surface materials with traceability documentation and controls, electropolished finishes with the surface roughness of Ra 0.4μm (15μ inch), as well as USP Class VI Elastomers that are tested for materials’ biocompability and toxigology safety. Sanitary 3-A certified.
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-43-PC Refractometer has a built-in features to enable configuration, monitoring, verification and diagnosis of the refractometer. The PR-43-PC Refractometer needs no recalibration or regular maintenance. The calibration of each refractometer can be verified using certified and N.I.S.T. traceable refractive index liquids and a built-in verification procedure.