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.