Product Manual (pdf)
K-Patents Pharma IQ & OQ Manual Appendix for lab and pilot testing with Laboratory Test Cuvette LTC (pdf)
K-Patents Pharma IQ and OQ Manual Appendix for vaccines, pilot and full scale manufacturing (pdf)
Instrument Verification (pdf)
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.
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.