The PR-43-P Process Refractometer for pharmaceutical use by K-PATENTS is a liquid phase analyzer specific for pharma & biotech capable of directly calculating the variation of the Refractive Index depending on the amount of solute dissolved in a solvent that is, of its Concentration.

The K-PATENTS PR-43-P Process Refractometer finds application in multiple highly challenging productions and performed with rigid and demanding protocols such as pharmaceutical bases, excipients, antibiotics, blood and blood products, proteins, vitamins, synthetic hormones, syrups, bioproducts, Vaccines & Serums ...

Why is it possible to safely use the PR-43-P Process Refractometer in the pharma or biotech sector in the PAT Process Analytical Technology family of analytical technologies? Because

It allows an accurate and real-time control of the Process
FDA 21 CFR Part 11 compliant
Document IQ / OQ support is extremely robust and consistent
PR-43-P is a scalable solution from the Laboratory, to the Pilot, to Production
It is all in SS316L with pharmaceutical finishes and Ra 0.4 μm roughness
The USP Class VI type elastomers used are tested for biocompatibility and possible toxicity
ADI Animal Derived Ingredients are not used
Sanitary 3-A and European Hygienic Equipment Design Group (EHEDG) Type EL Class I approvals for cleaning and CIP / SIP operations are standard.
Thanks to its analytical characteristics:

Refractive Index Range nd = 1.3200 - 1.5300, equivalent to 0 -100 Brix
Optional Extended Range nD = 1.2600… 1.4700
Accuracy nd ± 0.0002 equal to ± 0.1% Brix or by weight
Optional High Accuracy - HAC in the range 0-30 Brix & 4-30 ° C equal to ± 0.05% Brix up to ± 0.02% Brix in the chosen set-points.
LED light source with 589 nm wavelength Sodium-d for a quick comparison with the standards in the literature and the results of the Laboratory
offers the Production Manager all the advantages of an accurate and continuous measurement while the Laboratory Manager is able to quickly check the validity of the analyzes in progress. K-PATENTS has developed a 3-stage calibration: Stage A represents the calibration of the refractive index nD with respect to the CCD sensor, Stage B represents the calculation of nD with dynamic temperature compensation through the Application Curve, the Stage C represents the eventual calibration in the field to integrate the real process conditions obtaining results comparable with the laboratory. What are the advantages? All PR-43 sensors are universally interchangeable with each other, and both the calibration and the accuracy of the instrument can be easily verified on-site, even directly by the customer, with a simple set of certified liquids.

The HMI Human Machine Interfaces available for the K-PATENTS PR-43-A Process Refractometer are many and technically perfect:

CI Compact User Interface: the Operator interacts with this remote electronics dedicated to each individual sensor thanks to the 10 "Touch screen. CI Compact User Interface is available in aluminum for installation in the control room or also in IP65 / NEMA 4 enclosure in field epoxy resin.

MI Multichannel User Interface: the Operator interacts with this multi-channel remote electronics able to manage up to 4 sensors, thanks to the 10 "Touch screen. MI Multichannel User Interface is enclosed in an IP67 / NEMA 6 enclosure completely in SS316 suitable for washing and sanitizing. MI Multichannel User Interface has been engineered according to 21 CFR 11 requirements for User Identification, Procedure Parameter Registration and Data Intangibility.

LTC Laboratory Test Cuvette: the Laboratory Technician or the R&D Manager can comfortably use this configuration for further synthesis studies, perhaps at different temperatures or with different ingredients. This part of the experimentation allows you to move to the Pilot plant and then to Production having a substantial database available. Thanks to continuous sampling, this K-PATENTS cuvette allows the use of sample microvolumes for an effective feasibility study

Therefore, the P-43-P Pharmaceutical Use Process Refractometer has been specifically designed to be used in a complete test and production cycle based on the following steps:

1. Laboratory test with static sample
2. Laboratory test with dynamic sample
3. Tests in the Pilot Plant
4. Installation in Production
    

The PR-43-P Process Refractometer is also available for hazardous areas.