Pharmaceutical PAT

Process Analytical Technology (PAT) and Verum NIR

The Process Analytical Technology (PAT) initiated by the FDA and EMA seek to improve the efficiency and quality of pharmaceutical production through in-process analysis and control. This involves the design, analysis and control of manufacturing processes through measurement of key process parameters that affect key quality attributes. The goal is to have quality built-in to the manufacturing process, not just tested after (Quality by Design [QbD]). NIR process systems have been widely regarded as a leading technology for the PAT initiative due to their capabilities for rapid, non-destructive analysis of a wide range of chemicals and materials in liquid, solid and slurry forms. Verum Analytics has the tools necessary to meet your PAT project goals.

Process Measurement Solutions

Get real-time analysis of:

Mixing and Blending End Product Identification Fermentation Bioreactors
API drying and coating Raw Material Analysis Cell culture
Granulation Polymorphic Forms and more…

Verum Analytics ApexBio Process systems are designed to be user-friendly, easy to integrate, and extremely cost effective. With up to 20 measurement points per analyzer, sterilizable CIP/SIP probes/sensors, and communication software for Modbus, 4-20mA and other protocols, designing a PAT solution with a high rate of return is within reach. Verum Analytics also provides commissioning, model development, and training onsite. Continuing product support is always available following installation–the systems can be accessed and troubleshooted remotely by Verum’s team of experts.

Additional Pharmaceutical Measurements

The ApexBio can also handle final product quality tests and incoming material validation. Measure dosage in tablets, uniformity, actives and excipients. Identify grades, sources, and counterfeits in seconds for raw materials and final products.  The ApexBio Bench-top instruments can be used by operators of any skill level. Analysis is done with the push of a button and qualitative or quantitative results are displayed on screen in accordance with your measurement requirements.

Applications – Listing
Acetonitrile and Alcohol ACN and Alcohol – request more information
Adhesive Gelatin Gelatin, Pectin, and NaCMC – request more information
Ampicillin/Ampicyllin Potency & Moisture – request more information
Amoxicillin Potency, Trihydrate, & Moisture – request more information
Antibiotics Fermentation Active Ingredient, Fat, and Nitrate – request more information
Bacterial Growth – Algae % Sodium Acetate in Algae Growth – request more information
Blood Glucose & Glucose in Saline – request more information
Cough Drop % Menthol – request more information
Cough Syrup Acetaminophen – request more information
Dosage % Dosage of Olanzapine – request more information
Ecoli Fermentation Acetate, Optical Density, Product Titer (Protein)  – request more information
Fermentation Glucose, Glutamin, & Antigesic Mass – request more information
Fermentation of Ecoli Dry Cell Weight, OD, Ethanol (EtOH)  – request more information
Fermentation of Mammalian Cells Glucose, Lactate, Glutamate, and more  – request more information
Gemfribrozil Dosage of Assay – request more information
Herbal Medicines Glycyrrhizin, Baicaline & Paeoniflorine – request more information
Isradipine % Active (dosage) – request more information
Lypholized Products % Moisture – request more information
Medical Patches NCO – request more information
Mixture Measurement of batch mixture – request more information
Mouthwash Glycerine & Alcohol – request more information
Pharmaceutical Powders Water Content – request more information
Pharmaceuticals Enalapril Maleate – request more information
Pharmaceuticals Dosage Forms, Optical Isomers, Polymorphism, & Particle Size – request more information
Polymorphic Phase Determination of molecular phase – request more information
Raw Material ID Discrimination between raw materials – request more information
Setraline HCL Determination of Polymorphic phase – request more information
Suspension Dosage (%Doxicillin) – request more information
Tablet – Didanosine %Active – request more information
Tetracycline Calculated Assay, REL CPD #1 – request more information

Updating Technology

Verum Analytics is now offering its newest analyzer design, the Apex NIR platform, in place of the IsoPharm.  The Apex offers many advantages without any drawbacks.  We provide trade-in offers to help our customers benefit from the latest and best analyzers.  Contact us if you are ready to upgrade.

    Watch our short introductory video and see how we can help you with your measurement requirements.

    Have a question about a measurement? Contact our applications department with your details.