Pharmaceutical, Chemical, & Dietary Supplement Value Creation
Process Analytical
A Process NMR Associates nuclear magnetic resonance analyzer installed on-line in a refinery to measure and control petrochemical composition. (Process NMR Associates is a business partner of Malawer & Associates Consulting, LLC.)
Question: How can a pharmaceutical or chemical process achieve a simultaneous increase in product quality and cost reduction?
Answer: Through the installation of one or more on-line analyzers which have been configured to the plant's DCS or PLC unit to provide feedback or feed-forward control.
Malawer & Associates Consulting provides guidance on process analytical problem resolution and can carry out project coordination activities through the implementation stage. Our firm also provides training in the form of a 2-day introductory short course on process analytical chemistry that can be brought onto a customer's site. (See Education.)
The benefits of incorporation of one or more on-line analyzers into any given process can include most of the following:
Reduced cycle time / increased capacity
Increased process reproducibility / reliability
Improved product quality
Better understanding of chemical processes
Increased automation of processes
Reduction of off-line (lab) in-process testing
Reduced scrap, rework, blending
Reduced chemical waste
Reduced pollution
Reduced energy consumption
Reduced raw materials usage
Improved process safety
The end results are:
Increased profitability for the firm
Increased job security for its employees
Better utilization of employees’ skills
Satisfied shareholders
Customers / Consumers - increased satisfaction with firm’s products
Patients (in the case of drug products) – greater safety
Satisfaction of regulatory agencies (e.g. FDA) through the firm's adherence to the tenets of the PAT (Process Analytical Technology) and QbD (Quality by Design) initiatives.
Question: So, why use Malawer & Associates Consulting for your firm's process analytical problem resolution?
Answer: Dr. Malawer has been successfully coordinating process analytical projects since 1991 with International Specialty Products. His consulting firm carried out a Raman analyer project for a large inorganic chemicals complex in 2007-2008 and is currently working with several major process analyzer firms to develop synergistic combination technologies to create instruments with expanded capabilties. He has also developed a short course for the American Chemical Society entitled "Introduction to Process Analytical technology". Dr. Malawer has published a review article in the March 2010 issue of the Cosmetiscope relating to the use of process analyzer technology in the personal care industry. The article can be viewed by clicking here. Dr. Malawer also assisted a major analyzer firm to increase its sales penetration into the personal care market.