Ask The Experts

PharmaManufacturing.com has assembled top experts in key fields for you to ask select questions about your pressing issues. We’ll post the answer as quickly as possible. If you would like to apply to become an expert yourself, click on the link below.

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Experts are available in the categories listed below. Please click on a category to read more about the expert and to view answers to previously submitted questions.

API Manufacturing and Process Control by Girish Malhotra, President, EPCOT International
Active Pharmaceutical Ingredient (API) manufacturing is an area where processes tend to be very complex. They needn't be. Engineering expertise can help reduce the complexity of API manufacturing processes and make them easier to scale up and control.


Auditing and Compliance by Michael J. Gregor, founder, Compliance Gurus Inc.
Ensuring the highest standards for compliance and quality systems is essential for any pharmaceutical company today. Not only internal operations, but those of business partners or would-be partners, must pass muster. Get pointers on how to vet your suppliers, eliminate weak links in your internal quality systems, and improve staff training.


Crystallization and Separation by Wayne Genck, Ph.D., President, Genck International, Inc.
Understanding the principles of crystallization is essential for optimizing many drug manufacturing processes and developing stable solid drug formulas. When handled correctly, crystallization can allow product characteristics to be controlled closely. Gain insight into structure, morphology and kinetics as well as scaleup and equipment requirements for this critical unit operation.


Excipients by Irwin Silverstein, Ph.D., President, IBS Consulting
The right excipient can make or break any pharmaceutical, and quality standards are essential. You need to find a supplier that you can trust, and ensure that materials meet top regulatory and quality requirements. Avail yourself of proven expertise from the International Pharmaceutical Excipients Auditing, Inc.’s Chief Operating Officer to help ensure that nothing is left to chance.


Lyophilization by Edward Trappler, President, Lyophilization Technology, Inc.
Aseptic packaging and preservation are driving lyophilization’s (freeze drying’s) use in pharmaceutical manufacturing. Expertise can help with product characterization, formulation and product design, as well as process optimization, troubleshooting, start up and compliance.


Mixing and Separation by Tom Post, Ph.D., President, Post Mixing, Inc.
Mixing presents a challenge in many pharmaceutical applications, particularly those involving sensitive biologicals. Whatever your application, this expert in liquid mixing and separations offers expertise in a broad range of areas.


NIR Spectroscopy and PAT by Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
Process Analytical Technology (PAT) is gaining traction in more pharmaceutical manufacturing operations, and Near Infra Red (NIR) is becoming a more important tool. However, there are challenges to using NIR properly, and then integrating it with the other efforts required to optimize pharmaceutical PAT programs.


Overall Equipment Effectiveness (OEE) by Robert Hansen, P.E., CMRP member, SMRP, R.C. Hansen Consulting, LLC
Overall Equipment Effectiveness (OEE) may be new to the pharmaceutical industry, but it is becoming an important tool for improving performance. The technique helps you determine which operations are the most problematic, and quantifies downtime as a percentage of total available time, providing a numerical gage for your line's efficiencies. However, the technique is often misunderstood or applied incorrectly. Gain more insights into OEE and what it can do for your operations.


Quality Metrics by J. Scott Tarpley
Statistical methods and models are becoming more important pharmaceutical quality tools today, providing an opportunity for manufacturers to understand their processes and the “root causes” of quality issues so they can remove them. From Design of Experiments to Measurement System Analysis and Process Capability analysis, this consultant has special expertise in the pharmaceutical industry, but has also worked as a quality consultant in other industries as well.


Solid Dosage and Tabletting by Fred Rowley, Solid Dosage Training, Inc.
Fred Rowley holds a B.S degree in Biochemistry from the University of Santo Thomas. He is currently Guest Speaker of Solid Dosage Training, Inc. He is also director of manufacturing technical support for a leading pharmaceutical firm. He has held senior manufacturing and technical positions at Stayner Pharmaceuticals, Shaklee Corp., Syntex Laboratories, Alza Corp. and Weider Nutrition International.


Team Building/Change Management by Cynthia Palka, President, Future Map, Inc.
Moving from a traditional to a team-based approach is helping more pharmaceutical companies improve productivity.  But establishing and nurturing effective teams can be extremely challenging in an industry as heavily regulated as the pharmaceuticals industry. This expert has a pharmaceutical industry background and specializes in team building for this industry.


Vaccine and Parenteral Manufacturing by Donald Gerson, President, Axenic, Inc.
Vaccine manufacturing is far more challenging than traditional pharmaceuticals or even biopharma. The need for stringent quality standards and regulatory compliance is greater than ever, while there is also a need to improve productivity and the bottom line. This consultant offers extensive expertise in vaccine manufacturing and an intimate knowledge of the issues involved.


Validation by Jim Agalloco, President, Agalloco & Associates, Inc.
Few subjects are as challenging, or frustrating, as pharmaceutical process and equipment validation. “Getting things right the first time” and optimizing data and work flow can help simplify the process.

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