Expert Details
Powders and Tablet Manufacturing
ID: 718457
Michigan, USA
He has developed sustain release sugar bead systems and also via the use of hydrogels. Additionally, he has developed an expert system approach to sustain release product development.
He has set up mixing systems using Vee mixers of 1, 3, and 100 cubic feet in size, using double cone mixes to 30 cubic feet, Nauta mixers 7 to 20 cubic feet, an air mixer to 30 cubic feet, and a fluid bed to 300 liters. He has conducted and written validation protocols, optimization designs, and simplex searches, as well as developed and conducted training sessions. He has developed a scale-up strategy for mixing and mixness prediction.
Expert has set up and validated three liquid manufacturing areas, including two deionized water treatment systems. He set up and is currently in the process of validating a tablet and capsule manufacturing facility.
He has developed a 2 1/2 day course on milling. His experience is with cone mills, hammer mills, pancake type micronizers, and opposing stream type jet mills. He has designed a lump breaker mill as well as screen impellers for a cone mill.
Expert developed a corrective information database during his 20+ years in the Quality Assurance area of the pharmaceutical industry.
Expert's Ph.D. thesis is in the area of optimization. He has applied these techniques to three liquid products and seven solid dosage forms with good success. He wrote an optimization program called "ORTHO" that is a part of his thesis. He currently has two active projects in this area, a capsule and a tablet formulation.
He has designed a cleaning life cycle program and is currently implementing a cleaning validation program as a module for a pharmaceutical maker.
Since entering the industry in 1963, Expert has been involved in troubleshooting tablet formulation and processes. He has worked on nutritional and OTC drug products. In addition, he has been involved in the development of a granulation system and direct compression formulas for tableting.
Expert has conducted training programs in solid dosage form manufacturing and powders processing as in-plant programs for most of the major pharmaceutical manufacturers. The course has been conducted in the U.S., Europe (both eastern and western) and in Israel.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1989 | Degree: Ph.D. | Subject: Industrial Engineering - Process/Product Optimization | Institution: Kennedy Western University |
| Year: 1967 | Degree: B.S. | Subject: Pharmacy | Institution: University of Health and Pharmacy - St. Louis |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1998 to 2015 | Employer: SPI-Pharma | Title: Manager of R&D | Department: R&D |
Responsibilities:Works in process and product development in fluid bed, high shear granulation, and tablet formulation. |
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| Years | Employer | Title | Department |
| Years: 1976 to Present | Employer: Undisclosed | Title: Course Director | Department: Tablet / Powder Processing |
Responsibilities:He lectures on tabletting and powder processing. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1998 | Employer: Fleming & Co | Title: Director of Technical Service | Department: R&D |
Responsibilities:He worked on the development of sustain release beads. |
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| Years | Employer | Title | Department |
| Years: 1995 to 1996 | Employer: Richwood Pharmacueticals | Title: General Manager/Technical Director | Department: cGMP |
Responsibilities:He was cGMP and operation manager. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1996 | Employer: Manufacturing Chemists | Title: President | Department: Tablet Contract Manufacturing |
Responsibilities:He was responsible for tablet design, validation and cGMPs. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1994 | Employer: University of Maryland | Title: GMP Facility Director | Department: Facilities |
Responsibilities:He was responsible for SUPAC, training, and cGMP compliance. |
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| Years | Employer | Title | Department |
| Years: 1963 to 1989 | Employer: SK Beecham | Title: Director QA & Technical Affairs | Department: QA |
Responsibilities:He was responsible for various QA and process design functions. |
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Career Accomplishments
| Licenses / Certifications |
|---|
| Expert is an R.Ph. in Missouri. |
| Professional Appointments |
|---|
| He serves on the Board of Directors of the Western Michigan Discussion Group. |
| Awards / Recognition |
|---|
| Received the Bristol Award. |
| Publications and Patents Summary |
|---|
| He has written a chapter in the Handbook of Granulation Technology, and published four papers granulation products and process for manufacturing. |
Additional Experience
| Expert Witness Experience |
|---|
| None |
| Training / Seminars |
|---|
| Expert has conducted seminars in Powder Technology, Granulation, and Tableting Technology. |
| Vendor Selection |
|---|
| Expert has experience locating vendors of solid processing equipment, optimization software, and formulation ingredients. He has access to industry contacts in the U.S. and Europe for assistance in vendor location. |
Fields of Expertise
tablet manufacturing, tableting, mannitol, controlled-release drug delivery, powder mixing, deionized water, deionized water system, pharmaceutical manufacturing, impact mill, pharmaceutical quality assurance, product optimization, cleaning validation, tablet, training, softgel technology, pharmaceutical liquid, over-the-counter drug product development, Current Good Manufacturing Practice, softgel capsule, fluid-energy milling, fluid-energy mill, pharmaceutical product development, drug validation, pharmaceutical capsule, optimization experiment, excipient, grinding (comminution), solid material handling, quality assurance, continuous solid handling machine, comminution, size reduction, powder, milling, protein food product, solid transportation, solid storage, slurry, quality control, powder handling, particle fluidization, over-the-counter drug, mixing, microencapsulation, information system, grinding mill, granulation, Good Manufacturing Practice, gastric antacid, feeder conveyor, drying, dry mill, dosage form, conveyor, chlorine, blending, ball mill