Our Courses

We teach solid dosage and we troubleshoot problems.

Solid Dosage, Solid Results.

We offer many courses, examples include:

  • Understanding powder granulating and blending operations

  • Basic tablet press operation

  • Effective limit setting and reject gate challenging

  • Preparing for an FDA inspection in the Tablet Press Unit Operation

  • Basic Aqueous Film Coating

  • Optimizing MUPS tablet compression

What We Offer

  • THE original two day course is based on a concept conceived by Fred Rowley and is now internationally recognized as the introductory course of choice. The course provides the basic knowledge needed to understand formulas, unit operations, manufacturing practices; common equipment used and provides a thorough explanation of what it takes to make a quality tablet (or capsule). The course emphasizes the theory and practice of solid dosage and capsule manufacturing and discusses common tablet (& capsule defects) and problem solving. There is no hands-on session/no workshop. Optional addition of a Hard Shell Capsule manufacturing module, 702 pages, 265 references

  • A Specific Discussion on Recent FDA Inspections: Compressing Force and Tablet Press Operation". This is a focused, 6 hour course designed as a technical discussion based on actual remediation experience dealing with the Critical Process Parameters (CPPs) for a tablet press and its operation. It focused on the specific requirements of many tablet press types: Fette, Korsch, SeJong, Cadmach etc. The course consists of  a classroom lecture of 5 hours presenting both the theory required to understand the fundamentals of running a tablet press and the established CCP’s  for successful operation. A process for establishing the reject limits for the AWC is a key part of the course. The discussion covers observations of the FDA and different approaches to addressing agency concerns to remediate the problem. 150 pages, many references.

  • Similar to the focused compressing force based FDA preparation course, this course is a larger single day course starting with the final blending unit operation and continuing in the powder staging and tablet press operation topics. Designed as a technical discussion based on actual remediation experience dealing with the Critical Process Parameters (CCPs) for a tablet press and its operation. It focused on the specific requirements of many tablet press types: Fette, Korsch, SeJong, Cadmach etc. The course consists of  a classroom lecture of 7 hours presenting the dry powder blending operation followed by the theory required to understand the fundamentals of running a tablet press and the established CCP’s for successful operation. A process for establishing the reject limits for the AWC is a key part of the course. The discussion covers observations of the FDA and different approaches to addressing agency concerns to remediate the problem. 231 slides, many references.

  • a single day course for the API manufacturer that provides the basic knowledge needed to understand the impact of active ingredient characteristics on tablet manufacturing. The course discusses the formulas, unit operations, manufacturing practices; common equipment used and provides a thorough explanation of what it takes to make a quality tablet. The course emphasizes the theory and practice of tablet manufacturing and discusses common tablet defects that are directly linked to the API being used in the formula. 243 references, 470 pages

  • A two day course that discusses the critical operating parameters and critifical factors for successful scale up of the granulating (high shear wet, dry, FBG), dry powder blending, tablet compressing and aqueous film coating of solid dosage forms. 760 pages, more than 1,000 references. Now available. 100+ pages, 100+ references.

  • A single day course for support personnel (Contract manufacturing administrators, Regulatory Affairs, Quality Unit personnel, Chemists, Clerks, Technicians, Purchasing agents, etc) that provides the basic knowledge needed to understand formulas, unit operations, manufacturing practices; common equipment used and provides a thorough explanation of what it takes to make a quality tablet or capsule. The course emphasizes the theory and practice of tablet and capsule manufacturing and discusses common tablet & capsule defects and problem solving. 243 references, 682 pages

Multiple Subject Courses

  • This course has 3 hours in the classroom and is engineered to provide a comprehensive understanding of the weigh room suite, proper staging of materials and verification, the operator role, the weigher and checker, using established “best practice” procedures, the proper use of scales & balances and the staging and movement of materials to minimize mistakes. The course is a four hour lecture on the theory and practice of successful weighing followed by an immediate workshop or hands-on demonstration in the weighing area. Textbook has a workshop. 25 references, 193 pages

  • This half day course is engineered to provide a comprehensive view of the powder milling operation within a pharmaceutical or nutritional supplement manufacturing facility. The course is a four hour lecture on the theory and practice of successful powder milling followed by an immediate hands-on demonstration in the granulating suite. Both the course and book contain a workshop with multiple problems.  192 pages, 176 references

  • This single day course is engineered to provide a comprehensive view of the granulation operation within a pharmaceutical or nutritional supplement manufacturing facility. The single day course is a six hour lecture on the theory and practice of forming and drying a granule; the different equipment available for wet massing, a discussion of critical processing parameters for each. This is followed by an immediate workshop or hands-on demonstration in the granulating area. Both the book and course contain a workshop with multiple problems to solve. 298 references, 314 pages.

  • The course is the only advanced course of its kind given today. Students are presumed to have some knowledge of basic powder granulating processes and prepared for a higher and more detailed course in powder granulating. This is a two day course that covers advanced topics such as the effect of low, medium and high shear granulating, powders in general and how they behave, methods of granule assessment and their direct impact on tablet defects. The course includes video examples of granulating processes, a workshop and a problem solving session.  386 references, 362 pages.

  • This single day course is engineered to provide a comprehensive view of the fluidized bed granulation operation within a pharmaceutical or nutritional supplement manufacturing facility. The course has a four hour lecture on the theory and practice of forming and drying a granule, with emphasis on basic fluidized bed technology. This is followed by an immediate hands-on demonstration in the granulating suite. Both course and book contain a workshop with multiple problems to solve.  264 pages, 138 references.

  • A single day course for operators and line staff on the dry granulating (roller compacting) and tablet slugging technologies. The four hour classroom lecture discussing the science behind roller compacting and the various machines available (Fitzpatrick/Gerteis/Alexanderwerk/Vector/Yenchen, etc.) and is followed immediately by a two to four hour hands-on demonstration in the wet granulating suite. There is a workshop with multiple problems to solve. 142 references, 229 pages.

  • A single day course for operators and line staff on the high energy granulation technology (aka RMG, HEMG, HSGC, etc.). The course has a four hour lecture on the theory and practice of forming and drying a granule, with emphasis on basic high energy granulating technology and the various machines available. This is followed by an immediate hands-on demonstration in the granulating suite. There is a workshop with multiple problems to solve. 212 references, 209 pages.

  • A single day course that presents the theory and practice of dry powder blending, powder characteristics, blender class types, working principles, the advantages and disadvantages of each mixer type, and factors which influence outcome. The four to six hour lecture is followed immediately by a workshop or a hands-on equipment demonstration. Both book and course contain a workshop with multiple problems to solve. 163 references, 163 pages

  • The course is the only advanced course of its kind given today. Students are presumed to have some knowledge of the basic dry powder blending process and are prepared for a higher and more detailed course in powder blending. This is a two day course that covers advanced topics such as the effect of low, medium and high shear blending, the effects of blend time; the movement of powders. The course includes video examples of blending processes. The course has a workshop and a problem solving session. 226 references, 241 pages.

  • A single day course that presents the theory and practice of dry powder blending, powder characteristics, blender class types, working principles, the advantages and disadvantages of each mixer type, and factors which influence outcome. We also discuss optimized powder sampling techniques for quality control personnel. The four to six hour lecture is followed immediately by a workshop or a hands-on equipment demonstration. The course contains a workshop with multiple problems to solve. 247 references, 225 pages.

  • : This single day or two day course is designed as a hands-on program. The course provides a classroom lecture of 6 hours presenting both the theory required to understand the fundamentals of running a tablet press and the specifics of many tablet types (Fette/Korsch/Kikusui/Cadmach etc). The lecture is followed immediately by a hands-on equipment demonstration. Each participant will understand how a tablet press works, how to identify capping, picking and sticking and other common tablet defects and how they are reduced or eliminated with machine adjustments. For the two day course, the operator will be required to make changes during machine operation. Both book and course have a workshop with multiple problems to solve.  Two day course has more time on the floor. 409 references, 566 pages.

  • The course is the only advanced course of its kind given today. Students are presumed to have some knowledge of tablet press operation. This is a one or two day course that covers advanced topics in great detail on proper press set up, tooling issues and has problem solving on the production floor and analysis of tablet defects. There are also video examples of ideal press operation and highlights common problems on the tablet press. The course has a workshop and a problem solving session.  More problems to solve and more time on the floor with the two day class. 238 references, 546 pages.

  • The course is the only advanced course of its kind given today specifically for NON-Pharmaceutical application. Students are presumed to have some knowledge of tablet press operation. This is a one or two day course that covers advanced topics in great detail on proper press set up, tooling issues and has problem solving on the production floor and analysis of tablet defects. There are also video examples of ideal press operation and highlights common problems on the tablet press. The course has a workshop and a problem solving session.   238 references, 35+ NON pharma, 494 pages.

  • This one or two day course is the only course of its kind currently offered in the world and is an expanded version of the course given to the US FDA at Silver Spring, MD in 2011. The course is comprised of an initial six hour discussion of the fundamentals of tablet press set up, operation and a thorough discussion of the common defects seen on the production floor. This is followed by a shop floor session that reinforces the basic theory of the correct set up and operation of a tablet press. In a single day course, a review of the 18 known factors is the last topic. Optional Day two is an intense review of the 18 known factors that cause overweight and underweight tablets. This six hour discussion is then followed by a shop floor session utilizing the firm’s available presses to attempt to produce overweight and underweight tablets resulting from one or more factors. There is an additional discussion on the advantages and disadvantages of dimensional sorting. Finally, a formal computer challenge is presented that approaches perfection in assuring that overweight/underweight tablets are not present in the batch produced.   652 pages, 400+ references.

  • This is the only course of its kind available today. This single day course is designed for departments wishing to better understand the science behind optimized DC powder preparation and tablet manufacturing. The course consists of two 4 hour classroom sessions and discusses common DC based tablet defects and problem solving. There is no hands-on session/no workshop. 451 pages, 263 references

  • This single day introductory course provides the specific knowledge needed to successfully compress various Multiple Unit Particle System formulas (MUPS). We will review specific examples of current formulas and their associated problems. The course emphasizes the critical operating parameters that must be present for successful MUPS tablet compression, based on current theory and good science. The course is 3-4 hours of theory, including requirements for reproducible content uniformity and dissolution results. This is followed by a shop floor demonstration on a tablet press; demonstrating the critical operating parameters for compressing MUPS tablets. 265 pages, 236 references

    We also offer an optional additional second day color coating module that discusses the technical issues associated with successful color coating of MUPS tablets. This module is 1.5 hrs in the class followed by a shop floor demonstration of successful MUPS film coating. 417 pages, 471 references.

  • This single day introductory course provides the specific knowledge needed to successfully compress various  OROS (Oral Osmotic) formulas. We will review specific examples of current formulas and their associated problems. The course emphasizes the critical operating parameters that must be present for successful OROS tablet compression/coating/drilling, based on current theory and good science. The course is 3-4 hours of theory, including requirements for reproducible content uniformity and dissolution results. This is followed by a shop floor demonstration on any available equipment; demonstrating the critical operating parameters for compressing OROS tablets. 265 pages, 36 references.

  • The course applies current science in the design and use of optimized punches for success on the press. We discuss the physical attributes of the punch, head flat, use of reliefs, tapered dies, types of steel to use and the various coatings available. We provide a checklist of tooling preparation items required for both polishing and buffing. We provide recommended materials for total preparation and installation of optimized tooling for the tablet press.

  • This is the only course of its kind available today. This two day+ course is designed for senior tablet press operators, maintenance mechanics, mechanical engineers, calibration technicians and people wishing to better understand the science behind optimized press maintenance. There is an initial 6 hour classroom session followed by multiple sessions on the production floor demonstrating and reinforcing concepts learned in the classroom. The number of production floor sessions depends upon the number of different press types (Fette/Korsch/Manesty etc presses)

  • This single day/two day course is engineered to provide a basic knowledge of a pharmaceutical or nutritional supplement coating operation. The course is comprised of a six hour classroom lecture covering the basic knowledge needed to understand the fundamentals of film coating, equipment, application and trouble shooting. This is immediately followed by a four hour hands-on demonstration in the coating room. Both book and course have a workshop with multiple problems to solve. The two day course has more time on the floor.  187 references, 348 pages.

  • This single day/two day course is engineered to provide a basic knowledge of classic sugar coating using either perforated or non-perforated coating pans. The course is comprised of a two-three hour classroom lecture covering the basic knowledge needed to understand the fundamentals of sugar coating, equipment, application and trouble shooting. This is immediately followed by a four hour hands-on demonstration in the coating room. Both book and course have a workshop with multiple problems to solve. 11 references, 148 pages.

  • This single day/two day course is engineered to provide a basic knowledge of a pharmaceutical  enteric or  extended release function coating operation. The course is comprised of a six hour classroom lecture covering the basic knowledge needed to understand the fundamentals of functional coating, equipment, application and trouble shooting. This is immediately followed by a four hour hands-on demonstration in the coating room. Both book and course have a workshop with multiple problems to solve. The two day course has more time on the floor.  187 references, 348 pages.

  • The course is the only advanced course of its kind given today. Students are presumed to have some knowledge of basic film coating. This is a two day course that covers advanced topics such as the effect of gun set up, pan pressure, inlet/outlet air temperature, spray rate, atomizing and pattern air and particle adhesion on pan surfaces and their direct impact on tablet defects. The course includes video examples of proper pan operation and highlights common problems in the pan. The course has a workshop and a problem solving session.  143 references, 444 pages.

  • This half day course is engineered to provide the student a full and complete understanding of how black and grey spots are produced. We present over 60 film coating formulas and discuss and link the probability of producing these common defects. Finally, we present a defense that may be used at any site and with any series of campaigns, regardless of the colors used. As an option, a full day course would have the lecture, followed by a hands-on demonstration in the coating room that is comprised of 1) a coating run producing black specs, 2) passivation of the pan and 3) a second coating run demonstrating that the black specs and grey smudges have been eliminated. Both book and course have a workshop with multiple problems to solve.  21 references, 135 pages.

  • This is a half day presentation for operators and line staff on the offset printing technology used in Pharmaceuticals and nutritional supplements. The course is considered the best tablet printing course in the world. The three hour classroom lecture is followed immediately by a two to four hour hands-on demonstration in the printing suite. Both book and course have a workshop with multiple problems to solve. 4 references, 141 pages.

  • This single day course is engineered to provide a basic knowledge of the theory and principles of pharmaceutical and nutritional supplement encapsulation, equipment selection, operation, and the advantages and disadvantages of each technology. The course is a four hour presentation immediately followed by a hands-on demonstration in the encapsulation suite.  All students are required to make both machine adjustments and perform in-process tests. The book and course contain a workshop with multiple problems to solve.  (a) 77 references, (b) 61 references, 235 pages.

  • Completely revised for 2017!  A single day presentation for operators and line staff on the principles of soft gelatin technology. The course also covers critical operating parameters, common defects and their root causes. The four to five hour lecture is followed immediately by a four hour hands-on demonstration in the soft gelatin manufacturing area. The book does not contain a workshop. 72 references, 285 pages.

     

  • The course is a single day presentation for operators and line staff on the WÜrster seed and particle coating technology. The four hour classroom lecture covers the principles of operation as well as machine set points and critical processing parameters. The lecture is followed immediately by a two to four hour hands-on demonstration in the WÜrster suite. Both book and course contain a workshop with multiple problems to solve. 123 references, 200 pages.

Single Subject Courses

  • We assume you know what you want in a formula or your customer told you what he wanted, but what comes next? Will it work, be cost effective, give more rework than it’s worth? This is a two day course that presents 11 different topics in basic formulating for both tablets and hard shell capsules. The topics covered are: introduction, understanding raw materials, dose sizing and potency calculations, basic tablet press operation; common problems and resolution, basic encapsulation; common problems and resolution, single entity vitamins, multiple entity vitamins, herbal formulas, sustained release vitamin formulas, and a formulating workshop. The text book covers all subjects and includes both a workshop and an optional final examination for certification as a formulator. 53 references, 601 pages plus 25 formulation problems to solve.

  • The course is a single day presentation for formulators and those interested in learning how to formulate and manufacture effervescent tablets. The course covers the principles of formulation, common excipients used and their application in effervescent tablet formulation. The book contains many examples of successful effervescent tablet formulas.  24 references, 220 pages.

  • A single day presentation for formulators and those interested in learning how to formulate and manufacture sublingual tablets. The course covers the principles of formulation, common excipients used and their application in sublingual tablet formulation. The book contains many examples of successful sublingual tablet formulas. 185 pages, 68 references.

  • A single day presentation for formulators and those interested in learning how to formulate and manufacture sustained release nutritional supplements. The book explains the various technical approaches to formulating a successful sustained release tablet. The course covers the principles of formulation, common excipients used and their application in sustained release tablet formulation. The book contains many examples of successful sustained release tablet formulas. 170 pages.

  • Blending problems and over-blending of the lubricant

    Successful tablet Compression of herbal products

    MUPS technology and manufacturing challenges

    Is pre-compression mostly misunderstood

    Anodized Aluminum and its effect (tablet presses)

    Automatic weight control, theory and discussion

    Bisects and tablet splitting, regulatory implications

    Capping and lamination

    Scale up in aqueous film coating

    The tablet compressing cycle, theory and explanation

    The glass transition phase and its effect on tableting

    Coating low hardness tablets

    Hygroscopicity and its effect on successful tablet production

    If the overload trips, what should I do?

    Lamination (cracks) and stability failures

    Orally disintegrating tablets

    The difference in pharmaceutical dyes and Lakes etc

    Slugging versus roller compaction

    Static electricity in blending and tablet compressing

    The paradox of high shear granulating

    The effect of correct blend occupancy on content uniformity and tablet hardness

    Selecting the correct steel for punches and dies

    Understanding Compressing Pressure:
    The maximum tip pressure and its’ relationships to tablet quality

  • MUPS technology and manufacturing challenges

    Is Pre-compression mostly misunderstood

    Hygroscropicity and Its’ Effect on Tablet Manufacturing

  • F.A. Rowley: “Overweight Tablets Are Not Going Away Anytime Soon”, presented to the US FDA, CDER Silver Spring, MD, May, 2011

     

    F.A. Rowley: “When Should We Stop The Tablet Press At Powder Run Out?”, presented to the US FDA, CDER Silver Spring, MD, October, 2014.

     

    *NOTE: Some courses are not available in countries where a prior agreement exists between Solid Dosage Manufacturing, Inc. and Vizen Lifesciences.

Formulating Courses

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