Oral Solid Dosage Forms: Process Monitoring Techniques and Challenges in Scale-Up and Technology Transfer (T10)

Level: Fundamental
Type: Classroom Training Course
ISPE CEUs: 1.3

Date Location Country Instructor(s)
24-25 October Berlin Germany Rob Walker

Description

Oral Solid dosage forms (Tablets and Capsules) are some of the most popular and convenient methods of drug delivery. They can be produced in a non-sterile environment and the process, equipment and technology is well defined and known, after more than 100 years of development. With the high volume of products produced in this dosage forms, it is important that the unit operations for their production be thoroughly understood. This course focuses on the fundamentals of each discrete processing step (unit operation) required for the manufacture and packaging of tablets and capsules.

The course will begin with a description of the three main OSD processing methods: Direct Compression, Wet Granulation and Dry Granulation. It will continue with a detailed review all of the major unit operations associated with OSD manufacturing process. This includes: Ingredient Dispensing/Formulation; Blending; Granulation; Drying; Compression/Encapsulation; Coating; Packaging and Miscellaneous Operations.

The course will focus on the process, equipment and technology associated with the unit operation, giving the attendee a general understanding of the OSD process and many of the issues, considerations and related concerns. The specific types of equipment and technology used in today’s modern manufacturing process will be discussed and attendees will gain an appreciation for the selection and evaluation criteria of such. For example, a discussion of granulation will include information on different types of granulators (low shear, high shear, top drive, bottom drive, integrated processing trains) and typical challenges encountered during operation and scale-up.

A variety of process monitoring techniques will also be discussed. The course will review many known techniques for process monitoring with particular emphasis on their utilization in scale-up and technology transfer, final dosage unit and analyze the necessary steps in the packaging operation to get from the finished tablet or capsule to the final filled and sealed container. Introduction to packaging equipment for tablet/capsule counting, capping, security seals and bands, labeling, cartoning, and blister packaging will also occur. The course will conclude with a discussion on technology transfer, how to get the product from the R&D laboratory to full-scale manufacturing, and how to transfer a marketed product from one facility to another. A competency test will be administered upon course completion.

Baseline Guide Cover Image

Immediately apply the course learning objectives with the complimentary copy of the ISPE Baseline Guide®: Oral Solid Dosage Forms.

Course Modules

  • Overview and Expectations, OSD Trends of Operational Integration and Continuous Manufacturing Processes
  • Facility and Critical Utilities
  • Formulation Background
  • Process Development & Scale
  • Mixing and Blending
  • Granulating Technologies
  • Drying and Sizing
  • Compacting
  • Encapsulating
  • Coating
  • Packaging
  • Process Analytical Technologies
  • Process Validation (newly issued FDA guidance)
  • References

Take Back to Your Job

  • Discuss the theory behind basic unit operations
  • Explain different methods for performing a unit operation
  • Describe how product characteristics dictate the unit operations method
  • Identify the types of equipment utilized to perform unit operations
  • State how the good manufacturing practice (GMP) influences unit operations and subsequent equipment design, production suites design, control and monitoring requirements
  • Utilize process monitoring techniques during the scale-up and technology transfer exercises

Attendance Suggested For

  • New pharmaceutical solid dosage unit professionals
  • Individuals with significant expertise from another industry who need to learn about solid dosage unit operations
  • Those with significant pharmaceutical industry experience who now have solid dosage responsibilities and want to gain a fundamental understanding of unit operations and equipment used to manufacture, package, and test solid dosage products

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Production Systems: Production Unit Operations - Drug (small molecule) and Biologics and Product Development: Formulation, clinical phases and manufacture. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Oral Solid Dosage Community of Practice (COP).

Continuing Education Units  

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

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