Oral Solid Dosage Forms
Process Monitoring Techniques and Challenges in Scale-Up and Technology Transfer

 ISPE CEUs*: N/A 
Type: Classroom Training Course

Upcoming Dates and Locations

Date Location Country Instructor(s) This course is not currently scheduled, but may be conducted on-site. Please contact ISPE Customer Service.

Description

Solid dosage forms are some of the least expensive, most popular and convenient methods for drug delivery. They can be produced in a non-sterile environment and the technology is well-known after more than 100 years of development. Since most pharmaceuticals are produced in solid 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 most common of solid dosage forms.

The course will begin by examining the finished dosage unit and will identify, in general terms, all unit operations required to get the unit into its finished form. Examples of these unit operations include blending, granulating, compressing, branding, and coating for tablets, as well as blending and filling for capsules. Once unit operations have been identified and defined, product characteristics will be examined to determine the type of equipment utilized in each of these operations.

This course will cover questions such as:

• Is the product hygroscopic?
• Is it toxic?
• Is it water soluble?
• Will it tolerate shear?
• Can it use direct compression or is it necessary to produce a granulation?

The specific types of equipment for each unit operation will also be discussed. For example, a discussion of granulation will include information on different types of granulators and typical challenges encountered during scale-up.

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. The course will also cover the 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. Topics for discussion will include packaging equipment for tablet/capsule counting, capping, security seals and bands, labeling, cartoning, and blister packaging.

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.

This course contains knowledge related to the CPIP™ technical knowledge competency elements Product Development and Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ispe-pcc.org.

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
• 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

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 mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.