Pilot Plant Scale-Up Techniques Introduction General Considerations during Pilot Plant Scale-up Need of Pilot Plant Studies State Drug Control Organization Uses of Pilot Plant General Requirements for Pilot Scale and Scale-up GMP Considerations Scale-up Pilot Plant Design for Tablets Pilot Plant Scale-up Techniques for Capsules Manufacturing of Hard Gelatin Capsules Manufacturing of Soft Gelatin Capsules Soft/Liquid-filled Hard Gelatin Capsules Scale-up Liquid Orals Formulation Aspects of Suspensions Formulation Aspects of Emulsions Formulation Aspects of Solutions Semi-solid Dosage Forms Pilot Plant Operation Scale-up and Post Approval Changes (SUPAC) Introduction to Platform Technology
UNIT-I (10 Hours)
Pilot Plant Scale-up Techniques: General considerations – including significance of
personnel requirements, Space requirements, Raw materials, Pilot plant scale-up considerations for solids, liquid orals, semi solids and Relevant documentation, SUPAC guidelines, Introduction to platform technology.
After completing this chapter, students will be able to understand:
It is a part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by the development of liable practical procedure for manufacture.
Bench studies (Product characterization purity).
Animal studies (toxicology, Pharmacokinetics PME, efficiency).
Increasing compliance with regulations as product moves through testing and
Increasing knowledge about the product.
Increasing knowledge about the possible problems, snags, pitfalls with manufacture processing, packing, storing and installing the product.
Ultimately facilitation of the transfer of product from laboratory into production
1. What do you mean by pilot plant scale-up? Give examples.
2. What is the significance of pilot plant scale-up with routine production procedure?
3. Explain the procedure for pilot plant scale-up for liquid orals.
4. Explain the procedure for pilot plant scale-up for semisolid dosage form.
5. Explain the procedure for pilot plant scale-up for liquid dosage form.
6. What do you mean SUPAC?
7. Write a short note on pilot plant scale-up for solid dosage form