What works for 100 tablets may completely fail for 1 million. This simple truth highlights why pilot plant operations and scale-up are considered the most decisive stages in drug manufacturing.
Pilot Plant - It is the part of the pharmaceutical industry where a lab-scale formula is transferred to a viable product by the development of a liable & pratical procedure of manufacture.
Scale-up - It is the art of desgining of prototype using the data obtained from a pilot plant model.
Importance of Pilot Plant -
- Process validation - Verify that the process works at a larger scale.
- Risk reduction - Identify & address potential issues before commercial scale.
- Innovation & Improvement - Test new ideas & improve existing processes.
- Product Quality Assurance - Ensure product Quality & consistency.
Steps in Scale-up:
Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing cost.
↓
Conduct Laboratory studies and scale-up planning at the same time.
↓
Define key ratter controlling steps in the proposed process.
↓
Conduct preliminary larger-than-laboratory studies with equipment to be used in the rate-controlling step to aid in plant design.
↓
Design and contract a pilot plant that includes provisions for process and environmental controls, cleaning and sanitizing systems, packaging and waste handling systems, and meets regulatory agency requirements.
↓
Evaluate pilot plants’ results (Product and process), including process economics to make any corrections and a decision on whether to process or not with a full-scale plant development.
Reference:
- Sampath Kumar, K. P., Bhowmik, D., Bhanot, R., & Goswami, S. (2020). Industrial pharmacy-II (1st ed.). Nirali Prakashan.
MBH/PS