Pilot Plant Scale Up Techniques [Industrial Pharmacy-2] Unit 1 B.Pharmacy 7th Semester 2025 (2024-2025) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

This comprehensive document explores pilot plant scale-up techniques, bridging laboratory formulations to industrial production in the pharmaceutical industry. Key highlights include:

• Core Concepts:

  • Definition of pilot plants as intermediaries for transforming lab-scale formulas into viable products.

  • Objectives: Cost-effective prototyping, critical process validation, and avoiding scale-up pitfalls.

• Operational Considerations:

  • Personnel: Multidisciplinary teams (scientists, engineers) with expertise in R&D and production.

  • Space Requirements: Dedicated areas for testing, equipment, storage, and administrative functions.

  • Equipment: Selection of scalable, efficient machinery to minimize waste and ensure reproducibility.

• Process Optimization:

  • Solids Handling: Dry blending, granulation (wet/dry methods), and compression for tablets.

  • Liquids & Semi-Solids: Parameters for mixing, filtration, homogenization, and viscosity control.

  • Stability Studies: ICH-compliant accelerated and forced degradation tests.

• Regulatory Compliance:

  • SUPAC Guidelines: FDA frameworks for post-approval changes (IR, MR, SS dosage forms).

  • Platform Technologies: Modular designs for sustained-release formulations and medical devices.