Pilot plant scale up consideration for solids.pptx

unit 1 of industrial pharmacy 2 of b pharm sem 7

1. Pilot plant scale up consideration for solids

2. Introduction The product developed should be efficient, economical, and consistently reproducible on a production scale. The design and construction of pharmaceutical pilot plant should have feature that facilitates maintainance and cleaning. Features in the pilot plant design : Fluorescent lighting fixtures should be the ceiling flush type. The operating areas should have floor drains to simplify cleaning. The area should be air-conditioned and humidity controlled. Equipment in the pharmaceutical pilot plant should be similar that used by production division- manufacture of tablets.

3. SOLIDS DOSAGE FORMS MATERIAL HANDLING CHEMICAL WEIGHING DRY BLENDING GRANULATION DRYING REDUCTION OF PARTICLE SIZE SPECIAL GRANULATION TECHNIQUE DRY BLENDING DIRECT COMPRESSION SLUGGING (DRY GRANULATION)

4. MATERIAL HANDLING In labs, material are scooped, dumped or poured by hands.This may also work in small or intermediate sized operations But for large scale operations, mechanical means of handling is necessary. Mechanical devices Lifting and tilting drums Vacuum loading systems Screw feed systems Metering pumps Selection of system depends on material characteristics-Density or static charge Deliver accurate amount of material at destination Accountability and compensation In case of more than one product-preventive measures for cross contamination should be taken- validated cleaning procedures

5. Chemical weighing Many companies have introduced central weighing department for all process areas Advantages- Centralization of responsibilities Avoidance of duplication of weighing facilities Lower labor cost After weighing, the item is entered and signed on batch sheet by a checker, properly packaged & identified. No need additional weighing at time of usage.

6. DRY BLENDING • Powders to be used for encapsulation or to be granulated must be well blended to ensure uniform drug distribution Inadequate blending at this stage could result in discreteportion of the batch being either high or low in potency. A larger batch is dry blended and then divided in multiple smaller section for granulation. Ensure that all the ingredients are free of lumps and agglomerates

7. EQUIPMENTS V- blender Double cone blender Ribbon blender Sigma blade blender Slant cone blender Bin SCALE UP CONSIDERATIONS Time of blending Blender loading Size of blender