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

6. 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.

7. 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

8. • 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