The document discusses considerations for scaling up a pilot plant for solid dosage forms production. Key features for the pilot plant include facilities for material handling, chemical weighing, dry blending, granulation, drying, particle size reduction, and compression. Material handling systems should accurately deliver materials to prevent cross-contamination. Chemical weighing is often centralized for efficiency. Dry blending must be thorough to ensure uniform drug distribution. The pilot plant equipment and processes should mimic production to effectively test scale-up.

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