This particular presentation will give idea about unit operations in tablet process. The information is in the flow chart form.

1. VALIDATION OF TABLET PROCESS
PRESENTED BY GUIDED BY
PRADNYA SHIRUDE Prof.Dr. M.R. Bhalekar
AISSMS COLLEGE OF PHARMACY

2. What is validation?
 Establishing documented evidence that provides a high degree of assurance
that a specific process will consistently produce a product meeting its
predetermined specifications and quality attributes.
 The field of validation is divided into a number of subsections
 Equipment validation
 Cleaning validation
 HVAC system validation
 Process validation
 Analytical method validation
2

3. Process Validation
Types of process
validation
• Retrospective process
validation
• Prospective process validation
• Concurrent process validation

4. STAGES OF PROCESS VALIDATION
1.Process design or pre-qualification
Stage based on the knowledge gained through development and scale up
activities
2.Process qualification
Capable of reproducible commercial manufacturing
3.Continued process verification
Ongoing assurance is gained during routine production that the process remains
in state of control.
PHASES OF PROCESS VALIDATION
1.Pre-validation phase
Example: formulation, pilot batch studies, scale up studies
2.Process validation phase
To verify that all established limits of the critical process parameters
are valid
3.Validation maintenance phase
Monitoring and improving control and reducing product and process

5. PROCESSING STEPS AND RESPECTIVE IN PROCESS VARIABLES DURING
TABLET MANUFACTURING

6. 1.MIXING OR BLENDING
Direct compression- one blending step
Wet granulation- two blending step
Prior to granulation to have a uniform drug/excipients
After milling the dried granulation to add other excipients, such as the lubricant
2.FACTORS AFFECTING TO THE DRUG/EXCIPIENT AND ITS
UNIFORM BLEND
Bulk density
Particle size distribution
Surface area

7. MIXING OR BLENDING OPERATION PARAMETERS
Mixing or blending technique
Mixing or blending speed/time
Drug uniformity
Lubrication
Distribution of colorant
Equipment capacity/load

8. WET GRANUATION
Low shear-e.g.Hobart
High shear-e.g.Diosna GEI-Collette
Fluid bed-e.g.-Glatt,fluid air
WET MASSING(FOR UNIFORM WEIGHT MASS)
Binder addition
Binder concentration
Amount of binder solution/granulation solvent
Binder solution/solvent addition rate
Mixing time
Granulation end point

9. DRYING
Factors
Air flow
Moisture uniformity
Equipment capacity
DRY MILLING
Mill type
Screen size
Mill speed and feed rate

10. TABLET COMPRESSION
Tooling
Compression speed
Compression ejection force
PROBLEMS OCCUR DURING
COMPRESSION STAGE
Appearance Capping, mottling
Hardness Mechanical shocks and aberrations
Friability Brittleness
Disintegration Thickness of the tablet
Weight uniformity Batch to batch variation

11. TABLET COATING
Surface chemistry and solid-liquid interaction is necessary for coating and printing
processes.
 Tablet coating parameters to be considered during development and
validation are as follows:
Pan coating
Inlet/exhaust temperature/humidity
Pan speed
Spray nozzle size and spray angle
Gun to bed distance and Tablets core characteristics

12. IN PROCESS TEST
TEST PARAMETERS
Moisture content o dried
granulation
Loss on drying- to determine whether
or not solvent is removed
Granulation particle size
distribution
Affect compressibility, hardness,
thickness-done by sieve analysis
Blend uniformity To analysed that drug is uniformly
dispersed or not-blend time
Individual tablets weight During compression-to ensure the
material is flowing properly and
consistently
Tablet thickness Determined periodically throughout the
batch-proper flow and compression
Tablets hardness Determined periodically throughout the
batch-to ensure that tablets are enough
for coating, packing and shipping and
not too hard to affect dissolution

13. FINISHED PRODUCT TESTS
TEST PARAMETRES
Appearance Mottling,picking of the monogram,
tablets filming and capping of the
tablets
Assay Determine whether or not the product
contains the labelled amount of drug
Content uniformity To ensure that the dosage form comply
with the standards
Tablets hardness Critical parameter to handle dosage
form and its performance
Tablets friability To check the ability to withstand
chipping,cracking or dusting during
packing operations
Dissolution To ensure proper drug release
characteristics and batch to batch
uniformity

14. ADVANTAGES OF VALIDATION
 Validation makes good business sense.
 Reduction in rejections and networks
 Reduction in utility cost
 Avoidance of capital expenditure
 Reduced testing process and finished goods
 Easier maintenance of process
 More rapid automation

15. REFERANCES
 Functional overview of process validation of tablets-A
critical review, Manasa S Reddy, Chandramouli R, Journal
of pharmaceutical research volume 16, issue 3Jul-sep
2017-268
 The theory and practice of industrial pharmacy by Leon
Lachamn, H. Liberman, J. Kanig, published by Varghese
publishing house, third edition, pg no.293-373
 http://www.researchgate.net
 www.vtu.com/ms&t/biotech

16. THANK YOU!