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Pilotplantscaleuptechniquesusedinpharmaceuticalmanufacturing 131002222820 Phpapp02
Pilotplantscaleuptechniquesusedinpharmaceuticalmanufacturing 131002222820 Phpapp02
Pilotplantscaleuptechniquesusedinpharmaceuticalmanufacturing 131002222820 Phpapp02
SCALE- UP TECHNIQUE
By
SUNILBOREDDY
Contents
Definition
Objectives
Steps in scale-up
General considerations
GMP considerations
Advantages and Disadvantages
Scale up of liquid dosage forms.
Scale up of semisolid dosage forms.
Contract manufacturing.
References
Definitions
Plant:- It is a place were the 5 Ms like money, material, man,
brought
together
for
the
Objective
To try the process on a model of proposed plant before
Objective
To identify the critical features of the process
Guidelines for production and process controls.
To provide master manufacturing formula with
STEPS IN SCALE UP
Design and construct a pilot plant including provisions for process and
environmental controls, cleaning and sanitizing systems, packaging and
waste handling systems, and meeting regulatory agency requirements
General considerations
1.
Reporting Responsibility
R & D group
with separate
staffing
2. Personnel Requirement
Scientists with experience in pilot
plant operations as well as in actual
production area are the most
preferable.
As they have to understand the intent
of the formulator as well as
understand the perspective of the
production personnel.
The group should have some
personnel
with
engineering
knowledge as well as scale up also
involves engineering principles.
3. Space Requirements
Administration
and information
processing
Physical
testing area
Standard
equipment
floor space
Storage
area
space:-
Storage Area
It should have two areas divided
as approved and unapproved
area for active ingredient as well
as excipient.
Different areas should provided
for the storage of the in-process
materials, finished bulk products
from the pilot-plant & materials
from the experimental scale-up
batches made in the production.
Storage area for the packing
material should also be provided.
Why?
Raw materials used in the small scale production cannot
necessarily be the representative for the large scale
production
8. Process Evaluation:-
Drying temp.
And drying time
Screen size
(solids)
Filters size
(liquids)
Order of mixing of
components
PARAMETERS
Mixing
speed
Mixing
time
Rate of addition of
granulating agents,
solvents,
solutions of drug etc.
Weight sheet
Processing
directions
Manufacturing
procedure
10. Product stability and uniformity:The primary objective of the pilot plant is the physical as
well as chemical stability of the products.
Hence each pilot batch representing the final formulation
and manufacturing procedure should be studied for
stability.
Stability studies should be carried out in finished packages
as well.
GMP
CONSIDERATION
Equipment
qualification
Process validation
Regularly schedule preventative maintenance
Regularly process review & revalidation
Relevant written standard operating procedures
The use of competent technically qualified personnel
Adequate provision for training of personnel
A well-defined technology transfer system
Validated cleaning procedures.
An orderly arrangement of equipment so as to ease
Advantages
Members of the production and quality control divisions
Disadvantages
The frequency of direct interaction of the formulator
Liquid orals
The physical form of a drug product that is pourable
solutions.
A solution
Formulation aspects of
oral liquids
Suspensions:
Purpose
Agent
-wetting agents
Salt formation ingredients
- Buffering-systems, polymers,
antioxidants
Sweeteners, flavorings
Formulation aspects of
oral liquids
Emulsions:
Purpose
Agent
Particle Size
Buffering-systems,
antioxidants, polymers
Colorings, Emulsifying
agents, Penetration
enhancers, gelling agents
Taste/smell masking
Sweetners, flavorings
Buffers, antioxidants,
preservatives
Maintaining the
appearance
Taste/smell masking
Sweeteners, flavorings.
Equipments
Mixer
Homogenizer
Filteration assembly
Bottling assembly
Filtration assembly
Measured and
weighed
Mixing
Distilled water
Filling
Packing
Quality Assurance
Quality assurance
Dissolution of drugs in solution
Potency of drugs in suspension
Temperature uniformity in emulsions
Microbiological control
Product uniformity
Final volume
Stability
Critical manufacturing
parameters
For a true solution, the order in which solutes are added
to the solvent is usually unimportant.
The same cannot be said for dispersed formulations,
Critical manufacturing
parameters
Critical manufacturing
parameters
Variations in the manufacturing procedure
that occur
after either of these events are likely to be critical to the
characteristics of the finished product.
also be considered:
1. In most cases, except those involving scale-up,
Contract manufacturing
Definition of contract
manufacturing
Contract manufacturing
Contract manufacturing is a process that established a
Contract manufacturing.
The
basic
working
model
used
by
contract manufacturers translates well into many different
industries.
Contract manufacturing
Even industries like personal care and hygiene products,
Contract manufacturing
At the same time, the manufacturer will demonstrate how the
arrangement.
production for one, two and even five year periods makes it
much easier to forecast the future financial stability of the
company.
Contract manufacturing
For the client, there is no need to purchase or rent
Contract manufacturing
All the client has to do is generate sales, forward orders to the
vendor, then resell the services at a profit to their own client base
Scopes of contract
manufacturing
The
Scopes of contract
manufacturing
Limits of contract
manufacturing
The Contract Manufacturing Procurement business scenario
date and quantity data originally requested are lost. Even if the
information is stored in SAP SNC, it is not possible to send this
information to the CM.
The Contract Manufacturing Procurement business scenario is
Limits of contract
manufacturing
No data import control functions are provided for messages
allowed.
Limits of contract
manufacturing
A supplier should be able to update the component
consumption in SAP SNC until a good receipt has been
posted in the customer ERP back-end system.
The subcontracting scenario of the Rosetta Network Order
Reference
The theory & practice of industrial pharmacy by Leon