Basic Structure Of Pharmacuetical Plants.pdf

on plant of medicine

1. Basic Structure Of PharmacueticalPlants

2. INTRODUCTION
Pharmaceuticalmanufacturingplantsarefacilitieswhere
pharmaceuticalproductsareproduced.Thesefacilitiesare
designedtomeetstringentqualitystandardstoensurethatthe
productsproducedaresafe and effective for human use.

3. Basic Structure :
•Pharmaceutical manufacturing plants are typically designed with a cleanroom environment that prevents
contamination of the products. The facility is divided into different areas such as production areas, packaging
areas, quality control areas, and storage areas.
•The basic structure of a pharmaceutical manufacturing plant is designed to meet the requirements of Good
Manufacturing Practices (GMP) and to ensure that the products produced are safe and effective for human use.
The facility is typically divided into different areas, each with its own specific purpose and functions

4. •The production areas are designed with a cleanroom environment that prevents
contamination of the products. These areas are typically arranged in a linear fashion,
with materials flowing from one area to another. The production area is divided into
different sections, such as fermentation, synthesis, purification, and drying, each with
its own specific functions.
•The formulation section is where the active pharmaceutical ingredients (APIs) are
formulated into the final product. This section is divided into different areas such as
granulation, compression, coating, and packaging

5. Pharmaceutical Plant Layout:
➢plant layout is a coordinate effort to achieve the final objective to integrate machines,
materials and personnel for economic production.
➢It involves the location of different departments and arrangement of machinery in each
department.
➢plant layout characteristics:
1. Provide space for machine/materials/storage/etc.
2. Flexible for future changes in capacity/ design/process etc
3. Deals with government rules & regulations
4. Safety of employees
5. Achieve economy

6. Types Of Plant Layout :
A.Process layout/ functional layout
B. Product/ straight line layout
➢Process layout:
The arrangement of machines of a particular class doing a particular type of work or
process as a separate department.
➢Product layout:
The arrangement of machines doing various operations in a line as one department....

7. Plant’s Layout

8. Production planning
➢Production is isa process of converting a set of inputs, namely men, capital, information and
energy into finished products or services. When a series of operations are involved in the
production, planning improves efficiency and effectiveness.
➢Production planning is the detailed preparation of a plan to manufacture a product.
➢Planning needs-
▪Quality of products to be produced with specifications
▪Quantity of products
▪Sequence of operations
▪Std. time for each operation
▪Availability of equipment
▪Std. time required for completion of process
▪Commencement of the operation

9. Steps involved in production planning
Productionbudget Selection of process
Selectionof
materials,methods
andmachinery
Selection of layout
Setup time & route
sheet process

10. 1.Planning of process:
•Consideration of cost of production
•Change the unit operation or equipment such as tray drying to FBD
•Product specifications to be considered
2. Planning of materials
•Once process is selected, the materials, tools should be selected.
•Should be of quality and right chemical compositions.
•Qualified vendors
3. Planning of process layout
•Should indicate every operations and their sequences.
4.Setup time
5. Route sheet
•These documents summarize the flow of operations or sequences of operations
•These route sheets are prepared and dispatched to production department

11. Factors affecting plant layout
Plant location & building
Space available & space
required
Waste disposal
problems
Production process
Typeofmachinery
Repairs & maintanance
Human needs
Plant environment

12. Special provisions of plant layout
1.Premises should be suitable for the purpose of drug manufacturing & should premixing ups of materials.
2.Building for the factory shall constructed so as to permit the production under hygienicconditions.
3.They shall conform to the conditions laid down in the Factories Act, 1948.
➢Any part of the building used for manufacturing shall not be used as sleeping place..
➢The walls of the rooms in which manufacturing operations are carried out shall have a height of feet from
the floor & waterproof.
➢The flooring shall be smooth, even and washable and do not permit any dust.
➢Floor should not have any chinks or crevices.
➢Buildings are arranged to permit economic production
➢Successive Unit operations can be done in adjacent rooms without superfluous transportation
➢Adequate facilities should be maintained to provide safety and fire protection.
➢Installation of devices in every process-room is essential so that in time of emergency the power supply can
be immediately cut off from the transmission machinery.

13. Storage space requirements
Adequate storage should be allocated for different materials and supplies.
►Sufficient additional storage facilities should be provided for any possible
increase in supplies.
►Stores-location
1.Should be located adjacent to the manufacturing area and finished
goods nearer to the shipping area, so that handling costs will be minimum.
2. Location of stores depend upon the nature and value of items to be
stored and the frequently which items are received.
3. Facillatesbetter inventory checks.
►

14. General storage space requirement
•Adequate storage facilities for raw materials, intermediates, reject materials etc, are essential
•Adequate space facilities for stocking incoming raw material, for their checking sorting,
inspection before they are placed at proper location.
•Adequate space should be provided for storing the tools and other supplies
•Storage space for packaging materials
•Special products that requires low temp., special conditions such as cold place are provided.
•Special storage facilities should be provided separately for the following products;
➢Highly toxic and dangerous substances
➢Narcotic drugs
➢Explosive & flammable
➢Rejected or recoverable

15. Containersforstorage of materials
➢Bulk storage of liquid is generally handled by a closed spherical tanks forpreventingthe escape
of volatile material. (drums, can, barrels etc.)
➢Liquids with V.P. above atmospheric pressure must be stored in vented tanks.
➢Gases are stored in atmospheric pressure in wet or dry sealed gas holders.
➢Solid raw materials are stored in wethertight tanks with sloping roofs. (boxes, barrels, bags,
pallets etc.)

16. Store layout
The layout of cores is given in
figure
1.Incoming material receiving
gate
2. Place for keeping raw material
3. Aisles for storing materials
4. Special storage
5. Office and record room
6. Dispensing area
7. Countersforkeeping materials
to be issued

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