This document discusses plant layout for pharmaceutical manufacturing facilities. It begins by defining plant layout and its importance for efficient production. There are two main types of layouts: process/functional layout which groups similar machines together and product/straight line layout which arranges machines in the order of operations. Key factors that influence layout include the production process, available space, operational convenience, and regulatory requirements. Special provisions for pharmaceutical facilities include preventing confusion or contamination. Storage areas for raw materials and finished goods are also discussed, including specific storage requirements. The document concludes by outlining the layout of sterile or aseptic manufacturing areas which separate different operations and control air flow and personnel movement to maintain sterility.

1. PRESENTD BY :-
PATIL PRANJAY SADASHIV.
FIRST YEAR M.PHARM.
DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur

2. Content :-
 Introduction
 Type of Plant Layout
 Factors Influencing Plant Layout
 Special Provisions of Pharmaceutical Plant
Layout
 Storage Space Requirements
 Sterile or Aseptic Area Layout

3. Introduction:-
 Plant layout is a coordinated effort to achieve the final objective to
integrate machine, material and personnel for economic production.
 Plant layout involves the location of different departments and
arrangement of machinery in each department.
 Potential problems could be analysed rapidly and an alternative
solution could be found.
 A proper layout has the advantages from the point of workers, labour
costs, other production costs.

4. Types of plant layout:-
A. Process layout or functional layout:-
Functional layout are arrangement of machines of a particular class
doing a particular type of work or process as a separate department.
For example, all cutting machines may be placed in one department
i.e., cutting department
B. Product or straight line layout:-
Product layout are arrangement of machine doing various operation in
a line as one department.
For example, in the manufacture of tablet; dispensing, powder
blending, granulation, drying, drying blending, compression , coating etc.

5. FLOWCHART OF MANUFACTURING OF TABLETS

6. Factor influencing plant layout:-
1. Type of process and product control:- Smooth and
continuous flow in the process is desirable. The layout
should be flexible. The machinery is arranged in way that
the changes of production process can achieved at the
least cost or distance

7. 2. Space available and space required:- Cubic space utilization is
essential. Boxes or bags containing raw material and good can be
stacked one above the other. This is layout essential for
warehousing.
3. Operational convenience :- Facilities (machinery, raw material
and workers) are integrated in a logical and balanced manner. Free
movement of goods and out of the department is essential.
4. Economic distribution of utilities and services:- Minimum
movement of workers and machinery is essential.

8. 5. Type of building and building code requirements:-
Depending on the space, the choice between single and
multi-store building can be made.
6. Health and safety consideration:- working space should
be safe, well ventilated and free from dust, noise, fumes,
odours and other hazardous conditions.
7. Waste disposal problems.

9. Special provision of pharmaceutical plant layout
 The premises should be suitable for the purpose of drug
manufacturing.
 It mean that all possible measures should be taken to prevent
confusion or mixing-up of substance or material and
contamination.
 The building for the factory shall be constructed so as to permit
the production under hygienic conditions.

10. Storage space requirements:-
A. Storages-Location:- Ideally, the stores should be located
adjacent to the manufacturing area and finished goods nearer
to the shipping area, so that handling costs will be minimum.
Advantages
• stores has better supervision and control.
• It requires less personnel to manage and involves reduced cost.
• It facilities better inventory checks.
• Security arrangements can be effective
• Better layout of stores can be planned.

11. B. General Storage Space Requirements:-
1) Adequate storage facilities for raw materials, intermediate
products, recycle material, rejected material and fuels are
essential for the operation of a processing plant.
2) Adequate space facilities for stocking incoming raw
material, for their checking, sorting, inspection, temporary
sorting before they are placed at the proper location.

12. C. Special Storage Space Facilities:-
I. Special product that require low-temperature storage, special conditions
such as cool place, cold storage, freezer etc. are provide.
II. Highly toxic and dangerous substance.
III. Narcotic drug and alcohol must be stored separately.
IV. Substance that present the risk of fire or explosion should be separate.
V. Rejected or recoverable rejects.

13. D. Containers for Storage Materials:-
1. Bulk storage of liquids is generally handling by a closed spherical or
cylindrical tanks for preventing the escape of volatile material and
minimizing contamination.
2. Liquid material are stored in drums, cans, barrels and bottles.
3. Gases are stored ( bulk storage ) at atmospheric pressure in wet or dry-
sealed gas-holders. Gases are kept in cylinders.
4. Solid raw material are stored in weather-tight tanks. Solid are placed in
boxes, barrels, bags, containers etc.

14. E. Stores-Layout :-
The layout of stores is given in figure:

15. Sterile or aseptic area-layout
 Sterile medication product are prepared in a specially
designed and constructed manufacturing department.
 The different operations such as component preparation,
filling and sterilization are effectively separated from one
another.

16. The plan is considered in terms of air inlet-outlet,
personnel in-out and material in-out . This detail given
below

17. A. Air flow:-
The air (supply) enters from the back (horizontal) at a pressure of 5
mm water gauge above atmospheric pressure to the two Class 1 rooms.
The air leaves via vents to the Class-2 and to the changing rooms
(pressure 2 mm water gauge) flowing in from the inner door and venting
to the outside via the entrance door.
For toxic material handling, the pressurization will be designed to
ensure that no escape of substance is permitted through the airlock

18. B. Personnel movement:-

19. B. Personnel movement:-
 Access to aseptic area is restricted to authorized persons who
enter through air locked changing rooms, where normal clothing
is exchange for special protective garments.
 The rooms should be flushed with filter air at a protective
pressure lower than the clean area or aseptic area.
 From the point of entrance to the changing room till the
entrance of the aseptic area personnel move against the airflow
and

20. The area enclosed is in progressively cleaner
conditions (from black to grey areas)
• Changing and washing should be followed as per a written procedure (SOP).
• Changing room are usually divided into:
i. Black area-where normal protective garments (for e.g. lab coat) are removed,
separated by step-over bench
ii. Grey area-where hands are scrubbed and protective garments donned.
iii. White area-where over boots are put on and if necessary, sterile gloves

21. REFERENCE:-
C.V.S Subhramanyam
“Pharmaceutical production &
management” vallabh prakashan , first
edition 2005, page no 12-29.