This document provides information on architectural layout and design considerations for pharmaceutical facilities. It discusses requirements for premises, building construction, and flooring and wall materials to allow for hygienic drug manufacturing conditions. The presentation outlines the process for designing a facility layout, including developing an accommodation schedule, conceptual layout, and final facility and equipment layout. It also describes design features for cleanrooms, airflow pressurization between rooms, and finishing materials for floors, walls, ceilings, and doors.

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Special Provisions
for pharmaceutical industry
&
Plant layout
Presented By

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CONTENTS
S.NO. Title SLIDE NO.
1. SPECIAL PROVISIONS 3
2. GMP CFR 21 PART 211.42 4
3. DESIRABLE ARCHITECHTURAL LAYOUT 5-8
4. MATERIALS OF CONSTRUCTION & SURFACE FINISHES 9-17
5. REFERENCES 18
6. ACKNOWLEDGEMENT 19-20
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SPECIAL PROVISIONS
• T h e p r e m i s e s s h o u l d b e s u i t a b l e f o r t h e p u r p o s e o f d r u g
m a n u f a c t u r i n g .
• T h e b u i l d i n g f o r t h e f a c t o r y s h a l l b e c o n s t r u c t e d s o a s t o p e r m i t t h e
p r o d u c t i o n u n d e r h y g i e n i c c o n d i t i o n s .
• T h e y s h a l l c o n f o r m t o t h e c o n d i t i o n s l a i d d o w n i n t h e F a c t o r i e s A c t ,
1 9 4 8 ( 6 3 o f 1 9 4 8 ) .
• Any part of the building used for manufacture shall not be used as resting place.
• The walls of the room in which manufacturing operations are carried out shall:
• Have a height of six feet from the floor.
• Be smooth and waterproof.
• Be capable of maintaining cleanliness.
• Have no cracks or crevices.
• The flooring shall:
• Be smooth, even and washable.
• Be in such a way as not to permit any retention or accumulation of dust.
• Have no cracks or crevices.
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GMP’S 21 CFR PART 211
- S U B PA R T C - B U I L D I N G A N D FA C I L I T I E S
2 1 1 . 4 2 D e s i g n a n d C o n s t r u c t i o n F e a t u r e s
a ) A n y b u i l d i n g o r b u i l d i n g u s e d i n t h e m a n u f a c t u r e ,
p r o c e s s i n g , p a c k i n g o r h o l d i n g o f a d r u g p r o d u c t s h a l l b e o f
a s u i t a b l e s i z e , c o n s t r u c t i o n a n d l o c a t i o n t o f a c i l i t a t e
c l e a n i n g , m a i n t e n a n c e a n d p r o p e r o p e r a t i o n s .
b ) A n y s u ch b u i l d i n g s h a l l h a ve a d e q u a t e s p a c e f o r t h e
o r d e r l y p l a c e m e n t o f e q u i p m e n t a n d m a t e r i a l s t o p r e ve n t
m i x - u p s b e t w e e n d i f f e r e n t c o m p o n e n t s, d r u g p r o d u c t
c o n t a i n e r s, c l o s u r e s, l a b e l i n g , i n p r o c e s s m a t e r i a l s, o r
d r u g p r o d u c t s, a n d t o p r e ve n t c o n t a m i n a t i o n .
c ) T h e f l o w o f c o m p o n e n t s, d r u g p r o d u c t c o n t a i n e r s,
c l o s u r e s, l a b e l i n g , i n - p r o c e s s m a t e r i a l s, a n d d r u g
p r o d u c t s t h r o u g h t h e b u i l d i n g o r b u i l d i n g s s h a l l b e
d e s i g n e d t o p r e ve n t c o n t a m i n a t i o n .
d ) O p e r a t i o n s s h a l l b e p e r f o r m e d w i t h i n s p e c i f i c a l l y d e f i n e d
a r e a s o f a d e q u a t e s i ze .
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ARCHITECTURAL LAYOUT
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ACCOMODATION
SCHEDULE
FACILITY &
EQUIPMENT
LAYOUT
CONCEPTUAL
LAYOUT
• The designer must understand the product and process
requirements.
• Accommodation schedule is the first step followed by conceptual
layout and facility layout of the pharmaceutical industry.
• Facility layout must be an integrated design that satisfies the
following:
1. Process requirements
2. Personnel flows
3. Material flows (product, component and raw material movements)
4. Equipment layout requirements
5. Operational access requirements
6. Maintenance access requirements

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ACCOMMODATION SCHEDULE
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• Accommodation Schedule:
• Defines all areas that can influence unit operations required for
manufacturing as well as the relationships and flows between them
• Materials and personnel are primary focus
• Can be developed once the process is known
• All process flow diagrams should be complete
• Also referred to as logic diagrams, or bubble diagrams

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CONCEPTUAL LAYOUT
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• Conceptual Layout Design defines as an early phase of the design
process, in which the broad outlines of function and form of
something are articulated.
• It provides a basic idea of the client vision of the project. Therefore,
the conceptual design involves an understanding and visualization of
your needs.
• The Conceptual Layout drawing communicates graphically the
details, the general look and feel of the design without all the detailed
engineering and development. It is the starting point of development,
the center of conversation in a design review that prepares
engineering for the research tasks at hand.
• Derived from Accommodation Schedule and equipment sizing needs.
• Building blocks of equipment lines are developed.
• Blocks of rooms are assembled based on necessary adjacencies and
process requirement.

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FACILITY & EQUIPMENT LAYOUT
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• Scaled drawing derived from conceptual layout
• Defines precise room sizes, structural grids, access routes
• Building and fire codes, means of egress are established in this phase.
• Building blocks of equipment lines are developed
• Blocks of rooms are assembled based on necessary adjacencies and
process requirements
• Part of detail design phase of project life cycle
EQUIPMENT LAYOUT FOR DISTILLATION
TOWER

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MATERIALS OF CONSTRUCTION & SURFACE FINISHING
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FLOORING
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• Flooring: Consider aesthetics, durability and cleanability
• Epoxy terrazzo:
• – hard, durable long-lasting surface with excellent chemical resistance
• – Very expensive to install
• Epoxy Resin Systems: (e.g. Stonhard)
• – Very popular in the Pharmaceutical industry
• – Easier to install than Terrazzo
• – Moderate durability and chemical resistance
• – Moderate price
• Welded Vinyl/PVC Sheet (e.g. Mipolam)
• – Durability an issue in high-traffic areas
• – Often used with identical wall system for matching

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SURFACE FINISHING
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• Cove base tiles are usually used at the base of tiled walls in lieu of
tile baseboards, to create a seamless and watertight transition
between the wall and the floor.
• And that's their primary purpose: cove base tiles cover the joint at
which two surfaces meet in a way that keeps moisture out.
• Radius cove base typically used in modular construction.
• Cornered edges should be retrofitted and covered by cove base to
prevent collection and accumulation of dust in cornered edges.

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CEILING SYSTEMS
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• Gypsum Wall-board (GWB) with finish coat of epoxy paint
– Pro’s:
• Flexible, easy to use
• Most common in the industry
-- Con’s:
• Restricts future above-ceiling access
• Requires careful coordination with other processes during
construction. (e.g. piping penetrations, HVAC diffusers, light fixtures,
filter housings).
• For Class 100 and Class 10,000 (Grade A and Grade B areas), radius
coves are often used in the ceiling to wall junction as well

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VISION PANELS
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• Flush with the wall to eliminate ledges.
• Often Stainless frame, double pane.
• Free of gaps along the perimeter.
A. SIDE VIEW
B. FRONT VIEW

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CLEANROOM AND DOORS
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• It is a facility ordinarily utilized as a part of specialized industrial
production ,designed to maintain extremely low levels of
particulates, such as dust, airborne organisms, or vaporized particles.
Cleanrooms typically have a cleanliness level quantified by the
number of particles per cubic meter at a predetermined molecule
measure.
• ISO 14644-1 defines the maximum concentration of particles per class and
per particle size with the following formula.
• CN= 10N(0.1/D)2.08
• Where is CN the maximum concentration of particles in a volume of 1m3 of
airborne particles that are equal to, or larger, than the considered particle size
which is rounded to the nearest whole number, using no more than three
significant figures, N is the ISO class number, D is the size of the particle
in µm and 0.1 is a constant expressed in µm.
• Full glass or half glass architectural aluminum doors are available with a
variety of hardware options, including pivot hinges, surface mounted closers,
concealed closers, panic hardware, and locksets.

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Classification Levels within an Pharmaceutical Facility
Manufacturing Zones (Five Zones)
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ROOM PRESSURISATION
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• US FDA and EU, MHRA, ISO requires
that rooms of higher grade must be at
higher pressure levels.
• Typically 0.05” water column difference
between classes.
• Ensures air flows from cleaner areas to
dirtier areas. Class 100 filling rooms
always have the highest pressure.
• How do you calculate water column?
• To calculate the hydrostatic pressure at the
bottom of the container consider: H = 8 inches
of water SG = 1 P = x PSI P=1 • 8 inches = 8
inches W.C. So the hydrostatic pressure (P) at
the base is equivalent to 8 inches of water
column. 1 inch of water column = 0.03613 PSI
(27.678 inches of water column = 1 PSI).

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CASCADING ROOM PRESSURE AT DIFFERENT ZONES
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ARRANGEMENT OF PRESSURE
LEVELS SUCCEEDING IN
DIFFERENT REGIONS
THROUGHOUT THE PRODUCT
LIFECYCLE ACROSS
PHARMACEUTICAL
MANUFACTURING PLANT.

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REFERENCES
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• Pharmaceutical Production And Management, Prof. C.V.S. Subrahmanyam; Principal, Gokuraja
Rangaraju College of Pharmacy; First Edition, 2005; Vallabh Prakashan.
• PhEn-602, Pharmaceutical Facility Design, Notes #8, Prof. Joe Manfredi, Department of
Chemical Engineering ,New Jersey Institute of Technology; Spring 2009, NJIT Course.
• CODE OF FEDERAL REGULATIONS, NATIONAL ARCHIVES, U.S. , Title 21,Chapter 1,
Subchapter C , cGMP for Finished Pharmaceuticals ,Part 211.42 Design and Construction
Features.

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“
In a battle between Doctors and disease,
the one who always wins the
pharmaceutical company. Pharma industry
is the art of making billions from
milligrams”.
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THANK
YOU