THIS PRESENTATION DESCRIBE ABOUT DIFFERENT FACTORS RELATED TO PARENTERAL PREPARATION OR PRODUCTION MAINLY AND HAVE DIFFERENT SPECIAL TERMS RELATED TO PARENTERAL DEPARTMENT ,BENEFECIAL FOR THE PHARMACY STUDENTS BOTH B.PHARM OR M.PHARM OR BIOTECHNOLOGY MAINLY

1. Presented by :Neha singh
M.Pharm 1st semester
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2. content
 Introduction
 Need of design consideration for parenteral
 Environmental control zones
 Design concepts
 HEPA filters
 Laminar air flow system
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3. Introduction
parenteral
Made up two greek words ‘para’ means
outside , ‘enteron’ means intestine.
Sterile drug manufacturers should have
awareness of the public health implications .
poor cGMP conditions at a manufacturing
facility can ultimately pose a life-threatning
health risk to a patient.
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4. Aseptic process :
 Personnel training & monitoring.
 Environmental HVAC system
 Process simulation
Controls for preventing contamination and cross contamination
Manufacturing area/equipment clearance and labeling
system
Flow of product waste and personnel performance.
Controlled sterilization of all product and added
ingredients, containers and closures , equipment .
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5. Need of design consideration for
parenteral production
For air , temperature , humidity , pressure control.
For product free from pyrogen, microorganism and
particulate matter.
Suggest facility be design to accomodate current and
future needs.
For effective monitoring of the conditions and good
manufacturing practices and FDA requirements fulfill.
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6. Design objectives
Temperature and relative humidity should be
controlled and air pressure regulated.
Contamination due to air borne particles should be
controlled by an efficient filtration system.
HVAC system , HEPA filter and laminar filter.
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7.  Environmental
control zone
grouping:
Plant
exterior
Warehousing
General
production
and
administratio
n on area
Clean area
Weighing ,
mixing and
transfer
area
Filing
area
Filing
line
Filing areaFiling line
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8. Design concepts
Principle of design consideration
for parenteral products :
Only sterile are used within the
sterile field.
Gowning is considered to be
sterile .
Person who sterile touch only
sterile area.
Sterile area are continuously
kept in view and sterile person
keep well within the sterile area.
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9. Other facilities-
Quality control
Wall and floor treatment
Glass bead sterilizer
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10. Air tight doors
Air swing flip doorAir shower
Sampling booth
Passing door
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11. Building design & layout:
Sharp corners
Tile joints in the floor should be carefully scaled
Lighting layout
To prevent fungus growth and elimination air leakage.
Designing the sterile processing department
Efficient infrastructure to support the processing of
instruments
Limit the number of staff.
Limit the movement of staff – proper layout of
surgical instruments .
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12. Cntd :
 The number of washers and
sterilizers , will determine
the number and types of
steam sterilizers , gas
sterilizers , plasma sterilizers
and other equipment.
 Traditional control of
temperature , humidity ,
suspended particulates , air
flow velocity , air flow
patterns , cross
contamination.
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13. Definition of clean room :
Part 1 :specification for control environmental clean
room , work station and clean air devices.
Part 2 : guide to construction and installation of clean
room , work station and clean air devices.
Part 3 : guide to the operational procedure and
disciplines applicable to clean rooms work stations
and air area .
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14. Critical and general clean room:
The production where contamination can gain direct
access to the process and area often protected by
localized laminar – Flow clean benchers and
workstations.
The rest of the clean room where contamination will
not gain direct entry into the product but should be
kept clean because of the transfer of contamination
into the critical area .
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15. General clean room design :
HEPA/ULPA filters on ceiling .
Drains in aseptic processing areas are inappropriate.
Airlocks and interlocking doors to control air balance.
Seamless and rounded floor to wall junction.
Limited equipment and perssonel.
Layout of equipment to optimized comfort and
movement of operators.
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16. classification of clean
room :
(1) Class 100,000
(2) Class 10,000
(3) Class 1,000
(4) Class 100
class 100 classroom
Class 10,000 classroom
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17. Environmental
contamination control
system and design :
Heating ventilation and air
conditioning system
(HVAC):
HVAC systems are an
internal part of
environmental control
system design to provide a
specific set of
environmental conditions
required for the
manufacturing process.
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19. Temperature and humidity control :
 Temperature 68-74⁰F(19-23⁰C).
 45-55% RH range.
Air filtration :
Main method for airborne contamination control in
production area .
Ventilation :
Determined by the number of people working in the
environment .
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20. HEPA filters :
Filter out particle in the air by forcing them
through microscopic pores.
Optimum parameters :
 Air changed per hour (fresh+ re-circulating ).
 Optimal temperature 18-25⁰C and optimal
humidity 15-20%
Function :
 HEPA filter acts like a sieve.
 Design to target much smaller pollutants and
particle.
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21. Classification of HEPA filters :
Based on use :
Based on type :
HEPA
Type A
HEPA filter
Type B
HEPA
filter
Type C
HEPA filter
Type D
HEPA
filter
Type E
HEPA
filter
Types of
HEPA filter
Horizontal flow Verticle flow
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22. Laminar air flow system:
HEPA filters +laminar air flow.
Laminar air flow system should provide a
homogenous air speed of 0.45 m/s±2.0% at the
working position.
Gives an ‘ULTRACLEAN AIR’
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23. References
 R.M.Mehta, Pharmaceutic II, first edition, Vallabh prakeshan;
2005, Delhi, 223-249.
 Lachman / Lieberman’s “ the theory and practice of industrial
pharmacy; published by CBS publishers and distributors,
ed.4th.
 Remington, The Science and Practice of Pharmacy; published
by Wolters Kluwer (India) pvt. Ltd, ed.21 , vol 1
 Design Considerations for Parenteral Production Facility Parag
V. Ingle1, Vivekanand K. Chatap 1, N. M. Bhatia2 International
Journal of Pharma Research & Review, August 2014; 3(8):15-28
ISSN: 2278-6074
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24. 9/7/2018

25. Queries……….????
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