A manufacturing facility for pharmaceutical products must be designed with minimizing the Introduction generation retention of airborne particles in mind Clean rooms must be designed having in mind: Location of the in and out airlocks Gowning and de-gowning Door interlocks Visibility Personnel flow Material flow The introduction of components Location of utilities Location of the equipment inside the cleanroom.

1. PLANT
ENVIRONMENTAL
MONITORING

2. Contents
Module C
⊷Procedure
⊷Process Flow
⊷Acceptance
Criteria
⊷Trend Analysis
Module A
⊷ Introduction
⊷ Definitions
⊷ EM Standards
Module B
⊷ Scope
⊷ Frequency
⊷ HVAC
2

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3

4. Module A
4

5. 1.
Introduction
A manufacturing facility
for pharmaceutical
products must be
designed with
minimizing the
• Introduction
• generation
• retention of
airborne particles
in mind

6. “
6
Clean rooms must be designed having
in mind:
⊸Location of the in and out air locks
⊸Gowning and de-gowning
⊸Door interlocks
⊸Visibility
⊸Personnel flow
⊸Material flow
⊸The introduction of components
⊸Location of utilities
⊸Location of the equipment inside the clean room.
Introduction

7. Definitions
⊷ Clean Room
A clean room (or clean room)
is an enclosed space in which
airborne particulates,
contaminants, and pollutants
are kept within strict limits.
7

8. Definitions
⊷ At Rest
Condition where the
installation is complete with
equipment installed and
operation in a manner agree
upon by the customer and
supplier, but with no
personnel present
8

9. Definitions
⊷ In Operation
Condition where the
installation is functioning in
the specified manner, with
the specified number of
personnel and working in the
manner agreed upon.
9

10. Definitions
⊷ Viable Count
The Counting of living
microorganisms in air.
e.g. Bacteria, Yeast & Molds
etc.
⊷ Non Viable Count
The Counting of non living
particles in air.
e.g. Dust Particles, Lint Particles
etc10

11. Environmental
Monitoring
Standards
1. Federal Standard
209 E
2. ISO 14644
11

12. 12
Federal Standard 209 E was stand
cancelled in 2001
Federal Standard 209 E was easier to
understand than ISO 14644
Many companies continue to test their
facilities along Federal Standard
209E

13. Environmental Monitoring of Clean Rooms
13
Grade A corresponds to:
Grade B corresponds to:
Grade C corresponds to:
Class 100 ISO 5
Class 100 ISO 5
Class 10,000 ISO 7
Class 100,000 ISO 8
(European Union) EUGGMP 2002
Grade D corresponds to:

14. Clean Rooms in Highnoon Plant
14
Area
Class (In
Operation)
Solid Manufacturing D
Blistering Area D
Liquid Manufacturing D
Drop/ Liquid Filling D
Hormone Area D
Semi Solid/ Dry
Powder Area
D

15. Module B
15

16. Scope
16
Plant Environmental Monitoring SOP is
applicable to
Production
• Solid Dosage Area
• Liquid Dosage Area
• Quarantine (Non Viable Count Only)
• Hormone Area
• Dry Powder and Semi Solid Area
Stores
• Raw Material Store (Non Viable Count Only)
• Dispensing and Sampling Booth (Viable Count)
• Packaging Material Store (Non Viable Count
Only)

17. Frequency
⊷ Viable Count: Once in
a month
⊷ Non viable count:
Twice a Year
17

18. Trivia
⊷ Which standard was stand
cancelled in 2001 to monitor
Environmental Monitoring?
A. ISO 14644
B. ISO 9001
C. Federal Standard 209E
Ans. Federal Standard 209E18

19. Trivia
⊷ Which standard is followed in
most of the countries to
conduct Environmental
Monitoring
A. Federal 209E
B. WHO Standard
C. ISO 14644
Ans. ISO 14644
19

20. HVAC
20

21. HVAC Components
21

22. 22
HVAC Components:
1 Expansion
valve
2 Fan
3 Compressor
4 Heat
exchange coils
Condenser

23. 23
HVAC Components:
1 Heat exchange coils
2 Fan
1
2
Air Handler

24. 24
HVAC Components: Duct System

25. 25
HVAC Components:
Supply Ducts
Return Grille
Return
Plenum
Air
Handler
Supply
Plenum
Duct System

26. Module C
26

27. Procedure
27

28. Viable Count
Count of Living
microorganisms in
clean rooms.
1. Settle Plate
Method
2. Surface Swab
Method
Enviornmental Monitoring
Consist of
Non-Viable Count
Count of Non-Living
particles in clean
rooms
⊷ Particle Counter
28

29. 29
Process Flow
Sterilization
Media
Preparation
Dry Heat Moist Heat
Temperature
121°C
15 min
15 lbs
Temperature
160 °C
2 hours

30. Process Flow
Pre Incubation
Pouring of
Plates
Pre Incubation
Pouring of
Plates
Exposure
in Area
Pre Incubation
Pouring of
Plates
Pre Incubation
Pouring of
Plates
Pouring of
Plates
Pre Incubation
Pouring of
Plates
Exposure
in Area
Pre Incubation
Pouring of
Plates
Exposure for 04
hours

31. Process Flow
Results
Incubation
of Plates
Reporting
of Results
48 hrs Bacteria
5 days Fungi

32. 32
Trivia
⊷ Viable count means
A. Count of non living particles
B. Count of living microorganisms
C. Count of rejected Capsules
Ans. Count of living microorganisms

33. 33
Trivia
⊷ Agar plates are exposed for at least
hours
A. 1
B. 9
C. 4
Ans. 4

34. 34
Settle Plate

35. 35
Settle Plate After Incubation

36. 36
Surface Swab Method

37. 37
Viable Count Limits

38. Non-Viable Count
Non-viable
count includes
counting of
particles that
does not
contain a living
microorganism
but acts as
transportation
for viable
particles.
This includes
following
Physical
Parameters
1. Temperatur
e
2. Relative
Humidity
3. Differential
Pressure
Particle
Count
Particle
Count is
conducted
by means of
Particle
Counter.
38

39. Non-Viable Count Limits
39

40. 40
Trivia
⊷ Non viable count means
A. Counting of batches manufactured
B. Counting of bacteria in air
C. Counting of non living particles in air
Ans. Counting of non living particles in air

41. 41
Differential Pressure
Manometer
Use to measure
Differential Pressure
Acceptance Criteria
Not less than 0.02
inches of water column

42. Temperature /Relative
Humidity
42
Whirling Psychrometer
Use to measure
Temperature/Humidity in
a clean room
Acceptance Criteria
Temperature
< 25°C
Humidity
55% + 5% (Other then
Dry Powder Area)
45% + 5% (Dry Powder
Area)

43. Particle Counter
43
Particle
Counter
Use to count
air borne
particles in a
clean room
Model
LASAIR II

44. Trend Analysis
44
If the frequency of
exceeding the limit is high
or show an upward trend
then action should be
taken which may include,
• An increase in
frequency of testing
•Observation of Operator
Techniques
•Investigation of cleaning
procedures
0
20
40
60
80
100
Blister
Area - 1
{On
Machine -
S1}
Blister
Area - 1
{On
Machine -
S2}
Blister
Area - 1
{Air Lock -
S3}
Blister
Area - 2
{On
Machine -
S4}
Blister
Area - 2
{On
Machine -
S5}
Blister
Area - 2
{Air Lock -
S6}
Blister
Area - 3
{On
Machine -
S7}
Blister
Area - 3
{On
Machine -
S8}
Blister
Area - 3
{Air Lock -
S9}
Blister
Area - 4
{On
Machine -
S51}
Blister
Area - 4
{On
Machine -
S52}
Blister
Area - 4
{Air Lock -
S53}
January February March

45. 45
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