Microbiological monitoring techniques to monitor the air , particle count and personnel monitoring to assure the cGMP of clean rooms.

2. CLEAN ROOM
 A clean environment designed to reduce the contamination of processes and
materials. This is accomplished by removing or reducing contamination sources.

3. CLEAN ROOM MONITORING METHODS
 Air Sampling
 Active Air Sampling
 Passive Air Sampling
 Surface Sampling
 Contact Plates
 Swabs
 Personnel Monitoring
 Finger Dabbing
 Contact Plates
 Particle Counting

4. 1.AIR SAMPLING
 Air Samplers (Active Air Sampling)
• A given volume of air is sampled; also known as 'active'
sampling.
• Agar: jelly-type material with nutrients added to support
microbial growth.
• Micro-organisms landing  temperature, time colony

5. 1.AIR SAMPLING
Settling plates (Passive Air Sampling)
 where micro-organisms are deposited, mainly by gravity, onto
an agar plate.
 Time and Temperature to grow
 Bacteria : 48 hours at 30° C to 35° C;
 Fungi: 72 hours at 20° C to 25° C
 Settle plate sampling: Petri dishes (diameter:90mm) containing
agar medium  opened and exposed  time (4 hours)
particles to deposit Petri dishes

6. 2. SURFACE SAMPLING
1. Contact Plates –
surface (flat) RODAC (Replicate Organisms Detection and Counting)
dishes are used  The agar is rolled over the cleanroom surface
Micro-organisms stick to the agar incubated time and temperature
micro-organisms grow & counted.
2. Swabs -
uneven surfaces: bud swab rubbed surface and then rubbed over an
agar plate

7. 3. PERSONNEL MONITORING
 Personnel are the primary source of micro-organisms in a
cleanroom.
 The methods commonly used are:
Finger dabs
The person's fingers tips, or their gloved hand, is pressed or wiped
on an agar plate and the number of micro-organisms detected.
Contact plates
The person's garments are sampled by pressing the plate onto their
clothing. This is best done as they come out of the cleanroom.

8. 4. PARTICLE COUNTING:
 Principles: The number of sampling locations must reflect the
size of the room and its cleanliness.
 Minimum number of locations:
Where NL rounded up to a whole
number
A is the area of the cleanroom, or
clean air controlled space, in m2.
ANL 

9. 4.PARTICLE COUNTING:
 One or more samples : at each location
 The volume sampled at each location: at least two liters
 The minimum sample time : at least one minute

10. ACCEPTANCE CRITERIA
VIABLE MONITORING NON-VIABLE MONITORING