·
WHO(World Health Organization) & EU (European Union) viable monitoring :
Class
|
Settling
plates
cfu/m2/4
hours
|
Active
Air sampling Cfu/m3
|
Surface
Monitoring
Cfu/plate
(25 cm2)
|
Personal
monitoring
Cfu/glove
|
|
5
|
A
|
<1
|
<1
|
<1
|
<1
|
6
|
B
|
5
|
10
|
5
|
5
|
7
|
C
|
50
|
100
|
25
|
--
|
8
|
D
|
100
|
200
|
50
|
--
|
·
Schedule-M (Drug and Cosmotic Act 1940) Limits :
Class
|
Settling
plates
cfu/2 hours
|
Active
Air sampling Cfu/m3
|
Surface
Monitoring
Cfu/plate
(25 cm2)
|
Personal
monitoring
Cfu/glove
|
|
5
|
A
|
<1
|
<1
|
<1
|
<1
|
6
|
B
|
5
|
10
|
5
|
5
|
7
|
C
|
50
|
100
|
25
|
--
|
8
|
D
|
100
|
500
|
50
|
--
|
·
Suggested
Initial Contamination Recovery Rates in Aseptic Environments
(As
per USP 40 general chapter 1116 ).
Class
|
Active Air
Sample
(%)
|
Settle Plate
(9 cm) 4 h Exposure
(%)
|
Contact Plate or
Swab
(%)
|
Glove or Garment
(%)
|
|
Isolator/Closed
RABS
(ISO
5 or better)
|
<0.1
|
<0.1
|
<0.1
|
<0.1
|
|
5
|
A
|
<1
|
<1
|
<1
|
<1
|
6
|
B
|
<3
|
<3
|
<3
|
<3
|
7
|
C
|
<5
|
<5
|
<5
|
<5
|
8
|
D
|
<10
|
<10
|
<10
|
<10
|
