Sunday 12 February 2017

Environmental monitoring (Viable monitoring) limits

·         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

What is the fumigation and fogging?

What is the fumigation and fogging?