Friday, 22 November 2019

NVPC Non Viable Particle Count | Complete Procedure

Non Viable Particle Count
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Non Viable Particle Count
The Non Viable Particle Count particle count test shall be performed by qualified and trained person only.
Measuring instrument being used shall be calibrated with reference to NPL/NABL traceable reference standard.
Ensure that the sampling locations are evenly distributed throughout the area of the clean room.
Sampling location shall be identified as per given table.
Sr. No
Area of cleanroom (m2) Less than or equal to
Min number of sample locations to be tested NL
Sr. No
Area of cleanroom (m2) Less than or equal to
Min number of sample locations to be tested NL
1.
2
1
15.
76
15
2.
4
2
16.
104
16
3.
6
3
17.
108
17
4.
8
4
18.
116
18
5.
10
5
19.
148
19
6.
24
6
20.
156
20
7.
28
7
21.
192
21
8.
32
8
22.
232
22
9.
36
9
23.
276
23
10.
52
10
24.
352

24
11.
56
11
25.
436
25
12.
64
12
26.
500
26
13.
68
13
27.
1000
27
14.
72
14
28.
>1000
Equation A.1






















Equation A.1: N = 27 [A/1000]
The volume sampled at each location shall be at least 2 litres, with a minimum sampling time at each location of 1 minute. The sampling probe shall be positioned at working level and air flow probe shall be directed vertically upward.
Where only one sampling location is determined, minimum of location shall be considered.
Acceptance Criteria: All the clean rooms should comply as per the designed class at rest as per ISO 14644-1 & WHO TRS 961.

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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