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Saturday, November 16, 2013

Clean room classification Pharma area classification particle count

Clean Room classification Area Classification particle count and Definition of clean room:

Clean room in sterile pharmaceutical dosage form manufacturing can be defined as an area with a complete control over airborne particulate matter which intern help to minimize or render the environment free from microbial contamination, such an environment is required for aseptic processing, manufacturing, manipulating, filling, packing operations for a product which is required to be sterile throughout its shelf life. Clean rooms are also used in some microprocessor manufacturing where in a small airborne particle might damage the micro systems.

In pharmaceutical sterile dosage form manufacturing company clean room is of very important manufacturing arias. Clean room in pharma is classified according to level of cleanness.

Pharmaceutical Manufacturing area requirement with respect to cleanness class clean room classification is based on particle count in clean room and up on the size of particles as well.

1) Tablets dosage form manufacturing class 100000 is required or it can be said a class 100000 aria suitable for solid oral dosage form.

2) Oral Liquid dosage form: Class 10000

3) Topical preparation : Oral Liquid dosage form: Class 10000

4) Parenteral dosage form and injectable dosage form: Class 100

Clean Room Classification:

Clean room is classified with respect to particle count it bare in a one cubic foot of air sampled. The particle size counted or considered of 0.5 micron and above 0.5 micron.

U.S FEDERAL STANDARD 209E clean room classification



Class
Limit of 0.5 micron particles
Limit of 5 micron particles
Cubic meter
Cubic foot
Cubic meter
Cubic foot
100
3530
100
NIL
NIL
1000
35300
1000
247
7
10000
353000
10000
2470
70
100000
3530000
100000
24700
700

1) Class 100:
Class 100 is a clean room with particle count below 100 number of particles found in its air equivalent to 1 cubic foot or below 3530 particles in cubic meter of air tested. The particle size being counted is 0.5 micron and no particle of size 5 micron (nil count).
Example: inject able aseptic filling aria, (laminar air flow work bench with HEPA filter efficiency of 99.99 % of 0.3 micron) 450 to 500 air changes per hour are required to maintain the level of cleanness to class 100

2) Class 1000:
Class 1000 is a clean room with particle count below 1000 number of particles found in its air equivalent to 1 cubic foot or below 35300 particles in cubic meter of air tested. The particle size being counted is 0.5 micron and above and no particle of size 5 micron (nil count). 7 particles of size range 5 micron in 1 cubic foot or 247 particles of size rang 5 micron in cubic meter of air tested.

3) Class 10000:
Class 10000 is a clean room with particle count below 10000 numbers of particles found in its air equivalent to 1 cubic feet or below 353000 particles in cubic meter of air tested. The particle size being counted is 0.5 micron and above. And no particle of size 5 micron (nil count). 70 particles of size range 5 micron in 1 cubic foot or 2470 particles of size rang 5 micron in cubic meter of air tested

4) Class 100000:
Class 100000 is a clean room with particle count below 100000 numbers of particles found in its air equivalent to 1 cubic feet or below 3530000 particles in cubic meter of air tested. The particle size being counted is 0.5 micron and above. And no particle of size 5 micron (nil count). 700 particles of size range 5 micron in 1 cubic foot or 24700 particles of size rang 5 micron in cubic meter of air tested


European Union classification of clean room:
European Union good manufacturing practices guidelines classification of clean room define on the basis of particle count observed not only at working condition of clean room but it also require to comply particle count at rest condition


Class
Limit of particles AT REST
      Limit of particles
        AT Operation
Number of 0.5 micron equal or above particles/  Cubic meter
Number of 5 micron equal or above particles/  Cubic meter
Number of 0.5 micron equal or above particles/  Cubic meter
Number of 5 micron equal or above particles/  Cubic meter
A
3500
0
3500
0
B
35000
0
350000
2000
C
350000
2000
3500000
20000
D
3500000
20000
-
-

Class A:
At rest:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 3500
Maximum allowable number of particles of 5 micron in cubic meter of air tested = 0 “ZERO”
In operation:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 3500
Maximum allowable number of particles of 5 micron in cubic meter of air tested = 0 “ZERO”

======================================================================
Class B:
At rest:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 35000
Maximum allowable number of particles of 5 micron in cubic meter of air tested = 0 “ZERO”
In operation:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 350000
Maximum allowable number of particles of 5 micron in cubic meter of air tested =2000

======================================================================
Class C:
At rest :
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 350000
Maximum allowable number of particles of 5 micron in cubic meter of air tested = 2000
In operation:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 3500000
Maximum allowable number of particles of 5 micron in cubic meter of air tested =20000
======================================================================
Class D:
At rest:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = 3500000
Maximum allowable number of particles of 5 micron in cubic meter of air tested = 20000
In operation:
Maximum allowable number of particles of 0.5 micron or above size in cubic meter of air tested = Not set.
Maximum allowable number of particles of 5 micron in cubic meter of air tested =Not set.

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Posted by: Martin

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