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Monday, October 12, 2020

Clean room classification Pharma area classification particle count

Clean Room classification Pharmaceutical Manufacturing Area Classification particle count 

Introduction: 
Clean rooms are classified as per ISO and Federal standards  209E
ISO 14644-1 and ISO 14698 is non regulatory while FED STD 209E are mandatory guideline of USFDA
ISO defines clean room classification by taking in consideration smallest size and qty of particle count, which is 0.1 μm 0.2μm and 0.3 μm and,0.5 μm 1 μm and 5 μm
While Federal Standard 209E define Clean Room  are defined from Class 1 which is equivalent to ISO 3 ISO 1, and ISO 2 are not considered in FED 209E, due to very finer level of classification.

Definition of clean room: Clean room in 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 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 clean room is required or it can be said a class 100000 aria suitable for solid oral dosage form.

2) Oral Liquid dosage form: Class 10000 Clean Room is required

3) Topical preparation : Oral Liquid dosage form:  Clean room of Class 10000 required

4) Parenteral dosage form and injectable dosage form: Clean room of Class 100 required


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 IN COMPARISON WITH ISO AND EU CLEAN ROOM GRADES. 
    

 

ISO


Cl
ass

(Federal Standard 209 E)

 

Grade

Limit of Greater Than or equal to 0.1 μm micron particles

Limit of Greater Than or equal to 0.2 μm micron particles

Limit of Greater Than or equal to 0.3 μm micron particles

Limit of Greater Than or equal to 0.5 μm micron particles

Limit of Greater Than or equal to 5 μm micron particles

 

 

Per Cubic meter

Per Cubic meter

Per Cubic meter

Cubic meter

Cubic foot

Cubic meter

Cubic foot

ISO3

1

    -

 1000

237

102

4

 NA

NIL

NIL

ISO4

10

    -

 10000

23700

1020

35

 1

 

 

ISO5

100

A at working condition

B at Rest

 100000

237000

10200

3530

100

NIL

NIL

ISO6

1000

       

1000000

NA

102000

35300

1000

247

7

ISO7

10000

    C

NA

NA

NA

353000

10000

2470

70

ISO8

100000

    D

NA

NA

NA

3530000

100000

24700

700


1) Class 100 Clean room 
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 Clean room
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 Clean room
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 Clean room
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
NA    
NA

Class A Clean room
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 Clean room 
Is similar to class A but particle count is done at rest condition.
Class B is provided just adjacent to Class A where cortical activity is done like feeling of injectable liquid or powder for injection in vials or Blow filling and sealing activity under laminar flow bench which provide class 100 environment, but surrounding to LAF Class B is required to maintained.
======================================================================
Class C Clean room
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 Clean room
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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