Clean room and the classification of
clean room are the most critical topic of the pharmaceutical industry. For the
manufacturing of the pharmaceuticals products (Active pharmaceutical ingredients,
Tablets, capsules, sterile dosage form) cleanroom room area is required .According
to the types of the product manufacturer has to maintain the clean room area.
What is clean room
Area?
Cleanroom is the controlled area where the specified size of
the airborne particles are allowed with required pressure humidity and
temperature to prevent the cross contamination and the microbial contamination.
Here, we are talking about the control environment control
means prevention of dust, prevention of the entry of larger particle, (Only
specified particle sized entry is possible into the clean room. The size of the
particle is mentioned in the guideline). There are the different guidelines
available which explains about the requirement for the clean room area in
pharmaceutical industry.
Guideline for the Clean
Room Classification:
There are so many
guidelines which explain the cleanroom classification. Now a day the other
guidelines are obsoleted. ISO 14644 is the guideline which is the
standard guideline followed for the clean room classification and qualification
ISO 14644 is a guideline which defines the cleanroom
classification. According to the 14664 guideline cleanroom can be classified
into following classes. As per the ISO guideline the clean rooms are classified
as ISO 1 to ISO 9 class.
Generally form ISO 5 area to ISO 9 is used in pharmaceutical
industry. Example: For the manufacturing of the sterile product ISO 5 area is
required.
Particle size range 0.3 µ, 0.5 µ, 1.0 µ, 3.0 µ, 5.0 µ, 10.0 µ.
Reading shall be taken for 0.5 V µ and 5.0 V µ particle size.
US Federal Standard FED STD 209E guideline was used for
the classification of the clean room according to the FED STD 209 clean room
are classified as class 1, class 10, class 100, class 1000.class 10000 class 100000
which equivalent to the class following ISO class Comparison is mentioned in
below table
Currently ED STD 209 E guide line is not used as FED released
the notation of cancellation and superseded for ED STD 209 E, airborne
particulate cleanliness classes in cleanroom and cleans zones in 2001.The
guideline was superseded by standard written for the International organization
for the standardization.
British standard BS 5295 guideline was used for the clean
room classification According to the guideline clean room classified as the
class1, class 2, class 3, and class 4. BS 5295 is British guideline which has
been also obsoleted and withdraws from the year 2007 and replaced with ISO
14644-6:2007.
|
Class |
maximum particles/m3 |
FED STD 209E |
|||||
|
>=0.1 µm |
>=0.2 µm |
>=0.3 µm |
>=0.5 µm |
>=1 µm |
>=5 µm |
||
|
ISO 1 |
10 |
2 |
|
|
|
|
|
|
ISO 2 |
100 |
24 |
10 |
4 |
|
|
|
|
ISO 3 |
1,000 |
237 |
102 |
35 |
8 |
|
Class 1 |
|
ISO 4 |
10,000 |
2,370 |
1,020 |
352 |
83 |
|
Class 10 |
|
ISO 5 |
100,000 |
23,700 |
10,200 |
3,520 |
832 |
29 |
Class 100 |
|
ISO 6 |
1,000,000 |
237,000 |
102,000 |
35,200 |
8,320 |
293 |
Class 1,000 |
|
ISO 7 |
|
|
|
352,000 |
83,200 |
2,930 |
Class 10,000 |
|
ISO 8 |
|
|
|
3,520,000 |
832,000 |
29,300 |
Class 100,000 |
|
ISO 9 |
|
|
|
35,200,000 |
8,320,000 |
293,000 |
Room Air |
BS 5295 Cleanroom
Standards
|
|
maximum particles/m3 |
||||
|
Class |
>=0.5 µm |
>=1 µm |
>=5 µm |
>=10 µm |
>=25 µm |
|
Class 1 |
3,000 |
|
0 |
0 |
0 |
|
Class 2 |
300,000 |
|
2,000 |
30 |
|
|
Class 3 |
|
1,000,000 |
20,000 |
4,000 |
300 |
|
Class 4 |
|
|
20,000 |
40,000 |
4,000 |
Requirement of the
Clean room in to the pharmaceutical industry:
Cleanroom classification is required in pharmaceutical
industry to prevent the microbial contamination in to the manufacturing area.
In pharmaceutical Industry airborne particle may adversely
affect the product quality hence to control the airborne particle into the
manufacturing area. In Cleanroom area only specified airborne particle is
allowed.
Prevent the dust particle entry into the manufacturing area.
Prevent the microbial contamination in the product.
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