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Frequently Asked Question - Cleanroom Section
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 European
Union Guide to Good Manufacturing Practice - EUGGMP
The most recent pharmaceutical standard that is used in Europe
came into operation on January 1997. This is called 'The rules governing
medicinal products in the European Union. Volume 4. Good manufacturing
practices - Medicinal products for human and veterinary use'. It
is often called the European Union Guide to Good Manufacturing Products
(EU GGMP), and is called that in these notes. The most relevant
part of the EU GGMP is Appendix 1, which was revised in 2003 and
incorporates changes relevant to cleanroom testing. These are included
in table 5, and the notes below.
Airborne classification in the EU GGMP
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Maximum permitted
number of particles/m3 equal to or above (a) |
| Grade |
at rest (b) |
in operation (b) |
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0.5 µm (d) |
5 µm |
0.5 µm (d) |
5 µm |
| A |
3 500 |
1(e) |
3 500 |
1(e) |
| B(c) |
3 500 |
1(e) |
350 000 |
2 000 |
| C(c) |
350 000 |
2 000 |
3 500 000 |
20 000 |
| D(c) |
3 500 000 |
20 000 |
not defined (f) |
not defined (f) |
(a) Particle measurement (are) based on the use of a discrete airborne
particle counter to measure the concentration of particles at designated
sizes equal to or greater than the threshold stated.
A continuous measurement system should be used for monitoring the
concentration of particles in the grade A zone, and is recommended
for the surrounding grade B areas.
For routine testing the total sample volume should not be less than
1 m3 for grade A and B areas and preferably also in grade C areas.
(b) The particulate conditions given in the table for the "at rest"
state should be achieved after a short "clean up" period of 15-20
minutes (guidance value) in an unmanned state after completion of
operations. The particulate conditions for grade A "in operation"
given in the table should be maintained in the zone immediately
surrounding the product whenever the product or open container is
exposed to the environment. It is accepted that it may not always
be possible to demonstrate conformity with particulate standards
at the point of fill when filling is in progress, due to the generation
of particles or droplets from the product itself.
(c) In order to reach the B, C and D air grades, the number of air
changes should be related to the size of the room and the equipment
and personnel present in the room. The air system should be provided
with appropriate terminal filters such as HEPA for grades A, B and
C.
(d) The guidance given for the maximum permitted number of particles
in the "at rest" and "in operation" conditions correspond approximately
to the cleanliness classes in the EN/ISO 14644-1 at a particle size
of 0.5 µm.
(e) These areas are expected to be completely free from particles
of size greater than or equal to 5 µm. As it is impossible to demonstrate
the absence of particles with any statistical significance the limits
are set to 1 particle/m3. During the clean room qualification it
should be shown that the areas can be maintained within the defined
limits.
(f) The requirements and limits will depend on the nature of the
operations carried out.
Examples of operations to be carried out in the various grades are
given in the table 6. The particulate conditions for a grade A zone
that is in operation should be maintained in the zone immediately
surrounding the product whenever the product or open container is
exposed to the environment. It is accepted that it may not always
be possible to demonstrate conformity with particulate standards
at the point of fill when filling is in progress, due to the generation
of particles or droplets from the product itself
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