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Quality Cleanroom Products

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Title: Quality Cleanroom Products


1
High Quality Clean Room Products Manufacturer
2
Cleanroom is a place of high level quality
control that intends to enhance the quality of
products by limiting the exposure of the products
to unwanted particles in the air. Cleanroom in
Pharmaceuticals refers to the purity of the air
in the room where pharmaceutical products are
manufactured or packaged.
3
In simple terms, a cleanroom gives an idea about
the size and amount of particulate matters that
are present in the air inside the room. In
addition, it sets limits for concentration of
particles in the room. The concentration of the
particles is measured as the number of specific
particles per cubic meter of the air.
4
The cleanroom in pharmaceuticals are classified
according to the amount of concentration of
particles in the air. However, the concept of
cleanroom does not provide any information about
the physical, chemical or radiological
characteristics of the particles. Therefore,
cleanroom is essentially concerned with the
amount of airborne particles.
5
Remember cleanrooms are assigned for industries
other than pharmaceuticals. Nonetheless, this
classification holds special relevance to the
pharmaceutical industries as the regulatory
guidelines for manufacture of medications are
more stringent than those for others. The
parameter of cleanroom classification varies on
the basis of the formulation of the medication
being manufactured.
6
For example, manufacturing facilities for aseptic
or injectable products need to have cleaner air
compared to those manufacturing topical
formulations such as cream, lotion and ointment.
Eye drops or ointments also called ophthalmic
preparations, also need to be sterile just like
the injectable preparations.
7
Hence one can expect similar limits for airborne
particulate matters for manufacture of eye
preparations. For manufacturing such products,
the facilities should also comply with the
standard limits for microbial contamination.
There is no doubt over the fact that public
health is a very sensitive issue. Medications are
used to treat, cure, prevent or diagnose diseases.
8
The level of sensitivity increases proportionally
when manufacturing injectable or ophthalmic
preparations. This is the reason why all the
pharmaceutical manufacturing or packaging
facilities should strictly comply with the
requirements set forth by the governing
authority. Hence cleanroom for pharmaceutical is
a must.
9
When people in the manufacturing and scientific
research world speak of a cleanroom, they are not
talking in the same manner that parents talk to
their children. This type of setting has a very
specific set of protocols that must be followed
in order to maintain a sanitary and safe
environment. These types of settings are just as
likely to be found in a manufacturing plant as
they are a research lab.
10
A cleanroom setting is required to maintain the
integrity of the manufacturing or research taking
place in that given area. In order for the room
to be considered a cleanroom, there are specific
guidelines stating the actual particles per cubic
meter that are allowed. In order to keep this
ratio proper, various supplies and items are used
in the daily operation of these facilities.
11
To Find Out More Information Cleanroom
Products Please Come And Visit Us Today Onwards..!
Utopia Aire Pte Ltd Contact Us 7 Kaki Bukit
Place, Eunos Tech Park, Singapore - 416185 Tel
(65) 6746-7577 Fax (65) 6746-4994 Email
contact_at_utopia.com.sg Web
http//www.utopia.com.sg/
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