Designing of aseptic
area
, Introduction
• Production of sterile products should be carried out in
a clean environment with a limit for the
environmental quality of microbial and dust particle
contamination.
• This limit for contamination is necessary to reduce the
product contamination.
• The production area is normally divided into
i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv)The quarantine area and v)The
packaging/labelling area.
,Flow diagram of aseptic
area
, Clean-up section
• The cleaning area has walls and ceilings made
up of film coating materials.
• Airinside the clean area should be free
from dust and microorganisms.
• This is ensured through high efficiency
(95%) filters.
• Airexisting in the clean area should be
frequently replace (10-15 air changes per hour).
area
, Introduction
• Production of sterile products should be carried out in
a clean environment with a limit for the
environmental quality of microbial and dust particle
contamination.
• This limit for contamination is necessary to reduce the
product contamination.
• The production area is normally divided into
i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv)The quarantine area and v)The
packaging/labelling area.
,Flow diagram of aseptic
area
, Clean-up section
• The cleaning area has walls and ceilings made
up of film coating materials.
• Airinside the clean area should be free
from dust and microorganisms.
• This is ensured through high efficiency
(95%) filters.
• Airexisting in the clean area should be
frequently replace (10-15 air changes per hour).
