Cleanroom Classification
The current demands in today’s pharmaceutical
industry for quality control and quality assurance have been driven by the
aspiration to deliver consistently high quality and safe products to the
consumer. The standards that are set to meet this goal are exorbitant and
tightly controlled both internally and externally.
Cleanroom environments are a crucial area for
the process and manufacture of pharmaceutical products. Cleanrooms are
controlled and maintained using very stringent protocols and guidelines
outlined by different organization. To monitor the quality of a room, proper standards
have to be established. Different room
classes are necessary for the different production areas as regards the different
production steps.
Area
|
Requirement
|
Critical Area A
|
sterile
products - sterilised in the final container closure system
- filling
sterile
products - aseptic preparations
aseptic
preparation
aseptic
filling
transfer of
partially closed containers (lyophilisation)
preparation of
creams, ointments, suspensions, emulsions
filling of
creams, ointments, suspensions, emulsions
production
steps with high risk: filling area, container for the stoppers, open ampoules
and vials
|
Critical Area B
|
sterile
products - aseptic preparations
background
areas for zone with class A
transfer of
partially closed containers (lyophilisation in sealed transfer rackets)
|
Controlled Area C
|
sterile
preparations - sterilised in the final container closure system
preparation of
solutions (production step with high risk)
filling
process
background
area for zone with room class A for filling of preparations
(production
step with high risk)
preparation of
ointments, creams, suspensions, emulsions
sterile
preparations - aseptic preparations
preparation of
the solution to be filled
background
area for blow-fill-seal-machines
|
Area with
Requirement D
|
sterile
preparations - sterilised in the final container closure system
preparation of
solutions and components for filling
background
area for blow-fill-seal-machines
sterile
preparations - aseptic preparations
handling of
components after the washing process
background
area for an isolator
|
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