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Sterile Injectables
Sterile Diagnostics
Dialysis solutions
Sterile Implants
Intraocular inserts
STERILE INJECTABLES
CLASSIFICATION BASED ON FILL /RE-CONSTITUTION VOLUME
1. Site selection:
The ambient air quality is a significant design concern. Very small airborne
particles (less than 1µm), excessive humidity, odors, industrial waste gases
are difficult to remove & therefore can create discomfort to the control
environment
Environmental concerns about the disposal hazardous wastes are more
serious. Waste disposal method should be included in the design feature
Site selection may also be influenced by company’s philosophy may dictate
the all facilities be built on a common site
STERILE INJECTABLES
2. Facility area use planning: Planning for a production facility requires
determination of the functions necessary & the size & location for each
function. After these needs are determined , a review of the functional needs
will lead to a determination of area requirements & relative location for each
function. The area use planning may influenced by:
A. General operational assessments
• Type of production line:
It may be batch operations
It may continuous batch operations
Or it may be integrated operations
Diversity of product line
Container size
Environmental control needs
Product characteristics etc………….
B. Area planning:
3. Design concepts: The progression from operational concepts and floor plans
to working drawings & then to a functioning plant requires grappling with
the real problems of just how something is to be done. Often, basic concepts
are involved, dictated by parenteral need or state of the art. Basic concepts
can be influenced by:
A. No. of filling suits.: It may a single filling line, two filling line, four filling ine or
multiple filling line operations.
B. Wall & floor treatments:
• The wall & floor should be smooth, cleanable.
• Exposed columns, wall stud, bracings & so on are unacceptable
• Walls & floors should withstand the cleaning & disinfectants
• To aid sanitization all wall & ceiling junctions must be coved or rounded
C. Miscellaneous:
Doors are preferred with push plates plates or arm hooks which replace usual
door knobs
STERILE INJECTABLES
Doors are preferred with push plates or arm hooks which replace usual door
knobs
Lighting fixtures should be recessed flush with the ceiling
Light fixture should be tightly sealed with the ceiling
Lamps should be replaced from outside room
The cleanability of the exposed sprinkler heads should be improved by use of
semirecessed heads & protective caps, although these caps cannot be sealed
Clean room telephones should be used instead of usual PABX to enhance
cleanabilty & to reduce contamination
There should be LAF aided dynamic pass boxes for material entry/exit form
the clean room
D. Mechanical services:
The air within the cleanroom suite moves from clean to less-clean areas
to minimise the movement of contaminated air. Air should move in the
correct direction through doorways and the fabric of the room.
The air supplied to the cleanroom is of a quality that will not add significantly
to the contamination within the room.
The air movement within the cleanroom should ensure that there are no
areas within the room with high concentrations of contamination
ADDITIONAL TEST
temperature
relative humidity
heating and cooling capabilities of the room
sound levels
lighting levels
vibration levels.
RE-TESTING TO DEMONSTRATE COMPLIANCE
MONITORING OF CLEANROOMS
air pressure difference
airborne particle count
where appropriate, microbiological counts.
AIRBORNE PARTICLE COUNTS
AIRBORNE PARTICLE COUNTS
AIRBORNE PARTICLE COUNTS
PARTICLE COUNTING IN DIFFERENT
OCCUPANCY STATES
As built: complete and ready for operation,
with all services connected
and functional, but without equipment or
operating personnel in the
facility
0 At rest: complete, with all services
functioning and with equipment
installed and operable or operating, as
specified, but without operating
personnel in the facility;
0 Operational: in normal operation, with all
services functioning and
with equipment and personnel, if applicable,
present and performing
their normal work functions in the facility.