PRODUCTION FACILITIES

Environment of the production area must be suitable for

preparation of parenteral products. Primary concern is to
prevent viable and nonviable contaminations when the
products are exposed to the environment.

Aseptic area: this area is the heart of sterile product operation.

The area is well designed to prevent contamination of all sorts
when products are exposed to the environment for processing.
 Major factors for designing an aseptic room
1. Site
2. Size
3. Window
4. Door
5. Surface Materials
6. Services
7. Surface Disinfectant
8. Personnel
9. Laminar Air Flow System
10. Handling of Air
Figure: Clean room layout
Site
• Undisturbed area
• Not near stair cases
• Preferably in a separate building
Size
• Optimum size,
• Not so small that causes problem in movement (man, material,
machine etc.)
• Not so big that increases operation expenses.
Window
• Large size closed glass panel are easy for inspection from
outside.
Door
• Air locked double-door system to prevent sudden onrush of
air when door is opened.
• The two doors are three feet apart.
• Both doors are not open at a time.
Surface materials

• Surface of the ceiling, walls and floor should be smooth,

• Easily cleanable,
• Impervious and resistant to chemicals.
• Mixture of cement and marble may be a suitable building material.
• In modern technology, surfaces are sprayed with suitable polymeric
materials to form a continuous coating.
Services
Services like
• Proper Ventilation,
• Electricity,
• Gas Supply,
• Compressed Air Supply,
• Vacuum System,
• Nitrogen Supply,
• Water Supply,
• Waste Disposal Unit Etc.
• must be present at appropriate locations of the aseptic area.
Surface disinfectants
• Ethanol
• Isopropyl Alcohol
• Chlorine
• Formalin
• Iodine
• Phenol
• Quaternary ammonium compounds
• UV light - 253 nm are used for surface disinfection.
Personnel
• Most difficult element to control in an aseptic area.
• Continuously discharging in the environment which may be a source
of microbial and particulate contamination.
• Should be properly trained for performing aseptic operations.
• Should be physically fit and in sound health, free from infectious
diseases. Health status is monitored regularly.
• Adequate preparation before entering an aseptic area such as taking
shower and dressing with proper garments.
Figure: A clean room with personnel wearing special
clean room clothing.
Garments for aseptic procedures include
• Mask
• Hood covering head and neck
• Uniform - made of synthetic fibers are preferred.
• Foot ware consisting boots with plastic or rubber sole
• Sterile Gloves
Types of Clean Room
There are two basic types of clean room; these are identified by the
method of ventilation, namely
1. The non-unidirectional type (sometimes called conventional
turbulent) and
2. The more effective unidirectional type (sometimes called laminar
flow).
Non-unidirectional: Non-unidirectional clean rooms have a ventilation
supply system similar to that found in offices and shops where ceiling
diffusers supply filtered, conditioned air which mixes and dilutes the
contaminated room air. It then removes airborne contamination through
air extracts at the bottom of the walls.

Figure: Conventionally ventilated type of clean room.

Figure 5. Unidirectional flow type of clean room
• Unidirectional clean rooms are ventilated through a complete ceiling
or wall of high efficiency filters.
• The velocity is usually about 0.30 m/s to 0.45 m/s.
• Contamination is thus swept in a unidirectional manner to the exhaust
system ensuring that the particle and bacterial contamination is usually
between 10 and 100 times better than that found in conventionally
ventilated rooms.
• Unidirectional clean rooms are substantially more conditioned air than
conventionally ventilated rooms and are, therefore, more expensive to
build and run.
Laminar air flow system

Laminar flow, also known as streamline flow, occurs when a

fluid (liquid, gas) flows in parallel layers with absolutely no
divergence.
High efficiency particulate air filter (HEPA filter)
At least 99.97% efficient in removing particles of 0.3 µm size and larger
HEPA filters are made of glass fibers associated with fillers or electrostatic precipitators.
► 10 – 20 complete air changes per hour is desirable.
► Air is also conditioned for temperature and humidity control.
► Pre filters are always used.
► Air velocity employed: 100 ± 2 ft. / min.
Vertical air flow system is usually used in larger area during aseptic operation
(air flow from ceiling to floor).

► Horizontal air flow system is usually employed in small work benches.

Clean room air quality is described by class value.