𝘼𝙎𝙀𝙋𝙏𝙄𝘾 𝘼𝙍𝙀𝘼

𝙎𝙤𝙪𝙧𝙘𝙚 𝙤𝙛 𝙘𝙤𝙣𝙩𝙖𝙢𝙞𝙣𝙖𝙩𝙞𝙤𝙣
Microorganisms are easily 𝙨𝙥𝙧𝙚𝙖𝙙 everywhere.
Asepsis is the method of practice to reduce or
eliminatecontaminants from the working areaand
to make the area sterile and cleanThe
contaminants are like bacteria,viruses, fungi and
other parasites. The area free from contamination
is known as aseptic area.
𝘾𝙡𝙖𝙨𝙨𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣
• 𝘼𝙩𝙢𝙤𝙨𝙥𝙝𝙚𝙧𝙚
• 𝙊𝙥𝙚𝙧𝙖𝙩𝙤𝙧
• 𝙍𝙖𝙬 𝙢𝙖𝙩𝙚𝙧𝙞𝙖𝙡𝙨
• 𝘽𝙪𝙞𝙡𝙙𝙞𝙣𝙜
• 𝙀𝙦𝙪𝙞𝙥𝙢𝙚𝙣𝙩
• 𝙋𝙖𝙘𝙠𝙖𝙜𝙞𝙣𝙜
𝘼𝙏𝙈𝙊𝙎𝙋𝙃𝙀𝙍𝙀
• Atmospheric gases namely oxygen and carbon dioxide
are the main sources for microbial growth.
Oxygen has more significant effect on microbial
growth.
• Dust particles in the outside air are the main
Carriers for the soil organisms like Clostridium,
Yeast, molds etc.
• Indoor air also contains bacteria like streptococcus,
staphylococcus species on cloths or human skins.
METHOD OF PREVENTION
• Maintain the air humidity level inside the clean room.
Operators should move as much as less inside the
clean room. Aseptic rooms are maintained at higher
differential air pressures than adjacent controlled
areas.
• Air filtration and air change rates should be set to
ensure that the defined clean room class is attained.
• The air velocity should be 100 ± 20 ft/min.
OPERATOR

• Operators are also another source for microbial

contamination like the skin, hair and clothing of the
operator.
• Skin mainly contains microorganisms like
staphylococci, lipophilic yeast and dermatophytic
fungi.
• Health and hygiene conditions also play an important
role for microbial growth. The skin coliforms and
other intestinal bacteria grown in poor health
condition.
METHOD OF PREVENTION
• Access to production areas must be controlled to
ensure entry is restricted to trained personnel
only.
• A high level of personnel hygiene must be
observed.
• All inexperienced workers whose activities may
affect the quality of the product must receive
regular training, including hygiene instructions.
• Personnel access must only be made via changing
rooms.
Raw Materials
• The raw materials used for production can be a
potential source of contamination.
• The main reasons for contamination from the raw
materials due to storage and handling
mistakescausing mix-ups or selection errors
contamination with microorganisms or other
chemicals,degradation from exposure to excessive
environmental conditions, improper labeling,
sampling and testing etc. • Water also plays a
major role for the microbial contamination. It acts
as carrier of all kinds of microbes.
METHOD OF PREVENTION
• Raw materials should be stored in proper dust
proof area with proper labeling.
• Water used in the manufacture of pharmaceutical
products should be suitable for the intended use
and should be of pharmaceutical grade,
microbiologically controlled and monitored.
• Steam used for cleaning and sanitization of
production tools and equipment, supply for
autoclaves and humidification must be clean and
free of additives.
BUILDING
• The buildings and manufacturing facilities may also
contribute to the contamination.
• The main reasons of contamination due to facility
issues like insufficient size and inadequate
organization of the space, cross contamination
between consumables, raw materials, in process
materials, and finished products, inadequate filth and
pest controls, rough floors walls and ceilings, lack of
air filtration systems; improper lighting and ventilation
and inadequate washing, cleaning, toilet, and locker
facilities, cleaning facilities and equipment.
METHOD OF PREVENTION
• Interior surfaces, eg floors, walls, ceilings should be
smooth, free from cracks and should permit easy
and effective cleaning.
• Windows/viewing panels should be non-opening,
flush with the wall panels and properly sealed to
prevent collection of dust and microbial material.
• Pipe work, ventilation and light points should be
designed to avoid creation of recesses which are
difficult to clean.
• Sinks within the production areas should be made of
stainless steel.
Equipment
• The equipments and other accessories that are used
in processing, holding, transferring and packaging
are the common sources of microbial contamination.
• The main reasons for contamination from the
equipment are inappropriate design, size, material
leading to corrosion and accumulation of static
material and/or adulteration with lubricants,
coolants, dirt, and sanitizing agents etc. Improper
cleaning and sanitization, design preventing proper
cleaning and maintenance, irregular service, and
deliberate use of defective equipments.
Method of prevention
• Areas must be regularly cleaned and disinfected.
• A high level of cleansing and hygiene should be
practiced for the manufacture of drug product.
• Suitable grade of cleaning agents should be used
to minimize health risks.
• Materials used for cleaning should not come in
direct contact with the product.
Packaging & Manufacturing Process
• Another way of contamination is the packaging
materials throughout the manufacturing process.
• The main reasons for contamination during
manufacturing process includes lack of dedicated
facilities to manufacture a single product,inappropriate
cleaning in-between batches to minimizethe amount of
product changeovers, use of an open manufacturing
system exposing the product to the immediate room
environment, inappropriate zoning absence of an area
line clearance according to approved procedures and
lack of cleaning status labeling on all equipment and
materials used within the manufacturing facilities.
Method of Prevention
• Flexible packaging used to inactivate
microorganisms associated with foods include
controlled atmosphere, vacuum, modified
atmosphere, active, and edible packaging.
• The combination of rigid packaging materials
made from metal, glass, or plastic with heat
provides the most effective and widely used
method for inactivating microorganisms.
• Manufacture process should maintain proper
hygienic condition.