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contamination of bio-clean rooms is the equipment/materials and people brought into the room.

An important precaution is while entering or carrying in equipment/materials to bio-clean rooms,

people and equipment must pass through barrier equipment.

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Aseptic Clean Rooms for Pharmaceutical and Bio-manufacturing
Aseptic is the absence of microorganisms capable of causing infection or contamination.

The objective of aseptic processing methods is to assemble previously sterilized product,

containers and closures within specially designed and controlled environments intended to

minimize the potential of microbiological or particulate contamination.

Levels of Protection

Based on the clean room class requirements, various ‘Levels of Protection’ have to be created,

including:

• Correlation between process operations and clean room classes

• Type of operation permitted in each Level of Protection

• Definition of clean room class (parameters, building materials, room requirements,

HVAC systems)

• Requirements for personnel and material in the different classes (clothing, training, type
of materials, etc.)

• Requirements on entry conditions for personnel and material (change procedures)

Parameters influencing Levels of Protection

• Number of particles in the air

• Number of microorganisms in the air or on surfaces

• Number of air changes for each room

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