ASEPTIC PROCESSING: ONE - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 231

the considerations necessary for success with aseptic processing are far more
extensive than this summary provides.
9.4.1 Facilities
Contamination is avoided in any operation by proper design of the facility in
which it will be executed. This includes aspects such as the following:
• material, personnel, and other flows that avoid mix-ups, cross-contamination,
etc.;
• adequate protection from the building surroundings including temperature,
humidity, and dust control;
• arrangement of operations such that soil and other potential contaminants
are minimized in preparation and processing areas;
• separate and dedicated areas for cleaning, waste treatment, and similar activ-
ities; and
• sufficient space for the operations within, including access for operation,
cleaning, and maintenance.
9.4.2 Environment
Within the overall facility, environmental controls must be provided over those
materials and activities vulnerable to contamination,
• Progressively cleaner environments should be utilized as products, compo-
nents, and equipment are cleaned, prepared for sterilization, and eventually
assembled into the finished product.
• The environments should be decontaminated on a periodic basis to minimize
microorganisms present during operations.
• The environments should be periodically monitored to establish their suit-
ability.
• Appropriate qualification activities should be performed to establish suitable
change rates, differential pressures and air flow that best maintain control
over conditions.
• The environment should provide a comfortable working environment for the
operators at all times with respect to temperature, humidity, noise level, and
lighting.
9.4.3 Equipment/Utensils
The equipment utilized for the process should be designed to minimize its con-
tamination potential and properly maintained in that state.