PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 283

Cleaning and sanitizing equipment are also part of the risk assessment. Some
other factors that the assessment should consider are as follows:
• equipment type, e.g., mops, sponges, or buckets;
• materials of construction, e.g., cloth or sponge mops, cloth wipes or sponges,
plastic or stainless steel buckets;
• cleanability of the equipment;
• size or ease of handling; and
• durability or life expectancy of the equipment.
If not readily cleanable, buckets, mops, and cloths can hold soil or contami-
nants from previous uses and redeposit or introduce these contaminants during
subsequent uses. If the mops or cloths are not made from nonshedding materials,
they could emit particles and thus contaminate surfaces or the environment.
The frequency of cleaning or sanitization can impact the cleanliness level. An
insufficient frequency to keep contaminants at a controllable level poses the risk
of product contamination.
11.2.4.3 Environmental Controls Each area and manufacturing room should
be assessed to determine the level of environmental control needed to protect the
product from airborne contaminants such as chemicals, nonviable contaminants,
and microbes. The level of control needed will depend on the use of the area or
room, the type and level of activities, and the extent to which the product will
be openly exposed to the manufacturing environment. Airborne contamination
is typically controlled by air filtration and may include air pressurization and
temperature and humidity controls. Inadequate air filtration poses the risk that
the environment will contain levels of contaminants sufficient to result in product
contamination.
Air pressure differentials can be used to control the risk of contamination
between adjacent areas with different air quality requirements. A room requiring
a higher air quality would have a greater air pressure than that of the adjacent
room. In practice, the higher pressure keeps the less-quality air of the adjacent
room from entering. For example, a filling room, where a product is likely to be
openly exposed to the environment during the process, would require a higher
level of air cleanliness than that of an adjacent hallway where product exposure
is not likely. To maintain its level of cleanliness, the filling room would have a
greater air pressure to hold back the less clean hallway air from entering. If the
level of air filtration, level of air pressure, or the air flow pattern is incorrect, the
product could be at risk of contamination.
Room air pressurization is often used to protect a product from the risk of
cross-contamination where highly potent or hypoallergenic chemical materials
are part of the manufacturing process. The air flow pattern should be designed
to contain the materials to a given area and keep them from traveling airborne to
adjacent areas. Using the filling room example, the air pressure would be greater
in the hallway adjacent to the filling room. The higher hallway air pressure