PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 285

using the wrong equipment, equipment not fit for the purpose intended, or using
the equipment incorrectly. Specifically, the risks, if any, associated with the
equipment or instruments being used in the performance of a particular task are
identified.
The assessment should consider if the equipment being used is the appropriate
equipment for the job. For example, something as simple as a scoop, a tool
typically with a short handle used to sample or extract materials from containers,
would be assessed for its use in a given situation. For taking materials from the
top of containers, a scoop may be an appropriate tool. However, its use for taking
a sample from the bottom of a deep container would not be appropriate because
it may require that the operator reach arm's length into the container exposing
the material to potential contamination from the operator's clothing or bare skin.
11.2.5.2 Cleaning and Storage Equipment design should be assessed for risks
associated with its inability to be completely cleaned, surfaces and especially
internal parts that may come in contact with the product. Small internal crevices
or open spaces within product-contact equipment can pose a risk of entrapping
materials in hidden or impossible to clean locations. A tablet, for example, may be
small enough to fall into the internal parts of a filling machine. In such situations,
there is an inherent risk that these materials can later be dislodged during the
manufacture of a subsequent batch, resulting in a product mix situation. Likewise,
powder, liquid, or semi-solid materials can collect in internal pockets, may dry
and harden, even possibly degrade to a different material or support microbial
growth (e.g., mold) and later become dislodged, contaminating a subsequent batch
if not removed.
Once cleaned, storage conditions should be assessed to ensure that they support
maintaining the integrity of the cleaned equipment. For example, what is the risk
to product quality if a piece of equipment (e.g., formulation tank or dispensing
pump) that is cleaned and rinsed with water is stored wet? What if the equipment
is not fully drainable and the residual water is allowed to remain? Will the wet
condition pose a risk that residual moisture will support microbial growth and
contaminate a subsequent batch? In this case, a drying step before storage may
be needed to mitigate such a risk. Or, consider whether the storage room air
quality or the type and extent of wrapping are adequate, as needed, to protect the
equipment from environmental contamination.
11.2.5.3 Maintenance and Calibration Routine equipment maintenance, emer-
gency repairs, and calibration practices should be assessed to ensure that:
• the methods are appropriate and adequate in scope;
• they are performed with sufficient frequency;
• they are performed at appropriate locations and time; and
• they are not performed at a time or in a way that would allow for product
contamination.