PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 284

would keep the potentially contaminated filling room air from traveling airborne
to contaminate adjacent areas.
There may be other environmental conditions that pose a risk to product quality
if not controlled. Therefore, product-specific requirements should be assessed to
determine if environmental protective measures are required. These may include
temperature and humidity or light sensitivity protection. Considerations for deter-
mining if temperature and humidity controls are critical to product quality should
include the following:
• product hygroscopicity;
• product sensitivity to temperature and humidity;
• product specifications; and
• preclusion of condensate on room and equipment surfaces.
Additional considerations for temperature and humidity control would include
operator comfort and equipment operation and exhaust.
Automated systems used to control air filtration, differential pressures, or tem-
perature and humidity should be equipped with indicators (e.g. alarms) that allow
operators to know if these systems are functioning or failing to maintain the
critical parameters.
The exposure of product-contact packaging materials or clean product-contact
equipment to an environment is another area of risk to product quality that should
be considered in the risk assessment. It may mean that product-contact packaging
materials (e.g., drum liners, super-sacks) or product-contact equipment need to
be protected. (e.g., keeping them covered, use of continuous drum liners or use
of laminar flow booths).
11.2.5 Equipment and Instruments
In general, any instrument or equipment used to sample, move, store, formu-
late, hold, dispense, test, clean, sanitize/sterilize, control, or monitor needs to be
considered when performing the risk assessment. This includes the more simple
manual equipment or instruments, e.g., scoops, container liners, or pH meters, to
the more sophisticated electronically operated and controlled equipment or instru-
ments. Different aspects of equipment selection and use should be considered;
for example, some aspects to consider are as follows:
• appropriateness for the intended purpose;
• cleanability;
• maintenance and calibration schedule and routine; and
• validation.
11.2.5.1 Appropriateness for Use Each piece of equipment or instrument
should be evaluated with regard to its functional role in the process step. As
mentioned earlier in Section 11.2.2, with regard to formulation operations and
Section 11.2.4 with regard to cleaning the facility, there are inherent risks in