Utilities
Utilities play an important
part in the production of safe and effective biologics, pharmaceuticals, and medical devices. To consistently provide
products that are safe and effective, utilities must be properly designed,
installed, monitored, and maintained. Utilities include, but are not limited
to, electrical power; compressed air; heating, ventilation, and air conditioning (HVAC)
systems; steam; gases, including medicinal; water,
including potable and water for injection
(WFI); vacuum; and drains. Each of these
items provides its own set of unique challenges to properly support production operations and prevent contamination and cross-contamination.
The selection and design of utilities should be made
on the premise of properly supporting production operations and preventing contamination and cross- contamination. Considerations should be made for the types
of materials used,
washing, sterilizing, and
depyrogenation. Use of medical-grade materials will help minimize contamination and reduce potential biocompatibility issues.
The Pharmaceutical
Inspection Convention’s Pharmaceutical Inspection Co-Operation Scheme (PIC/S) P1 009-3 details
a seven-step process
for pharmaceutical water systems
that includes key design parameters, qualification, inspection, quality control (QC) testing, monitoring, maintenance and calibration, and documentation.
Design considerations for water used in the production of pharmaceuticals, including WFI, should use good
engineering practices (GEP) using a risk-based approach that is planned
and structured throughout the entire life cycle of the system. The system should consider the required water quality and its intended use, the
initial water source, and storage
considerations. Water shall be supplied under continuous positive pressure in a system that prevents the possibility of
contamination. Additional design considerations should include weld quality, passivation, vent filters, suitability of construction materials, slope of pipe works,
recirculation velocities and temperatures, check valves to prevent backflow, sanitary joints, capacity relative to
demand, vales, draining and flushing, and sampling ports and locations.
Particularly important is the passivation stainless steel piping.
The passivation process uses nitric or citric acid to coat
the surface, thereby improving the corrosion-
resistance properties by dissolving iron that has been embedded in the
surface during the manufacturing
process, creating a thin, transparent oxide film. When materials are not passivated, the iron can corrode and
react with other materials, causing stains, discoloration, and product contamination.
Design considerations
for compressed air and gas
systems in the production of pharmaceuticals should use GEP with a risk-based
approach that is planned and
structured throughout the entire life
cycle of the system. The system
should consider the required gas quality and its intended
use, the initial source, and storage considerations.
Once utility systems
have been designed
and installed, qualification/validation should be
done to ensure the system is capable. At this time, the company should determine and set operational, cleaning, sanitization, and sterilization
parameters for the systems. Appropriate consideration should be given to maintenance and calibration activities.
Quality-testing methods, along with acceptable
thresholds, should be developed and documented
in appropriate procedures and work instructions. These procedures should document who will conduct the sampling,
when samples will be taken, the minimum required
sample volume, handling and storage of the samples, chemical, biological, and particulate levels, and how to handle out of specification (OOS) results. Frequent monitoring (for example,
temperature, pressure, velocity), maintenance, and calibration activities should be conducted according to established
procedures to ensure that the system(s) are functioning as intended.
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