CLEANROOM TECHNOLOGY & CONTROL
A handy guide to validating high purity water systems High purity water is critical to pharmaceutical processing. Validation of the systems used to produce high purity water and close adherence to the SOPs are essential to maintaining the quality and integrity of the water generated. Kenneth Amaral of Fabtech outlines points to consider in order to increase the odds of successful validation.
W
ater is the most widely
and quality of water during operations
• operating procedures
used raw material
and maintaining this according
• maintenance instructions and records
in the production of
to specific written operating and
• training of personnel
pharmaceuticals, and in
maintenance procedures.
• environmental records
some products, like parenterals, it’s a
The following factors are involved in
• plant inspection documentation.
vital element. Water is also used to clean
proving the validation of high purity
Once validation is complete, an effective
vessels and systems used to manufacture
water systems:
standard operating procedure (SOP)
pharma products.
• engineering design
is finalised, with the assurance that the
• operating procedures and acceptable
system can consistently produce water
A unique aspect of high purity water used in the pharma industry is that it’s possibly the only element, which, as a rule, must be produced by the drug manufacturers themselves as it’s not available in ready to use form. Irrespective of the system used to
ranges for control parameters • maintenance procedures to accomplish it • the system has to be designed,
according to specification and over long periods. If any deviations from the SOP are observed, it’s necessary to determine the change and impact on the whole
installed and successfully tested in all
system and carry out revalidation based
operating conditions
on the change and impact.
generate high purity water, regulatory
• variations in daily, weekly and annual
Any validation protocol must include
guidelines around the world mandate
usage patterns must be validated.
the elements outlined above. However,
validation of the system. Validation
A validation report is written at the
the validation process is long and often
is necessary to monitor system
conclusion of equipment, instrumental
small details can be overlooked.
performance including that of storage
and operational qualification and
and distribution systems. It ensures
at the completion of the validation
UV Lights
the system is operating within design
protocol. This report serves as the primary
One of the most commonly overlooked
parameters along with the consistent
document during inspection by the
considerations is UV lights. When UV
production of water of a desired quality.
regulator and as a reference document
lights pass through microorganisms,
Validation also prevents unacceptable
if any changes are made to the system
they inhibit reproduction and disrupt
microbial, chemical and physical
and revalidation is needed.
the DNA of the cell. A UV lamp must function at optimum efficiency at all
impurities from being generated during water generation, storage
Documentation required
times to maintain the quality of UV rays
and distribution.
During validation, the following
and keep microbial contamination
documentation is required:
in check.
It allows manufacturers to prove the performance of processes or systems under all conditions, encountered during future operations. This is achieved by consistently producing the same quantity
• verification of design documentation
analysed before and after UV exposure
and functions and specifications
to determine whether microbiological
of functions
A reverse osmosis system installed within a pharmaceutical processing plant
42 | JANUARY
2020 | P C Review
Water samples from test ports are
including a description of installation
contamination is present. UV systems
