Pharmaceutical companies must ensure that process water consistently meets defined ionic,
microbial, and organic thresholds through validated system design, monitoring, and service
programs. Flier’s pharmaceutical RO systems are custom-designed to support your facility’s
water quality criteria, throughput goals, and applicable good manufacturing practice (GMP)
requirements.
Systems are developed to conform to USP conductivity expectations for Purified Water
(confirmed under specified test conditions such as temperature and method). For applications
that cannot achieve the required conductivity specifications or recovery targets using only a
single pass electrodeionization system because of feedwater chemistry or process limits, a
multi-stage EDI system may be used. Component selection will also be based on a documented
source-water profile (TOC, ionic composition, and hardness). These are aligned with the
guidelines of ICH Q7 for the API water systems. Systems include proven processes and
hygienic distribution loop designs, as well as URS documentation.
Membrane housings and wetted components are fabricated from materials compatible with
routine hot water sanitisation, and piping / internal flow paths are crafted with sufficient velocities
to minimize the formation of biofilms (site-specific monitoring needed).
Online conductivity and TOC monitors with adjustable alarm setpoints and continuous electronic
recording are provided and can be implemented as part of a facility’s broader controls for
electronic records under 21 CFR Part 11, where applicable.
Planning a pharmaceutical RO system or reviewing an existing setup? Flier’s application
engineers can talk through your feedwater, throughput, and purity requirements with you.
Feedwater profile testing considers anticipated seasonal variations to support consistent
permeate quality from the selected membrane configuration over time, not just at the time of
installation. A pressure source and inlet pre-treatment are created to accommodate anticipated
changes in feedwater chemistry throughout the membrane’s service life, instead of relying solely
on nominal design parameters. Exceptional changes may necessitate membrane replacement
or operational adjustment.
Each installation includes Installation Qualification (IQ), Operational Qualification (OQ), and
Performance Qualification (PQ) documentation to substantiate proper installation and
functionality and to assist regulatory evaluations. A preventive support plan is offered for each
end-user and comprises membrane integrity testing, scheduled chemical cleaning, and control
of hardness breakthrough. Flier’s offers 24/7 response to service calls to support uptime and
production continuity.
If an existing RO system needs attention, reach Flier’s at (616) 583-9040 or
purewater@fliersinc.com to discuss the issue with the service team.
RO membranes do not effectively reject dissolved carbon dioxide. Once CO2 enters the membrane, it dissolves in the permeate and forms carbonic acid, which increases conductivity
independently of other dissolved ions. When a single-pass RO system operates without a
downstream electrodeionization unit or demineralization, attaining a conductivity level of ≤1.3
µS/cm can be challenging.
The modification formally recognises membrane-based technologies as an acceptable approach
for producing Water for Injection (WFI) in the EU, where systems are precisely designed,
validated, monitored, and maintained. The revised Annex 1 states that WFI may be produced by a
purification process equivalent to distillation, which may include reverse osmosis coupled with
appropriate techniques such as EDI, ultrafiltration, or nanofiltration.
Microbial plate counts measure only viable microorganisms capable of growth under the test
conditions. They do not measure bacterial toxins such as lipopolysaccharide (LPS), which
remain after Gram-negative bacteria die and can persist in films. Because endotoxins are
biologically active even when the source organisms are no longer culturable, microbial counts
do not provide a complete assessment of biological safety.
