GE P&W Ultrapure and Drinking Water TOC Analyzers - Sievers Technology Transfer Protocols - Manual

GE Power & Water
Water & Process Technologies
Analytical Instruments
Fact Sheet
In the drug industry, implementing changes
or change management is often discussed
in terms of resources, documentation, and
time spent on the manufacturing process
or the final product. However, changing
from legacy technology to new technology,
in addition to implementing a process for
new TOC analyzers, requires a structured
procedure and tools.
To help with this objective, GE Analytical
Instruments has released Technology Tran-
sition Protocols that facilitate the change
from the Sievers 400 ES to the 500 RL, and
from the Sievers 800 to the 900 Series Labo-
ratory TOC Analyzers. Since the transition to a new TOC
analyzer can take a signficant time commitment, GE’s
unique validation protocols (tools) can greatly accelerate
this conversion.
Aligning with the Current Best
Practices Process
By definition, the International Conference of
Harmonization (ICH) describes a form of technology
transfer in ICH Q10 as “activities or validation steps
associated with the transfer of process knowledge
or data between departments, manufacturing sites,
or related technologies/ equipment.” However,
this document states that “this
knowledge forms the basis for the
manufacturing process, control
strategy, process validation approach
and ongoing continual improvement.”
It is important to note, though, that
without a clear path in transitioning to
new TOC technologies, this can be a
multifaceted process.
In addition to ICH Q10, the United
States Pharmacopeia (USP) has come
forward in USP <1058> Analytical
Instrument Qualification to provide
additional guidance by highlighting
a transition to new technology associated with
analytical instruments. USP <1058> suggests that this
type of transition involves a form of “change control”
that should evaluate elements of design, as well as
operational and performance qualification. Figure 1
highlights GE Analytical Instruments’ rationale and
justification for developing these transition protocols.
Key Components of GE’s
Transition Protocols
TOC instruments have historically been employed to satisfy
compendial requirements involved in the measurement of
organic contamination in pharmaceutical waters. When
Sievers Technology Transfer Protocols
A QSO Product for Upgrading from Legacy Sievers TOC Analyzers
to the 900 and 500 RL Models
Figure 1. The Transition Process for New TOC Technologies