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Pharmaceutical Water
Systems
| Case Study -
Gerard Laboratories
Honeyman
Delivers New Purified Water System Project to Gerard Laboratories
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Gerard
Laboratories are a fully-owned subsidiary of Merck KGaA of Germany
since their acquisition in 1995, and manufacture a broad range of
medicines at their facility in Baldoyle, near Dublin, Ireland. Gerard
are a major supplier of generic pharmaceuticals to the worldwide
market, and the Baldoyle site has enjoyed significant growth and
investment in recent years.
The
Honeyman Group was initially engaged by Gerard to investigate their
existing Purified Water system concerning its future capacity and
capability with regard to their facility upgrade and expansion
plans. After a detailed evaluation, Honeyman concluded, and advised
Gerard, that a replacement water system represented the most
effective and cost-efficient option. This decision resulted in
Honeyman Group subsequently being appointed by Gerard for the
design, project management and the quality management aspects of the
new water system project. Honeyman have subsequently been retained
by Gerard Laboratories for the on-going monitoring and assistance in
the quality management of the operational water system, involving
chemical and microbiological analysis and regular data and plant
performance review.
The new
water system project consisted of many integrated elements in which
Honeyman Group acted as consultants, installation invigilators and
project managers in the construction phases, in addition to being
overall process designers. The initial User Requirement
Specification (URS) was drafted by Honeyman based upon user data
supplied by Gerard Laboratories. The URS was a fundamental document
to the success of the project as it laid down the high level user
requirements of the system in terms of quantity, quality, volumetric
usage patterns of water, and set out key aspects of the build
specification.
Vendors
and contractors were invited to tender for the water system package
against the Honeyman design and system specification. The bid
process and evaluation of tenders was jointly carried out by
Honeyman, Gerard and Merck, with the final vendor selection being
made at Merck in Germany.
The
validation trail was initiated and carried out by Honeyman Group
running alongside the engineering project. This included the Design
Qualification, the Installation Qualification, the Operational
Qualification and the Performance Qualification, including the water
testing/analysis and summary report preparation.
During
the validation process Honeyman used their comprehensive check sheet
system, which was developed over many years performing similar work
for other water projects. These acted as the master documents to
ensure compliance with design, delivering visibility of progress,
and allowed timely control over the receipt and collation/completion
of all documentation. This streamlined process ensured that a
compliant, cost effective water system and the corresponding
validation package, were delivered on time.
Honeyman
provided an original copy of the documentation package to Gerard
Laboratories at system handover, with the qualification
documentation being organised in a hierarchical structure to ensure
comprehensive completion and easy retrieval of information. All
files were copied and data will be held by Honeyman for a minimum of
five years for future reference and referral in their continued
support of Gerard.
The
project management of the water system installation was carried out
under the experienced guidance of Honeyman Group, who have 15 years
experience of successful delivery within this industry sector. In
total, the new Purified Water system was active within three months
from the start of construction. This was important to Gerard
Laboratories, as their requirement was for a fast-track,
‘right-first-time’ project within the tight timeframe given.
To
enable this completion deadline to be met, Honeyman had to
effectively and efficiently coordinate all of their specialist
resources across a wide range of disciplines and activities. This
was the key to successful delivery on this occasion, and without
Honeyman’s considerable experience of handling similar fast-track
water projects, the deadline may not have been met.
One
challenge which Honeyman successfully overcame involved the careful
selection and installation of piping routes. Many ‘standard’ or
non-specialist piping designers might have missed the intricacies
and nuances of this crucial stage of the design which was
fundamental to the success of the project. The problems related to
issues of differing roof void heights, made it especially difficult
to ensure that the pipework met the requirements for drainability,
however Honeyman’s experience in the design and mapping of
appropriate piping routes overcame this and significantly shortened
the installation time.
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