What
is HydroGienic®?
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HydroGienic® is a new and novel, cGMP compliant piping system designed
for the distribution of pure water throughout pharmaceutical and biotech
facilities.
What’s
different about it?
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o HydroGienic®
connects user points in parallel (rather than in a conventional
'loop' arrangement)
o Small-bore PTFE hoses are used for delivery rather than welded stainless
steel tubing
o Hydraulic balancing and hygienic flow & pressure conditions are
maintained by a patented technique giving 100% user diversity (All
taps can be opened together)
What
advantages does parallel configuration provide?
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o
Easy to add /remove and modify offtakes without disrupting other users
o
Gives complete flexibility of pharma-water systems
o
Allows easy modular facility build and expansion
o
May be used to add new users to existing systems
o
All user taps may be opened together (100% diversity)
o
Easy to isolate individual offtakes for local sanitisation
What
are the advantages of using PTFE hoses?
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o
Installation is very quick and simple compared to stainless steel and
uses relatively unskilled labour
o
Installation is much less disruptive to facilities
o
Validation paperwork is kept to a minimum – 1 certificate per hose –
significantly less than numerous stainless steel fittings and all the welding and inspection records that go with it
o
No
rouge generation – unlike stainless
Cost
benefits – How does HydroGienic® compare to conventional systems?
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HydroGienic® is cost effective in several ways - in terms of capital
cost, validation/qualification cost, and lifetime cost of ownership,
including energy consumption.
If the
downtime costs of facilities are taken into account for installation
disruption, then the cost benefits of HydroGienic® are even greater.
Modifications and alterations to user points that might be expected in
production areas over the typical lifetime of the system, can be
performed at significantly lower cost with HydroGienic®, adding further
to the lifetime cost benefits.
Often,
HydroGienic® systems are cheaper in capital procurement terms than
conventional systems. However, the comparative costs do vary according
to the specific application. Generally, the larger the building (i.e.
the greater lengths of pipework and the more user offtakes), the greater
are the savings of HydroGienic® when compared to conventional stainless
loop designs.
Give a
typical cost comparison example
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A project
completed in 2006 for a pharmaceutical manufacturer client involved a
conventional Purified Water system installation comprising 18 offtakes
and 450 metres of 2½”stainless loop pipework.
The
equivalent HydroGienic® system would have saved 17% of capital cost
(around £100,000), and halved the installation time from 71 weeks to
just 36 weeks in this example. (Cost breakdown details are available to
interested enquirers).
Have
many Pharmaceutical companies expressed an interest?
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They
certainly have. We have made dozens of presentations at all levels to
many of the World’s largest pharmaceutical manufacturers across Europe
and everyone is interested in adopting the technology in their
manufacturing sites. There are more and more problems coming to light
with conventional stainless systems to owners, users and regulators. A
particular concern is the increasing presence of ‘rouge’ in stainless WFI systems for example – which would be a problem eliminated by
employing the HydroGienic® system.
Pharmaceutical companies are increasingly interested in eliminating
today’s, often very costly, water system problems – so they can get on
with the business of making pharmaceuticals!
Is
there a need for new water system technology? Don’t the old systems
work?
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There is
a perception that today’s water systems ‘work’. Well they do to a point,
but their limitations are often not fully understood or appreciated.
There is
a definite need to move on to a water system technology that works for
their owners – not the other way round, giving production departments
the opportunity to maximise their outputs and efficiencies.
It is
only a matter of time before HydroGienic® advantages and
benefits have been seen and accepted by users and owners, at which point
they will fully appreciate just how limiting and restricting existing
loop systems are.
Has
the principle been proven in practice – in a working system?
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Yes
absolutely!
During
the proof of concept stage, we worked collaboratively with GSK in 2006,
and installed a 6 offtake pilot plant in a GSK site, which successfully
completed OQ and PQ trials. GSK have consequently endorsed the
technology and plan to use it in their next generation of water systems.
(The operation and performance data is available for interested parties
to review).
Where
can we see a system working?
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Two
options at the moment. Firstly, the ex-GSK pilot plant is fully
operational at our offices in Barnard Castle. We would be delighted to
show you the system working and to present all of the GSK trial OQ and
PQ data.
Alternatively, we have a fully operational demonstration trailer, so we
can actually bring the HydroGienic® system to your
own site for you to evaluate in-situ. Just contact us to book a visit
either way.
Why
haven’t you got hundreds of systems installed yet if it is so good?
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Simple.
Because compliance is the death of innovation , and we have to change
attitudes and minds first, just as all other successful pioneers have
had to do before us.
It took
more than 10 years for electro-deionisation to be finally adopted as a
standard water purification method in the pharma industry – so we are
in good company!
Can HydroGienic® be added to an existing system, or is it only suitable
for new installations?
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HydroGienic® is equally applicable to both new and existing systems
alike. All that is required is a water storage vessel with suitable
connection ports.
Describe how a HydroGienic® Project might run
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Honeyman
will develop enquiries and quotations based upon the URS and system
criteria as discussed and agreed with the client. This preliminary
work will result in a detailed design and specification for the specific
HydroGienic® application being completed by Honeyman, and agreed at
Design Qualification (DQ).
Thereafter, there will typically be 5 essential elements to a
HydroGienic® project:-
1. Fabrication and delivery of the storage vessel
2.
HydroGienic® skid, FAT testing and delivery to site
3.
Plant room site installation and services
4.
Site installation of hose delivery pipework to offtake points
5.
Commissioning and setting to work of the system
Honeyman
will have overall responsibility for execution and delivery of the
project, including system-related cGMP issues, validation and
qualification documentation.
The site
work, which will be much reduced in comparison to conventional systems,
may be carried out quickly using relatively lower-skilled labour than
might traditionally be employed for a conventional system installation.
HydroGienic® designs uniquely lend themselves to a number of flexible
installation options for clients.
These
include:-
-
Installation
and commissioning of plant room only – offtakes may be
added singularly or in any combination, as required
-
Adding HydroGienic® users to an existing system whose user points may
remain in continuous use
-
Providing a parallel build alongside an existing system
I am interested in hearing
more about HydroGienic® – what do I do next?
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For general enquiries or if you would like to
discuss your specific requirements, please contact us at –
Honeyman Group Ltd
Harmire Enterprise Park
Barnard Castle
County Durham
DL12 8BN
Tel: +44 (0)1833
690101
Fax: +44 (0)1833 690102
Email:
enquiries@hydrogienic.com
To request a copy of the
HydroGienic®
brochure, simply
Click Here.
