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Press Release...
"Hypergienic" Rotary Valves meet high
pharmaceutical standards.
[August 2005]
Rota Val Ltd. has further developed its leading
‘Hypergienic’ range of rotary valves dedicated for use in
exacting pharmaceutical applications. This latest
development further enhances the ability of the range of
valves to meet increasing demands, particularly on issues
such as Occupational Exposure Levels (OELs), explosion and
flame containment, and safe handling without compromising
design performance.
Originally developed through a three-way process between a
major pharmaceutical company, Rota Val and a leading
supplier of processing equipment to the industry, the
‘Hypergienic’ range broke completely new ground in
providing a rotary valve to perform successfully inside an
isolator (glove) box whilst offering full clean-in-place
facilities with minimal operator effort. The new valves
incorporated a range of special features to ensure that no
crevices could trap product while providing drainage,
fluid injection and air blast systems to cope effectively
with wash procedures. Leakage monitoring points permit
integration with the users own safety systems. Unique
design provided simple and fast strip down accompanied by
long service life even under the demanding conditions of
frequent cleaning and arduous duty cycles. Critical to
this, in some cases, is that surface finishes are not
compromised through inadvertent component contact during
assembly and disassembly.
Since then, Rota Val has continued to research and develop
the range. The advent of EC Directive 94/9/EC (ATEX), has
focussed attention on a different aspect of the role of a
rotary valve. Whilst these valves still have a vital
function in providing accurate control of powder flow
through a pneumatic conveying system, the emphasis has
moved on to ensuring totally safe conditions within the
working environment.
A key concern in the manufacture of potentially harmful
pure chemicals is the Occupational Exposure Level (OEL) to
which employees are subjected. In designing rotary valves
for use within isolation boxes, Rota Val had to consider
the need to consistently maintain OELs of between
0.01gms/m3 and 0.001gms/m3 under normal production
conditions over a very long time.
This involved the design of valves with extremely close
operating tolerances and seals to virtually eliminate
product loss. Further reductions in leakage are made
possible by the introduction of an inert gas at positive
pressure into the seals. These features have proven value
in reducing the waste of expensive pure chemicals, lower
disposal costs, and better containment with a subsequent
improvement in working conditions. Ease of manual
strip-down without special tools and effortless cleaning
can also result in reduced system downtime and a
consequent improvement in productivity with lower
maintenance costs.
Rotary valves which achieve the relevant European
standards are now used increasingly to act as an
autonomous safety device in the event of an explosion.
Rota Val submitted representative samples of its wide
range via Notified Body Baseefa Ltd. to the Health and
Safety Laboratory at Buxton for rigorous testing for
explosion and flame containment for St2 Dusts, and has
been fully approved. This means that the valves will
withstand a 10barg explosion pressure (actually tested in
excess of this level, to more than 11 barg) and have
undergone 20 successive full explosion tests using Zinc
Stearate with an explosive rating of Kst293. In addition
to type approval with full documentation, every
‘Hypergienic’ valve is individually tested hydrostatically
to 13 barg before leaving the factory as part of the
product verification process.
Working conditions are not entirely about meeting
international OEL standards, however. By reducing the
manual handling and physical effort required to clean a
valve, together with eliminating the need for the operator
to wear respiratory protective equipment at all times,
Rota Val actively contributed to an improvement in Safety,
Health and Environment standards. Employees have expressed
high levels of satisfaction with the ‘Hypergienic’ valves
wherever these have been introduced. As one production
manager said, “If operators are happy with the equipment,
they enjoy using it, clean it regularly and maintain or
exceed the very high standards we as a company have set.
Removing the need for heavy lifting also means operators
are subjected to much less strain, which has a knock-on
effect in reducing the number of working days lost through
injury.”
Rota Val Ltd. has a long history of innovative
development. Formed in 1970, the company is dedicated to
the design, manufacture and servicing of rotary valves,
blowing seals, diverter valves and associated equipment.
By specialising in this technology, Rota Val has amassed a
vast wealth of experience in the behaviour of different
materials within pneumatic and vacuum conveying systems.
From sticky, glassy particulates to abrasive granules or
very fine powders, the range of materials handled can
present a challenge to the valve designer. Pharmaceutical
applications rarely require large throughput volumes, but
the value of the product may be very high and its effect
on employees potentially harmful if losses to atmosphere
occur.
Acutely aware of these constraints, the company has
further developed the original ‘Hypergienic’ valve designs
to enhance performance in these areas. A crevice-free
design is assured by machining the valve body from solid
stainless steel, which also has the advantage over cast
bodies in that small inclusions, pinhole porosity and
other defects often found in castings are completely
eliminated. The optional use of pharmaceutical joint seals
further aids the internal crevice-free design.
Minute attention to detail has produced a range of valves
which can be washed down under pressure at 75°C above
ambient without affecting performance. Rota Val maintains
test facilities for high-temperature washdown which permit
testing of all valve types for this essential feature.
Despite the close rotor to body tolerances essential for
explosion containment, unique design means that the rotor
will not make contact and damage the body during
strip-down and reassembly. This feature ensures that
valves safely operate over many CIP cycles and still
achieve the desired performance characteristics.
Whether supplied for normal environment or isolator box
installation, all valves are constructed to make
strip-down fast and simple. Versions with large handles
and quick-release toggles can be supplied for applications
requiring frequent cleaning, making the process more
efficient and reducing downtime. Connections to the
conveying system and other process equipment include
flanged, quick-clean and types individually specified by
the customer. Where required, the motor can be totally
encased. FDA-approved seals complete an outstanding design
which comes with full validation documentation. Versions
intended for isolator box mounting are equipped with
additional seals and remote geared motor with a removable
drive shaft. All models come with full safety interlocks
according to customer needs.
Through rigorous testing on prototypes, continuous
development and extensive experience in handling products
with a very wide range of characteristics, Rota Val have
honed the ‘Hypergienic’ rotary valves to successfully
manage the flow of even highly cohesive materials. For
instance, valves may be specified with large inlets to
discharge in a precisely controlled manner at low
throughputs, ensuring smooth, progressive conveying
through the system. Position indicators provide operators
with the essential information to confirm rotor pockets
are empty before the valve is opened for cleaning, while
true blow-through facilities also ensure full pocket
evacuation of product. Dummy end covers incorporating a
spray ball may be supplied for certain CIP applications.
Rota Val’s long experience is revealed by the depth and
quality of service provided. Whilst there is a wide range
of standard ‘Hypergienic’ valves already available with
inlet sizes from 100mm to 300mm, the company is always
pleased to consider the design and manufacture of valves
with special features to meet new application
requirements. Standard or custom-designed, every valve
produced has a detailed technical specification record,
meaning spares and replacement consumable parts are always
available to guarantee long service life.
Managing Director Ian Blackmore commented “A clean,
well-designed plant is actually looked after better by
staff. There is a significant effect on productivity, and
operators feel valued in that their views have been
considered closely at the valve design stage. The new
‘Hypergienic’ valves allow users to improve containment
capability, make the working environment easier and safer,
and save time in handling and cleaning. The rotary valves
perform a vital function in the smooth control of product
conveying, and are an essential part of modern autonomous
safety systems. Our ATEX and QA approvals are the
customer’s assurance of exceptional performance, and our
reputation an assurance of competence and high quality
service.”

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