[0001] The present invention relates to a modular isolator comprising a plurality of conjoined
modules, each module enclosing a quadrantal processing zone, and to the module
per se.
[0002] Effective containment is essential for the safe and hygienic handling of a pharmaceutical,
chemical or biological product. At each stage, handling must be controlled and managed
to provide optimum protection for the operator and to maintain the integrity of the
product. For example, current Good Manufacturing Practices (GMP) exercised within
the pharmaceutical manufacturing industry demand good containment performance and
acceptable operator exposure levels.
[0003] For handling a solid (eg powder) or liquid product of a sensitive or hazardous (eg
toxic) nature in a processing zone, there are available a number of different types
of containment assembly. In one such containment assembly, the air quality in the
processing zone may be controlled using forced ventilation. One category of forced
ventilation is "downflow" in which surrounding air is pushed downwardly to entrain
airborne particles to a level below the processing zone (eg to a level below the operators
particular breathing zone). For downflow containment, exhaust is usually carried out
at low level relative to source of particles. This permits the downflow assembly to
provide operator, product, and/or environmental protection for a range of powder and
liquid handling applications. A downflow containment assembly may comprise an operator
booth of sufficient size to admit the operator for the purposes of (for example) manipulating
powder handling equipment (eg large powder kegs or bins weighing devices). One such
assembly is disclosed in EP-A-1146293.
[0004] An alternative conventional containment assembly is a barrier isolator with gloved
access to the processing zone in which a product and/or handling equipment may be
manipulated. The use of a barrier system offers improvements in the handling of pharmaceutical
products in circumstances where product protection and the maintenance of asepsis,
and/or operator protection and the control of hazardous substances are critical requirements.
A barrier isolator offers two fold protection, namely the use of glove ports to maintain
a physical barrier between the product and the operator and a fan system to create
air flow for removing airborne particles from the processing zone and into filters.
In this manner, a barrier isolator may achieve high containment typically down to
less than 10µg/m
3 of contamination in the surrounding environment. One such isolator is disclosed in
EP-A-1264668.
[0005] As a result of the economic and operational advantages of isolators, their use in
hospital pharmacy in the UK is now widespread and over 400 are currently in use. They
are designed and installed as individual units for aseptic preparation and dispensation
of all forms of parenteral products and are commonly used in centralized cytotoxic
reconstitution services, centralized IV additive services (CIVAS) and for the preparation
of total parenteral nutrition (TPN) solutions. Isolators have several advantages over
conventional clean rooms and laminar flow cabinets for aseptic preparation and dispensation
of injectable formulations. Firstly they may be sited in an unclassified environment
and still provide an acceptable level of sterility for aseptic operations. Secondly
costs can be minimized because a minimum amount of costly protective clothing is needed.
Furthermore, their operator and product protection efficiency is not affected by air
turbulence around the cabinet since the processing zone is totally enclosed (whereas
the protection properties of a vertical laminar flow drug safety cabinet for example
can be significantly reduced by air turbulence across the front opening of the cabinet).
Isolators cannot however be regarded as totally sealed units since there must be open
access to the processing zone when materials are transferred in and out and the processing
zone is continuously supplied with HEPA filtered air. Otherwise the processing zone
of the isolator is sealed from its background environment in use.
[0006] Most isolators for aseptic processing use laminar (unidirectional) airflow, turbulent
airflow or a combination of the two within the processing zone for the removal of
airborne particles from the processing zone and into filters. It is generally accepted
that the critical zone of the controlled surface should be equivalent to the EC grade
A but the airflow in the critical zone need not be laminar flow. In the situation
where a laminar flow system within the controlled critical zone is not provided, it
is standard industry recommended practice for tests to be performed so as to confirm
that only air complying with the requirement of EC Grade A is supplied to the critical
zone. Furthermore, it is required that air should be effectively swept from the processing
zone and standing vortices and stagnant areas should not exist.
[0007] Isolator technology is now widely used for the aseptic industrial processing of pharmaceuticals.
Although the revenue and capital savings that hospitals have achieved may not be realized
in industry, isolator technology can improve operator and product protection and increase
sterility assurance. Production lines with integrated isolation technology are now
being introduced into the pharmaceutical industry. Isolators are also used in microbiology
departments for sterility testing which relies heavily on an effective aseptic technique.
[0008] Although one of the major advantage of these generally bespoke products is that they
can be custom built at reasonable cost to comply with recommendations set out in current
GMP guidelines, there is little or no consideration as to their aesthetic appearance
and configuration. Indeed the majority of such products adopt a rather unsophisticated
configuration (typically a box-like (eg square) configuration).
[0009] The present invention seeks to address certain disadvantages of a conventional containment
assembly by providing an isolator whose modularity offers numerous permutations of
overall size and shape whilst beneficially assisting the operator to work at maximum
efficiency. In particular, the present invention relates to a modular isolator comprising
ergonomically designed modules which may be conjoined in various configurations to
provide versatile and effective containment.
[0010] Thus viewed from one aspect the present invention provides a modular isolator comprising
a plurality of conjoined modules, each module comprises a rigid body enclosing a processing
zone and being adapted or adaptable to permit an operator outside the processing zone
to reach into the processing zone, wherein the processing zone is substantially quadrantal
in the horizontal plane.
[0011] The rigid body may comprise a front face adapted or adaptable to permit an operator
outside the processing zone to reach into the processing zone and opposing, substantially
perpendicular side faces convergent into a connecting rear face (or a common rear
edge). Thus the quadrantal configuration of the processing zone is such that the side
faces of the isolator are not perpendicular to the front face thereby advantageously
optimising the ergonomic performance of the module (eg improving access to the side
faces and to internal components or for rendering cleaning more straightforward and
effective).
[0012] The rigid body may be manufactured to meet the requirements of the internal components
that it houses. Typically the rigid body will be constructed from stainless steel
and appropriate chambers provided for the internal components which it houses. Examples
of internal components may include one or more filters or fan unit(s). For example,
one or more fan units and valves may be housed in a rear chamber of the rigid body.
[0013] Such is the versatility of the modular isolator of the invention, an appropriate
number of modules may be advantageously arranged to be used in isolation, against
a flat wall of any length, in an interior or exterior comer, around a pillar (or similar
elongate structure), against a stepped wall or wrapped around the walls of a room
(eg wrapped around the three exterior walls of a square room). The modules may be
abutted directly against the walls or indirectly via a single connecting module or
more than one linearly conjoined connecting module. The modules may be conjoined directly
or indirectly (eg spaced part by a single connecting module or more than one linearly
conjoined connecting module).
[0014] In a preferred embodiment, the modular isolator comprises twin modules.
[0015] Particularly preferably the twin modules are conjoined directly and may be used in
isolation or abutted (for example) directly against a flat wall. Alternatively the
twin modules are conjoined directly and may be abutted (for example) indirectly against
a flat wall via a single connecting module to create an island extending away from
the wall (or more than one linearly conjoined connecting module where it is desired
to extend the island further away from the wall).
[0016] Particularly preferably the twin modules are conjoined indirectly by a single connecting
module (or more than one (eg two) linearly conjoined connecting modules) and may be
used in isolation or abutted (for example) directly against a flat wall.
[0017] In a preferred embodiment, the modular isolator comprises three modules.
[0018] Particularly preferably the three modules are conjoined directly and may be used
in isolation, wrapped around an elongate structure (such as a pillar) or abutted (for
example) directly against an exterior corner wall.
[0019] It will be appreciated that more sophisticated arrangements of modules and connecting
modules may be constructed in accordance with the invention to abut against (for example)
stepped walls or the interior or exterior walls of a room. A plurality of conjoined
modules (optionally with connecting modules) may be advantageously exploited in a
stepwise process whereby each module facilitates a single step of the process.
[0020] The (or each) connecting module will be generally of a similar size to that of the
modules of the invention to which it is connected. The (or each) connecting module
is typically a conventional module which comprises a rigid body enclosing a processing
zone and which may be adapted or adaptable to permit an operator outside the processing
zone to reach into the processing zone, wherein the processing zone is substantially
quadrangular (
eg square) in the horizontal plane. In all other respects, the preferred features of
the (or each) connecting module are as defined herein for the module of the invention
and may be chosen according to the requirements of the operator. Suitable connection
means (such as rapid transfer ports) known to those skilled in the art may be deployed
to connect the connecting module to a module in a contained manner.
[0021] The processing zone may be conveniently divided into a series of chambers which are
tailored in terms of size, shape and position to meet the requirements of the use
to which each module of the modular isolator is to be put. Typically an operating
chamber is provided at or near to the height of the torso of an operator of average
height (preferably in the seated position) and towards the front of the processing
zone. The operating chamber may be bound by an internal rear wall (to the rear of
which is a rear chamber). The sides of the operating chamber may be bound by side
walls (which are preferably parallel).
[0022] In a preferred embodiment, at least an upper portion of the front face of each module
is multi-faceted (
ie provided with a plurality of exterior faces). Preferably at least one exterior face
is adapted or adaptable to permit an operator outside the processing zone to reach
into the processing zone. Particularly preferably at least two exterior faces are
adapted or adaptable to permit an operator outside the processing zone to reach into
the processing zone.
[0023] Preferably the upper portion of the front face of each module is bi-faceted (
ie provided with two exterior faces). In practice, this provides the upper portion of
the front face of each module essentially with a quarter of an octagonal profile and
this angular disposition has been found to offer ergonomic advantages (in particular
in optimising the operators reach).
[0024] Preferably the (or each) exterior face is inclined. This may serve to optimise ergonomic
comfort of the operator and/or to assist airflow characteristics. Particularly preferably
the internal rear wall bounding the operating chamber is inclined so as to be substantially
parallel to the (or each) exterior face.
[0025] Preferably the (or each) exterior face is fully or partially transparent to provide
visibility to the processing zone (
eg to the operating chamber).
[0026] Typically the exterior face adaptable to permit an operator outside the processing
zone to reach into the processing zone is a barrier means. The barrier means may be
detachable (
eg removable or openable) by suitable means to provide unhindered access to the processing
zone if desired. For example, the barrier means may be hinged at one or more locations.
The barrier means may be sealed against the rigid body using conventional sealing
methods to provide product and operator protection and maintain aseptic conditions.
The (or each) seal may be fitted to the barrier means or rigid body in such a way
as to provide maximum sealing of the barrier to the isolator in all conditions. For
example, the seal may be housed in the barrier means and act against a suitable sealing
platform (
eg on the rigid body). The seal may be fitted to the barrier means by (for example)
a groove running along the external circumference of the barrier means and may be
pneumatically or hydraulically controlled using a suitable mechanism to provide optimum
sealing force and pressure against one or more rigid support structures on the rigid
body. Pipe work or supporting connections to the seal can be channelled to enhance
the aesthetics of the modular isolator (
eg a pneumatic seal hose could be channelled through the hinge mechanism(s)).
[0027] Preferably the (or each) exterior face comprises one or more apertures (
eg substantially oval apertures) each fitted with a flexible portion in the shape of
a glove (or capable of being deformed into the shaped of a glove) which permits an
operator outside the processing zone to reach into the processing zone (whilst providing
physical protection from the processing zone and any biological, chemical or other
substances that may be present). Typically the (or each) exterior face comprises two
flexible portions in the shape of a glove (or capable of being deformed into the shape
of a glove) sealed conventionally for operator protection during (for example) cleaning.
[0028] In a preferred embodiment, the (or each) flexible portion in the shape of a glove
(or capable of being deformed into the shape of a glove) comprises a flexible sleeve
terminating in a gloved end (
eg a gauntlet). Preferably in use the flexible sleeve extends from the exterior face
(
eg the barrier means) to beyond the operators elbow (to optimise manoeuvrability). The
flexible sleeve may be composed of natural or synthetic rubber or polyurethane. The
gloved end is typically (but not necessarily) composed of less flexible material than
the flexible sleeve. For example, the gloved end may be composed of thicker polyurethane
than that of the flexible sleeve (or alternatively of thicker PVC, rubber or other
material).
[0029] The gloved end may be integral with the flexible sleeve or attached to the flexible
sleeve in any conventional manner. Preferably (but not necessarily) the joint between
the gloved end and the flexible sleeve comprises an internal strengthening ring to
which the ends of the gloved end and the flexible sleeve are attached and/or secured.
For example, the ends of the gloved end and the flexible sleeve may be secured to
the internal strengthening ring by an elastic band or the like.
[0030] The end of the (or each) flexible portion in the shape of a glove (
eg the flexible sleeve) may comprise a bead or rolled edge for fitting to the exterior
face (
eg the barrier means). For example, the bead or rolled edge may be stretchably mounted
on to a face ring (
eg a groove of the face ring) on the exterior face (
eg barrier means) to produce an airtight joint. The joint may be strengthened by a strengthening
ring (
eg an o-ring) inserted into a second groove on the face ring. Suitable glove sealing
arrangements are disclosed in EP-A-1265257.
[0031] Typically the position and orientation of the (or each) flexible portion in the shape
of a glove may be tailored to suit the particular operation to be conducted in the
processing zone. For example, the (or each) flexible portion in the shape of a glove
may be right hand or left hand oriented as desired.
[0032] In an embodiment of the invention, the rigid body further comprises: one or more
transfer ports to permit contained transfer from the processing zone to a remote location.
Preferably the (or each) transfer port is a tubular transfer port. The remote location
may be a module of the invention, a connecting module, a powder bin, containment assembly,
etc.
[0033] A first transfer port may be incorporated into a first side face. A second transfer
port may be incorporated into a second side face. The quadrantal configuration of
the processing zone is such that any transfer port in the side face of the isolator
is not perpendicular to the front face adapted or adaptable to permit an operator
outside the processing zone to reach into the processing zone thereby optimising the
ergonomic performance of the module (
eg optimising operator access to the transfer port).
[0034] The processing zone may be provided with a work platform (preferably a perforated
work platform). Such a work platform is typically in the operating chamber and may
be equipped with means for determining its horizontal level (
eg by using a spirit level type device) and may be adjustable by (for example) adjustable
screw fixings, pneumatic or hydraulic levelling mechanisms. Normally the work platform
is located at or near to the waist height of a typical operator. Beneath the working
platform is a lower chamber.
[0035] The modular isolator may be adapted to provide non-circulatory airflow in the processing
zone. For example, air exhausted from the processing zone may be ducted to atmosphere
or to a remote location (
eg a fan/filter stack).
[0036] In a preferred embodiment, the modular isolator further comprises:
a rigid body defining a first and second chamber;
recirculating means for inducing re-circulatory airflow in the processing zone, wherein
the first chamber is adapted with one or more outlets to receive the airflow from
the processing zone and
the second chamber is adapted with one or more inlets to transmit the airflow to the
processing zone.
[0037] Preferably the first chamber is the lower chamber and the second chamber is the upper
chamber. For example, the or each outlet may be incorporated in (but not necessarily
parallel to) a lower wall bounding the lower chamber (beneath the working platform)
and the or each inlet may be incorporated above (but not necessarily perpendicular
to) the working platform. The or each outlet is generally fitted with an outlet filter
and the or each inlet is generally fitted with an inlet filter. A filter may be fitted
to the rigid body using conventional mechanical and/or adhesive means (
eg using silicone gel and knife-edge sealing technology in a suitable configuration).
Typically the filter is a conventional HEPA filter.
[0038] Preferably the modular isolator of the invention is adapted so that air flows downwardly
in an undisturbed, non-turbulent manner in the processing zone at a pre-determined
velocity.
[0039] Preferably the rigid body is adapted to attain laminar flow (eg perfect laminar flow
(PLF) of air in the processing zone). For this purpose, the inlet is preferably fitted
with PLF material (
eg a PLF screen) through which the air flows to the processing zone. For example, the
inlet may be fitted with a tensioned monofilament woven screen providing uniform air
flow over its entire area. The screen may be fitted to the inlet in a conventional
manner (
eg using standard adhesives such as urethane adhesives). The PLF screen may be a perimeter
frame (
eg of welded steel) which is typically cross braced (
eg with hollow tubes) to resist the tensile forces of a monofilament textile screen
stretched and fixed to the perimeter of the frame. The monofilament textile screen
retards the passage of air so that it is forced to pass through it with an even velocity
distribution (the down flow velocity) which suppresses the rise of particles in the
processing zone. In microbiological processing (and similar) applications, it is generally
necessary to include a HEPA filter upstream of the PLF screen to reduce the relevant
risk of environmental contamination.
[0040] In a preferred embodiment, the inlet filter itself provides laminar flow air to the
processing zone. For this purpose, the inlet filter (
eg HEPA inlet filter) may be a construction with appropriate rigidity and structure
and a suitable shape to provide a similar function to a PLF screen. The inlet filter
retards the passage of air so that it is forced to pass through it with an even velocity
distribution (the down flow velocity) which suppresses the rise of particles in the
processing zone.
[0041] In an embodiment of the modular isolator of the invention, the upper chamber defines
a plenum capable of transmitting the airflow downwardly into the processing zone.
Preferably the upper chamber is adapted to contribute to laminar flow (
eg PLF). The upper chamber may take the form of a profiled canopy capable of providing
a smooth and uninterrupted airflow into the inlet fitted with a PLF screen and/or
the inlet filter (
eg a HEPA filter).
[0042] The means for inducing airflow may comprise any conventional fan unit
eg a fan unit driven by a flange mounted inverter controlled motor which ensures smooth
drive via a flexible coupling. The means for inducing air flow may be located in the
rear chamber. The fan unit may be placed downstream from a filter ensuring that it
only receives clean filtered air. The fan unit may be a double scroll double inlet
type fan optionally but preferably with automatic constant volume control which compensates
for filter congestion and with set back duty for when the modular isolator is operated
in isolator mode. The fan unit may be seated on highly compressed antivibration mounts
to ensure that no vibration is passed onto adjacent parts of the body. The fan may
be programmable to switch between any number of different volumetric flow rates for
use in various operational modes and process requirements.
[0043] The rigid body may comprise a bleed port (
eg suitably dusted from the airflow circuit) which is open for use in standard isolator
mode but which may be closed (if desired) to allow the discharge of air for the effective
operation of the modular isolator. The bleed port may (if desired) be substituted
by a filter (
eg a HEPA filter) to further minimize the risk of environmental contamination.
[0044] The modular isolator may further comprise one or more vents to ensure that the temperature
of the air in the motor section does not rise to unacceptable levels though the action
of the motor on the fan (if the fan is not self cooling). The venting of the motor
chamber may be aided by an additional cooling or air-circulating fan.
[0045] In a preferred embodiment, the modular isolator is adapted to accommodate negative
and positive pressure (
eg by operating valves for inlet and outlet airflow in relation to filter position in
the airflow circuit).
[0046] Laminar flow light fittings or luminaries may be mounted in the upper chamber or
operating chamber of the rigid body. The light fittings may be removable from the
rigid body and replaced (for example) with ultra-violet light fittings in the original
setting whilst the module is in normal operational mode. The light fittings may be
removable from a front or top face of the module. The lighting pod may be removable
for changing damaged light fittings or changing to (for example) ultra-violet lights
for certain process applications before, during or after operation of the isolator.
The lighting pod is a tube or shaped form constructed from a clear material (
eg plastic acrylic or glass) suitably sealed to the rigid body. Within the lighting
pod is a smaller item that includes the lights, starter capacitor and other required
wiring and components such as a plug or twist fit connector. The lighting pod is capped
off by a lid and secured in a closed position on the front face of the isolator. Any
number of light fittings my be used to obtain the relevant amount of light and light
distribution in the processing zone. The removable section of the light fitting may
adopt a "Y" or "X" shape where the uppermost section of the Y or X includes the lighting
components and other sections contain tube lights. The surface upon which the lights
are mounted may be of a reflective material providing a greater distribution and diffusion
of light.
[0047] The modular isolator may be mobile. The exterior of the rigid body may be fitted
with a plurality of mobility means for rendering the modular isolator mobile (
eg castors). Preferably each means for rendering the modular isolator mobile is mounted
on the end of an elongate member (
eg a steel frame leg). Typically the modular isolator comprises a plurality of castors
mounted at suitable locations at the ends or comers of the base of the rigid body
for effective mobility.
[0048] Suitable shelving or other storage means may be provided in the processing zone (
eg in the operating chamber).
[0049] Typically the modular isolator is configured to permit the operator to reach into
the processing zone (
eg to conduct the process or processes for which the isolator is designed) from a seating
position. Typically the modular isolator is adapted to fit through industry standard
doors (
eg through a standard door height (
eg 1950mm)).
[0050] The modulator isolator may further comprise: a housing for mechanical and electrical
and/or electronic components to facilitate the operation of the isolator and/or required
airflow characteristics.
[0051] Preferably the modular isolator of the invention may be used to conduct processes
such as transfer of hazardous products, sterility testing, processing pharmaceutical,
biotechnology and/or medical products, laboratory testing, packaging and other processing
applications within the pharmaceutical, biotechnology and related fields. The versatility
of the modular isolator is such that conjoined modules may be used to carry out complimentary
steps of a process
eg sterility testing in a first module and packaging in a second, conjoined module.
[0052] The configuration of each module
per se is such that a single one is usable in isolation or in confined or restrictive locations
(
eg around an interior comer) with optimum ergonomic performance. Thus the module
per se is independently patentable.
[0053] Viewed from a further aspect the present invention provides a module as hereinbefore
defined.
[0054] The module may be used in isolation or abutted (for example) directly against an
interior corner wall. Alternatively the module may be conjoined with a single connecting
module (or more than one linearly conjoined connecting modules) and use in isolation
or abutted against an interior corner wall.
[0055] The invention will now be described in a non-limitative sense with reference to the
accompanying Figures in which:
Figure 1 illustrates a perspective view of an embodiment of the module of the invention;
Figure 2 illustrates a plan elevational view of the embodiment of the module of the
invention;
Figure 3 illustrates a front elevational view of the embodiment of the module of the
invention;
Figure 4 illustrates a side elevational view of the embodiment of the module of the
invention;
Figure 5 illustrates a sectional view (along AA of Figure 3) of the embodiment of
the module of the invention;
Figure 6 illustrates a simplified sectional view of the embodiment of the module of
the invention; and
Figure 7 illustrates a plan elevational view of various embodiments of the modular
isolator of the invention.
[0056] Figures 1 to 6 illustrate various views of an embodiment of the module of the invention
1 which comprises a rigid body 100. The upper portion of the front face 1a of the
rigid body 100 is essentially bifaceted (
ie with first and second exterior faces 1b and 1c) so that its external surface adopts
a quarter octagonal configuration defining internally a processing zone 2 which is
substantially quadrantal.
[0057] Two transparent clear plastic (or glass) barrier doors 3a and 3b are attached respectively
to the first and second exterior faces 1a and 1b. Each door 3a and 3b is provided
with a single or double hinge 4 for opening in a horizontal plane (but it will be
appreciated that the hinge could equally be provided on an upper edge for opening
in a vertical plane). The doors 3a and 3b are provided with a door locking mechanism
200 comprising a rotating rod 200a extending into a specified fixing and locking point
200b. A seal (not shown) runs around the outer circumference of the door 3a, 3b acting
against the door frame along the direction of the doors height and width but not the
doors thickness and locks itself into a groove on the doorframe ensuring a good seal
and acting as a door locking mechanism. This ensures that there are little or no stresses
created in the door 3a, 3b so that a separate physical locking mechanism (such as
a lever) is not required. A seal hose connection 5 and hydraulic/pneumatic components
serve to inflate and deflate the seal as required.
[0058] Three part injection moulded glove ports 6 are provided for the safe installation
and changing of gloves. Connections 7 in the lower front part of the rigid body 100
are routed internally to relevant ducting points to provide vaporized hydrogen peroxide
for decontamination and sterilization of the processing zone. A control section 8
houses user or maintenance interface components and is closed by door 20. A process
equipment bay 9 houses specified equipment to facilitate desired operations. Process
equipment may be located and installed in a process equipment bay 10 specifically
catering for standard components such as a Millipore integral sterility testing system.
A touch panel user interface 11 includes digital and analogue feedback on isolator
performance and processes, alongside a full control interface for processes and applications.
[0059] Attached to the rear of the rigid body 100 is a motor section cover 15 covering
inter alia air flow dynamics control valves and piping 25. An internal wall 39 and parallel
side walls define an operating chamber 16 with provision for shelving and ensure PLF
conditions to a pre-determined pressure and flow rate. In the operating chamber 16
is a perforated work platform 32 beneath which a lower chamber 33 defines a plenum.
The operating chamber 14 is also fitted with a removable lighting pod 28 encapsulated
by a fully sealed clear plastic or glass light pod bay 30 and being fully sealed to
enable interchange of light fittings during product processing without compromising
sterility. The lighting pod 28 may be fitted with non-standard light fittings (such
as UV fittings) before, during or after a process. A lighting pod power connector
38 is provided with a twist or plug action fitting. A front handle 29 is provided
for light pod removal using a twist locking mechanism.
[0060] Side panels 13 may be provided with rapid transfer ports (not shown) or other user
specified equipment as required. Five castors 12 are located on the base of the rigid
body 100 for transportability.
[0061] An upper chamber 14 defines a plenum 26 (front section) and 37 (rear section) encasing
an inlet filter 17 having dual functionality as a PLF screen and HEPA filtration unit.
Access ports (not shown) may be located in the upper chamber 14, plenum (front section)
26 and/or plenum (rear section) 37. A gel sealing section 18 is provided for the inlet
filter 17 using knife edge gel seal technology.
[0062] Airflow is controlled by a high power dual scroll centrifugal fan 22 with integral
motor mounted on a motor mounting 23 and supply air valves 21 downstream thereof.
Return filter bays 24 in the lower chamber 33 encapsulate a return filter 42 (a HEPA
filtration panel) with a knife edge seal 43 in which gel is applied to the return
filter 42 itself and a handle 31 for sealing and locking the return filter 42. The
handle 31 extends from a plate 31a covering the gap between the return filter 42 and
the return filter bays 24 and a wedge section 34 on the plate 31a is positioned against
locking lugs 35 to seal and clamp the return filter 42 in place.
[0063] Figure 7 illustrates schematically various embodiments of a modular isolator of the
invention in which modules as described with reference to Figures 1-6 have been arranged
in various configurations and locations:
(1) A single module 45 in isolation and in an internal comer of a building or processing
facility with product input P and output Q located behind walls W1 thereby ensuring
separation of sterile environments.
(2) Twin modules 45a, 45b in isolation, against a flat wall W2 of a building or processing
facility with product input P and output Q locations ensuring separation of sterile
environments and against a flat wall W6 with two pairs of linearly conjoined connecting
modules 44 with product input P and output Q locations behind wall W6 thereby ensuring
separation of sterile environments. The overall assembly protrudes out into open space
like an island.
(3) A single module 45c in isolation with two linearly conjoined connecting modules
44 with product input P and output Q locations ensuring separation of sterile environments
or against an internal corner of a building or processing facility with product input
P and output Q located behind walls W5 thereby ensuring separation of sterile environments.
(4) Two spaced apart modules 45d, 45e against a flat wall W3 of a building or processing
facility conjoined by two linear connecting modules 44 with product input P and output
Q locations behind wall W3 thereby ensuring separation of sterile environments.
(5) Three modules 45f, 45g, 45h in isolation or against an external comer of a building
or processing facility with product input P and output Q locations behind walls W4
thereby ensuring separation of sterile environments. This arrangement may equally
be arranged around a pillar (not shown).
(6) Two spaced apart modules 45k and 45l against a stepped wall W7 of a building or
processing facility with one pair of connecting modules 44a and a single connection
unit 44b and with product input P and output Q locations highlighted behind wall W7
ensuring separation of sterile environments into (for example) different laboratories.
(7) Two pairs of twin modules 45m, 45n and 45p, 45q wrapped around the walls W8 of
a room (eg of a building or processing facility) with a pair of linearly conjoined
connecting modules 44 and with product input P and output Q locations highlighted
behind the walls W8 ensuring separation of sterile environments.
1. A modular isolator comprising a plurality of conjoined modules, each module comprising:
a rigid body enclosing a processing zone and being adapted or adaptable to permit
an operator outside the processing zone to reach into the processing zone, wherein
the processing zone is substantially quadrantal in the horizontal plane.
2. A modular isolator as claimed in claim 1 wherein at least one exterior face is adapted
or adaptable to permit an operator outside the processing zone to reach into the processing
zone.
3. A modular isolator as claimed in any preceding claim wherein at least two exterior
faces are adapted or adaptable to permit an operator outside the processing zone to
reach into the processing zone.
4. A modular isolator as claimed in claim 2 or 3 wherein the or each exterior face is
inclined.
5. A modular isolator as claimed in claim 2, 3 or 4 wherein the internal rear wall bounding
the operating chamber is inclined so as to be substantially parallel to the or each
exterior face.
6. A modular isolator as claimed in any of claims 2 to 5 wherein the or each exterior
face comprises one or more apertures each fitted with a flexible portion in the shape
of a glove or capable of being deformed into the shaped of a glove which permits an
operator outside the processing zone to reach into the processing zone.
7. A modular isolator as claimed in any preceding claim wherein the rigid body comprises:
a front face adapted or adaptable to permit an operator outside the processing zone
to reach into the processing zone and opposing, substantially perpendicular side faces
are convergent into a connecting rear face or a common rear edge.
8. A modular isolator as claimed in any preceding claim comprising twin modules.
9. A modular isolator as claimed in claim 8 wherein the twin modules are conjoined directly.
10. A modular isolator as claimed in claim 8 wherein the twin modules are conjoined indirectly
by a single connecting module or more than one linearly conjoined connecting modules.
11. A modular isolator as claimed in any of claims 1 to 7 comprising three modules wherein
the three modules are conjoined directly.
12. A modular isolator as claimed in claim 10 wherein the or each connecting module comprises
a rigid body enclosing a processing zone and which is adapted or adaptable to permit
an operator outside the processing zone to reach into the processing zone, wherein
the processing zone is substantially quadrangular in the horizontal plane.
13. A modular isolator as claimed in any preceding claim wherein at least an upper portion
of the front face of each module is multi-faceted.
14. A modular isolator as claimed in any preceding claim wherein the upper portion of
the front face of each module is bi-faceted.
15. A module as defined in any preceding claim.