Room decon - external gassing (Bioquell Clarus C) - CapellaScience

Bioquell | Clarus C
• Hydrogen peroxide vapour (HPV) bio-decontamination
technology, capable of 6-log sporicidal reduction
• High capacity fixed, mobile or semi-permanent
configuration for enclosures and rooms up to 350m 3
• Fast, validatable bio-decontamination cycles
• Excellent material compatibility including
sensitive electronics

Bioquell Clarus C hydrogen peroxide vapour generator
The Bioquell Clarus C hydrogen peroxide vapour generator is an
advanced solution for low temperature, residue free bio-decontamination.
Clarus units have been installed worldwide giving reliable, continuous
bio-decontamination of pharmaceutical isolators, clean rooms,
pass-through devices and many other applications.
• Multi-purpose generator capable of bio-decontaminating
equipment (e.g. isolators, RABS, transfer chambers) or
multi-room facilities
• Fully compliant with the requirements of GMP
• Bioquell dual circuit technology for fast and efficient
bio-decontamination cycles
• Capable of storing multiple gas cycle parameters for
multiple applications
• Remote operation available and connection to building
management system (BMS) capability
• No requirement for room dehumidification prior to cycles
Bioquell hydrogen peroxide solution
• Bioquell hydrogen peroxide is specified
and approved for use with Bioquell
HPV generators
• Approved for use as a biocide by
regulatory bodies (BPD, EPA)
• Selected for optimal biocidal effectiveness
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Common room configurations
HVAC aeration
Ceiling fans distribute
the vapour throughout
the entire room
Recirculating
vapour
Vapour distribution
into room
Semi-permanent configuration:
• For room bio-decontamination without the need
to enter the affected area
• Ideal for locations which require biodecontamination
or emergency bio-decontamination
after a bio-spillage
• A single HPV generator can be used to
bio-decontaminate multiple discrete areas
• HPV introduced, recirculated and monitored via
proprietory gassing interface plate
Permanent configuration:
Rotating gas
distribution
nozzles
• For frequent and regular bio-decontamination of a
room or suite of multiple rooms
• Highly efficient distribution of HPV using
rotating nozzles
• Clarus C HPV generator can be located in technical
space remote from area to be bio-decontaminated
• System can be integrated with building management
system (BMS)
• Clarus C dedicated to area to be
bio-decontaminated
• Fully validatable for GMP facilities
HVAC or mobile aeration
Mobile configuration
• For infrequent or periodic bio-decontamination
• No need for modification of room/facility
infrastructure
• Operated via a remote control panel located
outside of the area to be bio-decontaminated
• Mobile aeration/distribution system for
enhanced distribution and faster cycle times

External materials of construction
Glass reinforced polyester
Temperature
Operating 15°C to 30°C
Storage -15°C to 50°C
Relative humidity
Operating
Storage
Power requirement
Operating position
Dimensions (WxHxD)
Open
Closed
Shipping carton
Weight
Maximum H 2
O 2
liquid volume
Waste liquid bottle size
H 2
O 2
liquid concentration
Gas hoses
Gas hose connections
Control system
Airflow rate
Gassing
Conditioning/aeration
Temperature of supply gas at outlet 60°C
H 2
O 2
liquid injection rate
Double HEPA filtration from room inlet
Noise level
80% RH maximum
80% RH at 38°C maximum
AC 230V, single phase, 50Hz, 6 amps
AC 120V, single phase, 60Hz, 11.5 amps
AC 200V, three phase, 50/60Hz, 9.2 amps
Upright only
680 x 1260 x 900mm
680 x 1060 x 900mm
780 x 1350 x 1100mm
140 kg, Gross shipping weight 170 kg
500 ml or external 4 litre option
500 ml, or external run-off, or external 4 litre option
30-35% w/w
38mm I/D x 2m long (optional extra)
38mm (1.5 inch) male/female Camlock fittings
Siemens ® S7 PLC
(software compliant with GAMP)
Greater than 30 m 3 /hr
Greater than 30 m 3 /hr
Approximate 1 – 8 g/min
99.997% efficiency
Less than 60dBA at 1 metre
Enclosure decontamination capacity For enclosures and rooms up to 350m 3
(subject to configuration and loading)
Data printer
I/O communication port
Locking brake
Standard instrumentation
• Wide range H 2
O 2
sensor (0-1000ppm)
• Auxiliary test port for Dräger tube /
hand pump sampler
• Relative humidity sensor
• Return and delivery gas temperature
sensors (PT100)
• Pre-heater temperature and safety cut-out
• Re-heater temperature and safety cut-out
• Vaporiser temperature and safety trip
Thermal print record
RS-485 D-type
Integral foot pedal on/off
• Cooling coil gas outlet temperature
sensor (PT100)
• Dosing system pressure / weight transducer
• Air flow measurement transducer
• Waste bottle full sensor
• Bottle position sensors (internal bottles only)
• Enclosure low/high pressure safety switches
• Enclosure pressure transducer
• Dual circuit valve position sensors
Features in brief
• Dual circuit technology for optimum cycle times
• Closed circuit operation – no external
vent required
• GAMP compliant software
• Compact and highly portable design
• Easily cleanable external surface
• Volt-free contacts for external signals
• Integral thermal paper printer
• Remote start/stop
• Simple connection, flexible supply/return hoses
and pressure monitoring
• Cycle edit and store facility for new applications
• Effective against a wide range of micro-organisms
• Utilises 30-35% w/w Bioquell hydrogen
peroxide solution
• Enclosures up to 350m 3
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Hydrogen peroxide vapour (HPV) technology
HPV concentration
1
2
3
Inactivation of micro-organisms
t=0*
GASSING DWELL AERATION
TIME
* Conditioning phase not shown (vaporiser reaches temperature)
Note: “features” on graph change e.g. depending on size of
chamber (& related temperature effect)
4
5
Schematic of Bioquell HPV concentration/time graph
1. HPV introduced – initial rapid increase in HPV concentration
2. HPV saturation/“dew point” achieved – onset of rapid bio-decontamination
3. HPV gassing plateau – sustained micro-condensation effecting bio-deactivation
4. Dwell period (contact time)
5. Aeration – removal of HPV from the atmosphere typically by catalytic
conversion to water vapour and oxygen, leaving no residues
Schematic of dew point and Bioquell kill dynamics
1. Injection of HPV into the enclosure starts (t=0)
2. Only slight decline in biological indicator population prior to dew point
3. Rapid micro-biological kill occurs immediately after saturation/“dew point” is achieved –
process optimised to achieve reliable 6-log sporicidal reduction on all exposed surfaces
4. Onset of micro-condensation correlates with rapid bio-deactivation
5. Bio-deactivation achieved via micro-condensation (invisible layer) of hydrogen
peroxide (2-6µm)
* Typical BI: Tyvek ® pouched 6-log
Geobacillus stearothermophilus spores
Key benefits of HPV
• Excellent material compatibility
including sensitive electronics
• Environmentally friendly -
“residue-free” (breaks down to
water vapour and oxygen)
• Effective against a wide range
of micro-organisms
• High level disinfection achieved
(6-log sporicidal reduction)
HPV applications
• GMP cleanrooms
• Aseptic processing
• Biologics
• Biomedical
• Biosafety/security
• Material transfer chambers
• Ambient decontamination of
autoclaves/freeze driers
• Robotic enclosures
• Safety cabinets/isolators
Key features and benefits of the Clarus C HPV generator
FEATURES
Optimised cycle performance producing fast and effective
bio-decontamination
Flexible multi-use generator
Critical condition monitoring with alarm set points for
‘Alert’ or ‘Action’
Advanced software and controls for ease of use and
operation
BENEFITS
Minimal process downtime – no need for preconditioning,
process operates with ambient environment
Can bio-decontaminate rooms and enclosures up to 350m 3 .
Small footprint requiring minimal floor space
Compatible with GMP and GLP requirements
Simple integration into a building management system (BMS)

Other unique bio-decontamination
solutions from Bioquell
Bioquell RBDS rapid facility bio-decontamination service
A unique bio-decontamination service from Bioquell
for zones, rooms and buildings:
• “Infinitely scalable” – no room or building too large
• Emergency, scheduled, contract or new-build
• Rapid deployment by highly trained Bioquell technicians
Bioquell HPV enabled material transfer solutions
Bio-decontamination chambers:
• Material transfer incorporating HPV bio-decontamination
at ambient temperature
• Rapid bio-decontamination leading to fast material transfer
• Inflatable door seals for reliable, safe operation
Bioquell Z HPV generator
State-of-the-art bio-decontamination equipment offering:
• Large scale room/zone bio-decontamination
• Parametric cycle control
• Simple to operate “plug and play”
Disclaimer: Bioquell UK Ltd or its affiliates, distributors, agents or licensees
(together “Bioquell”) reserves the right to change the specification of
the Bioquell Clarus C without notice. In addition, Bioquell makes no
claims as to the guarantee of sterilisation using these products; however,
Bioquell recommends that customers ensure that the requisite level of
bio-decontamination is achieved using standard biological indicators such as
6-log Geobacillus stearothermophilus spores; and the Bioquell Clarus C, subject
to appropriate cycle development, is designed to be able to provide such levels of
bio-deactivation.
Your local distributor:
Clarus / Bioquell / RBDS are registered trade marks of Bioquell UK Ltd.
© Bioquell UK Ltd (2010). All rights reserved.
For further information on Bioquell’s technology:
E: info@bioquell.com
W: www.bioquell.com
Bioquell UK Ltd
T: +44 (0)1264 835 835
Bioquell Ireland
T: +353 (0)61 603 622
Bioquell Inc
T: +1 (215) 682 0225
Bioquell SAS
T: +33 (0)1 43 78 15 94
Bioquell Asia Pacific Pte Ltd
T: +65 6592 5145
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