Bioquell | Z-2 - Labotal.co.il
Bioquell | Z-2 - Labotal.co.il
Bioquell | Z-2 - Labotal.co.il
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<strong>Bioquell</strong> | Z-2<br />
• Large scale room/zone bio-de<strong>co</strong>ntamination<br />
• Parametric cycle <strong>co</strong>ntrol<br />
• Simple to operate “plug and play” system<br />
• Excellent material <strong>co</strong>mpatib<strong>il</strong>ity including<br />
sensitive electronics
<strong>Bioquell</strong> Z-2 hydrogen peroxide vapour (HPV) room/zone<br />
bio-de<strong>co</strong>ntamination system<br />
The <strong>Bioquell</strong> Z-2 is a <strong>co</strong>mplete solution for room/zone bio-de<strong>co</strong>ntamination,<br />
offering user-friendly operation with unique parametric cycle <strong>co</strong>ntrol, eliminating<br />
the necessity for gas cycle development studies (non-GMP fac<strong>il</strong>ities).<br />
The <strong>Bioquell</strong> Z-2 in<strong>co</strong>rporates a HPV generator, gas distribution and catalytic<br />
aeration in a single mob<strong>il</strong>e system. The system is eas<strong>il</strong>y operated with user-friendly<br />
touch screen <strong>co</strong>ntrols and can bio-de<strong>co</strong>ntaminate areas up to 250m 3 , using<br />
parametric <strong>co</strong>ntrol (larger volumes can be validated using timed cycles).<br />
Features in brief<br />
• Simple menu-driven user interface to set cycle parameters<br />
• Graphical display of bio-de<strong>co</strong>ntamination cycle progress in real time<br />
• Communication port allows <strong>co</strong>ntrol via a bu<strong>il</strong>ding management system (BMS)<br />
• <strong>Bioquell</strong> dual-circuit technology for fast, efficient bio-de<strong>co</strong>ntamination cycles<br />
• No need for room pre-<strong>co</strong>nditioning or dehumidification<br />
• System includes room measuring device and hand-held H 2<br />
O 2<br />
monitoring device<br />
<strong>Bioquell</strong> hydrogen peroxide solution<br />
Cycle <strong>co</strong>nditions and progress is<br />
re<strong>co</strong>rded via the integral printer<br />
• <strong>Bioquell</strong> hydrogen peroxide is specified<br />
and approved for use with <strong>Bioquell</strong><br />
HPV generators<br />
• Approved for use as a biocide by regulatory<br />
bodies (BPD, EPA)<br />
• Selected for optimal biocidal effectiveness<br />
• Ava<strong>il</strong>able in 0.5 litre, 1 litre and 5 litre bottles<br />
Standard accessories include:<br />
Hand-held laser dimension finder<br />
Hand-held HPV detector<br />
Anc<strong>il</strong>lary equipment neatly<br />
stored in the lectern
Safe and simple to operate<br />
1<br />
The <strong>co</strong>ntrol lectern<br />
is removed from<br />
the <strong>Bioquell</strong> Z-2<br />
at an appropriate<br />
<strong>co</strong>ntrol point; the<br />
<strong>Bioquell</strong> Z-2 is<br />
then placed inside<br />
the <strong>co</strong>ntaminated<br />
zone<br />
2<br />
With the lectern<br />
in place outside<br />
the area to be<br />
de<strong>co</strong>ntaminated,<br />
the area is sealed<br />
with tape and<br />
any vent<strong>il</strong>ation<br />
systems are<br />
isolated<br />
3<br />
Room dimensions<br />
are entered<br />
allowing the<br />
<strong>Bioquell</strong> Z-2 to<br />
calculate HPV<br />
cycle parameters.<br />
Final safety checks<br />
are made via the<br />
<strong>co</strong>ntrol panel on<br />
the lectern. The<br />
cycle can then be<br />
activated<br />
4<br />
Multi-directional<br />
nozzles deliver<br />
the vapour,<br />
switching to<br />
automatic<br />
aeration (via<br />
parametric<br />
<strong>co</strong>ntrol) after the<br />
gassing phase is<br />
<strong>co</strong>mplete<br />
5 6<br />
The touch screen<br />
displays the<br />
cycle progress<br />
and indicates<br />
when the cycle is<br />
<strong>co</strong>mplete<br />
At the end of the<br />
cycle, HPV levels<br />
are manually<br />
checked from<br />
outside the room<br />
and the area is<br />
then rapidly put<br />
back into service<br />
Validation and service<br />
Fully validatable to <strong>co</strong>mply with requirements<br />
of GMP using GAMP-<strong>co</strong>mpliant software.<br />
<strong>Bioquell</strong> provides a <strong>co</strong>mplete service including:<br />
• Installation and integration<br />
• Preventative maintenance plans<br />
• Extensive field-based service<br />
engineer network<br />
• IQ/OQ/PQ documentation and execution<br />
• Bio-de<strong>co</strong>ntamination cycle development<br />
services (if GMP fac<strong>il</strong>ity and not using<br />
parametric <strong>co</strong>ntrol)<br />
• Ongoing MQ and RQ support*<br />
*Provided as part of a preventative maintenance plan
Unit part number<br />
230V<br />
120V<br />
100V<br />
Materials of <strong>co</strong>nstruction<br />
TD068-0000-230V<br />
TD068-0000-120V<br />
TD068-0000-100V<br />
Temperature<br />
Operating 15°C to 30°C<br />
Storage 0°C to 35°C<br />
Relative humidity<br />
Operating<br />
Storage<br />
Power requirements<br />
Power supply<br />
Power <strong>co</strong>nsumption<br />
230V<br />
115V<br />
100V<br />
Operating position<br />
Pollution degree environment 2<br />
Dimensions (WxHxD)<br />
With lectern<br />
Without lectern<br />
Weight<br />
With lectern<br />
Lectern<br />
Maximum liquid volume<br />
Control system<br />
Airflow rates<br />
Vapour<br />
Air distribution<br />
Aeration<br />
Temperature of vapour supply<br />
H 2<br />
O 2<br />
liquid injection rate<br />
230V<br />
120V/100V<br />
Polypropylene (PP), acrylonitr<strong>il</strong>e butadiene<br />
styrene, polycarbonate mix (ABS/PC), (ABS),<br />
aluminium, stainless steel, polyvinylchloride (PVC)<br />
80% RH (maximum)<br />
80% RH (maximum non-<strong>co</strong>ndensing)<br />
AC 230V 50/60 Hz 13 amps<br />
AC 120V 50/60 Hz 12 amps<br />
AC 100V 50/60Hz 15 amps<br />
Installation category II<br />
3kW<br />
1.4kW<br />
1.5kW<br />
Upright only<br />
660 x 1444 x 710mm<br />
660 x 1444 x 560mm<br />
95 kg<br />
11.5 kg<br />
4.3 litres (usable)<br />
Siemens ® S7 200 PLC<br />
50 m 3 /hr<br />
800 m 3 /hr<br />
1000 m 3 /hr<br />
50-70°C<br />
20 g/min<br />
10 g/min<br />
Catalyst HEPA efficiency 99.997%<br />
Noise<br />
Hydrogen peroxide<br />
78 dBA (in aeration)<br />
30-35% w/w <strong>Bioquell</strong> hydrogen peroxide (stored at 2-8°C)<br />
Features in brief<br />
• Dual circuit technology for optimum<br />
cycle times<br />
• Gas distribution catalytic aerator included<br />
• Siemens ® <strong>co</strong>lour touch screen<br />
• GAMP <strong>co</strong>mpliant software<br />
• Compact and highly portable design<br />
• Eas<strong>il</strong>y cleanable external surface<br />
• Volt-free <strong>co</strong>ntacts for external signals<br />
• Integral thermal paper printer<br />
• Remote start/stop<br />
• Unique <strong>Bioquell</strong> parametric <strong>co</strong>ntrol process<br />
– no need for gas cycle development<br />
• Cycle edit and store fac<strong>il</strong>ity for new applications<br />
• Effective against a wide range of micro-organisms<br />
• Hydrogen peroxide vapour gas sensor
Hydrogen peroxide vapour (HPV) technology<br />
HPV <strong>co</strong>ncentration<br />
t=0*<br />
1<br />
2<br />
3<br />
Inactivation of micro-organisms<br />
GASSING DWELL AERATION<br />
TIME<br />
* Conditioning phase not shown (vaporiser reaches temperature)<br />
Note: “features” on graph change e.g. depending on size of<br />
chamber (& related temperature effect)<br />
4<br />
5<br />
Schematic of <strong>Bioquell</strong> HPV <strong>co</strong>ncentration/time graph<br />
1. HPV introduced – initial rapid increase in HPV <strong>co</strong>ncentration<br />
2. HPV saturation/“dew point” achieved – onset of rapid bio-de<strong>co</strong>ntamination<br />
3. HPV gassing plateau – sustained micro-<strong>co</strong>ndensation effecting bio-deactivation<br />
4. Dwell period (<strong>co</strong>ntact time)<br />
5. Aeration – removal of HPV from the atmosphere typically by catalytic<br />
<strong>co</strong>nversion to water vapour and oxygen, leaving no residues<br />
Schematic of dew point and <strong>Bioquell</strong> k<strong>il</strong>l dynamics<br />
1. Injection of HPV into the enclosure starts (t=0)<br />
2. Only slight decline in biological indicator population prior to dew point<br />
3. Rapid micro-biological k<strong>il</strong>l occurs immediately after saturation/“dew point” is achieved –<br />
process optimised to achieve reliable 6-log sporicidal reduction on all exposed surfaces<br />
4. Onset of micro-<strong>co</strong>ndensation <strong>co</strong>rrelates with rapid bio-deactivation<br />
5. Bio-deactivation achieved via micro-<strong>co</strong>ndensation (invisible layer) of hydrogen<br />
peroxide (2-6µm)<br />
* Typical BI: Tyvek ® pouched 6-log<br />
Geobac<strong>il</strong>lus stearothermoph<strong>il</strong>us spores<br />
Key benefits of HPV<br />
• Excellent material <strong>co</strong>mpatib<strong>il</strong>ity<br />
including sensitive electronics<br />
• Environmentally friendly –<br />
“residue-free” (breaks down to<br />
water vapour and oxygen)<br />
• Effective against a wide range<br />
of micro-organisms<br />
• High level disinfection achieved<br />
(6-log sporicidal reduction)<br />
• Low temperature<br />
bio-de<strong>co</strong>ntamination process<br />
HPV applications<br />
• GMP cleanrooms<br />
• Aseptic processing<br />
• Biologics<br />
• Biomedical<br />
• Biosafety/security<br />
Key features and benefits of the <strong>Bioquell</strong> Z-2<br />
FEATURES<br />
Unique <strong>Bioquell</strong> parametric <strong>co</strong>ntrol algorithm<br />
Complete system in<strong>co</strong>rporating gas distribution<br />
and catalytic aeration<br />
Fast, high capacity HPV vaporiser<br />
Fully <strong>co</strong>mpliant with GMP requirements<br />
Mob<strong>il</strong>e system<br />
BENEFITS<br />
Fast, efficient cycles with no need for gas cycle<br />
development<br />
Single system HPV for the <strong>co</strong>mplete<br />
bio-de<strong>co</strong>ntamination process<br />
Quick bio-de<strong>co</strong>ntamination of volumes up to 250m 3 , using parametric<br />
<strong>co</strong>ntrol (larger areas can be validated using timed cycles)<br />
Able to be used in regulated areas (if used with<br />
timed HPV cycles)<br />
Can be eas<strong>il</strong>y moved to areas requiring<br />
bio-de<strong>co</strong>ntamination
Other unique bio-de<strong>co</strong>ntamination<br />
solutions from <strong>Bioquell</strong><br />
<strong>Bioquell</strong> RBDS rapid fac<strong>il</strong>ity bio-de<strong>co</strong>ntamination service<br />
A unique bio-de<strong>co</strong>ntamination service from <strong>Bioquell</strong><br />
for zones, rooms and bu<strong>il</strong>dings:<br />
• “Infinitely scalable” – no room or bu<strong>il</strong>ding too large<br />
• Emergency, scheduled, <strong>co</strong>ntract or new-bu<strong>il</strong>d<br />
• Rapid deployment by highly trained <strong>Bioquell</strong> technicians<br />
<strong>Bioquell</strong> Material Transfer Solutions<br />
Bio-de<strong>co</strong>ntamination chambers:<br />
• Material transfer in<strong>co</strong>rporating HPV bio-de<strong>co</strong>ntamination<br />
at ambient temperature<br />
• Rapid de<strong>co</strong>ntamination leading to fast material transfer<br />
• Inflatable door seals for reliable, safe operation<br />
<strong>Bioquell</strong> Clarus L2<br />
Multi-function HPV generator for small rooms, enclosure<br />
and equipment.<br />
• Fixed or mob<strong>il</strong>e <strong>co</strong>nfigurations up to 75m 3<br />
• Capable of 6-log sporicidal reduction<br />
• Fast, validatable bio-de<strong>co</strong>ntamination<br />
Disclaimer: <strong>Bioquell</strong> UK Ltd or its aff<strong>il</strong>iates, distributors, agents or licensees (together<br />
‘<strong>Bioquell</strong>’) reserves the right to change the specification of the <strong>Bioquell</strong> Z-2 without<br />
notice. In addition, <strong>Bioquell</strong> makes no claims as to the guarantee of ster<strong>il</strong>isation<br />
using these products; however, <strong>Bioquell</strong> re<strong>co</strong>mmends that customers ensure that<br />
the requisite level of bio-de<strong>co</strong>ntamination is achieved using standard biological<br />
indicators such as 6-log Geobac<strong>il</strong>lus stearothermoph<strong>il</strong>us spores; and the <strong>Bioquell</strong><br />
Z-2, subject to appropriate cycle development, is designed to be able to provide such<br />
levels of bio-deactivation.<br />
Your local distributor:<br />
Clarus / <strong>Bioquell</strong> / RBDS are registered trade marks of <strong>Bioquell</strong> UK Ltd.<br />
© <strong>Bioquell</strong> UK Ltd (2010). All rights reserved.<br />
For further information on <strong>Bioquell</strong>’s technology:<br />
E: info@bioquell.<strong>co</strong>m<br />
W: www.bioquell.<strong>co</strong>m<br />
<strong>Bioquell</strong> UK Ltd<br />
T: +44 (0)1264 835 835<br />
<strong>Bioquell</strong> Ireland<br />
T: +353 (0)61 603 622<br />
<strong>Bioquell</strong> Inc<br />
T: +1 (215) 682 0225<br />
<strong>Bioquell</strong> SAS<br />
T: +33 (0)1 43 78 15 94<br />
<strong>Bioquell</strong> Asia Pacific Pte Ltd<br />
T: +65 6592 5145<br />
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