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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 />

203/10

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