WIBObarrier® OCS - Open Containment Systems WIBObarrier ...
WIBObarrier® OCS - Open Containment Systems WIBObarrier ...
WIBObarrier® OCS - Open Containment Systems WIBObarrier ...
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WIBOjekt® and <strong><strong>WIBObarrier</strong>®</strong> Air Curtain <strong>Systems</strong>.<br />
The perfect protection for person, product and environment.<br />
Filling • Weighing • Sampling • Research<br />
Safe handling<br />
with high potent products / API<br />
<strong><strong>WIBObarrier</strong>®</strong> <strong>OCS</strong> - <strong>Open</strong> <strong>Containment</strong> <strong>Systems</strong><br />
<strong><strong>WIBObarrier</strong>®</strong> CCS - Closed <strong>Containment</strong> <strong>Systems</strong>
<strong><strong>WIBObarrier</strong>®</strong> - Duo<br />
<strong>Open</strong> <strong>Containment</strong> <strong>Systems</strong><br />
<strong><strong>WIBObarrier</strong>®</strong> - Duo<br />
as a seated workplace for four workers, used in a<br />
microbiological laboratory.<br />
Ventilation technology<br />
H14<br />
Air guidance principle<br />
<strong><strong>WIBObarrier</strong>®</strong>- Duo<br />
<strong><strong>WIBObarrier</strong>®</strong>- Duo<br />
The Barrier fulfils the requirements of exposure<br />
limit and protection of person according to DIN EN<br />
12469,C3 with both sides free front opening 300<br />
mm high and a product protection/clean room<br />
class ISO 5 according to EN ISO 14644-1 within<br />
the working area.<br />
<strong><strong>WIBObarrier</strong>®</strong> - Duo<br />
A safe workplace for sampling packages containing<br />
high potent steroid agents and/or APIs (active<br />
pharmaceutical ingredients).<br />
Integrated in a pallet conveying system which passes<br />
through the Barrier. The sampling is carried out from<br />
two sides to ensure that the person does not have to<br />
bend over the packages during sampling.<br />
Priority is given to the protection of person with a<br />
maximum product exposure of OEL 1-10 µg/m 3<br />
and the product protection/clean-room quality ISO 7<br />
according to EN ISO 14644-1 above the product.
<strong><strong>WIBObarrier</strong>®</strong> - Horizontal<br />
<strong>Open</strong> <strong>Containment</strong> <strong>Systems</strong><br />
The reliable air guidance system for<br />
modern filling technology.<br />
The system consists of two modules, a transmitter and a<br />
receiver,which are positioned vertically opposite each<br />
other. The filling and emptying station for packages, big<br />
bags, containers and so forth are located between them.<br />
H14 filtered air flows through the transmitter laminator<br />
horizontally over the filling/emptying station towards<br />
the receiver unit. The air curtain which builds up<br />
through the vertical and horizontal transmitter unit<br />
ejectors supports and stabilises this clean air curtain.<br />
In addition, a stable clean-airflow is drawn in by the<br />
receiver unit and is built up through the filling/<br />
emptying station ensuring that the emissions emanating<br />
from the filling/emptying station are contained within<br />
the protected area and are safely conveyed to the extraction<br />
unit. At the same time penetration of emissions emanating<br />
from personnel or from the room into the product<br />
area are prevented.<br />
Cross contaminations which could result from there being<br />
a number of filling/emptying stations with different products<br />
in one room, are prevented by the high directional<br />
stability of the airflow.<br />
Flow technology settings enable prioritisation of<br />
personnel or product protection.<br />
<strong>WIBObarrier</strong> Horizontal<br />
Abluft<br />
exhaust air<br />
Zuluft<br />
supply air<br />
Barrier<br />
Stabilisator<br />
stabilizer<br />
Air guidance principle<br />
<strong><strong>WIBObarrier</strong>®</strong>- Horizontal<br />
Advantages<br />
■ Protection factor > 100,000, possible for<br />
both personnel and product protection<br />
■ Product exposure for personnel and room<br />
according to OEL 10-30 µg/m 3 achievable<br />
■ Air quality up to ISO 7 according to EN ISO<br />
14644-1 when set up in the" black" area<br />
■ No product removal as a result of low air speeds<br />
with high directional stability<br />
■ Free access from three sides makes integration<br />
of filling/emptying equipment and materials<br />
handling possible<br />
■ Modular construction means configuration as<br />
either stationary or mobile units is possible<br />
■ Also available in an acid resistant plastic version<br />
<strong>WIBObarrier</strong> ® - Horizontal
VARIO-Isolator with WIBOjekt®<br />
Absolute protection of personnel by the isolator when handling high riskpotent materials.<br />
Effective protection of personnel by WIBOjekt® when handling high potent materials.<br />
The VARIO-Isolator is used where a controlled atmosphere<br />
isolated from the surrounding area affording protection<br />
of person and product at the same time needs to<br />
be created.<br />
The VARIO-Isolator is operated at 70 Pa below atmospheric<br />
pressure. The unit operates with supply and exhaust air<br />
system. Exhaust is 100 %.<br />
The purity class corresponds to Class 5 according to<br />
EN ISO 14644-1.<br />
The Hepa exhaust filter is installed as a "pousse-pousse"<br />
filter system (contamination free changeable) in the system<br />
area.<br />
The work surface is also the base of the isolator. Equipping<br />
the work area is carried out through the alpha beta<br />
double cover lock flanged onto the left hand side.<br />
A waste chute with a sliding lockable lid and continuous<br />
bag is located on the right hand side.<br />
The isolator stands on a resistant floor unit including<br />
integrated extraction. The floor unit is equipped with a<br />
removable tub where a 20 liter tank is located to catch<br />
cleaning fluid. An overfill safety device is inserted in the<br />
tank so that when the adjustable filling level is reached it<br />
sets off an alarm.<br />
Weiss GWE GmbH<br />
Wiechmannsallee 3<br />
27798 Hude<br />
Germany<br />
Tel.: +49 (0) 4484 189-0<br />
Fax: +49 (0) 4484 189-189<br />
contact@gwe.de<br />
www.gwe.de<br />
The WIBOjekt air guidance system is used for<br />
work at an open front panel. In this case an<br />
ejector track is fitted in the front and the exhaust<br />
volume flow is increased from 30 to 300 m 3 /h.<br />
The contaminated air from the work area is pulled<br />
along by the ejector system which creates a cleanair<br />
curtain around the work area and is led to the<br />
extraction opening which is fitted below the<br />
exhaust air filters.<br />
The clean-air curtain remains stable even if the<br />
operator reaches through it. This robust retention<br />
keeps contaminant escape within the levels set<br />
according to the German Chemicals Law (BG<br />
Chemie).<br />
<strong>WIBObarrier</strong> / WIBOjekt = Registered trademark ®<br />
Subject to technical alterations / Version: 01/2007
<strong><strong>WIBObarrier</strong>®</strong>- CCS<br />
as weighing and dispensing table for API<br />
■ Infinitely adjustable sliding front panel<br />
with glove ports<br />
■ Material air locks on both sides for<br />
removal and target package<br />
■ Lift and tilt table for removal packages<br />
■ Integrated label printer<br />
2 <strong><strong>WIBObarrier</strong>®</strong>- CCS<br />
installed in sequence<br />
■ <strong>Open</strong> reach through in the Barrier<br />
work areas<br />
■ Infinitely adjustable front panels with<br />
glove ports<br />
■ Integrated media connections<br />
<strong><strong>WIBObarrier</strong>®</strong>- combined with<br />
WIBOjekt®- table<br />
as laboratory workplace for high potent API<br />
<strong><strong>WIBObarrier</strong>®</strong>- CCS<br />
■ Double leaf front door with horizontally<br />
sliding safety glass front panel<br />
■ Drum location station over the whole width<br />
■ Integrated media connections<br />
■ Transfer hatch to the second <strong><strong>WIBObarrier</strong>®</strong><br />
<strong><strong>WIBObarrier</strong>®</strong>- CCS<br />
■ Table top over the whole width with integrated<br />
waste chute<br />
■ Top hinged front panel with glove ports<br />
WIBOjekt®- table<br />
■ Drum station<br />
■ Double leaf front door in safety glass with<br />
glove ports<br />
■ Transfer hatch to the second <strong><strong>WIBObarrier</strong>®</strong><br />
CCS – Configurations<br />
<strong><strong>WIBObarrier</strong>®</strong>- CCS<br />
as weighing and dispensing table for API<br />
■ Front door with glove ports<br />
■ Drum station<br />
Cleaning lock<br />
■ Transfer hatch with pneumatic<br />
shutter to the Barrier<br />
■ Compressed air for cleaning inliners<br />
■ Inliner welding gun<br />
■ Front door with glove ports<br />
Loading lock<br />
■ Front door with glove ports<br />
■ Conveyor for dispatch packages at<br />
ground level, equipped with lifting<br />
table<br />
■ Table top with opening for dispatch<br />
inliner<br />
Transfer trolley between Barrier<br />
and locks
<strong><strong>WIBObarrier</strong>®</strong> - CCS<br />
Closed <strong>Containment</strong> <strong>Systems</strong><br />
<strong>OCS</strong> - CCS - RABS - Isolators<br />
Whats behind these concepts?<br />
In developing the <strong><strong>WIBObarrier</strong>®</strong> CCS - Closed<br />
<strong>Containment</strong> <strong>Systems</strong> and <strong><strong>WIBObarrier</strong>®</strong> <strong>OCS</strong> -<br />
<strong>Open</strong> <strong>Containment</strong> <strong>Systems</strong>, Weiss has placed<br />
priority on maintaining OEL-Level and clean-air quality<br />
according to DIN EN ISO 14644-1, while retaining a<br />
high degree of free access, flexibility and ergonomics.<br />
The <strong><strong>WIBObarrier</strong>®</strong>- system works according to the<br />
three zone principle. The integrated jets in the front<br />
hood area build up a stable clean-air curtain with<br />
ejector effect (Barrier curtain) between the product and<br />
operator/room.<br />
Particles which escape in the product area are attracted<br />
by the Barrier curtain like by a magnet and conveyed<br />
directly to the contaminant extraction apertures, so<br />
that staff and room are protected from product<br />
emissions.<br />
H14 filtered clean air is fed through the laminator in<br />
the hood area into the work area with unidirectional<br />
flow at a flow rate of 0.17 m/s to 0.45 m/s, adjustable<br />
according to product and task, so that a clean<br />
room zone is created.<br />
Equipment and advantages<br />
of the <strong><strong>WIBObarrier</strong>®</strong> - CCS<br />
■ Handling substances of<br />
risk category (up to OEB 5)<br />
as CCS-System with closed<br />
front panel<br />
■ Safe splash and carryover<br />
protection through top<br />
hinged front panel with<br />
glove ports<br />
■ Product/material transfer<br />
through integrated locks or<br />
direct through top hinged<br />
front panel<br />
■ Robust retention (Product<br />
exposure) through the<br />
stable Barrier curtain even<br />
if the front panel is open<br />
and there is free access<br />
Particles which are liberated as a result of the operator<br />
reaching into the work area, are also caught by the<br />
Barrier curtain which conveys them back to the front<br />
extractor, so that they do not contaminate the product.<br />
<strong><strong>WIBObarrier</strong>®</strong> - CCS, the Closed <strong>Containment</strong><br />
System among the <strong><strong>WIBObarrier</strong>®</strong>-applications:<br />
A multifunctional and flexible workplace for dispensing,<br />
weighing and other handling of high potent pharmaceutical<br />
substances and API (active pharmaceutical<br />
ingredients).<br />
The <strong><strong>WIBObarrier</strong>®</strong> - CCS with closed front panel as<br />
physical barrier between operator/room and product<br />
area can be seen in sub areas as the first stage in a<br />
series of contained safe workplaces, in the same way<br />
as isolators and RABS systems.<br />
F 9<br />
Filter<br />
H 13<br />
OEB* OEL*<br />
5 0 – 1 µg/m 3<br />
4 1 – 10 µg/m 3<br />
3 10 – 100 µg/m 3<br />
2 100 – 1000 µg/m 3<br />
1 1000 – 5000 µg/m 3<br />
*OEB = Occupational Exposure Band<br />
Danger category of a substance taking<br />
*OEL = Occupational Exposure Limit<br />
Average product exposure in breathin<br />
measured in µg/m3,over 8 hours in a
Laminator for unidirectional airflow<br />
Air guidance principle<br />
<strong><strong>WIBObarrier</strong>®</strong>- CCS / <strong>OCS</strong><br />
WIBO®-system solution<br />
BDK-Isolator<br />
<strong><strong>WIBObarrier</strong>®</strong>-CCS<br />
<strong><strong>WIBObarrier</strong>®</strong>-CCS<br />
<strong><strong>WIBObarrier</strong>®</strong>-<strong>OCS</strong><br />
<strong><strong>WIBObarrier</strong>®</strong>-Horizontal<br />
<strong><strong>WIBObarrier</strong>®</strong>-<strong>OCS</strong><br />
<strong><strong>WIBObarrier</strong>®</strong>-Horizontal<br />
<strong><strong>WIBObarrier</strong>®</strong>-<strong>OCS</strong><br />
<strong><strong>WIBObarrier</strong>®</strong>-Horizontal<br />
WIBOjekt®<br />
<strong><strong>WIBObarrier</strong>®</strong>-<strong>OCS</strong><br />
<strong><strong>WIBObarrier</strong>®</strong>-Horizontal<br />
WIBOjekt®<br />
toxicity into account<br />
g area of operator,<br />
40 hour, five day week.<br />
Light<br />
<strong><strong>WIBObarrier</strong>®</strong> - <strong>OCS</strong><br />
<strong>Open</strong> <strong>Containment</strong> <strong>Systems</strong><br />
Equipment and advantages<br />
of the <strong>WIBObarrier</strong> - CCS<br />
■ Handling substances of risk<br />
category (up to OEB 4)<br />
■ Splash and carryover protection<br />
through horizontally sliding<br />
protection glass pane<br />
for the protection of person,<br />
equipped with glove ports<br />
■ Unrestricted transfer of product<br />
and material directly<br />
through the front opening<br />
■ Reaching through protection<br />
for risk areas (Crusher /<br />
mills) by means of controllable<br />
light grids<br />
■ Robust retention (Product<br />
exposure) through the stable<br />
Barrier curtain despite free<br />
access, even without front<br />
panel<br />
When handling less dangerous substances the front<br />
panel is clipped open or swung up and the Barrier<br />
can be freely accessed and used as <strong>OCS</strong>.<br />
<strong><strong>WIBObarrier</strong>®</strong> - <strong>OCS</strong>, the <strong>Open</strong> <strong>Containment</strong><br />
System among the <strong><strong>WIBObarrier</strong>®</strong>-applications:<br />
An ergonomic workplace for the protection of operator,<br />
room and product with integrated clean-room<br />
zone up to ISO 5, for dispensing and filling, refining<br />
and sampling.<br />
Its patented air guidance system guarantees a robust<br />
retention, despite the very gentle airflow, following<br />
EN 14175-3, with free open front up to 1,000 mm<br />
high. Splash and carryover protection can be provided by<br />
installing a front panel, easy to be slid horizontally, available<br />
even with glove ports.<br />
Isolators, which guarantee the highest safety level<br />
as far as personnel and product protection are concerned<br />
are not always economically appropriate or necessary<br />
because of the limited access in the product area<br />
and the legal air and cleaning regulations at the<br />
increasing flexibility requirements for production<br />
processes.<br />
Advanced development of the CCS/RABS (Restricted<br />
Access Barrier <strong>Systems</strong>) means that the requirements<br />
of increasing production flexibility in contained workplaces<br />
have already been taken into account. RABS<br />
are used primarily in aseptic filling.<br />
In contrast to the isolator, RABS systems achieve only<br />
a partial separation between sterile operations and<br />
work area. This is possible without sacrificing quality<br />
and safety limitations, because the operator is always<br />
working in a clean room Class ISO 7 and ISO 5 is provided<br />
in the product area of the RABS. In contrast to<br />
isolators, RABS need not be operated in controlled<br />
pressure areas and do not need to be hermetically<br />
sealed.<br />
<strong><strong>WIBObarrier</strong>®</strong> - CCS is also available in RABS configuration.
<strong><strong>WIBObarrier</strong>®</strong>- <strong>OCS</strong><br />
as weighing station for API<br />
■ Horizontally sliding front panel<br />
with glove ports<br />
■ Table surface with weighing plate<br />
■ Drum station<br />
■ Lifting column, 200 kg capacity<br />
■ Material lock with active cleaning<br />
■ Transfer trolley from production<br />
room up to lifting column<br />
<strong><strong>WIBObarrier</strong>®</strong>- <strong>OCS</strong><br />
as sampling station<br />
■ Lift turntable for pallets<br />
■ Transverse carriage for lift turntable<br />
■ Pneumatic lift gates<br />
■ Integrated pallet transport<br />
<strong>OCS</strong> – Configurations<br />
<strong><strong>WIBObarrier</strong>®</strong>- <strong>OCS</strong><br />
as dispensing and laboratory workplace<br />
■ Drum station<br />
■ Lift and tilt column with drum turning<br />
device 120 kg capacity<br />
■ Weighing plate in the table surface<br />
■ Spot extraction for container interiors<br />
■ Catch tub with perforated plate cover<br />
<strong><strong>WIBObarrier</strong>®</strong>- <strong>OCS</strong><br />
as weighing station for API<br />
■ Horizontally sliding front panel<br />
with glove ports<br />
■ Drum location station with floor<br />
weighing machine<br />
■ Articulated arm with weighing<br />
terminal<br />
<strong><strong>WIBObarrier</strong>®</strong>- <strong>OCS</strong><br />
as dispensing station for API<br />
■ Lift and tilt column with floor<br />
weighing machine,150 kg capacity<br />
■ Drum turning device<br />
■ Drum location station for target<br />
package with floor weighing<br />
machine