WIBObarrier OCS - Open Containment Systems WIBObarrier CCS - Closed Containment Systems

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1 WIBOjekt and WIBObarrier Air Curtain Systems. The perfect protection for person, product and environment. Filling Weighing Sampling Research Safe handling with high potent products / API WIBObarrier OCS - Open Containment Systems WIBObarrier CCS - Closed Containment Systems

2 WIBObarrier - Duo Open Containment Systems The Barrier fulfils the requirements of exposure limit and protection of person according to DIN EN 12469,C3 with both sides free front opening 300 mm high and a product protection/clean room class ISO 5 according to EN ISO within the working area. WIBObarrier - Duo as a seated workplace for four workers, used in a microbiological laboratory. Ventilation technology H14 Air guidance principle WIBObarrier - Duo WIBObarrier - Duo A safe workplace for sampling packages containing high potent steroid agents and/or APIs (active pharmaceutical ingredients). Integrated in a pallet conveying system which passes through the Barrier. The sampling is carried out from two sides to ensure that the person does not have to bend over the packages during sampling. WIBObarrier - Duo Priority is given to the protection of person with a maximum product exposure of OEL 1-10 µg/m 3 and the product protection/clean-room quality ISO 7 according to EN ISO above the product.

3 WIBObarrier - Horizontal Open Containment Systems The reliable air guidance system for modern filling technology. The system consists of two modules, a transmitter and a receiver,which are positioned vertically opposite each other. The filling and emptying station for packages, big bags, containers and so forth are located between them. H14 filtered air flows through the transmitter laminator horizontally over the filling/emptying station towards the receiver unit. The air curtain which builds up through the vertical and horizontal transmitter unit ejectors supports and stabilises this clean air curtain. In addition, a stable clean-airflow is drawn in by the receiver unit and is built up through the filling/ emptying station ensuring that the emissions emanating from the filling/emptying station are contained within the protected area and are safely conveyed to the extraction unit. At the same time penetration of emissions emanating from personnel or from the room into the product area are prevented. Cross contaminations which could result from there being a number of filling/emptying stations with different products in one room, are prevented by the high directional stability of the airflow. Flow technology settings enable prioritisation of personnel or product protection. WIBObarrier Horizontal Abluft exhaust air Zuluft supply air Barrier Stabilisator stabilizer Advantages Protection factor > 100,000, possible for both personnel and product protection Product exposure for personnel and room according to OEL µg/m 3 achievable Air quality up to ISO 7 according to EN ISO when set up in the" black" area No product removal as a result of low air speeds with high directional stability Free access from three sides makes integration of filling/emptying equipment and materials handling possible Modular construction means configuration as either stationary or mobile units is possible Also available in an acid resistant plastic version Air guidance principle WIBObarrier - Horizontal WIBObarrier - Horizontal

4 VARIO-Isolator with WIBOjekt Absolute protection of personnel by the isolator when handling high riskpotent materials. Effective protection of personnel by WIBOjekt when handling high potent materials. The VARIO-Isolator is used where a controlled atmosphere isolated from the surrounding area affording protection of person and product at the same time needs to be created. The VARIO-Isolator is operated at 70 Pa below atmospheric pressure. The unit operates with supply and exhaust air system. Exhaust is 100 %. The purity class corresponds to Class 5 according to EN ISO The Hepa exhaust filter is installed as a "pousse-pousse" filter system (contamination free changeable) in the system area. The work surface is also the base of the isolator. Equipping the work area is carried out through the alpha beta double cover lock flanged onto the left hand side. A waste chute with a sliding lockable lid and continuous bag is located on the right hand side. The isolator stands on a resistant floor unit including integrated extraction. The floor unit is equipped with a removable tub where a 20 liter tank is located to catch cleaning fluid. An overfill safety device is inserted in the tank so that when the adjustable filling level is reached it sets off an alarm. The WIBOjekt air guidance system is used for work at an open front panel. In this case an ejector track is fitted in the front and the exhaust volume flow is increased from 30 to 300 m 3 /h. The contaminated air from the work area is pulled along by the ejector system which creates a cleanair curtain around the work area and is led to the extraction opening which is fitted below the exhaust air filters. The clean-air curtain remains stable even if the operator reaches through it. This robust retention keeps contaminant escape within the levels set according to the German Chemicals Law (BG Chemie). Weiss GWE GmbH Wiechmannsallee Hude Germany Tel.: +49 (0) Fax: +49 (0) [email protected] WIBObarrier / WIBOjekt = Registered trademark Subject to technical alterations / Version: 01/2007

5 CCS Configurations WIBObarrier - CCS as weighing and dispensing table for API Front door with glove ports Drum station Cleaning lock Transfer hatch with pneumatic shutter to the Barrier Compressed air for cleaning inliners Inliner welding gun Front door with glove ports Loading lock Front door with glove ports Conveyor for dispatch packages at ground level, equipped with lifting table Table top with opening for dispatch inliner Transfer trolley between Barrier and locks WIBObarrier - CCS as weighing and dispensing table for API Infinitely adjustable sliding front panel with glove ports Material air locks on both sides for removal and target package Lift and tilt table for removal packages Integrated label printer 2 WIBObarrier - CCS installed in sequence Open reach through in the Barrier work areas Infinitely adjustable front panels with glove ports Integrated media connections WIBObarrier - combined with WIBOjekt - table as laboratory workplace for high potent API WIBObarrier - CCS Double leaf front door with horizontally sliding safety glass front panel Drum location station over the whole width Integrated media connections Transfer hatch to the second WIBObarrier WIBObarrier - CCS Table top over the whole width with integrated waste chute Top hinged front panel with glove ports WIBOjekt - table Drum station Double leaf front door in safety glass with glove ports Transfer hatch to the second WIBObarrier

6 WIBObarrier - CCS Closed Containment Systems Equipment and advantages of the WIBObarrier - CCS Handling substances of risk category (up to OEB 5) as CCS-System with closed front panel Safe splash and carryover protection through top hinged front panel with glove ports Product/material transfer through integrated locks or direct through top hinged front panel Robust retention (Product exposure) through the stable Barrier curtain even if the front panel is open and there is free access F 9 Filter H 13 OEB* OEL* µg/m µg/m µg/m µg/m 3 OCS - CCS - RABS - Isolators Whats behind these concepts? In developing the WIBObarrier CCS - Closed Containment Systems and WIBObarrier OCS - Open Containment Systems, Weiss has placed priority on maintaining OEL-Level and clean-air quality according to DIN EN ISO , while retaining a high degree of free access, flexibility and ergonomics. The WIBObarrier - system works according to the three zone principle. The integrated jets in the front hood area build up a stable clean-air curtain with ejector effect (Barrier curtain) between the product and operator/room. Particles which escape in the product area are attracted by the Barrier curtain like by a magnet and conveyed directly to the contaminant extraction apertures, so that staff and room are protected from product emissions. H14 filtered clean air is fed through the laminator in the hood area into the work area with unidirectional flow at a flow rate of 0.17 m/s to 0.45 m/s, adjustable according to product and task, so that a clean room zone is created. Particles which are liberated as a result of the operator reaching into the work area, are also caught by the Barrier curtain which conveys them back to the front extractor, so that they do not contaminate the product. *OEB = Occupational Exposure Band Danger category of a substance taking *OEL = Occupational Exposure Limit Average product exposure in breathin measured in µg/m3,over 8 hours in a WIBObarrier - CCS, the Closed Containment System among the WIBObarrier -applications: A multifunctional and flexible workplace for dispensing, weighing and other handling of high potent pharmaceutical substances and API (active pharmaceutical ingredients). The WIBObarrier - CCS with closed front panel as physical barrier between operator/room and product area can be seen in sub areas as the first stage in a series of contained safe workplaces, in the same way as isolators and RABS systems µg/m 3

7 WIBObarrier - OCS Open Containment Systems Laminator for unidirectional airflow Air guidance principle WIBObarrier - CCS / OCS Light Equipment and advantages of the WIBObarrier - CCS Handling substances of risk category (up to OEB 4) Splash and carryover protection through horizontally sliding protection glass pane for the protection of person, equipped with glove ports Unrestricted transfer of product and material directly through the front opening Reaching through protection for risk areas (Crusher / mills) by means of controllable light grids Robust retention (Product exposure) through the stable Barrier curtain despite free access, even without front panel WIBO -system solution BDK-Isolator WIBObarrier -CCS WIBObarrier -CCS WIBObarrier -OCS WIBObarrier -Horizontal WIBObarrier -OCS WIBObarrier -Horizontal WIBObarrier -OCS WIBObarrier -Horizontal WIBOjekt WIBObarrier -OCS WIBObarrier -Horizontal WIBOjekt toxicity into account g area of operator, 40 hour, five day week. Isolators, which guarantee the highest safety level as far as personnel and product protection are concerned are not always economically appropriate or necessary because of the limited access in the product area and the legal air and cleaning regulations at the increasing flexibility requirements for production processes. When handling less dangerous substances the front panel is clipped open or swung up and the Barrier can be freely accessed and used as OCS. WIBObarrier - OCS, the Open Containment System among the WIBObarrier -applications: An ergonomic workplace for the protection of operator, room and product with integrated clean-room zone up to ISO 5, for dispensing and filling, refining and sampling. Its patented air guidance system guarantees a robust retention, despite the very gentle airflow, following EN , with free open front up to 1,000 mm high. Splash and carryover protection can be provided by installing a front panel, easy to be slid horizontally, available even with glove ports. Advanced development of the CCS/RABS (Restricted Access Barrier Systems) means that the requirements of increasing production flexibility in contained workplaces have already been taken into account. RABS are used primarily in aseptic filling. In contrast to the isolator, RABS systems achieve only a partial separation between sterile operations and work area. This is possible without sacrificing quality and safety limitations, because the operator is always working in a clean room Class ISO 7 and ISO 5 is provided in the product area of the RABS. In contrast to isolators, RABS need not be operated in controlled pressure areas and do not need to be hermetically sealed. WIBObarrier - CCS is also available in RABS configuration.

8 OCS Configurations as weighing station for API Horizontally sliding front panel with glove ports Drum location station with floor weighing machine Articulated arm with weighing terminal as weighing station for API Horizontally sliding front panel with glove ports Table surface with weighing plate Drum station Lifting column, 200 kg capacity Material lock with active cleaning Transfer trolley from production room up to lifting column as dispensing station for API Lift and tilt column with floor weighing machine,150 kg capacity Drum turning device Drum location station for target package with floor weighing machine as sampling station Lift turntable for pallets Transverse carriage for lift turntable Pneumatic lift gates Integrated pallet transport as dispensing and laboratory workplace Drum station Lift and tilt column with drum turning device 120 kg capacity Weighing plate in the table surface Spot extraction for container interiors Catch tub with perforated plate cover