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Weiss GWE GmbH
Brochure WIBOIifescience

Brochure WIBOIifescience

Product catalog summary

Overview: The document outlines advanced systems designed to protect personnel, products, and environments within the pharmaceutical industry. It emphasizes the importance of comprehensive, operational, and cost-effective systems that include planning and after-sales service. Key features include protection for products and personnel, maintaining clean-room quality, preventing cross-contamination, cleaning exhaust air, and ensuring GMP/FDA qualification.

Main Systems:

WIBOjekt System: Employs a clean-air curtain to protect products and personnel by capturing dust and gases, directing them to extraction systems.
WIBObarrier System: Enhances clean-room quality by combining the WIBOjekt system's benefits with additional protection against air turbulence caused by personnel.

Applications:

WIBOjekt Worktable and Free Workplace: These setups use clean-air curtains for ergonomic and economical workspaces, suitable for tasks like weighing and refilling, with integrated pollutant extraction.
WIBObarrier Vertical: Provides a clean-room zone up to ISO 5 (A) class, suitable for various pharmaceutical processes.
House-in-House Systems: Modular systems for creating clean rooms and other controlled environments tailored to specific needs.

Additional Features:

Isolators: Offer controlled atmospheres with laminar flow and underpressure options, including integrated filter systems.
Laminar Flow Modules: Protect products by creating large clean-room zones over production areas.
WIBOjekt Economy: Safety fume hoods designed to meet EN 14175 standards, ensuring high safety levels.

Operational Benefits: The systems are designed for low operating, cleaning, and validation costs, with features like integrated exhaust air filters to prevent cross-contamination. They offer flexibility in installation and operation, suitable for various pharmaceutical and chemical applications.

Specifications: The modular WIBOlifescience House-in-House System features a stable, self-supporting panel and ceiling system with integrated ventilation components. It allows for optimal integration of WIBOjekt system units to safely capture airborne dust and gases. The modular design permits easy dismantling and reconfiguration, even after installation. The construction uses smooth stainless steel or glass surfaces for easy cleaning and features a sandwich construction with an inner aluminum support for sound and heat insulation.

Procedures: The document outlines procedures for various manufacturing processes, including basic and fine cleaning, sluicing into barriers, and vacuum sealing under clean-room conditions. It emphasizes maintaining clean-room standards and preventing cross-contamination.

Standards and Compliance: The system meets EU, GMP, and FDA requirements, ensuring precise airflow and contamination control. It includes features like person and material locks, air-counterflow principles, and processor controls for process and safety monitoring.

Recommendations: The document recommends using the WIBOlifescience system for tasks requiring high levels of cleanliness and contamination control, such as sampling and quality control. It suggests using the WIBObarrier system for efficient product and personnel protection during sampling, reducing product loss and filter costs.

Key Features: The system includes sampling cabins with integrated lighting, high-efficiency filters, and options for circulating or exhaust air operation. It also offers isolator systems for handling toxic products and protecting personnel and the environment.

Applications: The system is suitable for various applications, including weighing, IPC isolators, wet granulation, and cleaning processes. It supports the integration of additional equipment like washing machines and glove cleaning systems.

Overview of WIBOsafe System: The WIBOsafe system is designed to meet the increasing demand for closed units in environments requiring high safety for both personnel and products. It is particularly suitable for operations involving high dust levels, offering a clean-air atmosphere and efficient pollutant capture.

Key Features:

High safety for operators and products.
Ergonomic handling and easy transfer with active cleaning.
High air recirculation and efficient dust and pollutant capture.
Options for circulating, total exhaust, or mixed air operation.
Easy cleaning, disinfection, and drying with a multifunction pistol.
Contamination-free exit transfer and disposal of packaging.
GMP/FDA compliant design, easy qualification, and validation.
Available in various sizes and designs.

Isolator for Hormone Handling: This isolator is designed for weighing and refilling hormones, ensuring protection for both personnel and the environment. It features a material lock for safe product transfer, an electro-polished work area with integrated scale and NIRS probe, and a CIP unit for cleaning. The air is filtered through HEPA filters, with a pollutant capture volume of approximately 200 m³/h.

Technical Specifications:

Width: 2500 mm; Depth: 630 mm.
Controlled by an S7 control system with a 6-channel recorder for monitoring.

Filter and Air Cleaning Systems: The arrangement of filter systems directly at the pollutant capture point minimizes contamination. The WIBOjekt system requires low air volume and offers high cleaning capacity with minimal space requirements. Various filter materials can be used, and maintenance is performed directly from the working area.

Laminar Flow Units: These units are used in various industries for product protection, including pharmaceuticals, food, and cosmetics. They feature adjustable blowers, illumination, and high-tech air filters with a separation rate of 99.99%. The modules can be configured in different dimensions and arrangements.

Applications: The systems are applicable in industries such as pharmaceuticals, biotechnology, cosmetics, food, electronics, and more. They are also used in laboratories, hospitals, and educational institutions.

Contact Information: Weiss GWE GmbH, Wiechmannsallee 3, 27798 Hude, Germany. Tel.: +49 (0) 4484 189-0, Fax: +49 (0) 4484 189-189, Email: [email protected], Website: www.gwe.de

Catalog excerpts

Personen-, Produkt- und Raumschutzanlagen sowie House-in-House-Systeme für die Pharmazeutische Industrie Units for the Protection of Person, Product and Room as well as House-in-House Systems for the Pharmaceutical Industry

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Trends und Zukunftstechnologien in der pharmazeutischen Industrie Trends and Future Techniques in the Pharmaceutical Industry Immer häufiger wird die Forderung nach kompletten, funktionsfertigen und wirtschaftlichen Anlagen und Units einschließlich Planung und After-Sales-Service laut, die folgende Eigenschaften aufweisen: · · · · · · The demand is continually increasing for complete, operative and economical systems and units, including planning and after-sale service which have the following properties: Produktschutz Personenschutz Reinraumqualität Vermeidung von Kreuzkontamination Abluftreinigung...

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WIBOjekt - WIBObarrier Vertikal House-in-House-Systeme WIBOjekt-Arbeitstisch - WIBOjektFreiarbeitsplatz (FAP) Personen- und Raumschutz durch die integrierten WIBOjekt Reinluftschleier, die die luftgetragenen Schadstoffe sicher erfassen und gezielt der Absaugung zuführen. WIBOjekt Worktable – WIBOjektFree Workplace Protection of the person and the room by integrated WIBOjekt clean-air curtains, which capture safely the air-borne pollutants and lead them precisely to the extraction. Eingebaut in kundenspezifisch konfigurierte Tische oder Freiarbeitsplätze garantieren die Reinluftschleier den ergonomischen...

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Isolator - Horizontal Barrier - Laminar-Flow WIBOjekt economy Isolator Personen-, Produkt- und Raumschutz. Kontrollierte Atmosphäre durch Isolator Protection of person, product and room. Controlled atmosphere by - Laminar-Flow Isolatoren - Unterdruck-Isolatoren – auch mit integrierten Filtersystemen - Spezielle Schleusen- und Andocksysteme - Laminar Flow Isolators - Underpressure Isolators – also with integrated filter systems - Special lock- and docking systems WIBObarrier Horizontal WIBObarrier Horizontal Produkt-, Raum- und Personenschutz beim Einfüllen/Entleeren von Inlinern, Containern,...

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Wiege- und Umfülltische Weighing- and Refilling Tables Wiege- und Umfülltische mit dem WIBOjekt System schützen den Mitarbeiter und den Raum gleichermaßen sicher durch den Reinluftschleier. Weighing- and refilling-tables with the WIBOjekt system protect the employee and the room equally safely by the clean air curtain. Varianten von der einfachen Anlage bis zur Komfortanlage mit mehreren eingebauten Waagen, Terminal und integriertem Bildschirm sind möglich. Die Aufteilungen und Größen sind genauso variabel wie die Ausstattungen. Variants ranging from a simple plant to a sophisticated installation...

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Freiarbeitsplatz mit integrierter Schadstoff-Ejektor-Absaugung Free Workplace with Integrated Pollutant Ejector Extraction Free workplaces are workplaces where almost all works can be carried out at any position inside the workplace. In contrast to normal work cabins, WIBOjekt free workplaces need considerably less air volumes. Operation with fresh air-circulation air is adjustable. In the area of filling, refilling, weighing, loading and unloading of metal racks with medical products, in case of installations etc. the free workplace has brilliantly proven its quality. Die Freiarbeitsplätze sind...

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WIBObarrier Vertikal - Arbeitsplatz mit Reinraumzone WIBObarrier Vertical - Workplace with Clean-Roomzone Viele Arbeiten und Verfahren konnen in kleinen Bereichen erfolgen. Es ge- nugt, wenn der eigentliche Arbeitsbe- reich als Reinraumzone gebaut ist. Auf teure Reinraume, hone Reinheitsklas- zichtet werden. Die Arbeitsplatze konnen in „Crau"- oder „Schwarzzonen", aber auch zur Erreichung einer hoheren Schutz- klasse in bereits vorhandenen Rein- raumen aufgestellt werden. Der Mitar- beiter wird durch die Reinluftschleier des Barrier-Systems (siehe Prinzip) reich hinter dem Reinluftschleier fur...

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WIBObarrier Horizontal ... beim Befüllen von Inlinern, Containern, Big Bags etc. ... on filling of inliners, containers, big bags etc. Die Tatsache, dass eine Kette immer nur so gut ist, wie das schwächste Glied, wird besonders beim An- und Abkoppeln offensichtlich. Hier werden trotz moderner Abfülltechnik Emissionen frei bzw. das Produkt ist nicht sicher geschützt. The fact that a chain is always as good as its weakest link becomes especially obvious at the coupling and disconnecting. Here, despite modern filling techniques, emissions are released resp. the product is not protected safely. Langjährige...

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Modulares House-in-House System Modular House-in-House System Das modulare WIBOlifescience House-in-House System: The modular WIBOlifescience House-in-House System: - stabiles, selbsttragendes Paneelen- und Deckensystem mit integrierten Lüftungskomponenten - optimale Einbindung der WIBOjekt-Systemanlagen zur sicheren Erfassung freiwerdender Stäube und Gase - die Module des House-in-House-Systems sind optimal aufeinander abgestimmt und fast beliebig miteinander kombinierbar - stable self-supporting panel and ceiling system with integrated ventilation components - optimal integration of the WIBOjekt...

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Vertical flow barrier House in House System beim Waschen during washing werden Implantate (Huft— und Kniege- lenke etc.) spangebend aus Edelstahl verpackten Ausschleusung - erfolgt in verketteten Weiss CWE-Anlagen (s. Ab- Die einzelnen Anlagen sind: House-in-House-System - Durch- 4. Vakuumeinschweidung unter Rein- tikel) - Barrier BA 200 mit Klasse 3 Produklschutz uber over (he ultrasonic balh passing through Produktschutz psim Kontektionieron during assembling material lech Implants (hip- and knee joints etc.) are produced and cutted of stainless steel in "black" manufacturing rooms. The production's...

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Personen- und Materialschleusen Person- and Material Locks Das WIBOlifescience Modulsystem schafft flexible und kostengünstige Personen- und Materialschleusen The WIBOlifescience module system leads to flexible and Iowcost person- and material locks Die Anforderungen an Schleusen werden immer umfangreicher. EU-Richtlinien, GMP und FDA Forderungen sowie deren Umsetzung bringen sie mit sich. Due to standards set by the EC, GMP and FDA, locks increasingly have to meet more and more complex requirements. Räume mit 10- oder 20-fachem Luftwechsel oder auch mit einigen größeren Luftdüsen erfüllen diese...

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Brochure WIBOIifescience

Brochure WIBOIifescience

Catalog excerpts

All Weiss GWE GmbH catalogs and technical brochures