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Aseptic Product Solutions Brochure

Aseptic Product Solutions Brochure

Aseptic Product Solutions Brochure

Product catalog summary
Overview: Extract Technology provides innovative aseptic solutions through a range of isolators and Restricted Access Barrier Systems (RABS) designed to enhance aseptic processes in clinical and pharmaceutical environments. These solutions offer an ergonomic and practical alternative to traditional clean rooms, ensuring guaranteed product protection and compliance with stringent cGMP and international regulations.
Key Products and Features:
  • Cell Therapy Isolators: Designed for the production of cells for clinical use, offering an ergonomic alternative to clean rooms.
  • Filling Line Isolators: Enclose filling, stoppering, and capping operations, providing an ISO 5 Grade A aseptic environment.
  • Sterility Test Isolators: Allow operators to perform sterility testing in an aseptic environment, ensuring process integrity.
  • Custom Design Options: Tailored isolators to meet specific customer requirements, including multiple chambers and ergonomic designs.
Design Features:
  • Fully welded 316L stainless steel construction.
  • Positive pressure regime with turbulent or unidirectional airflow systems.
  • Hydrogen Peroxide decontamination and full process equipment integration.
  • Controlled environments with options for N2, RH, and temperature control.
RABS (Restricted Access Barrier Systems):
  • Open RABS: Utilize existing clean room air supply systems for HEPA filtered air delivery.
  • Closed RABS: Feature onboard fan/filtration units for a positive pressure system with recirculated airflow.
Manufacturing and Testing:
  • High-quality stainless or alloy steel construction with rigorous testing, including H2O2 chemical indicator testing and particle monitoring.
  • Factory Acceptance Testing ensures equipment meets design parameters before deployment.
Additional Solutions: Extract Technology also offers containment isolators, downflow booths, pack-off and process sampling facilities, and mobile cleanrooms.
Contact Information: For more details, visit the Extract Technology website or contact their offices in the UK or Americas.
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Catalog excerpts

Aseptic Product Solutions Brochure-1

DELIVERING INNOVATION TO PROTECT ASEPTIC SOLUTIONS STERILITY TEST ISOLATOR DESIGNED TO PERFORM STERILITY TESTING IN AN ASEPTIC ENVIRONMENT PROVIDING ASSURANCE OF PROCESS INTEGRITY CELL THERAPY ISOLATOR CRABS & ORABS ERGONOMIC AND PRACTICAL ALTERNATIVE TO TRADITIONAL CLEAN ROOMS FOR THE PRODUCTION OF CELLS FOR CLINICAL USE C-RABS AND O-RABS DEVELOPED TO ENHANCE ASEPTIC PROCESSES CARRIED OUT IN CONVENTIONAL CLEAN ROOMS STERILITY TEST FULL PROCESS EQUIPMENT INTEGRATION WITHIN A GRADE A ISO 5 ENVIRONMENT CELL THERAPY FILLING LINE FILLING LINE ISOLATOR

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Aseptic Product Solutions Brochure-2

Aseptic Isolators Restricted Access Barrier Systems Complete Aseptic Solutions based around an innovative range of Isolators and RABS bringing different features and benefits to your application, but all have one thing in common: they provide Guaranteed Product Protection. EXTRACT TECHNOLOGY ASEPTIC ISOLATORS ARE DESIGNED TO ALLOW OPERATORS TO PERFORM ASEPTIC PROCESSES IN A STERILE ENVIRONMENT PROVIDING ASSURANCE OF PROCESS INTEGRITY. EXAMPLE BELOW: DESIGN FEATURES Fully welded 316L stainless steel construction Positive pressure regime Turbulent or unidirectional airflow systems available Air...

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Aseptic Product Solutions Brochure-3

4. Factory Acceptance Testing We generate conceptual designs based upon proven solutions, before finally compiling product specifications, standard operating procedures (SOPs) and working schematics (P&IDs) Only when the equipment is fully built and fully tested to the design parametersis it exposed to a range of tests and standard operating procedures (SOPs). These can include H2O2 chemical indicator testing, particle monitoring tests, smoke studies and full scale operational tests of performance all being performed within our separate test environment. We can create full scale mock–ups which...

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Aseptic Product Solutions Brochure-4

STERILITY TESTING CUSTOM STERILITY TEST ISOLATORS ARE DESIGNED TO ALLOW OPERATORS TO PERFORM STERILITY TESTING IN AN ASEPTIC ENVIRONMENT PROVIDING ASSURANCE OF PROCESS INTEGRITY. THEY ALSO PROVIDE A CONTROLLED MEANS OF LOADING AND REMOVING THE PROCESSED PRODUCT AND WASTE MATERIALS FROM THE ISOLATOR ENCLOSURE. DESIGN FEATURES CUSTOM DESIGN We know that not all customers’ requirements will fall into our standard Steripharm Isolator design. For that reason we offer custom designed isolators to suit individual customer requirements including Half suits, 6 glove ports, Multiple chamber construction...

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Aseptic Product Solutions Brochure-5

Restricted Access Barriers (RABs) were developed to enhance aseptic processes carried out in conventional clean rooms. Extract Technology custom RABs are designed to fully comply with our customers' requirements for aseptic processing. RABS ARE AVAILABLE IN OPEN OR CLOSED DESIGNS. OPEN RABS • •> OPEN PASSIVE RABS utilise exsisting clean room overhead air supply systems to deliver HEPA filtered air over a critical process before returning air back into the clean room without the need for additional fans or filters. The RABs enclosure is not sealed to the filling machine. • •> OPEN ACTIVE RABS...

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Aseptic Product Solutions Brochure-6

STANDARD PRODUCT RANGE —» Europe -» A«a -» Australasia —► Russia -♦ Middle East —» Aftca —» South America -* Central Amenco —» Nath America EXTRACT TECHNOLOGY LTD UK OFFICE +44 (0) 1484-432-727 BRADLEY JUNCTION IND ESTATE, LEEDS RD, HUDDERSFIELD, HD2 1UR, UNITED KINGDOM EXTRACT TECHNOLOGY AMERICAS OFFICE FOR MORE INFORMATION ON OUR PRODUCTS PLEASE VISIT OUR WEBSITE OR CONTACT US DIRECTLY: EXTRACT TECHNOLOGY +1 608-562-7761

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.