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GloveFAST Cyto/Aseptic

GloveFAST Cyto/Aseptic

GloveFAST Cyto/Aseptic

Product catalog summary
Overview: The document provides detailed specifications and features of the GloveFAST Cyto/Aseptic isolators, designed for cytotoxic and sterility testing applications in pharmaceutical environments. These isolators ensure protection, safety, and reliability for operators handling hazardous materials.
Specifications:
  • Construction: The isolators are constructed with epoxy painted steel, optionally available in AISI 304L stainless steel. The working surfaces are made of AISI 316L stainless steel with a scotch brite finish.
  • Filtration: Equipped with H14 HEPA/ULPA filters, providing 99.995% efficiency according to CEN EN 1822 and 99.999% according to IEST-RP CC00 1.3 USA. The filters ensure low pressure drop and are used in both the main body and transfer hatches.
  • Gloves: Neoprene gloves with polypropylene O-Ring flanges and coated PVC textile sleeves.
  • Glass: Frontal windows are made of 12mm safety glass, with transfer hatch doors in high resistance P.E.T.G. polyester resin.
  • Outlets and Valves: Electrical outlets vary by model size, with options for pneumatic or electric valves for decontamination and leakage tests.
Features:
  • Monitoring System: ECS® microprocessor-based system provides real-time status reports, including airflow velocity, temperature, filter life, and pressure tests.
  • Alarms: Audio-visual alarms for airflow issues, filter saturation, UV lamp lifecycle, exhaust blockages, fan-motor malfunctions, and power failures.
  • Compliance: Meets standards such as EN 1822, DIN 12980:2005, ISO 14644-1, and ISO 14644-7:2004.
Applications:
  • GloveFAST Cyto: Designed for handling cytotoxic drugs and hazardous materials, ensuring operator safety through negative pressure and unidirectional airflow.
  • GloveFAST Aseptic: Provides a positive pressure environment for sterility testing of non-hazardous drugs, maintaining product integrity.
Technical Specifications: The document includes detailed dimensions and construction materials for different models, emphasizing the use of high-quality stainless steel and advanced filtration systems.
Options: Additional features include stainless steel construction, pressure decay test gauges, and adjustable height stands.
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Catalog excerpts

GloveFAST Cyto/Aseptic-1

GloveFAST Cyto/Aseptic Isolators PROTECTION, SAFETY, RELIABILITY. AND MORE.

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GloveFAST Cyto/Aseptic-2

GloveFAST Cyto/Aseptic Faster Isolator for Cytotoxic and Sterility test COMMON FEATURES FILTRATION Filtration is provided by seven absolute filters H14 HEPA/ULPA with typical efficiency of 99.995% MPPS according to CEN EN 1822 and 99.999% conforming to IEST-RP CC00 1.3 USA. All the filters are low pressure drop certified H14 HEPA/ULPA WORKING SURFACES Fully made in AISI 316L stainless filters. Transfer hatches are equipped with a set of inlet and re-circulating steel with scotch brite finishing. Back walls in AISI 304L stainless filters whilst the body of the isolator is equipped with a full...

 Open the catalog to page 2
GloveFAST Cyto/Aseptic-3

GloveFAST Cyto/Aseptic Faster Isolator for Cytotoxic and Sterility test THE USER-FRIENDLY PRACTICAL KEYBOARD ECS® MICROPROCESSOR BASED MONITORING SYSTEM: full status report provided via 2-line digital display by the new generation microprocessors - which automatically control all functions and all safety alarm systems ensuring that performance characteristics are maintained according to safety requirements. High power lithium battery keeps safety data saved to microprocessor system. THE USER-FRIENDLY PRACTICAL KEYBOARD and the rear-lit LCD will continuously display all required data keeping the...

 Open the catalog to page 3
GloveFAST Cyto/Aseptic-4

GloveFAST Cyto Faster Isolator for cytotoxic applications SAFETY WITHOUT COMPROMISES Faster GloveFAST Cyto cytotoxic isolators are negative pressureglove-box devices which separate a pharmaceutical process or activity both from the operator and the surrounding environment when it comes to reconstitution of lyophilized drugs and toxic materials handling. Faster GloveFAST Cyto units secure from contamination assuring an healthy and safe environment for the operators with a cost-efficient solution. Primarily conceived for safe aseptic handling of hazardous materials such as preparation and handling...

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GloveFAST Cyto/Aseptic-5

GloveFAST Aseptic Faster Isolator for Sterility test STERILITY TESTING Sterility testing of sterile pharmaceutical products is essential to determine acceptability of a production lot. Required by the Pharmacopoeia as last mandatory control to be performed before release to market distribution, it is an essential element of sterilization validation and it must be performed on sterile drugs and ophthalmic products. Faster GloveFAST Aseptic is a positive pressure isolator primarily conceived for product protection of non-hazardous drugs providing a positive pressure work. The H14 HEPA/ULPA filtered...

 Open the catalog to page 5
GloveFAST Cyto/Aseptic-6

TECHNICAL SPECIFICATIONS GloveFAST Cyto/Aseptic Transfer hatch overal Transfer hatch usefu 3ody Epoxy powder painted steel coated with Alesta® Dupont antimicrobial painting Transfer hatch Epoxy powder painted steel coated with Alesta® Dupont antimicrobial painting Work surface AISI 316L stainless steel, 4B finishing with thickness of 1,2 mm and 1,5 mm Transfer hatch Inlet low pressure drop certified H14 HEPA filters with typical efficiency of 99,995% MPPS CEN EN 1822-U EPA filter with typical efficiency of 99,999% at 0,1 to 0,3 pm as per EST-RP-CCO01,3 USA Recircualting low pressure drop certified...

 Open the catalog to page 6

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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.