GloveFAST Cyto Pharma

Name: GloveFAST Cyto Pharma
Brand: FASTER S.r.l.
Availability: InStock
Rating: 4.5 (1 reviews)

The GloveFAST Cyto Pharma isolator complies with the following standards and certifications: - **DIN 12980:2017-05**: Specifies requirements for isolators used in pharmaceutical applications. - **DIN EN ISO 14644-7**: Pertains to cleanrooms and associated controlled environments, focusing on isolators. - **EN 61010**: Covers safety requirements for electrical equipment for measurement, control, and laboratory use. - **VDE / DIN 57789**: Relates to testing and inspection of electrical equipment. - **VDI 2083-1 and VDI 2083-3**: Provide guidelines for the qualification and testing of cleanrooms and associated controlled environments. - **DIN EN ISO 14644-1**: Defines the classification of air cleanliness in cleanrooms and associated controlled environments. - **EN 1822**: Specifies testing methods for high-efficiency particulate air (HEPA) filters. - **ISO 5**: Denotes a cleanroom classification with a maximum allowable particle count. Additionally, the isolator is TÜV Nord GS-certified, indicating compliance with German safety standards.

Description

A state-of-the-art isolator for safe handling of cytotoxic substances, featuring a hermetically sealed housing and integrated glove ports for contamination-free manipulation.

Applicable Standards

ANSI/IEST/ISO 14644-1
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ANSI/IEST/ISO 14644-7
Cleanrooms and associated controlled environments-Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments
EN 1822-1
High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
ISO 14644-1
Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
EN 61010-2-101
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
ISO 10648-2
Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods