Faster ASEPTIC, Operating And Maintenance Manual

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a D:GROUP Company
00254EN – Rev. 01 – 11/2012 3
1 GENERAL
Vertical laminar airflow isolators with positive pressure within the working area and physical separation
between operator and product (gloves), the ASEPTIC isolators are principally designed to protect the material
to be manipulated from contamination coming from environment.
The filtered and sterile air passing through the main HEPA filter ensures optimum airflow laminarity on the
work surface. Air cleanliness is also better than ISO 5 @ 0.3 and 0.5
µ
m particles according to ISO EN
14644-1 standard.
The ASEPTIC isolators are especially suitable for applications such as:
-
Sterile manipulation
-
Sterility testing
-
Microbiology
-
Preparation of culture media
-
Preparation of ophtalmic solutions
-
TPN Preparation
The performances of the isolators are detailed in the TESTING CERTIFICATE.
Furthermore ASEPTIC isolators fulfil the harmonized standards EN 61010-1 as well as EN 61326 according
to the applicable European directives regarding the CE marking.
ASEPTIC isolators comply with the above-mentioned standards ONLY if the instruments connected to the
electrical socket positioned inside the work chamber are "CE" marked or in any case it meets the above
mentioned standards aiming to avoid any electromagnetic interference.
All Faster’s isolators are provided with high insertion loss filters.
Faster s.r.l. cannot be held responsible for malfunctions, damage to people or property due to non-
compliance, poor or no maintenance, or improper use of the isolator.