User’s Manual / Manuale Uso Trio.Bas 16
COMPONENTS CHARACTERISTICS /
CARATTERISTICHE COMPONENTI
The equipment has been designed to meet the main
requirements of the FDA for environmental monitoring,
as indicated in the guidelines on Sterile Drug Products
produced by Aseptic Processing.
It is fully compliant with national and international
standards for monitoring ambient air.
There is also a certificate of ATEX “non sparkling”
device, Ex nA type of protection that corresponds to the
standard "EN 60079-15".
The Rules Governing Medicinal Product In The
European Community Vol. IV: Guide to Good
Manufacturing practice for medicinal products, 199207.
ISO EN 16498-1 and 2 Clean rooms and associated
controlled environments-Biocontamination control part 1
and Part 2 (Ref. Number: ISO 14698 -1:2003(E)).
Lo strumento è stato realizzato per soddisfare i
principali requisiti
della
FDA
per il monitoraggio
ambientale
accettabile,
come indicato
nelle linee guida
sulla
Sterile
Drug
Products
prodotta da
Aseptic
Processing
.
È completamente
compatibile con gli standard nazionali
ed
internazionali
per
il
monitoraggio
dell'aria
ambientale. Inoltre è disponibile nella versione dotata di
certificato ATEX di strumento
“non scintillante” con
modo di protezione “nA” corrispondente alla norma “EN
6007915".
The Rules Governing Medicinal Product In The
European Community Vol. IV: Guide to Good
Manufacturing practice for medicinal products, 199207.
ISO EN 16498-1 and 2 Clean rooms and associated
controlled environments-Biocontamination control part 1
and Part 2 (Ref. Number: ISO 14698 -1:2003(E)).
CE MARK / MARCATURA CE
The standard equipment complies with the following
standards:
EN 61010-1-2010 Safety requirements for electrical
equipment
for
measurement,
control
and
laboratorty use
– Part1: General requirements
EN
61326-1:2006
Electrical
equipment
for
measurement, control and laboratory use
– EMC
requirements
– Part1: General requirements
EN
62321:2009
Electrotechnical
products
–
Determination of levels of six regulated substances
(lead, mercury, cadmium, hexavalent chromium,
polybrominated biphenyls, polybrominated ethers)
Lo strumento standard è certificato secondo le seguenti
normative:
EN 61010-1-2010 Safety requirements for electrical
equipment
for
measurement,
control
and
laboratorty use
– Part1: General requirements
EN
61326-1:2006
Electrical
equipment
for
measurement, control and laboratory use
– EMC
requirements
– Part1: General requirements
EN
62321:2009
Electrotechnical
products
–
Determination of levels of six regulated substances
(lead, mercury, cadmium, hexavalent chromium,
polybrominated biphenyls, polybrominated ethers)
ATEX CERTIFICATION /
CERTIFICAZIONE ATEX
The equipment carries, in ATEX version, the following
marking:
Lo strumento, nella versione ATEX, riporta la seguente
marcatura:
II 3G Ex nA IIC T4 Gc IP 2x
Operation of this ATEX certified sampler is permitted in
hazardous areas for the presence of gas and dust
classified as zone 2.
L’utilizzo dello strumento certificato ATEX è ammesso
in luoghi pericolosi per presenza di gas e polveri
classificati come zona 2.
The power supply, any printer and accessories, if free
ATEX marking, must not be used in areas at risk of
explosion.
The equipment can only be used for the air sampling;
eventual disassembly etc. must be carried out in a safe
area.
L’alimentatore, l’eventuale stampante e gli accessori di
calibrazione se esenti da marcatura ATEX non devono
essere utilizzati in luoghi con pericolo di esplosione.
Lo strumento può essere solamente utilizzato (chiuso)
per
il
campionamento;
eventuali
operazioni
di
smontaggio ecc. devono essere effettuati in zona
sicura.