73
MANUALE ISTRUZIONI
Rev. 01_05_2018
Serie Clinic 3
INNOVATIVE CLEAN TECHNOLOGY
ETHAFILTER s.r.l.
Via Dell’Artigianato, 16/18
I-36050 Sovizzo (Vicenza) Italia
Tel. + 39 / 0444 376402
Fax +39 / 0444 376415
e-mail: ethafilter@ethafilter.com
CERTIFICATE of CONFORMITY
STERILE FILTER ELEMENT
Model: EDT 5635SR
These aseptic class filter elements are produced to the highest quality standards to ensure the requirements of sterile
degree in compressed air and gas feed.
Materials of construction are as follows:
Endcaps:
AISI 304 grade stainless steel or FDA allowed white sintetic material
Inner and outer cylinder:
expanded AISI 304 grade stainless steel
High Efficiency Filtration layer:
"depth sandwich" of borosilicate glass micro fibre
Sealant:
white silicone compound, selected for resistance to high temperature,
composition in accordance with F.D.A. recommendations.
O-ring:
high temperature silicone compound, composition in accordance with F.D.A.
recommendations.
The high efficiency filter media is made of certified HEPA grade borosilicate glass microfibre, having a penetration of
less than 0.0001% at 0.3
μ
., equivalent to an overall efficiency
≥
0.3
μ
when tested with a DOP aerosol and measured
with a nucleus condensate particle counter.
Sealant remains flexible when warming-up, in order to compensate for metal parts expansion during sterilisation.
N.B.:
It is User's responsibility to ensure that a suitable process for inhibiting growth of trapped bacteria and virus is respected. It
is therefore recommended to sterilise the filter prior commencement of each sequence of aseptic duty. These elements are
capable of withstanding sterilisation phases of 20 ÷ 30 minutes in autoclave at 120 °C (50 steps maximum executable). For
"in situ" steam sterilisation, conventional steam condition for this purpose should be balanced across filter element with a
small flow orifice directed from outside to in. After steam sterilisation, the element should be allowed to flash dry before
the process gas is turned on. For maximum service life, it is recommended to check from time to time filter integrity. In
case testing equipment is not available, it is suggested to replace the filter element every six calendar months.
FILTER ELEMENT SPECIFICATION:
Filter grade
0.01
μ
Max. temperature
200 °C
Max. sterilising temperature
138 °C (as per BS3970, part 3, cycle A)
Initial pressure drop, clean and dry
150 mbar
Change filter element
400 mbar
IMPORTANT NOTE:
-
Before replacing the filter element, make sure that the o-ring and the housing are clean and lubricated with
silicon compatible oil approved by F.D.A. (Food and Drug Administration)
-
Once differential pressure limits or working hours are reached, filter element must be replaced.
-
Only competent Personnel is allowed to install, perform maintenance or replace filter elements.
-
It’s forbidden to move or to replace any filter element from the filter housing under pressure.
INSTRUCTION MANUAL
MAN_CNC3_A001
EN
Summary of Contents for CLINIC 3/24
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