Page 20 - Healthcare

/ Point-of-use filters

BACTERIAL CHALLENGE OPTIMISED TRACEABILITY

BIOFIL filters are approved using the ASTM F838* To control the health risks associated with water,
method. the whole process from the manufacture of the
This test confirms the effective bacterial retention medical device components to the use of the finished
power of the filters used for the decontamination of product must be completely traceable.
liquids.
The microbiological challenges carried out on Individual packet label
BIOFIL filters in laboratories using the species All BIOFIL filters have a unique batch number
Bacteriologically controlled Brevundimonas diminuta, Legionella pneumophila which can be easily traced back through
water and Pseudomonas aeruginosa demonstrate a the production process.
retention efficiency of 7 log for all waterborne
microorganisms which are larger than the filter pores
which have a nominal porosity rating of 0.1μm 2
and absolute porosity rating of 0.2μm. 30261 BIOFIL
Filter Hollow
unit  fibres When subjected to this test, all BIOFIL filters delivered

an effluent free from bacteria, so they have a
Resin 18, rue du Maréchal Foch
 sterilising grade of 0.1 micron nominal-rated. T : +33 (0)3.22.60.22.74
www.delabie.com
* Standard Test Method for Determining Retention of Membrane GTIN
Filters Utilized for Liquid Filtration. 21006211
NON
Section of the BIOFIL tap filter STERILE 240618
Double labelling on the filter
LIFESPAN
2 3 All filters are supplied with 2 waterproof labels which
MONTHS MONTHS identify the product and ensure traceability when the
BIOFIL anti-Legionella and all-germ filters can filter is changed.
be used for up to 4 months after initial installation One is positioned on the product, the other can be
4 (depending on the model installed). removed and transferred to the record log, ensuring
MONTHS After the time period marked on the filter (2, 3 or 4 traceability.
months), DELABIE recommends changing the filter
A
to avoid any risk of retro-contamination from the Date entrée service / Date In
Maximum lifespan bacteria concentrated in the filter especially in at-risk ..... /..... /....
B
areas. BIOFIL 2 Date sortie service / Date Out
..... /..... /....
Ref. 30261
GTIN
Note: The amount of impurities in the water will vary 18, rue du Maréchal Foch 21006211-40
riville
between water systems. Filters will, therefore, T : +33 (0)3.22.60.22.74 240618
www.delabie.com
become clogged at different rates.
If the filter becomes clogged prematurely, it is
necessary to change it. We recommend pre-filtration
upstream to filter out suspended solids and/or COMPLIANCE
colloids, etc.
Bacterial proliferation is significantly reduced in an
Tilted to optimise the position installation where the water is pre-filtered, and the CE marked class 1 medical devices
of the tap filter BIOFIL non-sterile filters comply with the European
lifespan of all equipment is greatly increased.
Regulation UE 2017/745 and benefit from the CE
Mark (2021).
Sterilisation complies with European standard
RESISTANT TO DIFFERENT WATER
EN ISO 11137
SYSTEM TREATMENTS After manufacture, BIOFIL filters are sterilised
using gamma rays. Each box has a visual marker
showing that the filters have been sterilised.
BIOFIL filters will withstand thermal and chemical After sterilisation, BIOFIL filters have a shelf life of 3
shocks. During chemical or thermal shocks, impurities years. The product expiry date is marked on the label.
become trapped in the filter and reduce its lifespan.
CE marked class I Medical DELABIE, therefore, recommends changing the filter Certificate of sanitary compliance
Devices for non-sterile filters after any treatment.
All BIOFIL filters conform to the CPDW directive
Resistance to thermal shocks: and the Order of 29 May 1997, as amended,
Temperatures of 70°C for a cumulative period and the French Ministry of Health Circular
of 30 minutes during its lifetime. DGS/SD7A2002 no. 571 of 25 November 2002.
Resistance to chemical shocks: WRAS
Chlorine levels for 2-month filters: 2 hours at 100ppm; Our BIOFIL filters are WRAS approved. WRAS
3-month filters: 3 hours at 100ppm; Approval demonstrates that a product complies
and 4-month filters: 4 hours at 100ppm. with the Water Supply (Water Fittings) Regulations
and Scottish Water Byelaws. The WRAS approval
standard is accepted as a quality benchmark by water
suppliers who enforce the Water Regulations and
Byelaws.

18 Point-of-use filters