Guideline Landscape. Quality Control

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1 Guideline Landscape Quality Control Environmental Water Testing Parma Biotec

2 Watertesting according to current standards & regulations Membranefilteroverview for accredited laboratories ISO 7704:1985 QC filters ow to release membranefilters as to be used for all filter releases Guideline Landscape Water All gridded 0.45 µm Sartorius filters are ISO7704 conform Correct coice of pore size as defined by te respective ISO for eac analysis listed Organism Guideline Filter per guideline Sartorius Enterococci ISO : µm E. Coli Legionella ISO DIS :2012 ISO WD 11731: µm Cellulose-Esters, every lot to be tested according to ISO µm black Cellulose Nitrate membranes Clostridium perfringens ISO DIS 14189: µm Pseudomonas aeruginosa ISO 16266: µm Campylobacter ISO 17995: µm; CE Salmonella ISO 19250: µm anaerobes (Clostridia) ISO : µm Bacteriopages ISO part µm

3 Test organism Sartorius Filter Dispenser ready filter Single sterile membranes Enterococci E. Coli 114H6Z SCM (wite) 138H6Z SCM (green) 114H ACN (wite) 138H ACN (green) Legionella Clostridium perfringens Pseudomonas aeruginosa 130H6Z SCM (black) 138H6Z SCM (green) 114H6Z SCM (wite) 114H6Z SCM (wite) 130H ACN (black) 138H ACN (green) 114H ACN (wite) 114H ACN (wite) Campylobacter 114H6Z SCM (wite) 114H ACN (wite) Salmonella 114H SCM (wite) 114H ACN (wite) anaerobes (Clostridia) 11407Z SCM (wite) ACN (wite) Bacteriopages 11407Z SCM (wite) ACN (wite)

4 Appendix: guideline passages ISO 7704:1985 (membrane filter) 5. Apparatus 5.2 Sterile membrane filters A tin non-fibrous filtration medium for liquids and gases, aving a mean pore size larger tan 0.01 μm in diameter, on wic particles larger tan te rated pore size are retained at or near te delivery surface wen suction or pressure is applied. 8. Membrane filter Te membrane filters sall be sterile. ISO 8199:2005 (Enumeration) Wit membranes of mean pore size 0.45 μm, it may be possible to filter several litres of suc water troug a single membrane, and so acieve a ig level of test sensitivity. For some organisms (like Legionella), owever, filtration troug a membrane wit a mean pore size of 0.2 μm may be necessary. ISO :2000 (Enterococci) Sterile membrane filters, nominal pore size 0.45 μm. Te quality of membrane filters may vary from brand to brand or even from batc to batc. It is terefore advisable to ceck te quality on a regular basis according to ISO ISO :2012 (Legionella) 5. Apparatus and glassware 5.5 Polycarbonate membrane filters 5.6 Black Membrane filters Polycarbonate membrane filters diameter 47 mm to 142 mm wit rated pore sizes of 0.2 μm. Black membrane filters from cellulose nitrate or mixed cellulose ester, diameter 47 mm to 50 mm wit rated pore sizes of 0.22 μm or 0.45 μm. Note Tis type of membrane filters are used for direct placing on to te culture media after filtration. Filters sall be evaluated prior to use in accordance wit ISO ISO :2012 (E.Coli & Coliforme) 5. Apparatus and glassware 5.5 Membrane filters Membrane filters, composed from cellulose esters, usually about 47 mm or 50 mm in diameter, wit filtration caracteristics equivalent to a rated nominal pore diameter of 0.45 μm and, preferentially, wit grids. Te filters sall be free from growtinibiting or growt-promoting properties and te printing ink used for te grid sall not affect te growt of bacteria. If not obtained sterile, tey sall be sterilized according to te manufacturer s instructions. Every batc of membranes sall be tested for its suitability for te test according to ISO 7704 especially since te use of different brands of filters may result in different recovery and colour development.

5 ISO 16266:2006 (Pseudomonas aeruginosa ) 6. Apparatus and glassware 6.4 Sterile membrane filters Sterile membrane filters, wit nominal pore size of 0.45 μm. Ceck filters on a regular basis as specified in ISO ISO :1986 (Anaerobes Clostridia) 7. Apparatus and glassware 7.9 Sterile membrane filters Sterile membrane filters, nominal pore size 0.2 μm. Note Te quality of membrane filters may vary from brand to brand or even from batc to batc. It is terefore advisable to ceck te quality on a regular basis according to ISO ISO 10705, part 1-4 (Bacteriopages) Only membranes defined for de-contamination purposes ISO DIS 14189:2013 (Clostridium perfringens) 5. Apparatus and glassware 5.3 Sterile membrane filters Sterile membrane filters, nominal pore size 0.45 μm. Te quality of membrane filters may vary from brand to brand or even from batc to batc. It is terefore advisable to ceck te quality on a regular basis. ISO 17995:2005 (Campylobacter ) 5. Apparatus 5.3 Membrane filters Sterile membrane filters made from cellulose ester wit a diameter of 45 mm to 50 mm and a pore size of 0.45 mm. Similar filters wit a pore size of 0.22 μm are recommended for sterilization of supplements. ISO 19250:2010 Salmonella 5. Apparatus 5.5 Sterile membrane filters Sterile membrane filters, wit a nominal pore size of 0.45 μm. Note Te quality of membrane filters may vary from brand to brand or even from batc to batc. It is terefore advisable to ceck te quality on a regular basis according to ISO 7704.

6 ISO 11133:2015 (Microbiology of food, animal feed and water Preparation, production, storage and performance testing of culture media) 7.3 Testing of culture media used for membrane filtration Te quality of te membrane filters used sall be previously evaluated to demonstrate teir suitability for use. See ISO To test te performance of a culture medium for use in membrane filtration, use working cultures and inocula as described in Inoculate te suspension medium e.g: dilution fluid, sterile water, wit a suitable inoculum level given in Filter te liquid according to te requirements of te specific standard. Place te membrane on te surface of te agar under test. Inoculate sufficient membranes plates to obtain a total of approximately 100 cfu for productivity testing. Repeat wit a new membrane and place te second membrane on te surface of te reference medium, using dilutions if required for selectivity testing. Incubate te plates according to te specific standard. Repeat te process eac time te batc of membranes canges as well as eac new batc of medium. If necessary, to evaluate te influence of te membrane on te result also spread te test inoculum onto te test medium and reference medium witout te membranes.

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8 Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse Goettingen, Germany Pone Fax USA Toll-free UK France Italy Spain Russian Federation Japan Specifications subject to cange witout notice. Copyrigt Sartorius Lab Instruments GmbH & Co. KG. Printed in te EU on paper bleaced witout clorine. Publication No.: SM-1505-e Order No.: Ver

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