CombiSart The economic way for fast ... - Unitech Scientific fast and reliable colony counting. ... Up-to-date expertise through training. ... the dried membrane filters onto a test

CombiSart®

The economic way for fast and reliable colony counting

Quality management in…

Sartorius brings more than 60 years of world-wide experience in membrane technology toeach application. As a leading internationalsupplier, we provide innovative products,cost-effective solutions, certified quality and responsive technical support.

Increasing our high quality standard.We place our highest priority on quality.From product design, testing and productionto marketing and administration, qualityassurance is our most important activity. Sartorius is also an accredited institution,playing a major role in quality assuranceissues, including the development of newstandards.

Innovative manufacturing processes.Our casting machines for manufacturing filter membranes have set new process and environmental standards in Germany andthroughout the world. We recycle 99% of the solvents used in production and we reuse 96% of the recycled material in our production processes.

Application research and development.Sartorius relies on their customers for inputand experience to help guide our new product development. This interaction helpsthe Sartorius R&D team to create innovative products and systems that meet customerneeds and exceed customer expectations.

Today, in cooperation with our partners andaccredited science and research institutes atindustrial centers throughout the world, Sartorius is developing the international standards of technology for tomorrow.

Up-to-date expertise through training.We stress continuous training and qualifica-tion of our employees in all areas. We alsooffer standard or customised training programmes for our customers employeeswho work with Sartorius separation techno-logy products.

…the pharmaceutical industry

Quality requirements for pharmaceutical,chemical and cosmetic products are preciselydefined. Worldwide pharmacopoeia andindustrial organizations, such as PhEu 4, the current USP, JP XIII and the AmericanStandard Methods APHA, provide guidelinesand detailed specifications on productbioburden and particle content.

The final product quality required can only beattained if the entire production process isadequately and reliably protected against contamination.

Applications.To assure the quality of a manufacturingprocess, appropriate in-process samples aretaken of the raw materials and the final products. These samples are examined for themicrobial colony and particle counts.Depending on the results, specific action istaken in production to guarantee productcompliance with the quality specifications.

Colony Count.Colony count is the quantitative determina-tion of microorganisms present in a sample.The quantity can represent either the totalbioburden, e.g., all bacteria, yeasts and molds;or the detection and quantification of a particular species of product-specific micro-organisms. The counts are expressed incolony-forming units per 1 ml sample volume(CFU/ml).

Particle analysis.Particle count depends on the particle sizesfound in the sample, and is expressed in unitsper sample for each particle spectrum.

Air Monitoring.Air monitoring involves active sampling ofairborne microorganisms and viruses presentin the air within the entire production area.The count is given in CFU/m3.

Sterility Test.Sterility of the final product is determined bymicroorganism growth in prescribed liquidnutrient media. Results show whether thesample is sterile or unsterile.

Manufaction Filling

Water

Raw material

Clean room area

Mixingvessel

AirMonitoring

ColonyCount

ColonyCount

ColonyCount

ColonyCount

ColonyCount

Colony Count Sterility Test

Incoming inspection, in-process and final quality control (Fig.)

Your requirements…

Methods.Usually, precise instructions are given for performing a specific laboratory test. At Sartorius, we distinguish between thedirect method and the membrane filtermethod. The direct method involves inocula-tion of the sample directly into liquid nutrientmedia. Instead Sartorius recommends themembrane filtration method in which micro-organisms and particles are concentrated onthe surface of a membrane filter and thusseparated from the other constituents of asample, such as inhibitors and liquids. Subsequently, the filter is quantitatively evaluated. This provides the following advantages:

Accurate detection of microorganisms.• Quantitative determination of low bio-

burden in large sample volumes• Inhibitors, such as antibiotics and preser-

vatives, can be rinsed away• Samples containing a high particle load can

be prefiltered

Economy.• No major equipment investment is needed• Eliminates time-consuming, labor-intensive

preparation• Long-lasting• Easy to store• Cost-effective

Results on file for future reference.The results can be documented by attachingthe dried membrane filters onto a test reportfor easy reference later

Low space requirements.• Space-saving test• Small-volume autoclaves are suitable

Sartorius can help you select the appropriatemembrane filtration products to provide thisfull range of benefits while meeting your regulatory i.g., membrane pore size, nutrientmedia requirements, etc.

Certificates.For your quality assurance Sartorius exclusively offers certified products. A lot certificate is included in the package ofeach consumable product, indicating that theproduct meets the specifications for release.Our stainless steel filter holders are individu-ally serial numbered. Moreover, Sartoriusprovides Validation Guides with detailedinformation on testing, results, and specifica-tions on request.

WaterThe PhEu 4, USP 26, and JP XIIIpharmacopoeias, including their supplements, TVO, DIN/ISO,APHA-STM.

CosmeticsBased on the pharmacopoeias forpharmaceuticals.

PharmaceuticalsThe PhEu 4, USP 26, and JP XIIIpharmacopoeias, including theirsupplements.

You will find detailed reference literature on the last page.

…are our performance

Over the years, the vacuum membrane filtra-tion technique has established itself as themethod of choice for colony counting andparticulate analysis. Systems used for qualityassurance testing by industry, at governmenttesting laboratories and required by govern-ment regulatory authorities must meet the most stringent conditions, yet be economical at the same time. This tabledemonstrates, feature by feature, the rangeof performance standards met by innovativeSartorius products.

BioS

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100

BioS

art

100

Med

ia

BioS

art 2

50

NPS

Filt

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Stai

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s st

eel

Product completely satisfies all requirements

• Current data not available at present

Not necessary to meetthis requirement

Product does not meet requirements or satisfies only part of them

Gla

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Poly

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Reliable results

Sterility of parts which Sterile upon delivery • • • • •are in contact with the sample Autoclavable (121°C or 134°C) • • • •

Sterilisable by dry heat (180°C) • •

Defined pore size and quantitativerecovery rates acc. to international Validation Guides available • •standards.

Certified quality builds confidence Enclosed certificate confirms all • • • • •and assures clarity specifications

Individual serial number •

Writing a SOP Easy to validate • • • • •

No growth inhibition caused by Bio-inert materials • • • • • • • •glues or binders on the membrane filter

No false-negative results caused Added media must pass through by secondary contamination of the the membrane filters first; and • • • • • • • •culture media the underside of the membrane filter

is sterile-vented

No false-positive results caused by • • • •secondary contamination of the sample Lid for funnel is available

Membrane filter can be filed: The The filter with the incubated colonies original filters are available for auditing can be removed, dried and glued onto • • • • • • • •at any time later a report for future reference

Colonies or particles are easy to see Different filter colors offer contrastingbackgrounds for each colony color • • • • • • • •

Parts which are in contact • • • • •with the sample are particle free Particles can be rinsed out

Easy disposal Melt down by autoclaving •

Time-saving procedure

Short filtration times High flow rate • • • • • •

Large filtration area • • • • • •

No filter changing in a sample High throughput • • • • • •

Few steps involved Easy to use • • • • • •

Maximum economy.Requirements and applications may changeover time. With CombiSart, you can quicklyadapt your current equipment configurationto meet new requirements. This means thatyou can switch from a reuseable filter holderto a disposable unit without requiring a newequipment investment.

Whatever requirements you place on ourproducts today, the choice of filter holdersthat best meet your needs is yours. Our fieldsales representatives will be happy to adviseyou concerning your specific requirements.Just ask us for an appointment.

To help you choose the Sartorius filter holdersthat best meet your needs, we have listed allsystems on the following pages. You will findnot only our product specifications andordering information, but also an easy guideto locating the features you need.

One glance at the pictograms will tell youhow a particular product will meet yourrequirements.

You will find a detailed overview of our indi-vidual systems on page 17.

Plus, you can fold out the last page to see acomplete overview of our accessories whileyou view our CombiSart product information.

CombiSart® Multi-branch Systems – Total reliability from a proven concept

You can rely on Sartorius’ experience to helpyou make a sound decision.

The right equipment for your application.The Sartorius CombiSart system enables youto select the optimal hardware and consum-ables for your needs in quality assurance.CombiSart features a modular design andfield-proven standard accessories to makeyour choice easier.

At the heart of the CombiSart system is astainless steel manifold designed to accom-modate all types of filter holders and funnelssuch as:• Ready-to-use units, including BioSart 100

Monitors and BioSart 250 Funnels• Flamable units such as stainless steel fun-

nels for colony counting• Autoclavable polycarbonate and glass filter

holders

A special feature of the CombiSart manifold isthat each filter unit can be individuallyvented. This rules out secondary contamina-tion of the underside of the filter. Since themost reliable sterilization method is auto-claving, the CombiSart design offers a uniqueadvantage for this method. After insertingthe membrane filters in the filter holders, youcan simply unscrew them as an entire unitfrom each workstation and autoclave them. You can even pour out a non-filterablesample from each unit. And CombiSart makesfiltration equally easy for left- or right-hand-ed users in your laboratory, because funnelscan be positioned to suit the individual user.

•

Glass filter holder, 30 mlFor particle counting and hybridization tests.

Stainless steel funnels, 40, 100, 500 mlFor colony or particle counting.

+

or

• Safe & reliable: Autoclavable; filter can be used for documentation

• Saves time: Easy to use• Saves money: Low consumable costs• Disposal: None, since filter holder is reusable

Ordering information Order no.30 ml capacity 16306

• Safe & reliable: Autoclavable; filter can be used for documentation; individual serial number

• Saves time: Sanitizable by flaming, easy to use• Saves money: Low consumable costs• Disposal: None, since funnels are reusable


100 ml capacity 6981065500 ml capacity 6981002

16840

Stainless steel manifolds, 3- and 6-branch.Made of high-grade stainless steel (B.S. 304S31|AISI 304); accommodates any type of vacuum

funnel. Stainless steel three-way valves (taps) allow the vacuum foreach filter holder to be individually controlled and each holder to besterilely vented. The low height of the manifold ports is particularlyadvantageous for working on a clean bench.

16836

Specifications

Dimensions (L|H|D) 3-branch manifold: 435|103|120 6-branch manifold: 910|103|120

Max. operating pressure Vacuum or max. 2 bar (29 psi) pressure

Inlets TR 20 + 2 female threads

+

+

16837

Outlet Hose nipple, DN 10

Sterilization By autoclaving (134°C max.) By dry heat (180°C max.)

Minisart SRP25 Order no. 17575-ACK, 0.2 µm, sterile filter for venting 50 units,individually sterile packaged, canbe autoclaved 5 times.

Ordering information Order no.

3-branch manifold 16842

6-branch manifold 16843

Polycarbonate filter holder, 250 mlFor colony and particle counting.

Glass filter holder, 250 mlFor colony and particle counting.

• Safe & reliable: Autoclavable; filter can be used for documentation

• Saves money: Low purchase price and cost of investment and consumables

• Disposal: None, since filter holder is reusable


• Safe & reliable: Autoclavable, filter can be used for documentation

• Saves time: Easy to use• Saves money: Low consumable costs• Disposal: None, since filter holder is reusable


or or

+ +

16840

16840

16414

5000 ml

BioSart®‚ 100 Monitors, 100 mlFor colony counting.

16835

• Safe & reliable: Individually packaged, sterile, validated, certified. Membrane filters: Meet ISO 7740; available invarious colors; can be used for documentation; without any hydrophobic adhesive areas

• Saves time: Ready to use; practical design that is easy touse; magnifying glass on the lid; ensures high flow rates,high throughputs; no preparation time necessary

• Saves money: No additional equipment needed• Disposal: Easy; can be melted down by autoclaving

Ordering information Order no.0.2 µm, white|black, 47 mm 16401-47-07-ACK0.45 µm, white|black, 47 mm 16401-47-06-ACK0.45 µm, green|dark green, 47 mm 16402-47-06-ACK0.45 µm, grey|white, 47 mm 16403-47-06-ACK

BioSart®‚ 250 Funnel, 250 mlFor colony and particle counting.

• Safe & reliable: Sterile, certified, filter can be used as documentation, can be autoclaved to a limited extent

• Saves time: Ready to use; practical design that is easy to use; ensures high flow rates, high throughputs; nopreparation time necessary

• Saves money: No additional equipment needed

Ordering information Order no.250 ml capacity, 50 units 16407-25-ALK250 ml capacity, 50 units 16407-25-ACK

or

+ +

or

Stainless steel funnels, 40, 100, 500 mlFor colony and particle counting.

Stainless steel funnel

Specially designed for use inmicrobiological quality assur-ance, these three filter holdersmade of high-grade stainlesssteel differ only in their capacity.

Their special locking clamp simplifies posi-tioning and removal of the membrane filter,ensuring secure lock-down. For traceability,each funnel has an individual serial number.

Lids and gaskets

To avoid secondary contamina-tion, the lid has a small centralair port into which a cottonplug can be inserted.

Single base 16840

For adapting a stainless steelfunnel for use on the manifold.The stainless steel frit used asthe filter support is designed toensure uniform distribution of

microorganisms and particles on the mem-brane filter surface. The pins on both sides ofthe base for holding the funnel clamp can bepositioned as required.

Specifications

Material Stainless steel, AISI 304 (B.S. 304S31) Capacity 40 ml, 100 ml or 500 mlFilter diameter 47 mm (or 50 mm)Filtration area 12.5 cm2

Max. operating pressure Vacuum onlySanitization By flamingSterilization By autoclaving (134°C max.)

By dry heat (180°C max.)

Order numbers Description

6981004 Stainless steel funnel capacity 40 ml6981065 Stainless steel funnel capacity 100 ml6981002 Stainless steel funnel capacity 500 ml


6981063 AISI 304 stainless steel lid for 100 ml funnel 6981064 Silicone lid seal (77.2 + 85.8 mm) for 100 ml funnel6981001 AISI 304 stainless steel lid for 500 ml funnel 6981003 Silicone lid seal (122 + 131 mm) for 500 ml funnel

Specifications

Materials AISI 304 stainless steel Gasket: Silicone flat gasket (41 + 50 + 1 mm)

Filter diameter 47 mm (or 50 mm)Filtration area 12.5 cm2

Max. operating pressure Vacuum onlySanitization By flamingSterilization By autoclaving (134°C max.) |By dry heat (180°C max.)Outlet TR 20 + 2 mm male thread with DN 24 (~ 24 mm)

hexagonal nut


16840 Single base for stainless steel manifold6980103 Stainless steel frit for 47 mm d membrane filters

Glass filter holders, 30, 250 mlFor colony and particle counting and for hybridization tests.

Glass filter holders

Two compact vacuum filter holders for easyparticulate analysis and colony counting (30 ml holder also suitable for hybridizationtests). Both the top and bottom part of thefilter holders are easily and securely fastenedtogether using the metal clamp. The center-ing rim on the filter support ensures correctpositioning of the membrane filter. The glassfrit filter support guarantees uniform distri-bution of retained microorganisms and parti-cles on the filter surface.

Adapter, 16836Adapter, 16837

For use of a glass filter holder, 16306 or16307, on a CombiSart stainless steel manifold.

Specifications

Materials Funnel and base Borosilicate glass, 3.3 Clamp Anodized aluminumFilter support PTFE|Borosilicate glass, 3.3Lid Silicone

(250 ml filter holder only) Gasket Silicone O-ring,

25 + 3 mm (30 ml filter holder) 45x + 3 mm (250 ml filter holder)

Max. operating pressure Vacuum onlySterilization By autoclaving (134°C max.)

By dry heat (180°C max.)

Order number Description

16306 Glass filter holder 30 mlFilter diameter 25 mm (or 24 mm)

Prefilter, 20 mmFiltration area 3 cm2

Capacity 30 mlOutlet 12 mm outer diameter


16307 Glass filter holder 250 mlFilter diameter 47 mm (or 50 mm)

Prefilter, 40 mm Filtration area 12.5 cm2

Capacity 250 mlOutlet 15 mm outer diameter

Specifications

Materials Base AISI 304 stainless steelStopper Silicone


By dry heat (180°C max.)Outlet TR 20 + 2 mm male thread


16836 Adapter with 11 mm opening in stopper; for using filterholder 16306 on a CombiSart manifold

16837 Adapter with 14 mm opening in stopper; for using filterholder 16307 on a CombiSart manifold

Polycarbonate filter holdersFor colony and particle counting.

Polycarbonate filter holder, 250 ml

This reusable, practical filterholder made of autoclavableplastic is ideal for microbiologi-cal and analytical testing outside the laboratory.

BioSart® 100 Monitors

BioSart 100 Monitors have been specially designed formicrobiological testing ofpharmaceuticals, cosmetics, water and other liquids. These

sterile disposables with an incorporatedmembrane filter and cellulose pad are readyto use. After filtration, just remove the 100ml funnel to convert the Monitor into a petridish. Culture media for wetting the pad areavailable in individually sterilized, convenientplastic ampoules. Each box contains 50 ampoules, each with 2.5 ml and a lot certificate. If stored underthe proper conditions (+4°C), the culturemedia have a shelf life of one year (except for Endo, which has a 9-month shelf life). Formore information, see the chart on page 13.

Specifications

Materials Housing PolycarbonateFilter support PolypropyleneGaskets Silicone O-rings, 40 + 5 mm;

80 + 3 mm; 14 + 2 mmCapacity 250 mlFilter diameter 47 mm, prefilter 37 mmFiltration area 11.5 cm2

Max. operating pressure Vacuum or 2 bar (29 psi) pressure max.Sterilization By autoclaving (121°C max.)Outlet TR 20 + 2 mm male thread


16511 Polycarbonate filter holder, 250 ml

Specifications

Materials Housing PolystyreneMembrane filter Cellulose nitrate; choice

of white or grey, with grid; can be used as documentation

Pad Cellulose Plug|adapter Polyethylene

Capacity 100 ml, 10 ml graduations

Pore size 0.2 µm or 0.45 µmFilter diameter 47 mmFiltration area 14.5 cm2

Max. operating pressure Vacuum only Sterilization Gamma irradiation Outlet 6.5 + 1.5 mmLot certificates Recovery rate, sterility and specificationsQuantity per package 50 units, individually sterilized

Order numbers Pore size Filter color|grid dd Qty.

16401-47-07-ACK 0.2 µm white|black 47 mm 48 units16401-47-06-ACK 0.45 µm white|black 47 mm 48 units16402-47-06-ACK 0.45 µm green|dark green 47 mm 48 units16403-47-06-ACK 0.45 µm grey1)|white 47 mm 48 units

1) grey filters turn black when wet

100

80

Ready-to-use BioSart® 100 MonitorsFor colony counting.

BioSart® 100 Culture Media

For Detection of Applications Type of Culture Monitor Type Incubation ResultsRegulations* Media Conditions

Total colony count Pharmaceuticals and Caso (pH 7,3) White |0.2 µm 24–72 h at Predominantly bacteria acc. to PhEu 4, USP 26 and cosmetics, raw materials 16401-47-07-ACK 30–37°C colonies of various sizes, APHA (water), TVO, water, waste water 16400-02-CA-K White |0.45 µm shapes and colourISO 9308-1 16401-47-06-ACK

Total colony count Water, waste water R2A (pH 7,2) White |0.2 µm 24–72 h at Predominantly bacteria acc. to APHA (water) and 16401-47-07-ACK 32–37°C colonies of various sizes, PhEu 4 16400-02-RA-K White |0.45 µm shapes and colour

16401-47-06-ACK

E. coli and coliforms Water, waste water, Endo (pH 7,2) White|0.2 µm 18–24 h at Red colonies; E. coli acc. to APHA (dairy) and raw materials, 16401-47-07-ACK 35–37°C and some coliforms have APHA (water), LMBG beverages, foods and 16400-02-EN-K White |0.45 µm a green metallic sheen

other products 16401-47-06-ACK

Pseudomonads, particulary Pharmaceuticals and Cetrimide White|0.2 µm 18–48 h at Pseudomonas aeruginosa Pseudomonas aeruginosa cosmetics, raw materials (pH 7,2) 16401-47-07-ACK 35–37°C usually forms blue acc. to PhEu 4, USP 26, water 16400-02-CE-K White |0.45 µm colonies with blue zones, APHA (water), DIN 38411, TVO 16401-47-06-ACK fluorescent

Yeasts and moulds Pharmaceuticals, Sabouraud Grey|0.45 µm 48–72 h at Yeasts develop smooth,acc. to PhEu 4, USP 26 cosmetics and raw (pH 5.6) 16403-47-06-ACK 20–30°C shiny white colonies;

materials 16400-02-SB-K moulds form fluffy, cotton-like white colonies

*) For a detailed list of reference literature, please refer to the last page

Which type for which application?

Adapters for BioSart® 100 Monitors

BioSart® 100 Monitor adapters

For adapting BioSart 100 monitors for use on the filtersupport of a CombiSart stainlesssteel manifold. The adapters ensure that the Monitors are

positioned perfectly level minimizing the riskof contamination during filtration.

Single base, 16840

For holding the BioSart 100adapter, 16414

Adapter, 16835

For adapting BioSart 100 Monitors for use on a Combi-Sart stainless steel manifold.This adapter is attached to thepolyethylene adapter – included

in the Monitor packaging – which is connect-ed to the outlet of the Monitor. The bottomthread of the 16835 adapter is then attacheddirectly to the manifold.

BioSart® 100 Monitor adapters

For adapting the BioSart 100Monitor for use on other vacuum filter holder supports.The adapters ensure that theMonitors are positioned

perfectly level minimizing the risk of conta-mination during filtration.

Specifications

Material Silicone Max. operating pressure Vacuum onlySterilization By autoclaving (134°C max.)


16414 Adapter for BioSart® 100 Monitors for use on single base, 16840 (or 16841)


16840 Stainless steel filter support for stainless steel manifold. See page 10 for specifications

Specifications

Materials Base AISI 304 stainless steelStopper Silicone


By dry heat (180°C max.)Outlet TR 20 + 2 male thread


16835 Adapter with 10 mm opening in stopper; for using BioSart 100 Monitors on a CombiSart manifold

Specifications

Materials Silicone (16410), polypropylene (16411)Max. operating pressure Vacuum onlySterilization By autoclaving (134°C max.)


16415 Adapter, for using the BioSart 100 Monitors on a vacuum filter holder support with a 50 mm d (S&S)

16416 Adapter, for using the BioSart 100 Monitors on avacuum filter holder support with a 59 mm d (MP)

Ready-to-use BioSart® 250 Funnels For colony and particle counting.

BioSart® 250 Funnel

The BioSart 250 Funnel has been specially designed formicrobiological and analyticalquality assurance in industry. The sterile 250 ml plastic funnel

guarantees fast filtration and high samplethroughputs during routine testing. Its largeinner diameter allows high flow rates, and thetapered inner walls permit thorough flushing of the funnel, after filtration.

Single support, 16840

For adapting a BioSart 250 Funnel for use on a CombiSartstainless steel manifold.

Gridded membrane filters

Sartorius cellulose nitrate mem-brane filters are offered in achoice of three different colorsto suit your specific test appli-

cation, and provide a high-contrast back-ground. For simple evaluation of the results,the grid divides the filtration area into 130squares, each measuring 3.1 x 3.1 mm. Themembrane filters are individually packagedand sterilized, and undergo stringent qualityassurance testing. The certificate included inevery package documents the quality assur-ance tests as well as the compliance of the0.45 µm membrane filter with ISO 7704.

Specifications

Material PolypropyleneCapacity 250 ml, 50 ml graduationsFilter diameter 47 mm (or 50 mm), prefilter 40 mmFiltration area 12.5 cm2

Max. operating pressure Vacuum onlySterilization Ethylene oxideLot certificates Sterility and Performance Tests


16407-25-ALK BioSart 250 Funnel, 50 units, sterile-packaged

16407-25-ACK BioSart 250 Funnel, 50 units, individually sterile-packaged


16840 Stainless steel filter support for stainless steel manifoldSee page 10 for specifications

Ordering diagram

Filter color| 114 White|black Grid 130 Grey|white

131 White|black and hydrophobic edge

138 Green|dark green

Pore size 07 0.2 µm06 0.45 µm05 0.65 µm04 0.8 µm03 1.2 µm

Diameter in mm

Packaging ACN 100 filters, individually sterile wrappedACR 1,000 filters, individually sterile wrappedSCM 3x100 filtersIndividually sterile wrapped for filter dispensers

114 06 047 ACN

Gridded membrane filters

Each nutrient pad is individually “plated” in a petri dish and sterilized. Just moisten thenutrient pad with 3.5 ml of sterile, deionizedwater to reactivate the medium. Dependingon the type, nutrient pads have a shelf life ofup to 24 months. All Nutrient Pad Sets areconveniently supplied with the appropriatemembrane filters, which are also individuallypackaged and sterilized.

These products undergo traceable qualityassurance tests on the basis of which a lot certificate is issued and included in everypackage.

Nutrient Pad Sets (NPS)For colony counting.

Microorganisms require the appropriate culture media for optimal reproduction.Ready-to-use Nutrient Pad Sets consist of a pad with culture medium in a petri dish anda gridded membrane filter. Made of inert cellulose, the nutrient pad is already impreg-nated with a culture medium of a specificformula and dehydrated.

For Detection of Applications Media Type Incubation ResultsRegulations* Conditions

Total colony count Pharmaceuticals and cosmetics, Caso (pH 7.3) 24–72 h Predominantly bacteriaacc. to PhEu 4, USP 26 and raw materials, water, waste water 14063-47-N at 30–37°C of different shapes and colorAPHA (water), ISO 9308-1 (2000)

Total colony count Water, waste water, water R2A (pH 7.2) 48–72 h at 35°C Colonies of different shapes and color.acc. to APHA (water) and PhEu 4 for pharmaceutical purposes 14084-47-N 5–7 days at 22°C Predominantly bacteria

Total colony count Water, waste water Yeast extract 44 ± 4 h Predominantly bacteriaacc. to TVO and ISO 6222 (pH 7.2) at 36° ± 2°C and of different shapes and color,

14090-47-N 68 ± 4 h most colorlessat 22° ± 2 h

E. coli and coliforms Pharmaceuticals and cosmetics, Endo (pH 7.4) 24 h Red colonies; E. coli usually has acc. to APHA (water), raw materials, water, 14053-47-N at 37°C a typical metallic sheen; by contrast, ISO 9308-1 (1990) waste water 14003-47-N coliforms lack a metallic sheen

E.coli and coliforms Water, waste water, Chromocult 24 h E.coli dark blue to violett colonies, raw materials, food, beverage (pH 6.8) at 35-37°C coliforms red to salmone coloniesand other products 14087-47-N

Escherichia coli acc. to Pharmaceuticals and cosmetics, ECD (pH 7.0) 18–24 h at E. coli colonies fluoresce under UV light APHA (water), ISO 9308-1 (2000) raw materials, water, waste water 14082 at 37°C at 360 nm

E.coli and coliforms acc. to Pharmaceuticals and cosmetics, MFC (pH 7.4) 18–24 h Lactose-positive microorganisms develop ISO 9308-1 (1990), APHA (water) raw materials, water, waste water 14068-47-N at 37°C (44°C blue colonies with a blue zone; lactose-

in a water bath) negative colonies are red or colorless

E. coli and coliforms acc. to Pharmaceuticals and cosmetics, Teepol (pH 7.2) 18–24 h Lactose-positive colonies develop with ISO 9308-1 (1990), APHA (water) raw materials, water, waste water 14067-47-N 37°C a yellow zone

E. coli and coliforms and Pharmaceuticals and cosmetics, Tergitol TTC 20 ±4 h E. coli colonies are yellow with a yellow other bio-indicators of fecal raw materials, water, waste water (pH 8.0) at 37°C zone; coliforms have red colonies, contamination 14056-47-N some with a yellow zoneacc. to ISO 9308-1 (2000) 14006-47-N

Enterococci Water, waste water Azide (pH 7.2) up to 48 h Brownish-red colonies;acc. to APHA (water), ISO 7899-2 at 37°C diameter up to 1 mm

Enteric bacteria Pharmaceuticals and cosmetics, Mac Conkey 18–24 h Gram-negative enteric bacteria form acc. to PhEu 4, USP 26 raw materials, water, waste water (pH 7.1) at 37°C colonies of various colors

14097-47-N

Staphylococci, particularly Pharmaceuticals and cosmetics, Chapman 48 h Staphylococcus aureus developsStaphylococcus aureus raw materials (pH 7.4) at 37°C golden-yellow colonies; other acc. to USP 26 14074-47-N staphylococci form whitish colonies

Pseudomonads, particularly Pharmaceuticals, cosmetics, raw Cetrimide 48 h at Pseudomonas aeruginosa usually Pseudomonas aeruginosa, raw materials, water, waste water (pH 7.2) 37°C develops blue colonies with a blue zoneacc. to PhEu 4, USP 26 and 14075-47-NAPHA (water), ISO 12780

Salmonella, particularly Pharmaceuticals and cosmetics, Bismuth-Sulfite up to 48 h Light-colored perimeter surrounding Salmonella thyphii, raw materials, water, waste water (pH 7.6) at 37°C a black center; zone plain black or acc. to USP 26 14057-47-N black with a metallic sheen

Yeasts and moulds Pharmaceuticals and cosmetics, Sabouraud 2–5 days Yeasts develop smooth, shiny white acc. to PhEu 4 and USP 26 raw materials, water, waste water (pH 5.4) at 25–30°C colonies; moulds form fluffy, cotton-like,

14069-47-N white colonies*For a detailed list of reference literature, please refer to the last page

Which type for which application?

CombiSart® individual systems

If you have a low number of samples to test,we recommend that you use our individualsystems. In this equipment set-up, you simplyuse a silicone stopper to fit your choice ofglass funnel (described on the previous pages)on a suction flask.

100

80

60

40

40100150200250

Stainless steel funnels40, 100, 500 ml

Glass filter holder30 ml

Glass filter holder250 ml

BioSart 100 HiQ,100 ml

BioSart 250 HiQ,250 ml

16510Polycarbonate filter holder,250 ml funnel andreceiver flask

17004 17005 17006 17004 17004

17173 17174 17175 17173 17173

16841

16409

1684116841

16673Hand vacuum pump with gaugeand 60 cm plastic tubing, PVC

2| Suction flask, 1 liter not acc. DIN 12476 (not available in Germany)

2| Suction flask, 2 liters with plastic hose nipple16672

To use all other types funnels with a suctionflask, Sartorius has specially developped thesingle base, 16841. The stainless steel frit andsilicone gasket are supplied with the singlebase filter.

1| Rubbervacuumhose16623

8| Prefilter attachment16807

6| Stainless steel foreceps16625

9| Container for anerobicincubation16671

7| Colony counter17649

4| Vacuum pump16612

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10| SMART® Filter Dispenser16711

Description Qty. Order numbers

1| Rubber vacuum hose for connecting system components 1 m 16623

2| Suction flasks, for collecting the filtrate, vacuum-resistant borosilicate glass, 3.3Suction flask, 5 liters, to DIN 12476, incl. stopper and glass tube 1 16672-1Suction flask, 2 liters, to DIN 12476, without stopper 1 16672Stopper for 2-liter suction flask 1 17173Tube connector for connecting a CombiSart stainless steel manifold 1 17204Suction flask, 1 liter (not available in Germany) 1 16606

3| Water traps, for preventing overflow of filtrate into a vacuum pump Vacusart, ready-to-connect filtration unit with a water-repellent, but air-permeable PTFE membrane 3 17804-MWoulff’s bottle, 500 ml, with stop cock 1 16610

4| Vacuum pumps, neoprene membrane pumps with low noise level,oil- and maintenance-free; reliable sources of vacuumMultiple filtration runs: 13 mbar final vacuum, 26 l/min max., 220 V, 50 Hz 1 16612Multiple filtration runs: 13 mbar final vacuum, 26 l/min max., 110 V, 60 Hz 1 16615Individual filtration run: 100 mbar final vacuum, 20 l/min max., 220 V, 50 Hz 1 16692Individual filtration run: 100 mbar final vacuum, 20 l/min max., 110V, 60 Hz 1 16695Water jet pump, with G 3/4 male thread 1 16611

5| Incubator, temperature range 20–50°C, 15 l capacity; 1 18113designed to hold the following numbers and sizes of petri dishes: 200 + 47 mm, or 160 + 56 mm or 72 + 90 mm.Dimensions (W|H|D) 340|270|431 mm

6| Stainless steel forceps with blunt-edged tips forprotection of the membrane filter, can be flamed and autoclaved 1 16625

7| Colony counter, handy, battery-operated 1 17649

8| Stainless steel prefilter attachment for removal of coarse particulate substances from samples in a single step along with bacteria-retentive filtration for subsequent bacteriological testing; clips between the filter support, 16840, and a stainless steel funnel (p. 10) or the BioSart 250 HiQ Funnel (p. 15); autoclavable and can be flamed 1 16807Bacteriological prefilters for the 16807 prefilter attachment, cellulose nitrate, pore size 8 µm, sterile and individually packed, diameter 50 mm 100 12301-050-ACN

9| Container for anaerobic incubation, stainless steel, for holding up to 14 + 60 mm or 6 + 90 mm petri dishes; DN 6 (approx. 6 mm) hose nipple on the inlet and outlet, with two taps and a vacuum gauge 1 16671

10| SMART Filter Dispenser, filter-dispensing system made of stainless steel and aluminum; weight 2.6 kg, for removing sterile-packed filters from a roll 1 16711

Accessories

5| Incubator18113

3| Water trap17804M

Sampling of airborne microorganisms and viruses.Together with Gelatin Membrane Filters, theMD8 airscan Air Sampling System is ideal fordetection of airborne microorganisms andviruses in conventionally ventilated rooms, inclean rooms with or without laminar flow,air-conditioning systems and in isolators. The MD8 airscan delivers precise and validat-able results.

The advantages of the MD8 airscan usedtogether with the Gelatin Membrane Filtermethod are as follows:• “Absolute”, reliable recovery rate and

detection of microorganisms • The filter maintains the viability of collected

microorganisms for a relevant and meaningful sampling time.

• One colony-forming unit can be detected inone m3 of air

• Isokinetic sampling under laminar-flowconditions is possible

• The MD8 airscan can be calibrated andadjusted using a special calibration unit(validation is possible)

• Suitable for use in class A|B cleanrooms andisolators because the MD8 airscan can bepositioned outside the critical work area.

Filter dispenser SMART®.The Smart Dispenser System putsan end to time-consumingunpacking of individual sterilefilters. Each turn of the knobreleases a new, sterile filter.

Order no.16711

The membrane filters included in a separate package with ourNPS are also available in adispenser pack, e.g., Standard.

Order no .14051-47 SDN14063-47 SDN14069-47 SDN14075-47 SDN

Additional product information

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Sterility testing.Pharmaceutical products, such as parenterals,ophthalmic preparations, veterinary andother products, that come in contact with theblood stream or otherwise enter the bodybelow the skin surface, must be sterile. Sterilization procedures and measuresdesigned to maintain sterility are therefore essential technological process steps. The manufacturer is responsible for demon-strating and verifying the safety and sterilityof these individual steps.

The current worldwide pharmacopoeias suchas the PhEu 4, USP 26, JP XIII and requireproof of the sterility of pharmaceuticals as acondition for the release of a production lot.

Sterility testing using the membrane filtra-tion method has two positive advantages overthe direct method of incubation:• It allows growth inhibitors to be flushed out• Low CFU counts can be detected in large

sample volumes

The membrane filtration technique is themethod of choice and should always be usedunless the sample to be tested cannot be rendered filterable.

For more information on sterility testing,please contact your local Sartorius office orrepresentative.

Reference Literature

APHA (water) American Public Health Association, American Water Works Association (AWWA) and Water Environment Federation (WEF): Standard Methods for the Examination of Water and Wastewater, 20th Edition, Washington, 1998.

DIN 12476 Deutsches Institut für Normung e.V. (= German Institute forStandardization)*, Laborgeräte aus Glas, Saugflaschen konischeForm, Juni 1983 (Laboratory glassware, filter flasks, conical shape,June 1983).

EU-GMP-Guideline Revision of the Annex I to the EU Guide to Good ManufacturingPractice. Annex on the Manufacture of Sterile Medicinal Products(1997).

PhEu 4 European Pharmacopoeia 4, Chapter VIII. 3. and 10.

ISO 7704 International Organization for Standardization, Water Quality,Evaluation of MembraneFilters Used for Microbiological Analysis, March 1985.

ISO 9308-1 International Organization for Standardization, Water Quality,Detection and Enumeration of Coliform Organisms, thermotole-rant coliform organisms and presumptive E.coli, Part 1: Membrane Filtration Method, October 1998.

JP XIII Japanese Pharmacopoeia XIII.

JP Forum JP Forum Vol. 6 No. 3 (1997).

TVO Verordnung über Trinkwasser und über Wasser für Lebensmittelbetriebe (German Drinking Water Regulations andon Water for the Food-Processing Industry), 2003.

USP 26 United States Pharmacopoeia, 26th Edition, Chapter 61 “Microbial Limit Test.”

ISO 6222 International Organisation for Standardization, water quality,Enumeration of culturable micro-organisms, 1999.

*) DIN standards and the “Amtliche Sammlung von Untersuchungsverfahren nach § 35 LMBG” (Official Compendium of Testing Procedures According to Section 35 of the German Law on Foodstuffs and Articlesof Daily Use) are available through the German publisher Beuth-Verlag, Burggrafenstr. 6, 10787 Berlin, Germany.

Note: All product names with the syllable “sart” are either registered brand names or trade marks of SartoriusAG, Goettingen or for which an application for registration has already been submitted. CombiSart is a brand name of Sartorius AG, Goettingen, Germany, and has been submitted for registration as a trade name.

Sartorius AGWeender Landstrasse 94–10837075 Goettingen, Germany

Phone +49.551.308.0 Fax +49.551.308.3289

www.sartorius.com

Sartorius Corporation131 Heartland Boulevard, Edgewood, New York 11717, USA

Phone +1.631.2544249Fax +1.631.2544253Toll-Free +1.800.3687178

Sartorius LimitedLongmead Business Centre Blenheim Road, Epsom, Surrey KT199QN, Great Britain

Phone +44.1372.737100Fax +44.1372.729972

Sartorius S.A.4, rue Emile Baudot91127 Palaiseau, France

Phone +33.1.69192100 Fax +33.1.69200922

Sartorius S.p.AVia dell’Antella, 76/A50011 Antella (FI), Italy

Phone +39.055.634041Fax +39.055.6340526

Sartorius K.K.No. 3 Hoya Building 8–17Kamitakaido 1-chome Suginami-ku Tokyo 168-0074, Japan

Phone +81.3.33295533Fax +81.3.33295543

Sartorius S.A.C/Isabel Colbrand 10-12Edificio Alfa IIIplanta 4, of. 12128050 Madrid, Spain

Phone +34.91.3586100Fax +34.91.3588804

Specifications subject to change without notice. Printed in Germany on paper that has been bleached without any use of chlorine.W/sart-142 · GPublication No.: SL-3017-e03074Order No.: 85030-511-36

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