cryo bio system - catalog

The value of a biological sampleresides in the combination ofquality, safety and traceability.Preservation of initial qualities,safe storage conditions (both forthe sample and its environment)and link with information throughtamper proof identification,define the value of a sample forscientific and / or medical use.

Cryo Bio System’s concept forcryopreservation and bioreposi-tories complies with the highestquality standards.It ensures the quality of storageand identification for traceabilityof the sample.The concept is compatible withall nitrogen freezers, both liquidand vapor, as well as mecha-nical -80°C and -130°C freezers. Itallows for more aliquots to bestored per freezer than in cryo-genic vials, boxes and metalracks.

Our parent company IMVTechnologies has manufacturedfor over 40 years instrumentationand consumables for animalreproduction. Twenty years ago,our founder envisioned makingthe company’s expertise incryopreservation available toscientists in all fields requiringpreservation and survival of livingorganisms. The specific demandsof life science combined with thecryopreservation experienceresulted in the CBSTM High Securitystraw storage concept.

In our premises in France - inL’Aigle – Normandy - manufactu-ring takes place in controlled airrooms. The quality managementsystem includes rigorous selec-tion of raw materials, tests at dif-ferent stages of production, steri-lity tests for gamma-radiatedproducts, endotoxin and mouseembryo testing for medicaldevices. Our equipment is speci-fically designed for CBSTM

High Security straws. Our networkof field technicians ensures instal-lation and maintenance serviceworldwide.

Cryo Bio System is ISO 13485 cer-tified for the development andmanufacturing of Medicaldevices following the Directive93/42/CE.

2

Cryo Bio System Biorepository Concept: High Security Storage

Cryopreservation with the highest standards for Quality, Safety, Traceabilityand Storage Space Efficiency.

Production site in L’Aigle, Normandy - France

3Edition 6/2008

510(k) Premarket Notification Database

Device Classification Name accessory, assisted reproduction

510(k) Number K002595

Regulation Number 21 CFR §884.6120

Device Name CBS STRAWCRYO BIO SYSTEM

Regulatory Class II

Classification Product Code MQG

Date Received 08/21/2000

Decision Date 11/17/2000

Decision substantially equivalent (SE)

Classification Advisory Committee Obstetrics/Gynecology

Review Advisory Committee Obstetrics/Gynecology

Statement/Summary/Purged Status Statement only

statement statement

Material

All Cryo Bio System straws aremade from a ionomeric resinthat is chemically inert, biocom-patible and has physical charac-teristics resistant to ultra lowtemperatures and pressurescreated by expanding liquidsand liquid nitrogen. Sealedstraws are resistance tested to150 kg/cm2 (2133 lb/sq.inch),both the seals and the materialshould resist in order to have thebatch approved.

Plugs

Straws are filled by aspirationthrough an air permeable pluginside the straw. Two types ofplugs are available:

- The factory plug made of twospecifically woven polyamidefibers enclosing a polymerizingpowder. In the filling procedurethe powder polymerizes assoon as the liquid samplecomes in contact and blocksthe filling. Plugs can come in 6different colors, for easy identi-fication in the cold environ-ment of a freezer.

- The hydrophobic plug made ofa 0.22 µm membraneattached to a hollow stem. Thismembrane allows air to passthrough it but neither liquid norbacteria.

Seal

Directly after filling, both extremi-ties of the CBSTM High Securitystraw are thermally sealed withone of our specific machines:SYMS, PACE or MAPI. This makesthe straw absolutely leakproof,preventing contamination of thesample and its environment.

Tamper proof identification

The primary identification of thestraw in the cold environment ofthe freezer is by its color, while itsdefinitive identification is by itsalpha-numerical and bar code.The CBSTM High Security straw isidentified by tamper proof ink-jetprint on a jacket around thestraw. The special ink is resistantto liquid nitrogen and to ice crys-tals as well as plastic materials.Once the straw is sealed, thejacket cannot be removed fromthe straw unless it is opened.

A second process of identifica-tion is available for 0.3 ml strawswhere a colored identificationrod with a label can be insertedinside the straw in the compart-ment behind the plug. This labelcan only be taken from the sam-ple when the straw is opened.

4

Where there is no compromise on QUALITY and SAFETY for storage of biological samples

Straw volume Plug type Color Compatibility with equipment0.5 ml weave plug MAPI, PACE, SYMS0.3 ml weave fixed insert MAPI, PACE, SYMS0.3 ml hydrophobic plug / insert SYMS0.5 ml hydrophobic plug SYMS

CBSTM High Security straws are available in 3 different volumes.

Storage

For storage, CBSTM High Securitystraws are placed in coloredcompartments called visotubeswhich are available in manycolors. These are further placedinto colored goblets. Colorcoding facilitates identificationof straws upon retrieval. A Daisygoblet can easily hold 144 straws(12 visotubes).

Applications

Virtually any liquid sample canbe stored in CBSTM High Securitystraws. Applications includeplasma, serum, buffy coat, redblood cells, extracted DNA,urine, mouth wash, cell suspen-sions, bacterial or viral strains,gametes and embryos.

Dimensions

• 0.3 ml and 0.5 ml strawsLength: 130 mm after sealingInternal diameter: 2.5 mm

Accessories

Filling nozzles for manual filling:0.3 and, 0.5 ml.Syringe connectors.Filling nozzles for MAPI and PACEautomated filling.

FDA 510 (k) ClearanceMEA and LAL tested

5Edition 6/2008

Color coded goblets for storageof CBSTM High Security straws.

CBSTM High Security straws areplaced in goblets for storage infreezers. Goblets come in8 different colors and theirsub-compartments (called viso-tubes) in 12 different colors.

In the Daisy configuration,goblets hold 12 visotubes ofdifferent colors and can easilyhold 144 straws of 0.3 ml or 0.5 ml.

The color configuration of eachgoblet can be customized to thestorage protocol. Colorbecomes an integrated part ofthe sample identification when itis associated with a sample type,protocol and / or storage level.Material and colors are fullycompatible and resistant to longterm storage at very low temper-atures, including immersion intoliquid nitrogen.

Goblets and lids are perforatedin order to facilitate the flow ofliquid nitrogen or nitrogen vaporinto the goblet and around thestraws. For storage in liquid nitro-gen, the visotubes have notbeen perforated at their base soas to maintain the liquid nitrogenaround the straws even if thegoblet is temporarily extractedfrom the freezer. The goblet andvisotubes maintain the sample ata stable low temperature until itsdecided thawing and use.

The colored plug ends of thestraws are visible in all peripheralvisotubes and in the clear centralround visotube. The centralhigher visotube protects thestraws under the lid when gobletsare stacked during storage.

6

ItemSpecifications

HexagonalVisotube133 mm

RoundVisotubeø 13 mm

Gobletø 35 mm133 mm

RoundVisotube

ø 17.5 mm

TriangularVisotube120 mm

Goblet withpre-attached

cover

Cover forGoblet

ø 65 mm

DaisyGoblet*

(bag of 1)120 mm

DaisyGoblet*

(bag of 5)120 mm

COLORS

ClearBlackBrownRed

GreenBlueGrey

PurpleYellow

PinkOrangePistachio

020486--

020491020488020487

--

020489-

020490-

020517--

020522020519020518

--

020520-

020521-

020523-----------

006924-----------

-018153018147018146018145018148018144018152018143018149018150018151

021224--

021228021226021225

-021229021227

---

006321-----------

015144--

015146015147015151018141015150015148

--

015149

015152--

015154015155015159018142015158015156

--

015157Packaging 10 10 10 100 100 10 50 1 5

CAPACITY

0.3 & 0.5 mlCBSTM straw 22 8 65 12 12 - - 144 144

*Complete goblet containing 11 triangular visotubes and 1 central round visotube, all of different colors and a lid.

Compatible with all types ofliquid nitrogen and vaporfreezers but also low-tempera-ture mechanical freezers, CryoBio System canisters are thesleeves that hold the goblets.

Five lengths of canisters areavailable, with a capacity of2 to 6 goblets stored on top ofeach other. A colored flag canbe placed on the lifter tofacilitate retrieval.

Canisters are placed in thenitrogen freezer before filling thecontainer with liquid nitrogen.Goblets are introduced andretrieved one by one with themetal lifter; all manipulation ofgoblets is in the cold environ-ment of the neck of the nitrogenfreezer to ensure the stable lowtemperature of the samples.

Flags for lifters are available in9 different colors:White 007328Yellow 015693Salmon-pink 015694Pink 015695Green 015696

Turquoise 015697Orange 015698Purple 015699Grey 015706

7Edition 6/2008

References Levels ofgoblets

DimensionH x Ø (mm)

Dimensionwith gobletsH x Ø (mm)

Canisterswithlifters

008644 2 245 x 70 280 x 70

008645 3 380 x 70 415 x 70

008646 4 515 x 70 550 x 70

007198 5 650 x 70 685 x 70

007199 6 785 x 70 820 x 70

Lifters

H x W (mm)

014762 5 lifter 725 x 65

016096 6 lifter 845 x 65

System for filling and sealingof CBSTM High Security straws

Automation for the packagingin straws of liquid biologicalsamples.

PACE automatically fills andthermally seals a user definednumber of straws from a primarysample tube. Both 0.3 ml and 0.5ml CBSTM straws with weave plugcan be used with PACE, eitherpre-identified or just before IDprinting with SIDE (see page 10).Sample is filled into the straw witha disposable filling nozzle(ref 014623) at the open end andan aspiration nozzle (ref 014621)at the plug end of the straw.

Tamper proof ink-jet printedstraws packaged in sets of study-specific color combinations areavailable on request from CryoBio System. Filled blank strawscan also be printed in the labo-ratory with a SIDE system.

PACE is the packaging system forlaboratories with large aliquotingand storage programs, with fixedor variable numbers of straws.The hopper is designed for distri-bution until the very last straw,enabling to load the exactnumber for each color.

The PACE consists of the strawhandling system and its controlbox. The small footprint of thestraw handling system can beplaced under a laminar flowhood for use in sterile conditions.

Output is dependent on studyprotocol, more specifically onthe number of straws per primarytube.

Technical specifications

Setup, maintenance and shut-down time are approximately15 minutes per day.Potentially contaminated partsof the system can be cleanedwith ethanol or non-corrosivedecontamination fluids.

Dimensions

• Straw handler380 x 300 x 370 mm (L x W x H)Weight: 25 kg (55 lb)

• Control box410 x 365 x 155 mmWeight: 14 kg (31 lb)

Electrical requirements:220V/50 Hz or 110V/60 Hz

8

9Edition 6/2008

System for filling, sealing andidentification of CBSTM HighSecurity straws

Automation for the packaging instraws of liquid biological samplesincluding ink-jet identification.

Starting from an open primarysample tube, MAPI fills and ther-mally seals the programmednumber of straws and prints oneach of them an identificationcode. In-line barcode readingvalidates the identification oneach straw and the various stepsof the process are checkedon-line through several sensors.

MAPI is a flexible system that canhandle the different samplealiquoting protocols of a labora-tory, different identifications andvariable numbers of straws. Strawfeeding hoppers with differentcolors are easily interchangeable.

The MAPI consists of the strawhandling system, a control box, aspecial ink-jet printer and a PCwith the MAPI pilot software. Aspecial ergonomical laboratorybench for the unit completes thesystem.

MAPI is the aliquote packagingsystem for laboratories with largestudy projects where importantnumbers of samples are to bealiquoted in straws. Thanks to itsversatility it can be sharedresource or technical platformequipment. The in-line printingenables the perfect correspon-dence of primary tube andaliquot identification numbers.

The MAPI pilot software featuresbarcode reading or keyboardentry of codes to be printed, vali-dation of number of filled andprinted straws and export ofproduction files. MAPI can becombined with Cryo Bio Systemstorage management software.

MAPI is compatible with 0.3 mland 0.5 ml CBSTM straws withweave plugs and white jackets.Sample is filled into the straw witha disposable filling nozzle(ref 014623) at the open end andan aspiration nozzle (ref 014621)at the plug end of the straw.

Output is dependent on studyprotocol, more specifically onthe number of straws per primarytube.


Setup, maintenance and shut-down time are approximately15 minutes per day.Potentially contaminated partsof the system can be cleanedwith ethanol or non-corrosivedecontamination fluids.

Dimensions

• MAPI straw system760 x 260 x 470 mm (L x W x H)Weight: 35 kg (77 lb)

• Support bench1200 x 600 x 900 mmHeight with automate included:1260 mm

• Control box430 x 380 x 190 mmWeight: 14 kg (31 lb)

• Printer control box650 x 450 x 375 mmWeight: 16 kg (35 lb)

Flexible to printer head: 4 m


Sealer for all types ofCBSTM High Security straws

Simply introduce the straw end inthe guide and, with one push onthe button or foot pedal thethermal pulse seal closes thestraw absolutely airtight. Then theopposite end of the straw issealed, after introduction of anidentification rod and / or labelOR around the straw a jacketthat can be pre-identified orprinted on SIDE after sealing.The small footprint of the SYMSmakes it easy to place under alaminar flow hood for sterileworking conditions. The sealingarea can be taken apart andeasily decontaminated withethanol or other non corrosivedecontamination liquids.

SYMS is compatible with all CBSTM

High Security straws.

The SYMS sealer comescomplete with cables, footpedal and a maintenance kit.


Setup, mainte-nance and down-time time area p p r o x i m a t e l y5 minutes per day.Potentially con-taminated parts ofthe system can becleaned withethanol or non-corrosive deconta-mination fluids.

Dimensions

• Sealer230 x 220 x 170 mm (L x W x H)Weight: 6 kg (13 lb)


Straw Identification System

Tamper proof ink-jet printingidentification system for openand sealed CBSTM straws.

SIDE is a flexible identificationsystem enabling the laboratory to:- print exactly the number ofrequested straws for a sample- print exactly the same code onthe straws as the sample toensure the link- print straws after sealing toensure sterility of the content- link through data export thesample identifications withstorage management software.

SIDE is compatible with 0.3 ml,0.5 ml and 1 ml straws with whiteor colored jackets and can printalpha-numerical codes and/orbarcodes (Code128). Openstraws are distributed from ahopper and printed with a out-put of

60 straws/minute. Sealed strawscan be placed manually on thedistributor.SIDE pilot software features bar-code reading or keyboard entryof codes to be printed andexport of production files in diffe-rent formats.The SIDE system consists of thestraw handler, a PC with pilotsoftware and an ink-jet printingsystem.


Setup, mainte-nance and shut-down time area p p r o x i m a t e l y15 minutes perday.

Dimensions

• Straw handler450 x 500 x 190 mm (L x W x H)Weight: ≈ 20 kg (44 lb)

• Printer control box640 x 460 x 230 mmWeight: ≈ 30 kg (66 lb)

Flexible to printer head: 4 m


10

11Edition 6/2008

Straw 0.5 mlStraw 0.5 mlBar-codeBar-code SealingSealing

PlugPlug

CoverCover14 straws14 strawsmaximummaximumper visotubeper visotube

12 visotubes12 visotubesper gobletper goblet

From 2 to 6From 2 to 6gobletsgoblets

per canisterper canister

LNLN22 container or freezercontainer or freezer

For more information on our products, please visit our website:

Sales & Marketing:

Technical services & Order department:

For all enquiries, please contact us at:

Cryo Bio System has a worldwide network ofdistributors and subsidiaries in the United States of

America, Italy, India and China (representative office).

non relevant pictures

Edition 6/2008

Your local contact:

Cryo Bio System29 rue Tronchet75008 PARIS – FRANCE

Tel: + 33 (0)1 49 24 05 05Fax: + 33 (0)1 49 24 05 01

Cryo Bio System10 rue Clemenceau

61300 L’AIGLE – FRANCE

Tel: + 33 (0)2 33 34 64 64Fax: + 33 (0)2 33 34 11 98

cryo bio system - catalog

Documents