Description SILBIONE MM SERIES 71791購術 U are silicone rubbers which cure

after addition of a vul商為canising agent (chosen對事 as a function of術鐘 the

production process刀花).

This series inclu科信des four products which di習能ffer by their hardness

once cured : 40-50-60 and 70 Shore A.

Once processed SILBIONE MM 舞冷SERIES 71791 U , "Food術的 contact

and biomedical grade&qu算校ot; are intended f國村or:

· biomedical applications

· applications req山用uiring a material that is non-to花兵xic under normal

conditions of use and inert to 窗紙food products.

SILBIONE MM SERIES 71791 U 男男, are elastomers comprisi路弟ng

polymethylvinylsiloxane 低子gums and silica. They heat cure a術自fter

addition of an organic peroxide co計西mpound. This vulcanisation must

be followed by post curing at 200°廠生C.

Special properties子紙 · Easy processin公購g

· Highly transparent

· Excellent mechanical proper姐女ties, including h山章igh tear strength

and a good compromise between tear s金問trength and

compression set

· Very good resistance to oxidising年請 agents (oxygen,又農 ozone, UV)

· Very good behaviour 商畫for all sterilisat員得ion modes

· Very good release pro內商perties

· Chemically iner快如t

Regulations The compositio在地n of SILBIONE MM SERIES 71791 U enable短畫s them to

be used in conformity w算門ith the definitions in the fo短輛llowing European and

American regulations.

Food contact:

France : Journa說對l Officiel – Brochure 1227– orde明店r dated 25 November

1992.

Germany : BGVV XVA 體花and LIIA.

United States : : US- FDA- 鄉煙CFR 21- part 177. 2600.

Italy : Gazetta Uf懂作ficiale – law dated 197行行3 and addendum.

Moreover, samples of拍制 SILBIONE MM SERIES 7179劇門1 U, catalysed

with dichloro- 2, 4 benzoyle家的 peroxide, have been subj錢購ect to

migration tests in accordance wi你樂th European regulations: Dire門很ctives

82/ 711/ EEC and 93/ 8 EEC and American拍弟 regulations: US-時高 FDACFR

21- part 177. 2600.

Regulations Drinking water cont我飛act

SILBIONE MM SERIES 71791 U of ha快問rdnesses 50 and 60 ShA, ha你弟ve

been successfully 還制proven to be in conformity 雜工with German KTZ

regulation part錢商 1.3.13.

Medical devices.

Basic biological studies; cytot票站oxicity, irritation,做雪 sensitisation and

hemocompatibility, re紅樹quired by directive 93/42 CE dated J自就une 14

1993, relative to medical dev章學ices and USP Class VI of U暗銀S, have

been carried out on samples of S離歌ILBIONE MM SERIES 71791 U ,

catalysed using dichloro 2,4 benzoyle 歌說peroxide.

The summaries of the biological st通他udies are available 內訊on request.

In all cases it is the finishe生問d article manufacturer行空’s

responsibility to check conformity 錯資with the tests imposed by

the appropriate regulations笑司.

For medical applications, Rhodia Silico山她nes SAS forbids 北店the

commercialisation of t知身hese elastomers for the production of

medical devices:

· implanted for more than 29 days

· in contact for慢購 more than 29 days 請笑with blood and the

mucous membranes (contraception, o校機bstetrics)

· for plastic sur麗國gery

Applications SILBIONE MM SERIES 71791 月跳U , once catalysed件草 and processed is

recommended for the manufacture of th城如e following article慢是s:

Those which enter in窗小 contact with food such謝國 as :

· Tubes for drink dis話章tribution, including potable water

· Baby’s bottle tops

· Various techn歌話ical parts.

· Sections, sleeves, calendered sheets,日有 belts and conveyor belts事兵

Those used in pha讀科rmacy such as:

· Tubes and piping for the circula看對tion of liquid or soluble

medicines

· Medicine conveyor belts, etc.遠畫

Those used for medical applications suc光海h as:

· Tubes and piping for e做那xtra-corporal circulation

· Oxygenotherapy tubes

· Self-injectable sy醫歌ringe seals

· Breathing masks

Quality Assurance 1-了錢 Manufacture

Rhodia Silicones takes pa城黑rticular care in man短事ufacturing and quality

control in order to 愛國guarantee users with the 唱對supply of an elastomer

whose quality level is in conformi水高ty with the special requirements in

these types of application:

· lack of cross-pol資又lution.

· high level filtration.

· Specific controls.

All of these operations are part of 畫多Rhodia Silicones文人’ quality control

policy, certified to IS女西O 9001.

Quality Assurance 2- Control

Specific controls are carried out 從山on each batch of信坐 SILBIONE MM

SERIES 71791 U to mee錢上t the various regulations.

The results are written on the analytic老化al test certificate i吧物n addition to

the mechanical characte鐘紙ristics.

SPECIFICATION FOOD GRADE MEDICAL GRADE

ON POST CURED VULCANISED PRODUC低厭T

Identity : IR Spectrum 學看In Conformity m m

Volatile content 靜視(%):

(200°C-10g-4h)

0.5 maxi. m

Residual peroxides動雨 (%) 0.08 maxi. m

Mineral oils (fluorescenc煙腦e) In Conformity m

ON AQUEOUS EXTRACT

Turbidity (NTU) 4 maxi. m

Alkalinity (ml 0.01 M HCl) 1也微 maxi. m

Acidity (ml 0.01M NaOH) 1.5 maxi但銀. m

Reducing substanc場好es

(ml 0.01 M Na2 微上SO3)

1 maxi m

ON HEXANE EXTRA技事CT

Hexane soluble (%) 3 maxi m m

Phenyl compounds (DO/工雨UV) 0.4 maxi. m

Heavy metals (ppm) (動可other than

aqueous extract)

10 maxi m

Processing metho機小ds The choice of vul大妹canising agent (peroxide) to ad鄉門d to the SILBIONE

MM SERIES 71791 U depends on the proc長農essing method and the

conformity with various “Food conta對哥ct grade” regulations.

The various processing 內務methods are summarised in 習店the table

below:

SILBIONE

MM SERIES 71791 U

Dichloro- 2, 4 benzoyle

Peroxide at 50 %

(E)

Dicumyl Peroxide

at 95 %

(D)

2, 5 dimethyl-

2, 5- di (tertio- butyl長新peroxy)

hexane at 72 %

(L)

compression

Moulding injection

0.6 parts per 100

master batch

0.6 parts per 100

master batch

hot air vulcanisat站山ion 0.9 to 1.25 為業parts per 100

master batch

6 to

12 bar

0.6 parts per 100

Extrusion pressurised 去妹master batch

steam

vulcanisation

12 to

20 bar

0.6 parts per 100

master batch

Calandering hot air vulcanisation

0.9 to 1.25 parts per 100

master batch

Characteristics 1- Physical pr信照operties

Type (according to AFNOR T 40002).靜如...... ..........花學.......................MVQ

Hardness Specific gravity at 25 °土鄉 C, approx.

40 ShA 1.10

50 ShA 1.13

60 ShA 1.15

70 ShA 1.18

Characteristics Natural colour......很低................... .............國拍...........................Transparent了化

2- Mechanical properties

Below we give an example of t低師he characteristics obtained u開拍sing

dichloro- 2, 4 b低很enzoyle peroxide (at 50%) as a vulcani照務sing agent.

Measurements are made機煙 on a 2 mm thick moul志著ded sheet, cured for

8 min at 115°C and 村鄉post cured for 4 hours at 200°志河C.

SILBIONE MM SERIES 717會對91 U 71 791/40 U火看 71 791/50 U 71 79跳能1/60 U 71 791/70 U金國

Peroxide dose in parts per 100 of maste人麗r batch 0.9 1 1.25 1.25

ShA hardness , points, approx

(Standard ASTM D 2240)

43 53 62 72

Tensile strength, MPa,民站 approx,

(Standard AFNOR NF T 46- 002)

9.0 9.5 10 9.5

Elongation at break, %, approx,家日

(Standard AFNOR NF T 46- 002)

600 640 500 410

Tear strength, kN/m, approx,

(Standard ASTM D 624 A)

31 38 38 34

Compression set ( 22h/ 177°C/ 2工新5%), %, approx,

(Standard ASTM D 395 B)

27 34 40 40

Rebound resilience (thickness 朋廠8 mm), %, approx,

(Standard DIN 5可通3 512)

50 45 42 37

Linear shrinkage %, approx, 3.銀林5 3.7 3.7 4.0

SILBIONE MM SERIES 71791 U m拍大ust be post cured at如雪 200°C

after vulcanisa唱河tion (it is recommended他些 not to exceed t知體his

temperature).

Post curing is essential in order to 個票:

· Ensure conformity with the legisl輛動ation and regulations著為 currently

in force

· Stabilise the mechanical properti對快es of the elastome鐘為r as well as

its dimensions

· Ensure the heat stability of the很市 elastomer

· Improve its chemical resistan畫看ce, especially with respect to

solvents, fats and steam

Processing 1- Adding peroxid物哥e to SILBIONE MM SERIES 71791 U

This operation is pe下購rformed on a two-roll mi家可xing mill.

Operating procedure :

à Check that the e用問quipment is scrupulously c街窗lean in order to avoid

including impurities that would 知志detract from the quality and prope美在rties of

the SILBIONE MASTER區友 BATCH.

à Plasticise the S吃車ILBIONE MASTER BATCH.

Use of a back / front rolle鐘工r speed ratio of between 1.2老科5 and 1.4 ensures

sufficient friction to give good p視金lasticising.

à Add the peroxide,姐可 then mix by cutt店自ing and crossing.

à Cool the cylinde鄉公rs throughout the operation朋為 in order to maintain the

SILBIONE MASTER BATCH at a tem紙是perature below 30°C;

In the case of catalysis u腦人sing crystalised dicumyl 見快peroxide, after

dispersion it is recommended to 音樹heat the elastomer to 50°C to ensure電聽 the

fusion of the pero用但xide, then to cool to 30° once fully i亮說ncorporated.

2- Processing

SILBIONE MM SERIES 7179飛河1 U obtained in this way can be做冷

processed using all conventi動白onal methods in the rubber pr南拿ocessing

industry used for t坐喝raditional materials.

Processing In t地新his way, using SILBIONE MASTER BATCH 票我plasticised on a

two-roll mixing mill, we co費他uld:

à Either roll a sheet to the requi街南red thickness f子通rom which we will 藍會cut

preforms for moulding.

à or cut bands that will be use雪外d for example to feed a他少n injection press or

to prepare sheets for calendering.

3- Vulcanisation and post curing

Vulcanisation of 訊筆SILBIONE MM SERIES 71791 U i器長s carried out at

temperatures according to the type of理山 peroxide used.

Once cured we remin外身d you that SILBI睡遠ONE MM SERIES 71791 U

must be post cured at 200°藍鐘C in forced air ovens wit紙暗h protected

heating elements.

The post cure d看遠uration depends on the thickness of th草黃e parts

obtained (moulded, extr中科uded or calendered).

Post curing gives the elastomer its op藍廠timum characteristics and ensures

its conformity with 鐘她the requirements of the regulations人生 currently in force.

Important comments 鐘下:

Post curing at a tempe現車rature above 200°C or any accide用北ntal increase in

temperature (e.g. t知家o around 250-300°C) can damage part舊頻s causing

stiffening, crackin吃是g or formation of a surfac舊煙e glaze. It is therefore

important to use good temper科高ature control together w和笑ith forced air

ventilation.

Non-ventilated ovens請照 or those with insufficient vent鐘商ilation can cause

"reversion" to水木 occur : a reduction in hardness個森 due to the onset of

depolymerisation.

Important notice RHODIA S山電ILICONES SAS guarantee下器s the properties given fo河商r

SILBIONE MM SERI歌來ES 71791 U .

However, our company ca什個nnot guarantee the水飛 behaviour of this ma還村ster

batch and the app日媽lication that i草窗s made of it by the user農科, since it has no

control over the conditi白低ons of application nor the process u關器nder which a

study has been conducted.

Packaging SILBIONE MM SERIES 71姐不791 U are available in 25 kg r謝我einforced

cardboard cartons.窗開 Each master bat遠著ch is enclosed in a release

coated sheet.

Storage and

shelf life

SILBIONE MM SERIES 71791 U may be s道去tored in its original

unopened packaging at a te機空mperature below +40鐵關°C for up to 18

months from the date of man答上ufacture marked clearly on the

packaging.

Past this date, Rhodia Silico月微nes no longer guarantees t男習hat the

product meets t多愛he sales specifications.When kept上美 in its original

unopened packaging,

According to the hardness, 熱姐it is recommended to slightly refreshe綠什n

SILBIONE MM SERIES 7不視1791 U before using.

Comment : Prolonged storage beyond th呢姐e recommended expiry date

generally means務謝 a reduction in 男離hardness and an incr自黑ease in refreshening

time

Safety Please refer to t唱能he Safety Data Sheets for SILBIONE MM 習靜SERIES

71791 U .

Warning to users The information co雜文ntained in this document 是金is given in good faith

based on our current knowledge. It is討員 only an indicat水飛ion and is in no

way binding, partic報民ularly as regards in年關fringement of or p討森rejudice to

third party rights throu場報gh the use of our products.

RHODIA SILICONES GUARANTEES THAT 子議ITS PRODUCTS

COMPLY WITH ITS SALES SPECIFICATIONS錢放.

This information must on no accoun風對t be used as a substitute讀機 for

necessary prior tests which alone can 家玩ensure that a product is

suitable for a 好那given use.

Users are respo新為nsible for ensuring compliance with l慢計ocal legislation

and for obtainin山見g the necessary certifications a煙通nd authorisations.

Users are requested t年上o check that they are in pos姐線session of the

latest version of this d志從ocument and RHODIA SILICON山呢ES is at their

disposal to suppl行唱y any additional inf務老ormation.