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894444 / 09/11 www.wolf-corporate.de Фармацевтическая промышленность Гигиенические процессы Представительство общества „БюркертКонтроматик Гезелльшафт м.б.Х.“ Ленинский проспект, д. 113/1, офис Е-715 117198, Москва, Россия Тел.: +7 (495) 510 61 80 Факс: +7 (495) 510 61 81 www.burkert.com.ru Bürkert Contromatic GmbH Diefenbachgasse 1 -3 1150 Vienna, Austria Тел.: +43 (1) 894 13 33 Факс: +43 (1) 894 13 00 [email protected] www.buerkert.at

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Page 1: Фармацевтическая промышленностьprocess-control.net/assets/catalog/catalog burkert...894444 / 09/11 Фармацевтическая промышленность

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Bürkert | !"#$"%&'()*&+,"- .#/$012&33/+(412 13

0010 00183539 2 PCE

type 3233

paths/posit ions 2 2 WAYS / 2 POSITION

sw itched posit ion 0 2-WAY

orif ice size 15,0 15MM (9/16" )

seal material EA PTFE-SEAT-SEALING + EPDM

body material VS SS IN FORGED VERSION

port connection SA42 WELD ENDS - EXTERNAL PIPE DIAMETER 21,3 MM

CONNECTION ACC. ISO 4200

actuator D050 HANDWHEEL AND PPS COWL

HA24 BOLTING BY LOCK

HD09 ACCOUNTERMENTS-SUPPLIER B

NK52 WITH CERTIFICATION 3.1

NO14 INTERNAL MECHANICAL POLISHED RA 0,5 MICROMETER /

RA APPR. 20 MICROINCH (ASME BPE SF 1)

pressure range 0 - 10 bar

Customer Part Number 000000000000183539

* * * * * * * * * * * * * * * * * * * * ** TECHNICAL DATA: ** * * * * * * * * * * * * * * * * * * * *

Press min. (BAR) : 0Press max. (BAR) : 10KV-Value (M* 3/H) : 6,0Fluid temp. min. (Degree C) : -10Fluid temp. max. (Degree C) : 80Amb. temp. min. (Degree C) : 0Amb. temp. max. (Degree C) : 80

THE TESTING OF FUNCTION AND LEAKAGE WAS DONE BY 110% OF NOMINAL PRESSURE

Bürkert Werke GmbH & Co. KG, D-74653 Ingelf ingen

Bürkert Contromatic S.A.R.L.PO Box 21F-67220 TRIEMBACH AU VAL

Your EDI Order Nr. 1190251173 from 18.07.2008 by BCAG

Hausanschrif t :Christ ian-Bürkert-Str. 13-1774653 Ingelf ingenTelefon (07940) 10-0Telefax (07940) 10-204

Kommanditgesellschaft Sitz Ingelf ingenRegistergericht Stuttgart HRA 590428Persönlich haftende Gesellschafterin: Bürkert GmbHSitz Ingelf ingen Registergericht Stuttgart HRB 590379Geschäftsführer: Gerhard Koch, Heribert Rohrbeck

Bürkert Werke GmbH & Co.KG

Inspection certificate 3.1 by DIN EN 10204Inspection certificate

Item Material Material Descript ion Quantity

Creation date 31.07.2008Client Code 00021000Order: 01260711 18.07.2008

Page: 1

0010 00442207                   5   PCE

type 3233paths/posit ions 2 2   WAYS   /   2   POSITIONsw itched   posit ion 0 2-­WAYorif ice   size 25,0 25MM   (1" )seal   material EA PTFE-­SEAT-­SEALING   +   EPDMbody   material VG SS   IN   CASTING   VERSIONport   connection TG44 CLAMP-­CONNECTION   ACC.   ASME   BPE   97

SHORT   VERSION   1   INCHactuator D050 HANDWHEEL   AND   PPS   COWL

NO06 INTERNAL   MECHANICAL   POLISHED   RA   0,8   MICROMETER   /RA   APPR.   30   MICROINCH   (ASME   BPE   SF   3)

pressure   range 0   -­   10   bar

Customer   Part   Number   000000000000442207

* * * * * * * * * * * * * * * * * * * * **     TECHNICAL   DATA:       ** * * * * * * * * * * * * * * * * * * * *Press   min.   (BAR) :   0Press   max.   (BAR) :   10KV-­Value   (M* 3/H) :   16,0Fluid   temp.   min.   (Degree   C) :   -­10Fluid   temp.   max.   (Degree   C) :   130Amb.   temp.   min.   (Degree   C) :   0Amb.   temp.   max.   (Degree   C) :   130

THE   TESTING   OF   FUNCTION   AND   LEAKAGE   WAS   DONE   BY   110%   OF   NOMINAL   PRESSURE  

Bürkert   Werke   GmbH   &   Co.   KG,   D-­74653   Ingelf ingen  

Bürkert   Contromatic   S.A.S.PO   Box   21F-­67220   TRIEMBACH   AU   VAL

Your   EDI   Order   Nr.   1190271140   from   09.12.2008   by   BCAG

Hausanschrif t :Christ ian-­Bürkert-­Str.   13-­1774653   Ingelf ingenTelefon   (07940)   10-­0Telefax   (07940)   10-­204  

Kommanditgesellschaft   Sitz   Ingelf ingenRegistergericht   Stuttgart   HRA   590428Persönlich   haftende   Gesellschafterin:   Bürkert   GmbHSitz   Ingelf ingen   Registergericht   Stuttgart   HRB   590379Geschäftsführer:   Gerhard   Koch,   Heribert   Rohrbeck  

Bürkert   Werke   GmbH   &   Co.KG  

Certification   2.2   by   DIN   EN   10204Test   Report

  Item Material Material   Descript ion Quantity

Creation   date 03.02.2009Client   Code 00021000Order: 01275628 09.12.2008

Page:   1

MANUFACTURER DECLARATION HERSTELLERERKLÄRUNG

Bürkert Werke GmbH & Co. KG

Kommanditgesellschaft; Sitz Ingelfingen; Registergericht Stuttgart; HRA 590428 Persönlich haftende Gesellschafterin: Bürkert GmbH Sitz Ingelfingen; Registergericht Stuttgart; HRB 590379 Geschäftsführer: Heribert Rohrbeck; Gerhard Koch

Creation date: /Erstelldatum: 17.04.2009 Revision - Place: /Ort: Öhringen

FDA / USP VI - Certificate of conformity for single weir diaphragm valves (basic type 2031)

FDA / USP VI - Konformitätsbescheinigung

für Einsteg- Membranventile (Basistyp 2031)

Declaration Erklärung

We hereby declare as manufacturer that the diaphragms with the below mentioned material code fulfil the listed requirements.

Hiermit bestätigen wir als Hersteller, dass die Membranen mit dem nachfolgend

aufgeführten Materialcode, der genannten Anforderungen entsprechen.

Material Code Materialcode Material Code

Materialcode Material Material Rubber Compound

Elastomercompound

MDPE BA EPDM AA7DKZ EPDM AA6ECZ

FDA-Conformity FDA-Konformität Code of Federal Regulations Title 21 Paragraph 177.2600 published by: FDA (Food an Drug Administration, USA)

Code of Federal Regulations Title 21Paragraph 177.2600 veröffentlicht durch: FDA (Food an Drug Administration, USA)

IV PSU USP VI The aforesaid compounds have met the requirements of the US Pharmacopeia Class IV:

- intracutaneous test, injection test, implantation test - Biomatech study 34527

Die o.g. Compounds entsprechen den Anforderungen der US Pharmacopeia Class IV:

- Intrakutantest, Injektionstest, Implantierung - Biomatech Studie 34527

ruhpluS Schwefel The compounds of the diaphragms don’t contain sulphur Die Compounds der Membranen enthalten keinen Schwefel

RoHS RoHS None ot the substances mentioned in Directive 2002/95/EC are used in the aforesaid compounds

Die o.g. Compounds enthälten keine in der Direktive 2002/95/EC genannten Substanzen.

gnikraM Kennzeichnung The diaphragms are marked with material code and production code (month / year)

Die Membranen sind mit dem Materialcode und dem Produktionsdatum (Monat / Jahr) gekennzeichnet

on behalf of im Auftrag Systemhaus Ingelfingen Inspector Prüfer

MANUFACTURER DECLARATION HERSTELLERERKLÄRUNG

Bürkert Werke GmbH & Co. KG

Kommanditgesellschaft; Sitz Ingelfingen; Registergericht Stuttgart; HRA 590428 Persönlich haftende Gesellschafterin: Bürkert GmbH Sitz Ingelfingen; Registergericht Stuttgart; HRB 590379 Geschäftsführer: Heribert Rohrbeck; Gerhard Koch

Creation date: /Erstelldatum: 07.04.2008 Place: /Ort: Criesbach Page: /Seite: 1/2

SURFACE FINISH OF STAINLESS STEEL BODIES – Diaphragm valves

OBERFLÄCHENGÜTE VON EDELSTAHLGEHÄUSEN - Membranventile

of types: /der Typen: 2031 / 2032 / 2033 / 2034 / 2035 / 3233 / 3234 / 3235 / 3236

Declaration Erklärung

We hereby declare as manufacturer that the surface finish of our stainless steel

bodies is according to the variant codes. The testing of the surface finish is based on DIN EN ISO 4288.

Hiermit bestätigen wir als Hersteller, dass die Oberflächengüte unserer

Edelstahlgehäuse den Angaben der Variablen Codes entsprechen. Die Überprüfung der Oberflächengüte erfolgt nach DIN EN ISO 4288.

Internal surface finish interne Oberflächengüte

Variant Code Variabler Code

Definition Definition

NO05 Ra=1,6µm (Ra~ 64µinch)glasperlengestrahlt Ra=1,6 µm (Ra~ 64µinch)

glass-beaded

NO06 Ra=0,8µm (Ra~ 30µinch) mechanisch poliert

ASME BPE SFV3

Ra=0,8µm (Ra~ 30µinch) mechanical polished

ASME BPE SFV3

NO07 Ra=0,25µm (Ra~ 10µinch) spiegelglanzpoliert Ra=0,25µm (Ra~ 10µinch)

mirror finish

NO08 Ra=0,1µm (Ra~ 4µinch) spiegelhochglanzpoliert Ra=0,1µm (Ra~ 4µinch)

mirror finish

NO14 Ra=0,5µm (Ra~ 20µinch) mechanisch poliert

ASME BPE SFV1

Ra=0,5µm (Ra~ 20µinch) mechanical polished

ASME BPE SFV1

NO18 Ra=1,6µm (Ra~ 64µinch)mechanisch poliert Ra=1,6 µm (Ra~ 64µinch)

mechanical polished

NO21 Ra=0,4µm (Ra~ 15µinch) mechanisch poliert Ra=0,4µm (Ra~ 15µinch)

mechanical polished

NO23 Ra=0,6µm (Ra~ 25µinch) mechanisch poliert

ASME BPE SFV2

Ra=0,6µm (Ra~ 25µinch) mechanical polished

ASME BPE SFV2

NO10 Ra=0,8µm (Ra~ 30µinch) elektropoliert Ra=0,8µm (Ra~ 30µinch)

electropolished

NO16 Ra=0,6µm (Ra~ 25µinch) elektropoliert

ASME BPE SFV6

Ra=0,6µm (Ra~ 25µinch) electropolished

ASME BPE SFV6

NO17 Ra=0,4µm (Ra~ 15µinch) elektropoliert

ASME BPE SFV4

Ra=0,4µm (Ra~ 15µinch) electropolished

ASME BPE SFV4

NO20 Ra=0,25µm (Ra~ 10µinch) elektropoliert Ra=0,25µm (Ra~ 10µinch)

electropolished

NO25 Ra=0,5µm (Ra~ 25µinch) elektropoliert

ASME BPE SFV5

Ra=0,5µm (Ra~ 25µinch) electropolished

ASME BPE SFV5

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