Diaphragm pressure gauge, flush For sanitary applications, NS 100 Model PG43SA-D, with integrated diaphragm element monitoring

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Pressure Diaphragm pressure gauge, flush For sanitary applications, NS 100 Model PG43SA-D, with integrated diaphragm element monitoring WIKA data sheet PM 04.17 for further approvals see page 4 Applications Hygienic pressure measurement for the pharmaceutical and biotechnology industries Mechanical pressure display on pipelines, fermenters, bioreactors and vessels Pressure display during processing and transport of high-quality and critical media Suitable for the production of active pharmaceutical ingredients (API) For gases, vapour; liquid, pasty, powdery and crystallising media Special features Integrated diaphragm element monitoring with status display (patent, property right: e.g. DE102016005568) Two barriers for secure separation of the process from the atmosphere Mechanical pressure transmission without transmission fluid Completely autoclavable, suitable for CIP and SIP Description The model PG43SA-D diaphragm pressure gauge has been designed specifically for the highest safety requirements in the pharmaceutical and biotechnology industries. Through its patented diaphragm element monitoring, the risk of an undetected rupture of the diaphragm is eliminated since a red warning dot is immediately displayed on the dial. If this point on the dial remains white, then the pressure element is intact and cost-intensive maintenance on the measuring point is not required. In the event of a diaphragm rupture, a second barrier in the instrument ensures the reliable separation of the environment and the process. The diaphragm pressure gauge transmits the pressure, purely mechanically and without transmission fluid, from the process to the pressure element. Due to their, the diaphragm elements are very robust and have high overpressure safety, ensuring a safe pressure measurement without any risk of contamination. Model PG43SA-D, with integrated diaphragm element monitoring, NS 100 The flush welded diaphragm element in conjunction with the aseptic process connections enables a dead-space free connection to the process. The independent pressure display, needing no external power, finds applications with the processing and transport of high-quality and critical media, for example on portable tanks. The PG43SA-D in hygienic design can be used for CIP (cleaning in place) and SIP (sterilisation in place) and in wash-down areas, or it can be completely sterilised in an autoclave. The measuring instrument can thus be cleaned reliably and time-efficiently. The model PG43SA-D conforms to the 3-A Sanitary Standard and is certified in accordance with EHEDG. A variety of 3.1 and 2.2 certificates are available for GMP-compliant documentation, such as a material certificate or the list of single measured values. WIKA data sheet PM 04.17 08/2018 Page 1 of 11 Data sheets showing similar products: Diaphragm pressure gauge, flush; model PG43SA-C, compact version, NS 63; see data sheet PM 04.15 Diaphragm pressure gauge, flush; model PG43SA-S, NS 100; see data sheet PM 04.16

Specifications Design Following EN 837-3 and ASME B40.100 Nominal size in mm 100 Accuracy class 1.6 per EN 837-3 Option: Grade A per ASME B40.100 Scale range Overload safety bar 0 2.5 4 0 4 8 0 6 18 0 10 40 0 16 40-1 +1.5 4-1 +3 8-1 +5 18-1 +9 40-1 +15 40 psi 0 36 58 0 60 120 0 100 300 0 160 580 0 200 580-30 inhg +30 58-30 inhg +60 120-30 inhg +100 300-30 inhg +150 580 Consider max. pressure rating () of the process connection, see page 4 onwards Option: Dual scale The given scale ranges are also available in kpa and MPa. Vacuum safety All scale ranges are suitable for the vacuum typical of CIP or SIP cleaning. Positive scale ranges < 6 bar (< 100 psi) are optionally available in a vacuum-tight version (to -1 bar). Pressure limitation Steady: Full scale value Fluctuating: 2/3 x full scale value Permissible temperature Ambient -20... +60 C Medium -30... +150 C CIP, SIP 150 C continuously for wetted parts Autoclaving 134 C, 20 minutes Storage, transport -30... +70 C Temperature effect When the temperature of the measuring system deviates from the reference temperature (+20 C): max. ±0.5 %/10 K of full scale value Ingress protection IP54 per IEC/EN 60529 Process connection Stainless steel 1.4435 (316L), UNS S31603, lower mount Clamp connection per DIN 32676 / ISO 2852 / BS4825 part 3 Aseptic connection per DIN 11864-1 /-2 /-3 Milk thread fitting per DIN 11851 VARIVENT NEUMO BioControl SMS threaded connection others on request For exact designs and nominal widths see tables from page 4 Pressure element Diaphragm element, welded to the process connection, NiCr alloy 2.4668 (Inconel 718), UNS N07718 Surface roughness of wetted parts R a 0.38 μm (15 μin), weld seam: R a 0.76 μm (30 μin) Option: Electropolished, Ra 0.38 μm (15 μin), per ASME BPE SF4, weld seam: Ra 0.76 μm (30 μin) Level of cleanliness of wetted parts ASTM G93 level C / ISO 15001 (residual content of non-volatile hydrocarbons 66 mg/m²) Movement Stainless steel Dial Aluminium, white, black lettering Pointer Aluminium, black Case Stainless steel 1.4301 (304), electropolished Surface roughness: Ra 0.76 μm (30 μin), (except for weld seam) Window Polysulphone Ring Crimp ring, stainless steel 1.4301 (304) VARIVENT is a registered trademark of the company GEA Tuchenhagen. BioControl is a registered trademark of the company NEUMO. WIKA data sheet PM 04.17 08/2018 Page 2 of 11

Diaphragm element monitoring Continuous monitoring of the pressure element Status display Diaphragm element intact Function The continuous diaphragm element monitoring indicates the current state of the pressure element. A defective diaphragm element will be immediately indicated to the user as a red warning dot on the dial (see picture). With the aid of the status display, the integrity of the pressure element can be checked both prior to installation and during operation. Diaphragm element defective Diaphragm element Second barrier Second barrier The diaphragm element serves as the first barrier between the process and the atmosphere. A second barrier, located behind it, guarantees the reliable separation of ambience and process, even in the event of a rupture in the diaphragm element. The risk of any contamination between the environment and the process is eliminated by the second barrier. In the event of a damaged diaphragm element Colour of the status display changes to red Measuring instrument is defective and can no longer be used as a reference for the process pressure Dismounting and exchange of the measuring instrument must be carried out in the depressurised state Despite a damaged diaphragm element, due to the second barrier no exchange has occurred between process and ambience Option: Sterilisation of the reference chamber The sterilisation of the reference chamber (space between the diaphragm element and the second barrier) is carried out using dry heat per ISO 20857/2010. The instrument is delivered including a 2.2 test report. Zero point adjustment External zero point adjustment, setting range ±15 The zero point adjustment can be made with a slotted screwdriver after the removal of the sealing plug on the top of the case. Deviations in the display due to natural fluctuations in the atmospheric pressure and altitude variations can be compensated with the zero point adjustment. WIKA data sheet PM 04.17 08/2018 Page 3 of 11

JUNE 2016 Approvals Logo Description Country EAC (option) Eurasian Economic Community Pressure equipment directive GOST (option) Metrology, measurement technology KazInMetr (option) Metrology, measurement technology Uzstandard (option) Metrology, measurement technology 3-A Sanitary Standard This instrument is 3-A marked, based on a third party verification for conformance to the 3-A standard number 74. Russia Kazakhstan Uzbekistan USA EHEDG Hygienic Equipment Design - CRN Safety (e.g. electr. safety, overpressure,...) European Community Canada Manufacturer s information and certificates Manufacturer's declaration regarding regulation (EC) no. 1935/2004 Certificates (option) 2.2 test report per EN 10204 (e.g. surface finish quality of wetted parts) 3.1 inspection certificate per EN 10204 (e.g. material proof, wetted metallic parts with suppliers' certificate (melting analysis), measurement accuracy: Listing of the single measured values) Others on request Patents, property rights Diaphragm pressure gauge with integrated diaphragm element monitoring (DE102016005568, US2016349128A1, CN 106197792) Approvals and certificates, see website WIKA data sheet PM 04.17 08/2018 Page 4 of 11

Type of process connection: Clamp connection per DIN 32676 Pipe standard: Pipes per DIN 11866 row C or ASME BPE NS h Ø Plf d k 14192077.01 1 ½" 38.1 x 1.65 40 100 92 35 50.5 15 2" 50.8 x 1.65 40 100 92 35 64 15 Type of process connection: Clamp connection per DIN 32676 Pipe standard: Pipes per DIN 11866 row B or ISO 1127 row 1 NS h Ø Plf d k 42.4 42.4 x 2 40 100 92 35 64 15 48.3 48.3 x 2 40 100 92 35 64 15 Type of process connection: Clamp connection per BS4825 part 3 Pipe standard: Pipes per BS4825 part 1 and O.D. tube NS h Ø Plf d k 1 ½" 38.1 x 1.6 40 100 92 35 50.5 15 2" 50.8 x 1.6 40 100 92 35 64 15 Type of process connection: Clamp connection per DIN 32676 Pipe standard: Pipes per DIN 11866 row A or DIN 11850 row 2 NS h Ø Plf d k 40 41 x 1.5 40 100 92 35 50.5 15 50 53 x 1.5 40 100 92 35 64 15 Type of process connection: Clamp connection per ISO 2852 Pipe standard: Pipes per ISO 2037 and BS 4825 part 1 NS h Ø Plf d k 38 38 x 1.2 25 100 92 35 50.5 15 40 40 x 1.2 25 100 92 35 64 15 51 51 x 1.2 25 100 92 35 64 15 For maximum pressure range consider pressure rating of clamp. EHEDG conformity only in combination with Tri-clamp sealings from Combifit International B.V. WIKA data sheet PM 04.17 08/2018 Page 5 of 11

JUNE 2016 Type of process connection: Threaded connection per DIN 11851 Pipe standard: Pipes per DIN 11850 row 2 with grooved union nut with threaded coupling 14192079.01 14192080.01 NS h1 h2 Ø Plf G d k1 k2 a SW 40 41 x 1.5 40 100 92 101 35 Rd 65 x 1/6 78 22 23 14 27 50 53 x 1.5 25 100 92 101 35 Rd 78 x 1/6 92 22 23 14 27 For a 3-A conform connection of process connections with milk thread fittings per DIN 11851, profile sealings from SKS Komponenten BV or Kieselmann GmbH have to be used. EHEDG conformity only in combination with ASEPTO-STAR k-flex upgrade, sealing from Kieselmann GmbH. WIKA data sheet PM 04.17 08/2018 Page 6 of 11

JUNE 2016 Aseptic threaded pipe connection per DIN 11864-1 form A with liner and grooved union nut with threaded coupling 14192081.01 14192082.01 Type of process connection: Aseptic threaded pipe connection per DIN 11864-1 form A Pipe standard: Pipes per DIN 11866 row A or DIN 11850 row 2 Outer Ø x wall NS h1 h2 Ø Plf G d1 d2 D k1 k2 a SW 40 41 x 1.5 40 100 96 99 35 Rd 65 x 1/6 54.9 55 78 22 23 14 27 50 53 x 1.5 25 100 96 97 35 Rd 78 x 1/6 66.9 67 92 22 23 14 27 Type of process connection: Aseptic threaded pipe connection per DIN 11864-1 form A Pipe standard: Pipes per DIN 11866 row B or DIN ISO 1127 row 1 Outer Ø x wall NS h1 h2 Ø Plf G d1 d2 D k1 k2 a SW 42.4 42.4 x 2.0 25 100 96 99 35 Rd 65 x 1/6 54.9 55 78 22 23 14 27 48.3 48.3 x 2.0 25 100 96 97 35 Rd 78 x 1/6 66.9 67 92 22 23 14 27 Type of process connection: Aseptic threaded pipe connection per DIN 11864-1 form A Pipe standard: Pipes per DIN 11866 row C or ASME BPE Outer Ø x wall NS h1 h2 Ø Plf G d1 d2 D k1 k2 a SW 1 ½" 38.1 x 1.65 40 100 96 99 35 Rd 58 x 1/6 54.9 55 78 22 23 14 27 2" 50.8 x 1.65 25 100 96 97 35 Rd 65 x 1/6 66.9 67 92 22 23 14 27 Permissible pressure in bar; these pressures may only be applied when using suitable sealing materials up to a temperature of -10 to +140 C. WIKA data sheet PM 04.17 08/2018 Page 7 of 11

JUNE 2016 Aseptic flange connection per DIN 11864-2 form A with flange with groove with flange with notch 14192087.01 14192088.01 Type of process connection: Aseptic flange connection per DIN 11864-2 form A Pipe standard: Pipes per DIN 11866 row A or DIN 11850 row 2 Outer Ø x wall NS h1 h2 Ø Plf d1 d2 d3 d4 D k1 k2 a1 a2 40 41 x 1.5 25 100 95 93 35 65 4 x 9 53.6 53.7 82 17.5 15 11.5 10 50 53 x 1.5 16 100 95 93 35 77 4 x 9 65.6 65.7 94 17.5 15 11.5 10 Type of process connection: Aseptic flange connection per DIN 11864-2 form A Pipe standard: Pipes per DIN 11866 row B or DIN ISO 1127 row 1 Outer Ø x wall NS h1 h2 Ø Plf d1 d2 d3 d4 D k1 k2 a1 a2 42.4 42.4 x 2.0 16 100 95 93 35 65 4 x 9 54 54.1 82 17.5 15 11.5 10 48.3 48.3 x 2.0 16 100 95 93 35 71 4 x 9 59.9 60 88 17.5 15 11.5 10 Type of process connection: Aseptic flange connection per DIN 11864-2 form A Pipe standard: Pipes per DIN 11866 row C or ASME BPE Outer Ø x wall NS h1 h2 Ø Plf d1 d2 d3 d4 D k1 k2 a1 a2 1 ½" 38.1 x 1.65 25 100 95 93 35 65 4 x 9 50.4 50.4 79 17.5 15 11.5 10 2" 50.8 x 1.65 16 100 95 93 35 75 4 x 9 63.4 63.5 92 17.5 15 11.5 10 Permissible pressure in bar; these pressures may only be applied when using suitable sealing materials up to a temperature of -10... +140 C. WIKA data sheet PM 04.17 08/2018 Page 8 of 11

JUNE 2016 Aseptic clamp connection per DIN 11864-3 form A with clamp with groove with clamp with notch 14192083.01 14192084.01 Type of process connection: Aseptic clamp connection per DIN 11864-3 form A Pipe standard: Pipes per DIN 11866 row A or DIN 11850 row 2 NS h Ø Plf d1 d2 D k1 k2 40 41 x 1.5 40 100 93 35 53.6 53.7 64 17.5 15 50 53 x 1.5 25 100 93 35 65.6 65.7 77.5 17.5 15 Type of process connection: Aseptic clamp connection per DIN 11864-3 form A Pipe standard: Pipes per DIN 11866 row B or DIN ISO 1127 row 1 NS h Ø Plf d1 d2 D k1 k2 42.4 42.4 x 2.0 25 100 93 35 53.6 53.7 64 17.5 15 48.3 48.3 x 2.0 25 100 93 35 65.6 65.7 65 17.5 15 Type of process connection: Aseptic clamp connection per DIN 11864-3 form A Pipe standard: Pipes per DIN 11866 row C or ASME BPE NS h Ø Plf d1 d2 D k1 k2 1 ½" 38.1 x 1.65 40 100 93 35 50.4 50.5 64 31 28 2" 50.8 x 1.65 25 100 93 35 63.4 63.5 77.5 31 28 Permissible pressure in bar; these pressures may only be applied when using suitable sealing materials up to a temperature of -10 to +140 C. WIKA data sheet PM 04.17 08/2018 Page 9 of 11

Type of process connection: VARIVENT 14192085.01 Access unit connection NS h Ø Plf d D k a Form F 25 100 94 35 49.95 66 17 12.3 Form N 25 100 94 35 68 84 17 12.3 Consider pressure rating of VARINLINE access unit Type of process connection: NEUMO BioControl Note: Suitable for installation into the VARINLINE access unit from GEA Tuchenhagen. VARIVENT and VARINLINE are registered trademarks of the company GEA Tuchenhagen GmbH. EHEDG conformity only in combination with EPDM O-ring from GEA Tuchenhagen GmbH. 14192086.01 BioControl connection 2) NS h Ø Plf d d1 d2 D k a Size 50 16 100 104 35 49.9 70 4 x 9 90 26 17 Size 65 16 100 104 35 67.9 95 4 x 9 120 26 17 2) Consider pressure rating of NEUMO BioControl connection WIKA data sheet PM 04.17 08/2018 Page 10 of 11

Ordering information Scale range / Type of process connection, pipe standard, dimension / Overload safety / Certificates / Approvals / Options 03/2016 WIKA Alexander Wiegand SE & Co. KG, all rights reserved. The specifications given in this document represent the state of engineering at the time of publishing. We reserve the right to make modifications to the specifications and materials. 08/2018 EN WIKA data sheet PM 04.17 08/2018 Page 11 of 11 WIKA Alexander Wiegand SE & Co. KG Alexander-Wiegand-Straße 30 63911 Klingenberg/Germany Tel. +49 9372 132-0 Fax +49 9372 132-406 info@wika.de www.wika.de