GEMÜ SUMONDO Safe, cost effective, automation-capable

Transcription

1 Safe, cost effective, automation-capable IPhEB St.Petersburg Valentin Rüttimann, Product Manager Single-Use Valves

2 As a new product from GEMÜ I am aiming to make Single-Use technology simpler, more precise and more cost-efficient worldwide! GEMÜ SUMONDO Safe, cost effective, automation-capable 2 of 17

3 I am GEMÜ SUMONDO! GEMÜ SUMONDO Safe, cost effective, automation-capable 3 of 17

4 Contents 1. Design 2. Technical data 3. Product features 4. Materials of Single-Use diaphragm valve bodies (SUB) 5. Accessories 6. Application 7. Product advantages GEMÜ SUMONDO Safe, cost effective, automation-capable 4 of 17

5 Design Control technology (optional) Stainless steel actuator Stainless steel mounting plate Stainless steel distance piece TPE diaphragm PP-R Natural valve body GEMÜ SUMONDO Safe, cost effective, automation-capable 5 of 17

6 Technical data Impressive technology: Proven, reliable actuator design Fast, precise and high number of switching cycles Reliable valve opening and closing Automation-capable and controllable Well-matched, modular instrumentation such as process controllers and display equipment such as electrical position indicators GEMÜ SUMONDO Safe, cost effective, automation-capable 6 of 17

7 Technical data Nominal sizes: 3/8 to 1 Connections: Hose barb, Clamp connection Body materials: PP-R Natural Diaphragm material: USP Class VI, BSE/TSE free TPE (Thermoplastic elastomer) USP Class VI, BSE/TSE free Media temperature: 5 C to 40 C Operating pressure: max. 4 bar / max. 58 PSI Version: straight way valve body, T valve body, angle valve body (right) GEMÜ SUMONDO Safe, cost effective, automation-capable 7 of 17

8 Product features of Single-Use diaphragm valve bodies (SUB) Maximum process reliability through: Mechanically stable, gamma-sterilizable body materials The medium wetted plastics fulfil: a) USP <87> Bioreactivity tests (in-vitro) for cytotoxicity b) USP <88> Bioreactivity tests (in-vivo) as per Class VI c) USP <661> Physiochemical tests for plastics Valve bodies manufactured and packaged in cleanroom of ISO Class 8 (in operation) and GMP Class C Purity requirements as per USP <85> and <788> Validation Guide (documentation of validation) available upon request GEMÜ SUMONDO Safe, cost effective, automation-capable 8 of 17

9 Materials of Single-Use diaphragm valve bodies (SUB) Pin material : PP-R Natural Diaphragm material : TPE Body material : PP-R Natural GEMÜ SUMONDO Safe, cost effective, automation-capable 9 of 17

10 Accessories Positioners and process controllers / combi switchbox GEMÜ 1434 GEMÜ 1436 GEMÜ 4242 Electrical position indicators GEMÜ 1230 GEMÜ 1235 GEMÜ 1236 GEMÜ SUMONDO Safe, cost effective, automation-capable 10 of 17

11 Downstream Ultrafiltration and Diafiltration Applications Low ph IEX 1 Buffer IEX 2 Virus Bulk Fill Protein A Safe, cost effective, automation-capable and already successfully in use! GEMÜ SUMONDO Safe, cost effective, automation-capable 11 of 17

12 Application Safe, cost effective, automation-capable and already successfully in use! GEMÜ SUMONDO Safe, cost effective, automation-capable 12 of 17

13 Application Single-use polypropylene diaphragm valves for recovery and TMP control Safe, cost effective, automation-capable and already successfully in use! GEMÜ SUMONDO Safe, cost effective, automation-capable 13 of 17

14 Application TMP regulation Product recovery Safe, cost effective, automation-capable and already successfully in use! GEMÜ SUMONDO Safe, cost effective, automation-capable 14 of 17

15 controls the world of Single-Use Technology Benefit from controllable Single-Use processes: Greater flexibility in plant engineering and production Faster production of small batches for clinical studies Greater reliability in production Reduction in investment costs Source: - BioTech 2013 presentation GEMÜ SUMONDO Safe, cost effective, automation-capable 15 of 17

16 Product advantages of GEMÜ SUMONDO : Protection of surrounding area and plant operators during disassembly of valve body Hermetic sealing through internally welded diaphragm Reduced documentation complexity Validation Guide available upon request Improved automation and control of Single-Use processes Proven, reliable actuator design for fast and precise control Safe operation through robust, high-purity valve bodies Mechanically stable, gamma-sterilisable valve body materials GEMÜ SUMONDO Safe, cost effective, automation-capable 16 of 17

17 Thank you for your attention. GEMÜ GmbH Lettenstrasse Rotkreuz, Switzerland Plastic Department Tel Fax Valentin.ruettimann@gemue.ch