RO and standards Your title can go in a clear space Craig Cooper, Getinge Healthcare Capital Product Manager, A.NZ – 0428 617 919 David Whiting, Getinge After Market Manager, QLD

Typical Sterilization department

4187:2014 was introduced December 2014 Standards 4187:2014 was introduced December 2014 There was 2 year time line for all Sterilizing/Decontamination to meet these standards 5 year extension provided to run from December 2016 until 2021 Layout 1 Image + text

What does the extension mean? Standards What does the extension mean? That all equipment that doesn’t meet current standards has to be replaced – NO That all equipment that is due to be replaced has to meet current standards – YES The QMS will show that all current equipment due to be replaced will meet the current standards – YES Layout 1 Image + text

Why Water Treatment Compliance Requirements Final Rinse Water – Washer Disinfectors (as per Section 7.2.3.1, AS/NZS 4187:2014) Steam Generator Feedwater – Steam Sterilizers (Table B.1 and Table E.2 of EN285 as per Section 7.2.3.2, AS/NZS 4187:2014) Instruments / Equipment: There are many signs when a poor quality rinse water is used. Again, white deposits can form on the instruments prior to sterilization. These white deposits occur simply because of dry down of the water and concentration of the hardness content on the surface of the instruments. Rust deposits may also appear on the instruments prior to sterilization. Pitting of instruments after sterilization can also mean that the instruments were exposed to high levels of chloride either in the rinse water or the steam. In addition, sterilization may be compromised. Experiments have been conducted to investigate this. Both Bacillus subtilis and Bacillus stearothermophilus were individually mixed with various soils, and kill curves were determined for steam sterilization. It was shown in our laboratories that crystals of both iron oxide/hydroxide (rust) and calcium carbonate (water hardness) significantly inhibited steam sterilization.  Compliance: 1. AS/NZS 4187:2014

What does this mean for Getinge as a manufacturer? Standards What does this mean for Getinge as a manufacturer? Sterilizers – have to be RO/ clean steam compatible – stainless steel pipework/ all associated valves/traps/safety valves etc required to be stainless steel Washers – have to be RO compatible – In a Washer this is quite simple and that is Final Rinse/Disinfection stage has to be RO water Layout 1 Image + text

The Getinge WPT Water Pre-Treatment Plant Complete treatment plant Small footprint (1000 x 600 x 1800 WDH) Plug and play Protects your investments Always connected Easy to service Full compliance with new Standards Variety of models WPT 150 150 litres p/hour production, 300 litre tank, >98% nominal rejection WPT 150 EDI 150 litres p/hour production, 300 litre tank, >99.9% nominal rejection WPT 500 500 litres p/hour production, 300 litre tank, >98% nominal rejection WPT 500 EDI 500 litres p/hour production, 300 litre tank, >99.9% nominal rejection

The Getinge WPT What’s Inside Main components of the Getinge WPT: Compact size Softener x 2 (in duplex for non-stop production) Integrated Brine Tank Prepack Particle and Carbon Filtration x 2 (1 micron) Reverse Osmosis Membranes x 2 Electrodeionization EDI (optional) UV Light Water Tank (300 litres) Reverse Osmosis Pump Control Panel (touch screen, Getinge Online integration) Distribution Pump

The Getinge WPT EDI - Electodeionizer Electrodeionization is a water treatment technology that utilizes electricity, ion exchange membranes and resin to deionize water and separate dissolved ions (impurities) from water. It differs from other water purification technologies in that it is done without the use of chemical treatments and is usually a polishing treatment to reverse osmosis (RO). Without EDI your WPT will remove 98% of dissolved ions. With EDI your WPT will remove 99.9% of dissolved ions.

The Getinge WPT Flow

The Getinge WPT WPT 150 Capacity Example product water capacity: Two 86-Seires Washer-Disinfectors and one GSS67H Sterilizer

The Getinge WPT WPT 500 Capacity Example product water capacity: Six 86-Seires Washer-Disinfectors and five GSS67H Sterilizer For larger installations we need to think about additional redundancy. The Getinge WPT can be installed in duplex / tandem configuration.

The Ring Main Product Water Distribution Loop One of the most important parts of the pure water system is the design of the ring main. We need to ensure that the system is built to ensure the consistent quality of water required. Some key considerations: Turbulence flow by pump to retard the biofilm development Velocity Maintenance in Return Line Tank Turn Over Monitoring & Data logging of the process parameters

The Ring Main Product Water Distribution Loop Getinge Australia recommend the following materials to be used for RO ring mains: Georg Fischer Infrared welded Polypropylene Homopolymer [PPH-IR] piping Georg Fischer Type 519 Diaphragm Valves ESP Sanitary Sampling Ports/Valves PNN Series Hydrophilic Nylon 0.2 Micron Membrane Filters (for advanced bacterial and endotoxin removal within circulating ring main product water).

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