Hy~Line and Ultima Lobe Pumps - Jabsco - #49

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2/00 6.101 Hy~Line and Ultima Lobe Pumps In truly sterile processes, all product-contact components need to be sterilised. This is usually achieved by heating to high temperature (up to 140°C, 285°F) to kill organisms still remaining on the surface of the equipment. This can be achieved by physically dismantling the pump and autoclaving the parts, bagging, taking back to the pump and reassembling; a long, costly process which causes problems to personnel and can result in accidental damage to components. But when using the either the Hy~Line or Ultima pumps it is possible to pass steam through the complete assembled system to sterilise the internal surfaces without dismantling the pump. To achieve 100% sterility, it is important to steam through for a period long enough for the coldest part of the system to reach the correct temperature and hold for the time period required to kill off the organisms. The Hy~Line and Ultima pump heads are designed to completely self drain, ensuring all surfaces are exposed to steam and the component shape and choice of materials ensures thermal stability and temperature tolerance. If using chemical sanitisers, follow guidelines as for CIP above. If using steam, pump specification must be chosen at time of selection noting: EPDM elastomers offer best resistance to repeated steam contact but will need to be changed periodically. PTFE (Teflon) is least suitable for steam contact - PTFE end cover joints may need to be replaced every time the pump is sterilised. Pump should be mounted with the port axis vertical to avoid collecting liquid pools. 1. Thoroughly clean pump and process lines prior to sterilisation. 2. If pump is fitted with sterile barriers (on seals, end cover) for the purpose of maintaining sterility, barrier fluid must be connected throughout SIP cycle to avoid re-infection. 3. Pass clean, wet steam through system until all component temperatures have stabilised. Steam must be free of scale, rust and particles - a filter may be necessary. Typically steam will be at 121°C (250°F) and 1 bar (15 psi). Soak time, to bring the pump up to temperature, is typically 20 minutes but this should be established, e.g. using thermocouples, as the required soak time will vary with individual installations. Do not rotate the lobe pump during this heating phase. Do not loosen or remove any pump components or pipe connections during steam sterilisation as escaping steam may cause serious injury. 4. Continue to pass wet steam through the lobe pump and process lines during the hold time. Hold time will be determined by the user to achieve desired level sterility. Typically this will be between 20 and 60 minutes. The lobe pump should not be rotated during this hold time unless absolutely essential to achieve sterility, due to increased risk of pump seizure. All pump components will normally reach desired temperature by thermal conduction without rotating the pump. If essential, the lobe pump can be rotated during hold time by hand - beware of danger of hot surfaces - or at a maximum of 50 rpm if the pump is fitted with either: Single carbon/stainless steel or carbon/silicon carbide seals (Code 8 or 3). Flushed or double seals (codes 1, 4, 5 or 7) provided a liquid flush, e.g. condensate, is connected and operating at a pressure above the steam pressure within the pump during SIP. If the lobe pump is fitted with single silicon carbide/silicon carbide seals (Code 2) it must not be rotated during hold time as the seal faces can bind together. 5. At the end of hold time, pump must be allowed to cool naturally or can be purged with sterile air/inert gas. Pump must not be rotated during cooling. 6. Do not allow cool liquid to enter the lobe pump before pump temperature has fallen to 60°C (140°F) or lower. If the pump is fitted with single silicon carbide/silicon carbide seals (Code 2), flood it with liquid to lubricate the seals before rotating it. Sterilising In Place Procedure