Guide. Sterilising and Sanitising Sterile Filter Cartridges. Filtrations-Separations-Technik P2 P3 T1 V1 V2

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1 P1 P2 P3 T1 V1 V2 D3 V3 D1 Guide Sterilising and Sanitising Sterile Filter Cartridges Technical specifications are subject to change without notice. Release

2 Contents 1. Introduction Wetting Out Static Soak Dynamic Flush Hot Water Sanitisation Chemical Sanitisation Autoclaving Steaming in situ...8 Notes Page 2

3 1. Introduction Various filter elements from FSTs filter product portfolio are designed to be sanitised or sterilised by: Hot water Sanitisation Chemical Sanitisation Autoclaving Steaming In-situ Please refer to the according product datasheets and validation guides for further informations which filter elements are suitable for sanitisation or sterilisation. It is the responsibility of the filter user to verify the method used for sanitising or sterilising achieves the desired state of cleanliness and does not damage the filter element. Filter elements with hydrophilic membranes must be wetted out before steaming or autoclaving. Page 3

4 2. Wetting Out Filter elements with hydrophilic membranes must be wetted out before steaming or autoclaving. There are two methods for wetting out a filter element prior to steaming or autoclaving: 2.1 Static Soak Place the filter element, open end up, in a container large enough to allow it to be totally submerged. Fill the container around the filter element with wetting fluid. Do not fill the central core of the filter element. Allow the wetting fluid to flow into the core of the filter element through the membrane. Keep the level of wetting fluid topped up to allow the filter element to become totally submerged. Agitate the filter element to remove any trapped air and allow to soak for 10 minutes. Remove the filter element, drain off any excess fluid and install it in the filter housing. 2.2 Dynamic Flush Install the filter element in the filter housing Open the vent valve and fill the filter housing with wetting fluid until liquid exits from the vent. Appropriate procedures should be used to avoid injury from aggressive wetting fluids Close the vent valve and re-circulate or flow fluid through the filter at 5-10 litres per minute per 10" element module for 5 minutes. Drain the filter housing upstream, downstream and the housing itself. Page 4

5 3. Hot Water Sanitisation Various types of filter elements can be sanitised with pre-filtered hot water, as documented in the appropriate Product Validation Guide. It is the responsibility of the filter user to verify the method used for sanitising or sterilising achieves the desired state of cleanliness and does not damage the filter element. Appropriate procedures should be used to avoid scalding by hot water. FST recommends integrity testing critical membrane filter elements after hot water sanitising. Install the filter element in the filter housing. Open the vent valve and slowly fill the housing until hot water exits from the vent. Close the vent valve and re-circulate hot water through the filter at 5-10 litres per minute per 10" element module for the appropriate time. Do not exceed 0.35 bar differential pressure across the filter. Drain the filter housing upstream, downstream and the housing itself. Page 5

6 4. Chemical Sanitisation Various types of filter elements are compatible with industry standard concentrations of hydrogen peroxide, peracetic acid, sodium hypochlorite and most other sanitising agents, as documented in the appropriate Product Validation Guide. It is the responsibility of the filter user to verify the method used for sanitising or sterilising achieves the desired state of cleanliness and does not damage the filter element. Appropriate procedures should be used to avoid injury from sanitising fluids. FST recommends integrity testing critical membrane filter elements after chemical sanitising. Install the filter element in the filter housing. Open the vent valve and fill the housing until fluid exits from the vent. Close the vent valve and re-circulate the sanitising agent through the filter at 5-10 litres per minute per 10" element module for the appropriate time. Drain the filter housing upstream, downstream and the housing itself. Flush the system with pre-filtered water to remove residual sanitising agent. Drain the filter housing upstream, downstream and the housing itself. Page 6

7 5. Autoclaving Various types of filter elements may be repeatedly autoclaved at conditions specified in the relevant Product Validation Guide. It is the responsibility of the filter user to verify the method used for sanitising or sterilising achieves the desired state of cleanliness and does not damage the filter element. It is the responsibility of the end user to ensure that the autoclave cycle is validated to give a sterile filter assembly and does not damage the filter and that the filter is integral after autoclaving. Filter elements with hydrophilic membranes must be wetted out before steaming or autoclaving. FST recommends integrity testing critical membrane filter elements after autoclaving. Wet out the filter element ( chapter 2: Wetting out, page Fehler! Textmarke nicht definiert.). Install the filter element in the filter housing. Cover the housing inlet and outlet with a steam porous covering. Open the housing drain and vent valves. Autoclave at conditions specified in the relevant Product Validation Guide, using a slow exhaust setting. After autoclaving, allow to cool and aseptically close the housing drain and vent. Page 7

8 6. Steaming in situ Various types of filter elements may be repeatedly steamed in situ using dry, saturated, filtered steam at conditions specified in the relevant Product Validation Guide. It is the responsibility of the end user to ensure that the steaming protocol is validated to give a sterile filter assembly and does not damage the filter. Appropriate procedures should be used to avoid injury from hot steam. Filter elements with hydrophilic membranes must be wetted out before steaming or autoclaving. FST recommends integrity testing critical membrane filter elements after steaming. Refer to the system diagram whilst following the steaming protocol: dry, saturated, filtered steam E1 P1 P2 P3 T1 V1 V2 D3 V3 D2 D1 Page 8

9 Wet out the filter element ( chapter 2: Wetting out, page Fehler! Textmarke nicht definiert.). Close all valves (V1, V2, V3, D1, D2, D3, E1). Crack open condensate drain D1. Open housing vent E1 and housing drain D2. Crack open Steam Valve V2 until the system pressure at P2 = 0.35 bar. Hold the pressure at 0.35 bar. Open the downstream condensate drain D3 to allow steam to flow through the filter. When condensate has been expelled, and steam is observed flowing from the condensate drains and housing vent, partially close the condensate drains D1 and D3, the housing vent E1 and housing drain D2. To ensure complete steaming and eliminate cold spots adjust the condensate drains and housing vent to allow stream to trickle through them whilst minimising steam loss. Continue slowly to open the steam valve V2 and increase the steam pressure P2 to 1 bar (the maximum specified steam pressure). At the same time, monitor the differential pressure across the filter (P2-P3). To avoid damaging the filter this must not exceed 0.35 bar. Steam for the required time when the system has reached the specified temperature. Do not exceed the maximum steaming time as documented in the appropriate Product Validation Guide. Continue to monitor the differential pressure across the filter. When the steaming is completed close the steam valve V2 and shut of the supply of the steam. Close the condensate drains D1 and D3. Close the housing vent E1 and housing drain D2. Depressurise the system by slowly opening the downstream condensate drain D3. Close D3 when the system pressure at P2 has dropped to 0.35 bar. Monitor the temperature gauges T1 until the filter assembly has cooled sufficiently for the process to run. Page 9

10 Notes Page 10

11 Page 11 Filtrations-Separations-Technik

12 FST GmbH Sales Office: Im Teelbruch 106 D Essen Head Office: Weiherdamm 17 D Netphen-Deuz +49 (0)2054 / (0)2054 / info@fstweb.de FST GmbH Netphen-Deuz Entwurf-QZA-Guide FST sterilising and sanitising filter cartridges-en ml Printed 12/2010