Pall Stax Instructions For Use Manual

Instructions For Use (IFU)
USD 2554c
Pall Stax™ Capsule Filters
216495 - Pall Europe Ltd GN12.5291.qxd:Layout 1 1/6/12 14:10 Page 1
1. Introduction
The instructions contained in the product documentation must be read thoroughly as they contain valuable information gained by extensive experience. It is very important that all instructions are carefully followed and where appropriate they should be incorporated into the end user’s standard operating procedures. If some of the procedures do not suit your
needs,
please consult Pall or your local distributor before finalizing your system.
Use of this product in a manner other than in accordance with Pall’s current recommendations may lead to injury or loss. Pall cannot accept liability for such injury or loss.
2. Specifications
The maximum working pressures and temperatures are specified in Table 1. Operation outside the specifications and with fluids incompatible with the materials of construction may cause personal injury and result in damage to the equipment. Incompatible fluids are fluids which chemically attack, soften, stress, attack or adversely affect the materials of construction. Please refer to Pall for a list of incompatible fluids.
Table 1
Operating Conditions
Maximum Operating Pressure 3.5 bar at 25 °C 1.0 bar at 60 °C
Maximum Operating Temperature 25 °C at 3.5 bar 60 °C at 1.0 bar
Recommended Operating Conditions Maximum differential Pressure 2.4 bar at 3.5 bar operating pressure
Contact Pall for advice in case of prolonged exposure at extremes of operating temperatures.
Warning: European Directive 94/9/EC (ATEX) Equipment Intended for Use in Potentially Explosive Atmospheres For information relating to European Directive 94/9/EC (ATEX), please refer to page 7. For information relating to Zone 0/20 Applications, please contact Pall. Mo
re information can be obtained through Pall, your local distributor or the
Pall website.
3. Receipt of Equipment
Caution: Stax standard capsule and manifold assemblies are suitable for sterilization by autoclaving. Stax carbon capsules incorporating Seitz®AKS media must not be autoclaved. Please check the product label prior to use to ensure product part numbers correspond to the application. Stax capsules and manifolds are supplied non-sterilized, if unsure of suitable sterilization method, please contact Pall.
1. Store the capsules and manifold assemblies in clean, dry conditions between 0 °C and 30 °C without exposure to irradiation sources such as direct sunlight, and wherever practical in the packaging as delivered.
2. Do not remove from packaging until just before installation.
3. Check that the bag or packaging is undamaged prior to use.
4. Ensure that the type of capsule assembly selected is suitable for the application.
5. In addition to the part number, each capsule assembly is identified by a unique identification batch number and a unique serial number.
6. Stax capsule modules should be used within 36 months after their production date as shown on the box label with the exception of Stax capsules with Bio-Series media, which must be used within 18 months after their production date.
7. The manifold kits are equipped with protective caps on the inlet and oulet connections. Please ensure these caps are removed prior to putting your system into operation.
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4. Installation and Operation
Before installation, it is essential to verify that the capsule assembly type selected is suitable for the product to be filtered and to follow the appropriate instructions listed below and the diagrams in:
Appendix A: Chassis User Instructions — Pilot Scale on page 8 Appendix B: Chassis User Instructions — Process Scale 5 and 10 High on page 10 Appendix C: Chassis User Instructions — Series Filtration on page 12.
4.1 Installation
The Stax caps
ule system must only be used in conjunction with the appropriate supporting chassis. Ensure that the required manifolds and capsules are installed in the correct orientation for flow and that the inlet and outlet ports are adequately supported. The distribution manifolds have the flow direction indicated on the pipes.
Figure 1
Typical Chassis Configurations (Drawings not to scale)
Pilot Unit 5-High Process Unit 10-High Process Unit
1. Ensure that the support chassis i
s located in a stable and level position. The process scale chassis must be bolted securely to the floor or when fitted with wheels these must be fully locked.
2. The Stax capsule assemblies must be stacked in a vertical orientation. Assembly of the Stax capsule system begins with the correct placement of a distribution manifold on to the base of the chassis. Capsules are then stacked on top in the correct orientation, ensuring that the sealing gasket is correctly positioned flat between each item within each capsule and distribution manifold retaining lugs, and then topped with the appropriate manifold.
For systems requiring flow in and out via the bottom distribution manifold, a vent manifold must be fitted to the top of the stack. For bottom in and top out flow, the stack must be topped with a distribution manifold. Refer to the Applications Note for recommendations on when to use the alternative flow modes. Fluid flow must be in the direction indicated on the distribution manifold and must be maintained within the specifications.
3. The Stax capsule assembly may also be operated in series filtration mode in the same process scale chassis with two sets of capsules containing different filter sheet grades. Refer to Appendix C: Chassis User Instructions — Series Filtration on page 12 for correct assembly. Both capsule sets should be completed with a vent manifold.
In series mode, the 10-high chassis is limited to 9 large capsules and in the 5-high chassis to 4 large capsules.
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4. Ensure that the capsule stack is correctly clamped by the chassis clamping plate before connecting the hoses. No gaps should exist between the capsules, manifold and the clamping plate.
5. Control valves should be fitted to the inlet and outlet pipes of the distribution manifolds to control fluid flow. Venting of the system must be carried out before operation through the valves on the vent manifold. When used with fluid flow in through the bottom of the system and out through the top, venting can be achieved through the control valve fitted to the inlet of the top manifold and through the outlet pipe.
6. To assist with post-use blown down, it is recommended that for bottom-in, top-out flow configuration, that the bottom outlet valve should be shut during normal operation and opened for draining down after use. Refer to section 7.1 for post-use drainage and blow down.
7. Where a positive pressure exists downstream of the capsule assembly, a sensitive check valve may be needed to prevent back pressure damage due to reverse flow.
8. Where pulsating flow is present, the capsule assembly should be protected by a surge tank or similar device upstream.
9. Where a rapidly closing downstream valve is present, the possibility of pressure pulsing and subsequent filter damage exists. The capsule assembly should be protected by a surge tank or similar device between valve and filter.
10. Depending on the application, rinsing with filtered water or buffer in a forward flow
direction is recommended prior to putting the Stax capsules into operation. Rinsing can be performed with product or a product-compatible liquid. The recommended rinsing volume is 50 L/m2of filter area for single layer filters and 100 L/m2of filter area for double layer filters. The recommended flow rate for the rinsing cycle is 1.5 times the process flow rate.
4.2 Operation
Warning: Do not remove or attempt to remove the blanking caps, vent and drain valves while the capsule assembly is in use. All valves or blanking caps must be closed during filtration once venting operations have been performed. Stax capsules and manifolds must not be used without the appropriate chassis.
4.2.1 Liquid Applications
1. Stax standard capsules are suitable for autoclaving and the system can be operated under sterile conditions. However, Stax capsule filter media are not sterilizing grade filters and will
not sterilize a non-sterile liquid.
Warning: Stax carbon capsules incorporating Seitz AKS media must not be autoclaved.
2. Remove the capsule and manifolds from their bags or protective autoclave wrapping and correctly assemble into the chassis as described in Appendix A: Chassis User Instructions — Pilot Scale on page 8 or Appendix B: Chassis User Instructions — Process Scale 5 and 10 High on page 10. Attach process lines to the appropriate inlet and outlet pipes of the manifold using sanitary flange connections, ensuring that the gaskets are properly installed and the clamps adequately tightened.
3. The valves are operated by rotation; rotate counter clockwise to open, rotate clockwise to close. Where fitted open the vent valves and slowly begin to fill the capsule. Close the vent valves as soon as all excess air escapes the assembly and liquid reaches the level of the vents.
4. Gradually increase the flow rate or pressure to the desired value. Do not exceed the maximum operating parameters listed in the specifications section of the product datasheet.
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5. When filtration is complete, residual fluid within the capsules can be displaced by an air purge to minimize hold-up of solution in the assembly.
6. The chassis should be cleaned after use and all moving parts checked for signs of wear. Worn parts must be replaced. Replacement parts can be ordered through Pall or your local distributor.
4.2.2 Gas Applications
The Stax Capsule system is not intended for gas applications. However, an air pres­sure hold installation test ma
y be conducted at < 0.35 bar (5 psi) to confirm system
assembly integrity before use.
5. Sterilization, Sanitization and Decontamination
Caution: Stax filter capsules and manifolds are not intended to be reusable. Discard capsules and manifolds in accordance with local Health and Safety and Environmental procedures.
Warning: Stax filter capsules and manifolds must not be in-line steam sterilized. Material design limitations will be exceeded when these filters are exposed to pressurized steam and the housing may rupture.
5.1 Autoclaving (standard capsules only)
Caution: Please refer to the appropriate Pall product information literature for products which can be autoclaved and the maximum recommended cumulative autoclave exposure time.
Autoclave sterilization procedures for standard Stax capsules are detailed in Pall publication USTR 805.
All materials can be autoclaved dry or wet post blow down.
Warning: Stax carbon capsules incorporating Seitz AKS media must not be autoclaved.
Do not autoclave the capsules in the bag supplied.
When sanitary connections are used, it is recommended that the sanitary clamp is not fully tightened prior to autoclaving. The clamp should be fully tightened only when autoclaving is completed.
The vent and drain valves should be fully opened before autoclaving.
Warning: Stax filter capsules and manifolds must not be gamma irradiated. Gamma irradiation can result in degradation of the materials of construction resulting in potential rupture of the capsules during use and may lead to personal injury.
The efficiency of the sterilization cycle is the responsibility of the user.
5.2 Hot Water Sanitization
The product can be sanitized either pre or post use with hot water up to 80 °C with a maximum operating pressure of 1 bar g (14.5 psi g) and no more than 60 minutes total exposure time at that temperature.
Caution: Hot water at 80 °C can lead to serious skin damage, so adequate care must be taken to avoid uncontrolled spillage of hot water during the sanitization process.
Caution: Special care is needed upon system venting.
Caution: Before opening the system for disassembly you must ensure the Stax system is no longer under pressure.
Caution: Hoses and tubings must be specified for use at 80 °C under pressure.
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