Pall Stax, Инструкция по эксплуатации

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Caution: Connections to drains must be secured to ensure controlled flow into the
plant drainage. Failure to do so may lead to serious health issues.
5.3 Sodium Hydroxide (NaOH) Decontamination
The product may be decontaminated once, post use, using an aqueous solution of up to
1M concentration of Sodium Hydroxide by either recirculation through the system at up to
250 liters/m
2
/hour or by filling the Stax system (static soak). Either method should not
exceed a 60 minute exposure time and a maximum solution temperature of 25 °C.
Warning: Stax capsules should not be exposed to 1M Sodium Hydroxide prior to use.
Caution: When decontaminating Stax systems with caustic solutions, appropriate
protective clothing including safety glasses must be worn.
Caution: Please liase with your local health and safety authorization on any plant specific
safety policies when handling these fluids.
Caution: Special care is needed upon system venting to avoid uncontrolled spillage.
Caution: Before disassemby of the modules, the system must be flushed with an
adequate amount of clean water to allow safe disposal.
Caution: Never attempt to open the system or associating tubings during caustic
exposure.
Caution: Hoses and tubings must be specified for use with 1 M NaOH.
Caution: Please liase with your plant safety authorization whether the required amount of
caustic solution can be handled by the plant sewage system directly or whether a
neutralization is needed prior to entering into the plant drainage system.
Caution: Any connections to drains or neutralization tanks must be secured to avoid
uncontrolled spillage. Failure to do so may lead to serious health issues.
6. Integrity Testing
The depth filter media incorporated into Stax filter capsules are not integrity testable to confirm
efficiency rating. Stax filter capsules are not supplied with sterilizing or virus grade membrane
that would be subject to integrity testing correlated to microbial efficiency. Stax filter capsules
can be installation tested by a low pressure hold test. Contact Pall for details.
7. Filter Assembly Replacement
Capsule assemblies and manifolds should be replaced in line with the GMP requirements of
the process. Where capsule assemblies are used for more than one manufacturing batch,
replacements are recommended when either the maximum allowable differential pressure has
been reached or the flow rate has become unacceptable whichever occurs first. Discard
capsule assembly in accordance with local Health and Safety and Environmental procedures.
No attempt should be made to clean disposable capsule assemblies and manifolds.
7.1 Post-Use Drainage and Blow Down
The blow down pressures are applicable to the filter media that has been wetted with water
only. After filtration with the product, add the value of the pressure differential of the Stax
system at the end of the process run to the pressures shown in Table 2: Blow Down
Pressures on page 7 and apply air pressure in incremental steps.
1. For units fitted with the vent manifold connect the air supply to the left hand vent valve.
Close the fluid inlet valve. Open the left hand vent valve fully and apply air pressure.
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216495 - Pall Europe Ltd GN12.5291.qxd:Layout 1 1/6/12 14:10 Page 6