Pall Stax, Инструкция по эксплуатации

Страница: 5 / 16

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 pres-
sure hold installation test may 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.
5
USD 2554c www.pall.com/biopharm
!
!
!
!
!
!
!
!
!
216495 - Pall Europe Ltd GN12.5291.qxd:Layout 1 1/6/12 14:10 Page 5