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Verfügbare Sprachen
Verfügbare Sprachen
Capsule Shell and Manifold
Separator and Edge Seal
Product Specifi cations
End Cap
O-ring
Handles
Approximate Volume
2
Capsule Fill Volume
Holdup Volume Post Blow Down
Pre-use Sterilization and Sanitization
Autoclave Sterilization
(Only 1 autoclave cycle)
Base Sanitization
(Only 1 base sanitization cycle)
Post-use Sterilization and Sanitization
Autoclave Sterilization
Sanitization
Required Preconditioning Flush Volume
Flush Volume, No Pre-treatment
Flush Volume, Post-autoclave
Flush Volume, Post Base Sanitization
- 50 mM phosphate buff ered saline
5
at pH 7.4
Miscellaneous
Connector
Recommended Use Flow Rate
6
Maximum Flow Rate
Storage Conditions
7
8
Shelf-Life
1
Do not use this product for continuous service with compressed gasses. The use of compressed gas is permissible for
post-use integrity testing and blow-down purposes. Limit post-use integrity test and blow-down gas pressures to less
than 1.4 bar (20 psig) and temperature less than 25°C. for no longer than 30 mins.
2
Capsule Fill Volume is defi ned as the volume of liquid that is required to fi ll the capsule.
3
Post Blow Down Hold up Volume is defi ned as the volume of the residual liquid after gas (air or nitrogen) blow down.
4
The Required Preconditioning Flush is a saline solution, having a conductivity in the same range as that of 25 to 150 mM
NaCl (typical 3-16 mS/cm). DO NOT use water to fl ush the capsule.
5
Review Regulatory Support File for recommended alternate buff er selection.
6
Do not allow the liquid diff erential pressure across the capsule to exceed 2.4 bar (35 psi). Maximum fl ow rate may be
limited by system diff erential pressure.
7
Do not allow product to be exposed to freezing or extreme heat conditions.
8
USP <88> Class VI compliance and high adsorption capacity for up to 2 years from date of manufacture if stored as
indicated. Product labeling includes the expiration date.
Polyphenylene Oxide/Polystyrene
Filled Polypropylene
BV800R
EMP710AEX020R
N/A
3.4 L
3
0.7 L
121°C for 30 minutes using
Pre-vac cycle
1M Sodium Hydroxide (NaOH) for 60 minutes
Post use 1 autoclave cycle at 126°C for 30 minutes
1M Sodium Hydroxide (NaOH) or 5% Bleach (NaClO) for post-use
4
12 L
12 L
24 L
1 ½" Sanitary Connectors
0.8 L/min
2.4 L/min
Controlled indoor temperature: 0 - 30°C (32 - 86°F) in original
2 years from date of manufacture @ 30°C maximum storage
WARNING
-6-
BV5600R
EMP770AEX020R
Polypropylene
Silicone
Filled Polyamide
10.6 L
4.7 L
121°C for 40 minutes using
Pre-vac cycle
sanitization
85 L
85 L
85 L
5.6 L/min
16.8 L/min
packaging
temperature
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