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Product Specifi cations
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
at pH 7.4
5
Miscellaneous
Connector
Recommended Use Flow
Rate
Maximum Flow Rate
6
7
Storage Conditions
8
Shelf-Life
1
Do not use this product for continuous service with compressed gasses. The use of compressed gas is permissible for
integrity testing and blow-down purposes. Limit integrity test and blow-down gas pressures to less than 1.4 bar (20 psig) and
temperature less than 25°C no more than 30 min.
2
Capsule Fill Volume is defined as the volume of liquid that is required to fill the capsule.
3
Post Blow down Hold up Volume is defined 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 flush the capsule.
5
Review Regulatory Support File for recommended alternate buffer selection.
6
Do not allow the liquid differential pressure across the capsule to exceed 2.4 bar (35 psid). Maximum flow rate may be limited by
system differential 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.
The Scale-Up Capsule must be fl ushed prior to use to remove the glycerin that is present as a
media stabilizer. Flush the capsule with 54 L/m
having a conductivity in the same range as that of 25 to 150 mM NaCl (3 - 16 mS/cm) at a fl ow rate
2
no higher than 210 L/m
/h (LMH). DO NOT use water as the fl ush solution. Flush in the forward fl ow
direction only. Intermittently bleed air off using the Luer Capped Air Vent on the capsule. Drain fl uid
from the capsule, if required, by opening the vent and outlet.
BV60R
EMP503AEX020R
EMP513AEX020R
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 sanitization
4
0.9 L
0.9 L
4.5 L
¾" Sanitary Connectors
60 mL/min
120 mL/min
180 mL/min
360 mL/min
Controlled indoor temperature: 0 - 30°C (32 - 86°F)
in original packaging
2 years from date of manufacture @ 30°C maximum storage
WARNING
2
(15.3 mL/bed volume) of a saline solution or buff er
-6-
BV120R
BV360R
EMP533AEX020R
121°C for 40 minutes
using Pre-vac cycle
1.8 L
5.5 L
1.8 L
5.5 L
5.4 L
10.2 L
360 mL/min
1080 mL/min
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