Integrity Tests And Integrity Test Data - Sartorius Maxicaps MR Virosart HF Instructions For Use Manual

General Information
1.7

Integrity Tests and Integrity Test Data

After wetting, Maxicaps
recommended that testing is performed by an automatic integrity testing
device like Sartocheck
For the Maxicaps
®
Test pressure:
Stabilization time:
Testing time:
Alarm values for the corresponding product:
3VI--28-MCG-MR2
3VI--28-MCG-MR3
3VI--28-MCG-MR4
3VI--28-MCG-MR5
3VI--28-MCG-MR6
3V2--28-IVG-MR3
3V2--28-IVG-MR6
For the Maxicaps
®
Test pressure:
Stabilization time:
Testing time:
8 Instructions for Use Maxicaps
MR Virosart
®
.
®
MR Virosart HF and Media the test conditons are:
®
2.5 bar | 36 psi
5 min
5 min
MR Virosart Max the test conditons are:
®
2.0 bar | 29 psi
5 min
5 min
can be integrity tested. It is highly
®
≤ 41.0 mL/min
≤ 60.0 mL/min
≤ 79.0 mL/min
≤ 99.0 mL/min
≤ 117.0 mL/min
≤ 48.0 mL/min
≤ 97.0 mL/min
MR Virosart HF, Max and Media
® ®