Material Qualification Dossier
|Viresolve® Barrier Filter User Guide|
Specifically designed to process cell culture media, Viresolve® Barrier filters are the last line of defense against bioreactor contamination. These filters have demonstrated high retention of virus, mycoplasma and bacteria, including spirochetes, while providing high flow and capacity.
Robust protection from adventitious agents
- ≥ 3.0 log removal of parvovirus
- ≥ 6.0 log removal of mycoplasma
- Sterilizing-grade protection from bacteria
- 100% integrity tested in manufacturing, ensuring quality and consistency
Efficient virus filtration for cell culture media
- No impact to cell culture media performance
- High-flux virus filtration
- Easy to implement, install and integrity test
- Scalable from preclinical through commercial manufacturing
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
|0.05 m2 capsule||0.15 m2 capsule||0.5 m2capsule||1.0 m2 capsule|
|Height||23.6 cm (9.3 in.)||23.6 cm (9.3 in.)||29.7 cm (11.7 in.)||39.6 cm (15.6 in.)|
|Diameter||19.0 cm (7.5 in.)||19.0 cm (7.5 in.)||19.0 cm (7.5 in.)||19.0 cm (7.5 in.)|
|Materials of Construction|
|Inlet and outlet||½ in. hose barb or 1½ in. sanitary flange|
|Vents||¼ in. hose barb on inlet end of capsule; fractional sanitary flange on outlet end of capsule|
|Maximum Differential Pressure|
|Forward||4.1 bar (60 psi) at 25 °C|
|Reverse||0.3 bar (5 psi) at 25 °C|
|Bacteriophage Retention||Filters exhibit LRV ≥ 4.0 using ΦX-174 bacteriophage at a minimum challenge level of 107 pfu/mL.|
|Mycoplasma Retention||Each lot of membrane is tested and exhibits LRV ≥ 6.0 using A. laidlawii ATCC® 23206 and our validated test method.|
|Bacterial Retention||Membrane and filters are validated as sterilizing grade - quantitatively retentive of a minimum B. diminuta challenge of 107 CFU/cm2 using ASTM® F838 methodology.|
|100% Integrity Tested in Manufacturing||Each device must pass the EMD Millipore Corporation integrity test correlated to the B. diminuta ASTM® F838 bacterial challenge test.|
|Toxicity||Component materials were tested and meet the criteria for non-cytotoxicity for the USP <87> Cytotoxicity MEM Elution Tests.
Component materials were tested and meet the criteria for USP <88> Biological Reactivity Tests for Class VI Plastics.88>
|Bacterial Endotoxin||An aqueous extract contains less than 0.25 EU/mL, per USP <85>, as determined by the Limulus Amebocyte Lysate (LAL) test.|
|Non-particle Releasing||Filters meet the requirements of USP <788>|
|Sterilization||Filter integrity and performance characteristics are maintained after exposure to a maximum gamma radiation dose of 40 kGy.|
|Good Manufacturing Practice||Filters are manufactured in a facility that adheres to Good Manufacturing Practices.|
|ISO® 9001 Quality Standard||Filters are manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO® 9001 Quality Systems Standard.|
|Particulate and Bioburden||Filters are manufactured in an ISO® Class 8 (per ISO® 14644-1) controlled environment for particulate classification only.|
|Animal Origin||Component materials are either animal free or in compliance with EMEA/410/01.|