|
|
0.05 m2 capsule |
0.15 m2 capsule |
0.5 m2capsule |
1.0 m2 capsule |
| Nominal Dimensions |
| 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 |
| Membrane |
Polyethersulfone (PES) |
| Support Layer |
Polyethylene |
| Housing |
Gamma-stable polypropylene |
| Vent |
Polyethersulfone |
| O-rings |
Silicone, EPDM |
| Standard Connections |
| 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. |
| 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. |
