EPI-MAX - EPIDURAL FILTER

Epi-Max filter is particularly suitable for the following filtra- tion applications:

Ampoule drug injection

Epidural anesthesia, local anesthesia Intraocular injectables

TPN solutions additives Low volume pain control Small volume sterilization Pharmacy admixture

Biosafety

Materials comply with USP class VI-121°C test and ISO 10993

Dimensions

WxLxD: 30.0 x 62.8 x 7.2 mm

Weight: 7.0 g

Hydrophilic filtration area

5.00 cm2

Inlet/Outlet connectors

Inlet: FLL female luer lock

Outlet: RMLL rotating male luer lock

Materials of construction

Housing: Clear / Amber Modified Acrylic

Filter media: Hydrophilic HI-FLO PES membrane 0.2 and 1.2 µm PES membrane 5.0 µm

Max bursting pressure

8 bar (116 psi)

Max operating temperature

5 - 40°C

Minimum Water Bubble Point

0.2/0.2pos µm: 3.7 - 4.8 bar

1.2 µm: 0.7 - 1.0 bar

5.0 µm: 0.15 - 0.3 bar

Minimum Water Flow Rate
0.2pos µm: > 10 ml/min @ 80 cm (31.5 in) water head pressure
0.2 µm: > 15 ml/min @ 80 cm (31.5 in) water head pressure
1.2 µm: > 90 ml/min @ 80 cm (31.5 in) water head pressure
5.0 µm: > 95 ml/min @ 80 cm (31.5 in) water head pressure
Pore Size
0.2 µm, other size available upon request
Bacterial Retention
0.2 µm – Brevundimonas diminuta
0.2 µm positive – Endotoxin
1.2 µm – Candida albicans
Priming volume
1.2 ml
Pyrogenicity
<0.25 EU/ml using the LAL test method
Sterilization Compatibility EtO or Gamma (25 kGy) Priming instructions
For an easy priming procedure, start with a dry Epi-Max in a vertical position with the flow arrow pointed up, i.e. invert to prime. The liquid will push the air through the filter before flow begins. After priming is complete (all air is evacuated from the housing), Epi-Max can stay any position.
Drug Compatibility
Epi-Max shows total compatibility with following drugs: 5-Flourouracil
Amphotericin B Bupivacaine HCL Dobutamine HCL Dopamine HCL Insulin
Lidocaine HCL Nitroglycerin Paclitaxel Piperacillin Sodium Citrate