- No drip formation
- Accurate volume filling
- Available in two different internal diameters to facilitate different fill volumes
- Female luer connection and hose barb connection facilitates easy integration in filling line or systems
Small volume parenterals filling in pharmaceutical and biopharmaceutical manufacturing
Construction |
Dimension |
Needle | ID | OD | Length | SSFNXXBXXXXR101 | 1.6mm | 2mm | 100mm | SSFNXXCXXXXR101 | 3mm | 3.5mm | 100mm |
|
Operational |
Water Flow Rate |
1.6mm Needle: >350ml/min @ 2.5psi
3.0mm Needle: >500ml/min @ 2.5psi |
Materials of Construction |
Hub |
Polypropylene |
Needle |
Stainless Steel 304 |
Assurance |
Bacterial Endotoxin |
Aqueous extracts exhibit < 0.125 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test |
Bioburden |
Bioburden level is < 1000 cfu/device as per ANSI/AAMI/ ISO11737-1 : 1995 |
Particle Release |
Complies with USP <788> test for particulate matter in injections |
Extractables |
Comply with USP <661> Plastic Packaging Systems and Their Materials of Construction; Physicochemical Tests for Nonvolatile Residue |
Type |
| | Code | Acufil Filling Needle | SSFN | | | | | | Radiation Sterilizable | | Code | No | X | Yes | R | | Sterility | | Code | Non Sterile | 1 | Gamma Sterile | 3 | | |
Example: