Acufil™ Single Use Filling Needles
mdi Acufil™ single use filling needles for aseptic filling of liquids are designed for accurate volume filling of both mobile and viscous drug products without drip formation. These offer ready to use filling solutions both as part of complete gamma sterilized single use filling lines and as a gamma sterile individually packed components to be used in existing filling lines.
mdi Acufil™ single use filling needles offer flexibility as these come in different sizes i.e 1.6mm, 3mm, 4mm, 5mm, and 5.4mm with female luer connection or hose barb connections.
- 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 | Sizes and Connections Available
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| Materials of Construction | |||||||||||||
| Hub | Polypropylene | ||||||||||||
| Needle | Stainless Steel 316 | ||||||||||||
| Operational | |||||||||||||
| Water Flow Rate | 1.6mm Needle: >350ml/min @ 2.5psi 3.0mm Needle: >500ml/min @ 2.5psi |
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| 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 ISO11737-1 : 2018 | ||||||||||||
| 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 | ||||||||||||
Please contact: info@mdimembrane.com