UA-44035381-1
  • Acufil Single Use Filling Needles

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 2 different sizes i.e 1.6 mm and 3 mm 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

NeedleIDODLength
SSFNXXBXXXXR1011.6mm2mm100mm
SSFNXXCXXXXR1013mm3.5mm100mm
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
XX
ID
Code
1.6mm B
3mm C
XXX
X
Radiation Sterilizable
Code
No X
Yes R
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Code
1 01

     Example:

SSFN XX C XXX X R 1 01
Datasheet Download
Certificate of Quality Download

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