Single-Use Filling Needles

Materials

SaniSure’s single-use filling needles consist of a 316L stainless steel tubing and a custom-designed polycarbonate housing to fit the needle holder of any filling machine. Each lot of the 316L stainless steel tubing has passed ISO 9626 testing for resistance to corrosion after cleaning and passivation. The polycarbonate used for the Filling Needle Housing is made from a USP Class VI, healthcare grade material certified to 21CFR177.1580. It is not made with animal sources and is compliant with EMA/410/01 Rev. 3, Section 6. It is not made with latex and does not contain phthalates, RoHS or REACH materials.

Cleaning, Inspection & Packaging

Final cleaning and inspection are conducted in an ISO Class 7 cleanroom. All filling needles are cleaned with 70% IPA and vertically dried under HEPA-fil[1]tered air. Each needle gets a final exterior wipe-down with 70% IPA and is visually inspected before it is sealed in a polybag inside the cleanroom. Mul[1]tiple single-bagged units are placed into a second bag which is also sealed under HEPA-filtered air. The double-bagged products are transported out of the controlled area in cardboard boxes layered with bubble wrap.

Overview
Product Information
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Sanisure’s Custom-designed Single Use Filling Needles

Come in a variety of sizes ranging from 0.8mm up to 5.0mm. They are easily integrated into new or existing single-use filling lines and can be gamma irradiated or autoclaved.The innovative in-house manufacturing process uses no oils or adhesives. Needle straightness (2mm/M) and overall concentricity are routinely inspected and critical dimensions are verified prior to lot release.

 

Features & Benefits

Co-Axial Filling Needles Custom-Designed For Final Filling Applications with Gas Overlay 

The Co-Axial Filling Needles have two concentric needle shafts to enable simultaneous filling of a gas overlay (via outer tubing) and liquid product (via inner tubing).SaniSure’s single-use Co-Axial Filling Needle consists of a custom-designed PEEK (polyetheretherketone) housing to fit the needle holder of any filling machine. The outer gas line tubing is 316L stainless steel and the inner tubing can be either PEEK or 316L stainless steel.

 

 

 

Product Literature

Dimensions:
  • Overall Length                        5.440in (138.2mm)
  • Shaft Length                           4.212in (107.0mm)
  • Housing Length                     1.260in (32.0mm)

 

Standard Housing Diameters:
  • 5 /16in (8.0mm)
  • 3/8in (10.0mm)
  • 1/2in (13.0mm)

 

Inner Tubing ID (1):
  • 0.8mm
  • 1.5mm
  • 2.5mm
  • 1.1mm
  • 2.1mm
  • 3.5mm

Additional Options:
  • The Gas Inlet Port is available in 90° or 45° configurations.
  • The Inner Tubing is available in 316L SS or PEEK.

 

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SaniSure, Inc. Main Office
1020 Flynn Road
Camarillo, CA 93012
877.777.3005 Toll Free
805.465.5600 Local