Allegro™ Single-Use Filling Needles product photo Primary L

Allegro™ Single-Use Filling Needles

For Single-Use Final Filling Applications

Filling inaccuracy, dripping and needle clogging lead to costly product losses and process downtime at a critical stage in the manufacture of drug products. Allegro single-use filling needles overcome these challenges through the inherent hydrophobicity of their unique reinforced polyether ether ketone (PEEK) construction and their availability in a wide range of internal diameters.

These combine to deliver accurate and reliable dispensing across a broad range of drug products and dosing volumes as part of an autoclaved assembly or when integrated into a gamma-irradiated single-use system.

Complete single-use assemblies incorporating the Allegro needles simplify filling machine operation, reduce assembly time and needle installation risks. The needles come in different sizes:

  • 0.8, 1.2, 1.6, 2.4 and 3.2 mm with female luer connection
  • 3.2, 4.0, 5.0 and 6.0 mm with a direct connection

Features and Benefits

 
Features Benefits
Ready to use, single-use No cleaning verification or validation needed; increase manufacturing up time and decrease turnaround and cleaning time; particulate and endotoxin claims per USP methods remove the requirement for pre-flushing and drying
Plastic needle reinforced by stainless steel Autoclavable, gamma irradiatable, and ready to use; product contact portion is PEEK (and polypropylene for luer connection)
Straightness of needle Allows bottom up high speed filling
Control of shaft diameter No drip formation (subject to other filling machine parameters); accurate volumetric filling
Female luer connection for sizes 0.8, 1.2, 1.6, 2.4 and 3.2 mm and direct connection for sizes 3.2, 4.0, 5.0 and 6.0 mm Allow for easy integration in filling lines or systems; o-ring prevents slippage in filling head assembly
Available in a range of lumen diameters Facilitate a range of filling volumes
Every needle is laser marked with part number and batch number Easy identification; fully traceable production history
 


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Pack of 12 SU Needles - 0.8mm luer product photo

Allegro™ single-use filling needle, 0.8 mm ID, with luer connection (pack of 12)

Product ID: DFNLR1208608
Unit of Measure
1/EA
Min Order Qty
1
Allegro™ single-use filling needle, 1.2 mm ID, with luer connection (pack of 12) product photo

Allegro™ single-use filling needle, 1.2 mm ID, with luer connection (pack of 12)

Product ID: DFNLR1208612
Unit of Measure
1/EA
Min Order Qty
1
Pack of 12 SU Needles - 1.6mm luer product photo

Allegro single-use filling needles, luer connection, 1.6 mm ID, pack of 12

Product ID: DFNLR1208616
Unit of Measure
1/EA
Min Order Qty
1
Allegro™ single-use filling needle, 2.4 mm ID, with luer connection (pack of 12) product photo

Allegro™ single-use filling needle, 2.4 mm ID, with luer connection (pack of 12)

Product ID: DFNLR1208624
Unit of Measure
1/EA
Min Order Qty
1
Pack of 12 SU Needles - 3.2mm luer product photo

Allegro™ single-use filling needle, 3.2 mm ID, with luer connection (pack of 12)

Product ID: DFNLR1208632
Unit of Measure
1/EA
Min Order Qty
1
Pack of 12 SU Needles - 3.2mm straight product photo

Allegro™ single-use filling needle, 3.2 mm ID, with direct connection (pack of 12)

Product ID: DFNST1201132
Unit of Measure
1/PAC
Min Order Qty
1
Pack of 12 SU Needles - 4.0mm straight product photo

Allegro single-use filling needles, direct connection, 4.0 mm ID, pack of 12

Product ID: DFNST1201140
Unit of Measure
1/PAC
Min Order Qty
1
Pack of 12 SU Needles - 5.0mm straight product photo

Allegro™ single-use filling needle, 5.0 mm ID, with direct connection (pack of 12)

Product ID: DFNST1201150
Unit of Measure
1/PAC
Min Order Qty
1
Pack of 12 SU Needles - 6.0mm straight product photo

Allegro single-use filling needles, direct connection, 6.0 mm ID, pack of 12

Product ID: DFNST1201160
Unit of Measure
1/PAC
Min Order Qty
1

Documents

Datasheets

Download: English

Description

For Single-Use Final Filling Applications

Filling inaccuracy, dripping and needle clogging lead to costly product losses and process downtime at a critical stage in the manufacture of drug products. Allegro single-use filling needles overcome these challenges through the inherent hydrophobicity of their unique reinforced polyether ether ketone (PEEK) construction and their availability in a wide range of internal diameters.

These combine to deliver accurate and reliable dispensing across a broad range of drug products and dosing volumes as part of an autoclaved assembly or when integrated into a gamma-irradiated single-use system.

Complete single-use assemblies incorporating the Allegro needles simplify filling machine operation, reduce assembly time and needle installation risks. The needles come in different sizes:

  • 0.8, 1.2, 1.6, 2.4 and 3.2 mm with female luer connection
  • 3.2, 4.0, 5.0 and 6.0 mm with a direct connection

Features and Benefits

 
Features Benefits
Ready to use, single-use No cleaning verification or validation needed; increase manufacturing up time and decrease turnaround and cleaning time; particulate and endotoxin claims per USP methods remove the requirement for pre-flushing and drying
Plastic needle reinforced by stainless steel Autoclavable, gamma irradiatable, and ready to use; product contact portion is PEEK (and polypropylene for luer connection)
Straightness of needle Allows bottom up high speed filling
Control of shaft diameter No drip formation (subject to other filling machine parameters); accurate volumetric filling
Female luer connection for sizes 0.8, 1.2, 1.6, 2.4 and 3.2 mm and direct connection for sizes 3.2, 4.0, 5.0 and 6.0 mm Allow for easy integration in filling lines or systems; o-ring prevents slippage in filling head assembly
Available in a range of lumen diameters Facilitate a range of filling volumes
Every needle is laser marked with part number and batch number Easy identification; fully traceable production history
 

Specifications

Quality Standards

  • Manufactured in an ISO class 8 clean room facility
  • Manufactured under a quality management system certified to ISO9001
  • Supplied with a Certificate of Test confirming the quality standards and quality control tests performed by Pall (including endotoxin per USP <85> and particulates per USP <788>)
  • Validation tests include:
    • Dimensional accuracy
    • Leak test for luer connected needles
    • Shelf life
    • Autoclave / irradiation
    • Extractables
  • The fluid path meets all regulatory requirements for:
    • Biological Reactivity Tests (In Vitro) for Class VI-121 °C Plastics ,USP <88>
    • Biological Reactivity Rests (In Vitro) for Cytotoxicity, USP <87>
    • Particulate Matter in Injections, USP <788>
    • Physiochemical Tests for Plastics, USP <661>
    • Bacterial Endotoxins Test, USP <85>

For materials of construction and product specifications, please refer to the product datasheet.

Applications

The Allegro single-use filling needle can be used in a variety of ways.

  • In existing filling machines where the needle can replace its stainless steel counterpart
  • Integrated in a single-use system for final formulation and filling with other Allegro components, such as product feed and surge vessel biocontainers, Kleenpak® sterile disconnectors, Kleenpak sterile connectors, and tubing sets
  • Can be used for a broad range of filling applications (subject to fluid compatibility studies): liquid injectable pharmaceuticals, biopharmaceuticals pre-lyophilization, high potency drug filling, blood derivatives, vaccine vialling, high viscosity biological fluids (monoclonal antibodies, polysaccharides, etc, high concentration drugs
  • Used to fill a variety of fill volumes depending on customer requirements

Contract manufacturing and filling organizations accrue additional benefits with fast turnaround and removal of the need to control needle inventory for different batches and different clients.

Clinical trials and other smaller batches can be economically filled with less preparation work.

Type

Filling Needles

Use

Filling

Product Summary

A cost-effective, unique direct replacement alternative to the stainless steel filling needles traditionally used for aseptic filling of liquids