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
|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|
The Allegro single-use filling needle can be used in a variety of ways.
- In existing filing 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 applications1:
- Liquid injectable pharmaceuticals
- Biopharmaceuticals pre-lyophilization
- High potency drug filling
- Blood derivatives
- Vaccine vialling
- Used to fill a variety of fill volumes depending on customer requirements
Contract manufacturing and filling organizations accrue additional benefits with fast turn around 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.
1 Subject to fluid compatibility studies.
- 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
- Hub integrity
- 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>