For Single-Use Final Filling Applications
The Allegro single-use filling needle offers a cost-effective, unique direct replacement alternative to the stainless steel filling needles that are currently used for aseptic filling of liquids.This versatile needle is easily integrated into new or existing single-use filling lines, where the fluid path is either autoclaved or gamma irradiated.Complete single-use assemblies incorporating the needles simplify filling machine operation, reduce assembly time and needle installation risks.
The Allegro single-use plastic filling needle consists of a Polyether Ether Ketone (PEEK) shaft reinforced with non-fluid contact stainless steel and a polypropylene hub.The needle comes in 6 different sizes - 0.8, 1.6 and 3.2 mm with female luer connection, and 3.2, 4.0, 5.0 and 6.0 mm with a direct tube connection.For use in a disposable sterile filling system, it can be either autoclaved or gamma irradiated.
The Allegro single-use filling needle is ready to use (after sterilization where required) and offers a completely disposable solution for final filling that avoids the cost and resource of filling needle cleaning verification and validation.Its use increases available manufacturing time and decreases down time of filling machines and associated equipment.
特色及优点
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Ready to use, single-use
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No cleaning verification or validation needed - Increase manufacturing up time and decreases turnaround and cleaning time
- Particulate and endotoxin claims per USP methods remove the requirement for pre flushing and drying
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Plastic needle reinforced by stainless steel
- Autoclavable and gamma irradiatable and ready to use
- Product contact portion is PEEK / Poly propylene for Stainless Steel sensitive biologics
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Straightness of needle
- Allows bottom up high speed filling
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Control of wall thickness
- No drip formation1
- Accurate volumetric filling
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Female luer connection for sizes 0.8, 1.6 & 3.2 mm and direct tube connection for sizes 3.2, 4, 5 & 6 mm
- Allows for easy integration in filling lines or systems
- O-ring prevents slippage in filling head assembly
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Available in a range of lumen diameters
- Facilitates a range of filling volumes
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Every needle is laser marked with part number and batch number
- Easy identification
- Fully traceable production history
1 Subject to other filling parameters
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
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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.
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 颇尔 (including endotoxin per USP <85> and particulates per USP <788>)
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Validation tests include:
- Dimensional accuracy
- Leak test for luer connected needles
- Shelf life
- Autoclave / irradiation
- Extractables
- Hub integrity
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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>
材料成分
| Allegro Single-Use Filling Needle Component | Material of Construction | |
| 1 | O-Ring | Silicone |
| 2 | Hub | White polypropylene (TiO2 colorant) |
| 3 | Shaft | PEEK with stainless steel reinforcement |
| 4 | Packaging sheath | 聚碳酸酯 |
Aqueous Extractables (NVR)
| Water at 20 – 25 °C after autoclaving and gamma irradiation | Typically < 1 mg |
Sterilization Methods
| Gamma irradiation | Maximum 50 kGy |
| Autoclave | 1 cycle @ 75 mins at 130 °C |
Operating Conditions
| Range of operating temperature | 2 – 40 °C |
尺寸
| 描述 | Luer Connection | Straight Connection | |||||
| Internal diameter (ID) |
0.8 毫米 (0.03 in.) |
1.6 mm (0.06 in.) |
3.2 mm (0.13 in.) |
3.2 mm (0.13 in.) |
4.0 mm (0.16 in.) |
5.0 mm (0.2 in.) |
6.0 mm (0.24 in.) |
| Overall length (A) |
120 mm (4.72 in.) |
120 mm (4.72 in.) |
120 mm (4.72 in.) |
120 mm (4.72 in.) |
120 mm (4.72 in.) |
120 mm (4.72 in.) |
120 mm (4.72 in.) |
| Shaft length (B) |
75 mm (2.95 in.) |
75 mm (2.95 in.) |
75 mm (2.95 in.) |
75 mm (2.95 in.) |
75 mm (2.95 in.) |
75 mm (2.95 in.) |
75 mm (2.95 in.) |
| Hub diameter (C) |
8.6 mm (0.34 in.) |
8.6 mm (0.34 in.) |
8.6 mm (0.34 in.) |
10.9 mm (0.43 in.) |
10.9 mm 0.43 in.) |
10.9 mm (0.43 in.) |
10.9 mm (0.43 in.) |
| Flange diameter (D) |
12 mm (0.47 in.) |
12 mm (0.47 in.) |
12 mm (0.47 in.) |
14 mm (0.55 in.) |
14 mm (0.55 in.) |
14 mm (0.55 in.) |
14 mm (0.55 in.) |
| Shaft outer diameter (E) |
2.2 mm (0.09 in.) |
2.2 mm (0.09 in.) |
3.8 mm (0.15 in.) |
4.6 mm (0.18 in.) |
5.4 mm (0.21 in.) |
6.4 mm (0.25 in.) |
7.4 mm (0.29 in.) |
| Part Number | 描述 | Packaging |
| DFNLR1208608 | 0.8 mm ID needle with luer connection | 12 per tray |
| DFNLR1208616 | 1.6 mm ID needle with luer connection | 12 per tray |
| DFNLR1208632 | 3.2 mm ID needle with luer connection | 12 per tray |
| DFNST1201132 | 3.2 mm ID needle with direct connection | 12 per tray |
| DFNST1201140 | 4.0 mm ID needle with direct connection | 12 per tray |
| DFNST1201150 | 5.0 mm ID needle with direct connection | 12 per tray |
| DFNST1201160 | 6.0 mm ID needle with direct connection | 12 per tray |
