groninger single-use filling needle

Single-Use Filling Needles

Increase production while reducing risk and utility consumption

groninger single-use filling needles are available in different sizes, are compatible with groninger filling machines but can also be integrated by various machine vendors. Unlike multi-use needles, our single-use filling needles are provided cleaned and gamma irradiated, sterile and double packed. This eliminates the need for the end-user to perform any cleaning or sterilization of the needles. The needles are manufactured out of SST 316L/1.4435 according to DIN EN 10204 3.1. They have an inside and outside surface roughness of Ra 0.4 (except welding seams). With our best in-class single-use filling needle, we ensure optimum fill/finish results by establishing the highest quality standards.

groninger single-use insertion
Insertion of the groninger single-use filling equipment
groninger Single-Use Packaging
Packaging of the single-use equipment
groninger single-use needle installation
Installation of the groninger single-use needle
groninger single-use needle
Single-use needle

Available in different sizes for a filling range from 0.1 ml – 100 ml

Outer Diameter [OD] in mm Inner Diameter [ID] in mm Length in mm
1.8 0.8 165
2.1 1.1 165
2.0 1.6 165
2.5 2.1 165
3.0 2.6 165
4.0 3.0 165
5.0 4.0 165
6.0 5.0 165
7.0 6.0 165
8.0 7.0 165
6.0 5.0 244
8.0 7.0 244

Benefits of Single-Use Filling Needles

  • Eliminates the need for inline CIP/SIP
  • Reduced CAPEX
  • Reduced risk for cross contamination
  • Closed system/process
  • Increased machine availability

Our single-use filling needles can be integrated into a final fill set manufactured by a single-use equipment supplier, or directly ordered and integrated by the end-user.
 

The needles are validated which includes the following:

Cleaning

  • Validation and revalidation of microbiological reduction (EN ISO 11737)
  • LAL Endotoxin Reduction (USP 85, ANSI/AAMI ST 72)
  • Particulate load (USP 788)
  • Cytotoxicity (EN ISO 10993)
  • Bioburden (EN ISO 11737)

Sterility

  • Validation and revalidation of gamma sterilization (EN ISO 11137) 
  • Validation on sterile barrier (EN ISO 11607, ASTM F 1980)
  • Transport validation (EN ISO 11607, ISTA 2A)
  • Accelerated storage-testing (EN ISO 11607, ASTM F 1980)

Storage

  • Temperature range: 10–25 ºC
  • Humidity: 30–60%
  • Sterilization method: Gamma (min. 25 kGy)
  • Max. dose: 50 kGy
  • Working temperature range: 5–45 ºC    
  • UV protected, avoid direct solar irradiation

Shelf life

  • 5 years after packaging (sterility claim for barrier system)

Certificate

  • Declaration of Conformity (DOC)
Filling path with single-use filling needles and single-use rotary piston pump

Single-Use Rotary Piston Pump

Ideally suited for difficult to fill products

Learn more