Prefillable glass syringes,needle syringes, glass needle syringes, ready-to-use, ready-to-fill
Gx® Prefillable Glass
Needle Syringes

Gx® bulk and Gx RTF® format

We offer an extensive portfolio of prefillable glass needle syringes that are adapted to the current requirements of the pharmaceutical industry and fulfill the requirements of modern filling systems. The glass syringes with glued in cannula are available as bulk goods (Gx® bulk) or in „ready-to-fill“ format (Gx RTF®). Syringes can be provided as a complete system with plunger stopper, plunger rod and backstop. Various options for siliconization and printing complete our offer. A Drug Master File Type III is available.

Your PLUS with Gerresheimer

Gx® bulk and Gx RTF® format

Packaging of bulk syringes in Rondo trays
Packaging of bulk syringes in Rondo trays in clean room GMP class D

Gx® bulk needle syringes are washed, sterilized, and filled by the customer. For this form, there is a division of labor between the primary packaging manufacturer and the pharmaceutical industry where we provide the unsterilized syringe bodies in flat trays (Rondo trays).

Packaging of Gx RTF® glass syringes in nests
Packaging of Gx RTF® glass syringes

Gx RTF® needle syringes are washed, siliconized, pre-assembled with needle shields or tip caps and sterilized with ethylene oxide (EtO) by Gerresheimer Medical Systems. This means we deliver the prefillable glass needle syringe completely prepared for aseptic filling. 

Gx RTF® syringes are packed in nests for easy handling and filling. These nests are suitable for all usual filling systems. Gx RTF® syringes are nested by:

  • 100 nest (10x10) for 0.5 ml, 1.0 ml long and 1.0 – 3.0 ml
  • 160 nest (10x16) for 0.5 ml und 1.0 ml long

Syringe sizes from 0.5 ml to 2.25 ml (additional formats upon request)

The high-quality prefillable glass syringes are produced from type I glass. The prefillable needle syringes are available in syringe sizes from 0.5 ml to 2.25 ml (individual solutions on request).

0.5 ml
47.6
6.85
4.65
1/2
1.0 ml long
54.0
8.15
6.35
1/2
1.0 ml standard
35.7
10.85
8.65
1/2 | 5/8
1.5 ml
43.2
10.85
8.65
1/2 | 5/8
2.25 ml
54.4
10.85
8.65
1/2

Integrated cannulas in various versions

Our range encompasses stainless steel cannulas of the most varied lengths, diameters and bevel types. They ensure intramuscular or subcutaneous injections with minimal pain. The steel quality of the cannulas used corresponds to AISI 304, the sizes to standard DIN 9626.

Cannula properties:

  • Siliconization in the RTF process with Dow Corning® 360
  • Cannula length: ½“ (12.7 mm) and  ⅝“  (15.9 mm)
  • Diameter: 23G, 25G, 26G, 27G, 29G
  • Standard and thin-wall cannulas
  • Bevel: 3 Bevel, 3 Bevel XL, V® Bevel
23G thin-wall cannula for prefillable glass syringes 1/2“ (12.7 mm) 3 Bevel
23G thin-wall cannula
1/2“ (12.7 mm)
3 Bevel
25G cannula for prefillable glass syringes25G cannula for prefillable glass syringes 5/8“ (15.9 mm) 3 Bevel
25G cannula
5/8“ (15.9 mm)
3 Bevel
26G thin-wall cannula for prefillable glass syringes 1/2“ (12.7 mm) 3 Bevel XL
26G thin-wall cannula
1/2“ (12.7 mm)
3 Bevel XL
27G cannula for prefillable glass syringes 1/2“ (12.7 mm) 3 Bevel XL
27G cannula
1/2“ (12.7 mm)
3 Bevel XL
27G cannula for prefillable glass syringes 1/2“ (12.7 mm) 3 Bevel
27G cannula
1/2“ (12.7 mm)
3 Bevel
27G thin-wall cannula for prefillable glass syringes 1/2“ (12.7 mm) 3 Bevel
27G thin-wall cannula
1/2“ (12.7 mm)
3 Bevel
27G cannula for prefillable glass syringes 1/2“ (12.7 mm) V® Bevel
27G cannula
1/2“ (12.7 mm)
V® Bevel
29G thin-wall cannula for prefillable glass syringes 1/2“ (12.7 mm) V® Bevel
29G thin-wall cannula
1/2“ (12.7 mm)
V® Bevel

Various needle shields

The needle shield protect the cannula against deformation up to injection, and keeps the cannula sterile until use. Our range encompasses flexible needle shields (FNS), rigid needle shields (RNS), as well as proprietary solutions like the Gx TERNS® (Thermoplastic Elastomer Rigid Needle Shield) exclusively developed and supplied by Gerresheimer.

RNS and FNS

EtO-sterilizable rubber formulas: Datwyler FM27, Stelmi 4800 GS, West 7025/65, project-related formulas and needle shields upon request

Rigid needle shield for prefillable glass needle syringes RNS
Rigid needle shield
Flexible needle shield for prefillable glass needle syringes, FNS
Flexible needle shield

Gx TERNS®

Thermoplastic Elastomer Rigid Needle Shield

  • Patented rigid needle shield
  • Protects cannula from damage
  • Protects user against needle injuries
  • Preserves needle point integrity and thereby reduces patient pain perception
  • Exceptional stable pull-off forces over storage time
  • Manufactured of medical grade Thermoplastic Elastomer (TPE) and Polypropylene using two-component injection molding
  • Steam-, gamma- and EtO-sterilization possible
  • Suitable for use in an auto injector
  • Silicone oil-free
  • Different colors for customization
Patented rigid needle shield Gx TERNS® for prefillable glass needle syringes
Patented Needle Shield Gx TERNS®

Round and cut finger flanges

We offer the Gx® bulk and Gx RTF® prefillable glass syringes with glued in cannula with round (small and standard) and cut finger flanges.

Prefillable glass needle syringe with small round finger flange
Small round
Prefillable glass needle syringe with standard round finger flange
Standard round
Prefillable glass needle syringe with cut finger flange
Cut

Various options for siliconization

Siliconization is critical to ensure reliable function of prefillable needle syringes. It ensures optimal syringe performance for delivering medications. Thanks to the hydrophobicity of the silicon layer, potential interaction between the glass and the drug formula is reduced. As a standard, our glass syringes are spray-siliconized using diving nozzle technology in order to ensure an even coating with the smallest possible amount of silicone oil. We also offer our Gx® Baked-on RTF® glass syringes, which are patented in Europe and the USA for the packaging of sensitive biotechnological medications that may interact with free silicone oil droplets. In this procedure, a silicone oil emulsion is applied to the inner surface of the syringe body and subsequently thermally fixated on the surface by heating. This significantly reduces the number of free silicone oil droplets. Despite the considerably reduced amount of silicone oil, the syringes offer reliable hydrophobic properties and especially low breakout and gliding forces that remain stable throughout the storage period.

Baked-on siliconization for prefillable glass syringes
Baked-on siliconization for the reduction of free silicone oil

Advantages of the Gx Baked-on RTF® syringe

  • Reduced interaction risk between drug formula and silicone oil 
  • Drastically reduced amount of silicone oil droplets below the visibility threshold
  • Masking and inactivation of the glass surface 
  • Long-term stable, evenly distributed, and chemically inert lubricity coating
  • Very even break loose and gliding force profile
  • Ensures optimal functionality and drug formulation stability over the period of medication storage
  • Patented in Europe and USA

Various possibilities for printing

Printing of prefillable glass needle syringes
Printing of the glass syringe body with metal-free paints

For the individual printing of the glass syringe body of the prefillable needle syringe we offer the most varied possibilities for printing such as metal-free paints, ceramic printing on glass, various designs of graduation, dose mark, various colors and other options on request.

Syringes as a complete system

Tungsten and metal-free production

Apart from silicone oil, additional substances of the prefillable needle syringe can interact with the active ingredient or components of the formula. For example, a tungsten pin is used to create the syringe bore in the standard glass forming process. When traces of tungsten or tungsten oxides remain in the bore area, protein-based medications may have adverse reactions in rare cases.

Avoiding tungsten residues by using forming pins of alternative materials
Avoiding tungsten residues by using forming pins of alternative materials

We offer various options for reducing or entirely avoiding tungsten residues. For example, forming pins of alternative materials can be used to form the cone in which case neither tungsten nor other metal residues remain behind in the bore. Alternatively, forming pins made of other metals/metal alloys can be used.

Avoiding tungsten oxides by integrating an additional cleaning step for glass syringes in the standard manufacturing process
The drum of a washing machine for the cleaning of glass syringes in order to reduce glass and tungsten particles

In addition to our standard manufacturing process we can offer a cleaning step for prefillable glass syringes following the forming of the glass using a washing machine. The combination of water and ultrasonic bath, our internally developed, multi-stage treatment system reduces not only the load of glass particles by up to 90 percent, but also reduces the tungsten load dramatically.

Prefillable COP plastic needle syringes
Prefillable COP plastic needle syringes for avoiding tungsten residuals

A third option is the use of plastics like Cyclo Olefin Polymers (COP) as syringe material. The production process has no potential for tungsten residuals. Our prefillable needle syringes of COP are therefore also exceptionally well-suited for the packaging of highly sensitive medication.

Method for detection and limit value for glue leachables

Method for detection of glue leachables for prefillable needle syringes
Gerresheimer offers a method for detection and a limit value for glue leachables

Syringes with glued in needles have lower loads of tungsten residues because the UV-hardened glue seals the sensitive syringe area. However, glue residues can nonetheless leach from the glue. We have optimized our production process reducing these residues, and additionally we offer a method for detection and a limit value for glue leachables.

Tailored, customer-specific solutions

Development of prefillable glass syringes and components
We develop your prefillable needle syringe adapted individually to the drug formula and the application area

Our development team would be happy to work together with you to develop a distinctive prefillable glass needle syringe which is matched to your specific agent, area of use and company brand.

Primary packaging and drug delivery device from one source

Development of a customized auto injector including the prefillable glass syringe
Gx® G-FixTM is a patented standard adapter for precise and reliable positioning of syringe and needle shield in an auto injector

Prefilled glass syringes are increasingly used in auto injectors or are equipped with safety systems against needle stick injuries. We have responded to this complex requirement profile by combining our know-how in glass and plastics with the creation of the newly defined Medical Systems business unit.

We have an established track record realizing customer-specific solutions in both glass and plastics. With our new team we are able to access an even broader base of experience in order to offer tailored solutions for increased medical technology challenges. This gives our customers the possiblity to develop, together with our experts for glass and plastics, a distinctive syringe, an application system or a combination product which is matched to a specific agent, area of use and company brand. 

Discuss your next syringe and medical device project with our experts!

Contact
Contact us!
Rolf Kitiratschky
Sales Europe
Phone
+49 (0) 5223 164 437
Karen Kanyok
Sales USA
Phone
+1 856 405 9737
Mike Nie
Sales Asia
Phone
+86 769 8851 7100 317