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IDENCY, the next generation of glass vials

IDENCY, the next generation of glass vials

IDENCY, the perfect Type I borosilicate complementary product to your current portfolio

The rising demand for parenteral drugs (+4% 2021 vs 20201) has subsequently increased supply chain pressures for glass vials.

SGD Pharma developed IDENCY, the perfect Type I borosilicate complementary product to your current portfolio.

IDENCY is suitable for all parenteral drugs, especially for the most sensitive ones.

  1. IQVIA, in volume, vials & bottles for parenteral only
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IDENCY, the next generation of glass vials

IDENCY product features

IDENCY vials combine high chemical and mechanical resistance with the same outer diameter as standard tubular glass vial to ease the integration into your existing filling lines.

IDENCY product features
Superior chemical durability vs uncoated converted vials
Good inspectability
capabilities after filling
Simply stronger
Dimensional compatibility with existing filling lines equipments
and change parts (Body diameter only)
25% reduced carbon footprint
vs standard 10R (tubular)

Patient safety

  • Proven chemical durability enhancing compatibility drug/glass (high hydrolytic resistance, low extractables, no surface degradation)
  • No glass delamination concerns
  • Good inspectability capabilities after filling

End to end path of IDENCY vials

End to end path of IDENCY vials

Chemical durability

Chemical durability

Comparative study between 10MR IDENCY and 10R tubular vials from 4 suppliers.

Surface Hydrolytic Resistance according to EP 3.2.1 and USP <660> (10 vials)
HCI mL
 
 
 
 
 
 
 
 
 
Lab reports 1968 and 1972 made by our R&D department in 2022
Total extractables through water attack (3 vials)
UGL
 
 
 
 
 
 
 
N/A
 
10MR IdencySupplier ASupplier BSupplier CSupplier D

The 10MR IDENCY vials shows stronger chemical durability compared with 10R tubular vials.

Chemical durability

Robustness

Stronger mechanical resistance when compared with standard 10R tubular vials. A smoother fill and finish process as the strong mechanical resistance limits vials breakage and line stops.

Compression in axial mode (Newton) - 30 vialsCompression in axial mode (Newton) - 30 vials
10R
 
10MR
 
2.5 x more resistant
Compression in vertical mode (Newton) - 30 vials Compression in vertical mode (Newton) - 30 vials
10R
 
10MR
 
4 x more resistant
Internal pressure resistance (bar) - 30 vials Internal pressure resistance (bar) - 30 vials
10R
 
10MR
 
1.5 x more resistant

Report 1022787 made by Cetim in July 2022

The 10MR IDENCY vials exhibit better mechanical resistance in comparison to the standard 10R tubular vial tested.

Drawing

Drawing

Drawing
Key criteria ISO molded 00770 Tubular 10R IDENCY 10MR
Body Diameter 25.4 ± 0.4 mm 24.0 ± 0.2 mm 23.8 ± 0.4 mm
Total Height 53.5 ± 0.6 mm 45.0 ± 0.5 mm 50.0 ± 0.5 mm
Brimfull capacity 15 ± 1mL 13.5 ± 1 mL 13.5 ± 1 mL
Weight ~ 21g ~ 9.5 g ~ 16 g

The new 10MR IDENCY vials have, including tolerances, the same maximum outer diameter as conventional 10R tubular vials.

Sustainability

Sustainability

Reduced carbon footprint impact through light weighting & thanks to the production process

Sustainability

SGD Pharma’s experts made a comparative calculation of the weight and the quantities of CO2 emitted during the production of an ISO 10mL molded vial, a 10R vial and an 10MR IDENCY vial (scope 1 & 2*).

10MR IDENCY compared with : CO₂ emission saving
Standard ISO 10mL molded -24%(Lightweighting)
Standard 10R tubular (1mm thick glass wall) -25%(Production process)
*Scope 1 and 2 do not include the downstream and upstream activities but only the production activities.

Sustainability

PRODUCT RANGE

10MR Clear & Amber samples available NOW !

To increase serenity in terms of depacking for your supply chain team, IDENCY is supplied with customized packaging :

  • Shrink pack
  • PP tray

SGD Pharma is going to continue to extend the range of IDENCY vials with new sizes.

ml
ml
g
mm
mm
Type I
Type I
Reference
Nominal capacity
Brimful capacity
Weight
Standard neck-finish
Height
Ø
Type of pack
Pcs per pack
Clear glass Type I
Amber glass Type I
20604
10
13.5
16
ISO 20
50
23.8
Shrink pack or tray
154 vials per tray
202 vials per pack

DID YOU KNOW…. ?

IDENCY molded glass vials are produced entirely in France at the Saint-Quentin-Lamotte plant, a state-of-the-art facility, world-leader in Type I glass, manufactured in a 100% electric furnace newly installed in 2018. In addition, this plant has an ISO8 clean room where IDENCY vials will be 100% inspected.

SGD Pharma's experts are committed to helping and supporting all our pharmaceutical partners whenever they need it. To reinforce this mindset, SGD Pharma launched a new service platform including specific training and support on our areas of excellence such as quality, technical and regulatory. SGD Pharma Plus