top of page
High-quality
COC materials
Manufacturing
with ISO
Sterillzation
with ISO
Prefilled
Syringe
Key
Information
Syringes are designed in accordance with ISO 11040-6:2019
(Prefilled syringes-Part 6:Plastic barrels for injectiales)
and manufactured under the Quality pursuant to ISO 13485:2016
(Medical devices-Quality management system - Requirement for
regulatory purposes)including the clreanroom ISO 8.
Raw materials
Cyclo-Olefin-Copolymer, Topas Advanced Polymer Gmbh
CAS No. 26007-43-2
Sterilization
Ethylene Oxide sterilization with validated parameters in accordance
ISO 11135:2014 Sterilization of health care products - Ethylene oxide
Hazardous substaneces
Preservative free
DEHP free
Latex free
Non-Pyrogenic
Cone
Luer Lock by ISO 80369-7:2016 Conical fittings with 6% (Luer)
taper for syringes, needles and certain ather medical equipment
- Part 2 Lock fittings
SAL (Sterility Assurance Level)
Color
Transparent
-6
10
Gliding Force
5mL Syrige only
Gliding force
A: Break loose region
B: Glide froce test region
Test method
ISO11040-6:2019 Annex E
ISO11040-6:2019 Annex E
Result
Mean 20.82N
Mean 7.6N
Product composition
1mL
5mL
10mL
Barrel
Tip Cap
Pluger Rod
Nest & Packaging
Mouse over text to view detailed specifications.
Manufacturing in accordance with ISO
It is manufactured according to ISO 13485 and thoroughly managed with quality and production control located at
manufacturing facilities including ISO class 8 Clean room which meets international standards and GMP standard.
Suitable Nest
This nest is suitable for all of the usual filling system.
High-quality Materials
The syringe barrels are made of Cyclic Olefin Copolymer material and are availables
as complete system including components such as tip cap, plugers and pluger rod.
Silicone Layer Suface
The siliconization is performed with a reactive silicone mixture which finally leads to a dense cross linked silicone layer on the polymer surface.
Prefilled Syringe
It is designed to be prefilled with various drugs under aseptic condition.
Test Data Sheet
Perfomance test
Flange breakage resistance
Syringe tip breakage resistance
Closure system integrity
Liguid leakage
Falling drop positive pressure liquid leakage
Sub atmospheric pressure air leakage
Stress cracking
Lubricant
Test method
ISO 11040-6: 2019 Annex C1
ISO 11040-6: 2019 Annex C2
ISO 11040-6: 2019
ISO 80368-20: 2015 Aneex B
ISO 80368-20: 2015 Aneex C
ISO 80368-20: 2015 Aneex D
ISO 80368-20: 2015 Aneex E
ISO 11040-6: 2019
Result
Not less than 300 N
Not less than 100 N
No leakage
No leak
No sign of leakage
Not leak
No leak
No adnormality
Biocompatibilty
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute System
Pyrogenicity
Test method
ISO 10993-5: 2019
ISO 10993-10: 2021
ISO 10993-10: 2021
ISO 10993-11: 2017
ISO 10993-11: 2017
Extraction
Appearance
pH
KMn04 reducing agnets
Evaporating residue
Heavy metals
UV-vis Spectrum
Result
No foreign material
Difference in pH ≤ 1.5
Difference in titers ≤ 1.5 mL
Difference in extractables ≤ 1.5 mg
Not darker than standard Solution
Difference in absorbance ≤ 0.1
bottom of page