For Biotech, Ophthalmics, and Vaccines Highly Sensitive to Silicone
Silicone oil can interact with highly sensitive molecules found in biotech products.1,2,3 Consequently, it has been recognized as one of the potential causes for aggregation and particle formation in therapeutic protein formulations.
Nipro's D2F™ Pre-fillable Glass Syringe - Silicone Oil-Free is a solution for drug products highly sensitive to silicone oil. The key quality attributes that are impacted by the absence of silicone have been tested4 thoroughly and the results confirm the excellent performance of the D2F™ Pre-fillable Glass Syringes - Silicone Oil-Free:
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Smooth Plunger Movement Performance
Consistent break loose and gliding forces due to plunger characteristics and hydrophilic glass surface with high surface free energy, good wettability, and good adhesiveness
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Very Low Particle Levels
Amount of visible and subvisible particles significantly below the limit criteria stated in EP 2.9.20 and EP 2.9.195
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Proven Container Closure Integrity
The syringes are offered in ENHANCE quality to meet the challenging drug product and service requirements of the pharmaceutical industry for sensitive drug products.
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Excellent Drug-container Compatibility
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Smooth Integration into Auto-injection Devices
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Optimized Processability for Minimal Drug Loss
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Extended Data Package for Fast Acceptance of Goods
Specifications
Product Range
| Volume (ml) | Outer Diameter (mm) | Tip | Flange | Shoulder |
|---|---|---|---|---|
| 1.0 long | 8.15 | Staked needle | Round | Round |
| Luer lock | Small round | |||
| Cut |
D2F™ Sterile Packaging
D2F™ syringes are manufactured in technologically advanced production sites that are certified according to ISO 15378, ISO 14001, and ISO 50001. Our fully automated cleaning and packaging process takes place in an ISO 7 / ISO 8 cleanroom with 100% monitoring under laminar air flow.
Special emphasis is placed throughout the entire D2F™ production process on particle reduction:
- Tub and nest are cleaned with ionized air
- No glass-to-glass contact
- Syringes are carefully washed
- Under laminar air flow
Nipro’s D2F™ packaging design is a smart and efficient choice enabling direct use on the filling line.
References
- Latoya S. Jones, Allyn Kaufmann, C. Russel Middaugh, Silicone Oil Induced Aggregation of Proteins, Journal of Pharmaceutical sciences, vol. 94, no. 4, April 2005.
- Michael Adler, Challenges in the development of pre-filled syringes for biologics from a formulation scientist´s point of view, American Pharmaceutical Review, 2012.
- Tina Tölke, Jenny Rudolf, Andreas Pfuch, Bernd Grünler, Syringe Siliconization, Pharm. Ind. 81, Nr. 3, 404-409, 2019.
- D2F Pre-fillable Glass syringes - Silicone Free - Nipro Product Development Report 2023.
- Compared to standard silicone oil syringe system
Downloads
Frequently Asked Questions (FAQs)
What does "PFS" stand for?
"PFS" stands for "Pre-Filled Syringe." A pre-filled syringe is a type of medical device used for the storage and administration of medications. It consists of a syringe barrel pre-filled with a specific dosage of medication, a plunger, and needle or needle cap. Pre-filled syringes are designed to be used immediately without requiring additional preparation or assembly by healthcare professionals.
What are the advantages of pre-filled syringes?
Pre-filled syringes offer various advantages when compared to other container types:
- Accurate dosing
- Convenience and ease of use
- Reduced risk of contamination
- Improved patient safety
- Minimized medication wastage
- No reconstitution is required
Do silicone oil-free prefilled glass syringes exist?
Yes, silicone oil-free syringes do exist. These syringes are manufactured using materials and processes that eliminate the presence of silicone oil, which can be a concern for certain pharmaceutical applications.
Need help?
Get in touch
For information regarding Nipro products, services, and resource material:
| Give us a call +32 15 263 500 |
E-mail us pharmapackaging@nipro-group.com |
| Submit a detailed inquiry: Contact per expertise |
View our manufacturing locations: Our global network |