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Prefillable Polymer Syringes – Cleanroom Production

Fully integrated clean room production

The production of SCHOTT TopPac® syringes is a continuous, fully integrated process taking place in a class B clean room. It starts by transferring TOPAS®1 granulate from silos directly to the injection moulding machines.

Automated assembly technology is supported by in-line process control. Advanced visual inspection technology controls dimensional and cosmetic aspects. Reliable quality systems and rigid quality controls guarantee the consistent high quality of the syringe sets.

Cleanroom ISO 6
Injection molding
The sophisticated injection molding process enables tighter dimensional tolerances on the syringe barrel and higher process stability for consistent quality.

After the injection molding and cooling phase, SCHOTT TopPac® syringes are siliconized with a reactive silicone mixture, which is followed by a curing process resulting in the cross linking of the silicone to the inside of the syringe barrel. This process ensures an even distribution of silicone in the syringe barrel with an extremely low level of free silicone.
Camera inspection and closure assembly
After siliconization the syringes are camera inspected for cosmetical defects and are fitted with tip caps. The tip cap design an the setting process are optimized to ensure closure tightness.

To protect the syringes against contamination and damage, they are placed in nests and transparent tubs, which can be easily processed in all common filling lines.

Tub sealing and packaging
A protective Tyvek®* inlay is placed in the tub followed by a Tyvek®* seal to build a barrier against microbial contamination. The sealed tubs are covered with a polyethylene double bag. They are then visually inspected, packed into boxes and pallets, and sent for sterilization.

*Tyvek is a registered trademark of E. I. du Pont de Nemours and Company
1TOPAS® is a registered trademark of TOPAS Advanced Polymers GmbH (