MicronDevice - 10mL BD Syringe, Cleanroom Sterile Packs GMP
Cytotoxic and Compounding Luer-Lock Syringe for Isolators and LAFs
Micronclean MicronDevice product series offers a particle reduced, cellulose-free and cleanroom packed and gamma irradiated for sterile syringes and accessories for the use in cyto-pharmacy and compounding cleanrooms.
The 3-piece BD syringes are each individually quality checked before packed in an ISO Class 6 (at rest), EU GMP grade C cleanroom dedicated to medical packaging only. The syringe multipacks are manufactured under EN/ISO 13485:2016 quality management system (class I medical device) and carry a CE-certificate. Each batch features a separate product code and batch number, which makes each syringe 100% retraceable. Additionally, we provide to each batch a conformity and sterilization certificate.
Barrel and plunger - polypropylene
Gasket - latex-free, medical grade rubber
Lubricant - medical grade silicone oil (<0.25 mg/cm²)
Area of application: Cyto-Pharmacy and Compounding
Cleanroom Classification: GMP A/B
Please also refer to the product sheet for detailed product specifications.
- double or triple packed
- gamma sterilized min. 25kGy (ISO 11137)
- free of cellulose
- four layer laminate
- easy tear notch
- primary packaging is alcohol and VHP compatible
- 3 year shelf-life