Frequently Asked Questions for the Aguettant System® for Pre-Filled Syringes
Following labelling and packaging the Aguettant System® for pre-filled syringes
is sterilized by terminal steam sterilization. The pre-filled syringe inside the sealed
blister pack is terminally steam sterilized by moist steam at 121 °C for 8 minutes.
The content of the unopened or undamaged blister pack, the pre-filled syringe, is completely sterile.
Terminal sterilization is the sterilization method preferred by the FDA1 and Health Canada2 when manufacturing sterile products over aseptic filling because it adds a higher degree of certainty for yielding a sterile product.3
Aguettant holds 2 international patents for this new patented sterile polypropylene pre-filled syringe. The first patent (CA 2619892) refers to its stopper and barrel design. Due to the patented innovation of the syringe’s barrel, the stopper is sterilized by the steam passing the inner lips of the syringe stopper. The second patent (CA 2637294) refers to the innovative tamper evident opening system which increases the stability, integrity, and sterility of the syringe’s Luer lock connection under the protective cap. More detailed information available here.
The innovative patented barrel design of the syringe features an integral barrel backstop which prevents the plunger from being removed from the barrel accidently.
After removal of the blister pack label or if the blister label is damaged, the pre-filled syringe is no longer sterile externally, though the contents of the syringe remain sterile.
No, the Aguettant System® for pre-filled syringe is latex free.
- Angrtrakool, Praphon, FDA, Terminal Sterilization vs Aseptic Processing ppt. http://forums.pharmacyonesource.com/phos/attachments/phos/pharmacy_ops/1377/1/terminal%20sterilization%20v%20aseptic.pdf
- Health Canada website, Process Validation: Moist Heat Sterilization for Pharmaceuticals http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/mhsp-schpp-eng.php
- Lynn Hadaway, Manufacturing of Pre-Filled Syringes – What Nurses Need to Know, http://www.excelsiormedical.com/pdfs/Lynn_Hadaway_Pre-Filled_syringes.pdf
- 2010 Pharmapack Award winner http://www.aguettant.fr/en/25/aguettant-system.html