Regulatory Open Forum

 View Only

  • 1.  Drug containing syringe

    Posted 17-Jul-2020 08:23

    Does anyone have experience with sterilization of drug-containing syringes? Specifically, sterilizing the contents with one method, and sterilizing the syringe with another method?

     

    Thank you.

     

    Stephanie Del Paine, PhD

    Regulatory CMC Scientist

    ISO 13485 Certified Lead Auditor

     

     

    Cook Research Incorporated

    1 Geddes Way

    West Lafayette, IN 47906 USA

    765.463.7537  ext. 32-1192

    765.586.9348 (company cell)

    CookMedical.com

    Stephanie.DelPaine@CookMedical.com

     

     

    CONFIDENTIALITY NOTICE:  This email and any files transmitted with it

    Are confidential and may be privileged.  If you are not the intended recipe-

    Ent, you may not read, copy, print, forward or use this information.  If you

    Have received this email in error, please notify the sender immediately.

     

     



  • 2.  RE: Drug containing syringe

    Posted 18-Jul-2020 09:57
    For a drug-filled syringe, usually the final filled dose form is sterilized as a unit.  If you sterile each component separately then you would need to have a sterile fill-finish process to assemble the final dosage form.

    ------------------------------
    Michael Hamrell, Ph.D., RAC, FRAPS
    Huntington Beach CA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Drug containing syringe

    Posted 20-Jul-2020 15:35
    This is generally how it works for biological drugs. The drug solution is sterilized by sterile filtration, the primary container components (syringes. stoppers, etc.) are sterilized by another method (autoclaving, gamma-irradiation, EtOx), and the drug product is filled under aseptic processing.

    ------------------------------
    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
    ------------------------------

    Original Message


Related Content