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  • 1.  Maximum Aseptic Fill Volume for Bags

    Posted 09-May-2017 13:19

    Dear RAPS Members,
    We are manufacturers of Large Volume Parenterals. I wanted to know if there is a maximum volume limit for aseptically filling (not terminal sterilization) the drug product in bags (for example- less than 100 ml or 250 ml etc?)

    If so, can you please share the guidance. Any help would be appreciated. 

    Thanks



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    Raza Mohammed
    Regulatory Affairs Manager
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  • 2.  RE: Maximum Aseptic Fill Volume for Bags

    Posted 09-May-2017 22:23
    Please refer USP General Chapter <1151>  Pharamceutical Dosage Forms.

    It provides the information on recommended excess volume for more than 50 mL is 2% for mobile liquids and 3% for viscous liquids.

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    Gaurang Bhavsar
    Edison NJ
    United States
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    Original Message


  • 3.  RE: Maximum Aseptic Fill Volume for Bags

    Posted 10-May-2017 08:32
    USP 1151 refers to excess fill volume in vials.
    My question is when you are filling an aseptically sterilized (not terminal sterilization) product into infusion bags (large volume parenteral ie <100 ml volume), is there a guidance from FDA which says that the volume in such situations should not exceed 250 ml or so??

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    Raza Mohammed
    Regulatory Affairs Manager
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    Original Message


  • 4.  RE: Maximum Aseptic Fill Volume for Bags

    Posted 10-May-2017 18:54
    As I understand, you are looking for the different pack size but FDA guidance very rarely specifies the numbers.

    Below is the reference for the machine specifically used for LVP with aseptic processing and they claim that you can fill from 50 ML to 2500 mL. You may contact the machine manufacturer and hopefully you will get the satisfactory answer.

    SYFPAC® LVP
    Brevettiangela remove preview
    SYFPAC® LVP
    Added to this there are several other advantages, which make BFS a preferred process: * bottles can be made from PP, PE or HDPE. This gives wide choice of material to suit cost, availability of packaging material, choice of sterilization temperature and compatibility with the fluid being packed.
    View this on Brevettiangela >


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    Gaurang Bhavsar
    Edison NJ
    United States
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    Original Message


  • 5.  RE: Maximum Aseptic Fill Volume for Bags

    Posted 15-Oct-2019 15:14
    Hi, I want to follow up on this thread with a related question.  How are mobile and viscous defined in USP 1151?  Is it just a subjective description?  I'm trying to make the appropriate interpretation for recommended excess volumes.
    Thank you,

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    Jennifer Judge
    Regulatory Scientist
    Pittsburgh PA
    United States
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    Original Message


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