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GMP5 Dead Leg calculation

Shown picture, if D=25mm & distance X is greater than 50mm, we have a dead leg that is too long.
Long dead leg is helpful to growth microorganisms. Long dead leg means to store excess water (WFI, PW etc). Long Dead leg does not circulate the water, hence it always short.
Dead leg is not more than 1.5D of the pipe line.
A Dead leg system can obtain than this type of problem created
Fluid pooling, Reduced Cleasnability, Difficult sterilization.
Hence dead leg always short.

Comments

  1. Unknown29 May 2018 at 02:08

    What is the difference between PW and WFI water...

    ReplyDelete
  2. pharmahelp31 May 2018 at 00:39

    GMP6 PW & WFI
    PW:-

    Purified water is water that comes from any source, but has been purified to remove any chemicals or contaminants. Its has been mechanically filtered or processed to remove impurities and make it suitable for use.

    Types of purification include distillation, Capacities de-ionization, microfiltration, ultrafiltration reverse osmosis (RO), and carbon filtration. It's from an underground source and may or may not have been treated and purified.

    PW is used in Non-Parental drugs.

    WFI:-

    It is water that is intended for use in the manufacture of medicines for parenteral administration whose solvent is water (WFI in bulk), or water that is used to dissolve or dilute substances or preparations for parenteral administration (heat- sterilised WFI)
    PW is treat convert
    WFI is used in Parental Drugs.

    WFI is water of extra high quality without contamination.

    The United States Pharmacopeia (USP) defines as highly purified water containing less than 10 CFU/100 ml of aerobic bacteria. The conductivity of WFI is less than 1.3 us/cm at the rate of 25 °C.

    ReplyDelete

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