Lyophilization of Parenteral Pharmaceutical Products : Pharmaceutical Guidelines

Lyophilization of Parenteral Pharmaceutical Products

Learn about the Lyophilization of pharmaceutical products and processing of Lyophilizers.
There are many other parenteral forms but some products are lyophilized. Some of the parenteral products are unstable in solution form therefore those products are lyophilized. Lyophilization increases the shelf life of the pharmaceutical drugs.

Pharmaceutical LyophilizationPenicillins, cephalosporins, erythromycin, doxycycline, chloramphenicol and some other products are unstable in the solution form. These products are lyophilized when produced as parenterals. This process is also known as freege-drying.

Lyophilization is the removal of water from frozen state to the gaseous state without going in liquid state. In lyophilization of parenterals, drug is dissolved in appropriate solvent and converted to ice form at very low temperature between −50 °C and −90 °C. Now it is dried by applying vacuum to remove the solvent. All the processing is done aseptically using the equipment called lyophilizer. Vials are filled with the solution of the drug and covered with the special bung for lyophilization. Vials are sealed aseptically after the completion of lyophilization.


The process of lyophilization is critical in respect to sterility. It is important to validate the lyophilization process for media fill. Problems are encountered frequently in sterilization of lyophilizers. Generally lyophilizers are sterilized by moist heat method with pressure. Sterilization validation of the lyophilizers should be done parallel as of an autoclave.

Lyophilized finished product must be tested for sterility and stability of product. Sterile water for injection (WFI) should be used to reconstitute the sample to be analyzed for sterility because bacteriostatic water for injection can kill the contaminants present in sample.



Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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1 comment:

  1. I need a lyophilizer validation procedure. I will be thankful if you can provide the same.

    kartikpharma@gmail.com,

    Regards,
    Kartik

    ReplyDelete

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