Sterility, syringeability ease of re-suspension, slow settling after shaking and drainage as well as absence of pyrogens and foreign particulate matter. Preparation of a sterile paraenteral suspension is a very difficult procedure. It requires complete attention to detail during the following broad phases of manufacture.
o Final re-crystallization of the drug
o Size reduction of the drug
o Sterilization of the drug
o Sterilization of the vehicle
o Aseptic wetting of the powder with a portion of the sterile vehicle
o Aseptic dispersion and milling of the bulk suspension
o Aseptic filling of the finished suspension into sterile containers
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