Injectable / Sterile / Parenteral Area
Parenteral preparations are sterile, pyrogen-free liquids (Solutions, Emulsions, or Suspensions) or Solid Dosage forms containing one or more Active Pharmaceutical Ingredients, packaged in either single-dose or multidose containers. They are intended for administration by injection, infusion, or implantation into the body. There are four main forms of parenteral preparations: injections, intravenous infusions (large volume parenterals), powders for injections, and implants. Certain injections and intravenous infusions may be presented in the form of sterile concentrated solutions.
The quality of starting materials, the design and maintenance of the equipment, and the method of manufacture must be such as to ensure the stability of the active substance and the final product which is sterile and free of pyrogens and particulate matter. From the clinical viewpoint all parenteral preparations must be pyrogen-free. For practical purposes, however, certain categories of parenteral preparations may be exempted from the test for bacterial endotoxinsor or the test for pyrogens as specified in the individual monograph.The manufacturing process should meet the requirements of Good Manufacturing Practice.
Typical equipments used in the manufacturing section are Vial Filling Machine, Vial Washing Machine, Injectable Powder Filling Machine, Aseptic Filling Machine etc.,
Ampoule Washing Machine
Ampoules Filling
Aseptic Filling Machine
Form-Blow-Seal Machine
Form-Fill-Seal Machine
Injectable Powder Filling Machine
Lyophilizer
Vial Filling Machine
Vial Inspection Machine
Vial Washing Machine
