Certificate Course in Parenteral Manufacturing

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Parenteral Manufacturing, QC and Technology

The administration of drugs to humans through injection was first recorded as early as the mid1800s; however, little was known about microorganisms at the time, so safely administering an injectable drug did not become a viable process until the early 1900s, when knowledge of microorganisms and sterilization techniques became more common. During the early years sterilization techniques were limited to either heat sterilization or steam sterilization (autoclaving). These techniques were extremely damaging to drug products, and it was not until the advent of HEPA filters, clean rooms, and sterilizing filters that aseptic manufacturing became a more common practice for producing aseptic drugs without heating the drug product directly—all of the components were pre-sterilized then brought together in a sterile environment. Thus Parenteral may be defined as

Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile preparations intended to be administrated directly into the systemic circulation in human or animal body.

Parenteral products are unique from any other type of pharmaceutical dosage form for the following reasons: • All products must be sterile. All products must be free from pyrogenic (endotoxin) contamination. Injectable solutions must be free from visible particulate matter.

A large volume parenteral (LVP) is a unit dose container of greater than 100ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a "catch-all" for all non-LVP parenteral products except biologicals.

In this Certificate Course in Parenteral Manufacturing following Industrial Unit Processes are covered.,

Filtration

Filling

Equipment used for manufacturing of Parenteral

Batch and Continuous Manufacturing

Plant Layout of Parenteral Unit

QC of Parenteral Preparation

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