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Renin Angiotensin Mechanism.

Sterility & Pyrogen testing: Introduction.

 

Introduction:

  • Sterilization is the process of complete removal of microorganisms from any surface or product.

  • Sterility hence can be defined as “Complete freedom from microorganisms”.

  • The tests for sterility are conducted to make sure there is complete absence of viable forms of microorganisms on a pharmaceutical product.

  • The products which are to be strictly supervised for absence of the microorganisms are those who come directly in contact with the systemic circulation e.g. ophthalmic preparations, parenteral injections, implants, bandages, surgical dressings, needles, surgical instruments etc.

  • The test for sterility has to be conducted in aseptic environment so as to avoid the contamination of the product.

  • A pyrogen can be defined as “Fever Producing Substance”, which induces “Fever (Hyperpyrexia)”.

  • Bacterial endotoxins are the most common type of “Exogenous Pyrogen”.

  • Bacteria, viruses, malaria parasites and fungi on entering in the body releases certain chemicals that act as Pyrogen.

  • During the sterilization process these microorganisms die but presence of pyrogens in the products may cause a febrile reaction.

  • Test for sterility ensures absence of microorganisms while the Pyrogen test ensures absence of pyrogens in the pharmaceutical products.

  • The lipopolysaccharide (LPS) from gram negative bacterias is a very common example of pyrogen.

  • The common pyrogen tests are,

    • LAL Test (Limulus Amoebecyte Lysate Test).

    • Sham Test (Rabbit Test).
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