Sterility Testing

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One should not confuse between the term sterility testing and Sterilization.

These two terms have wide difference in their action as well as meaning. Sterilization1 is a process by which any article and its surface can make free from viable (living) microorganisms including spores. Sterility testing2 means to check the article or product which was made sterile by sterilization method is actually free from contaminant (sterile) or not, like a confirmatory test. The test has been carried out by exposing formulation to the condition which favour growth of microorganisms.

Sterility testing is very important especially in case of parenteral preparations as preparation directly entering or coming in contact with blood. When any formulation is given by oral route, the formulation have to cross plenty of barriers provided by body's primary defense mechanism like gastric mucosa, saliva, gastric acid, different enzyme systems and so on prior to enter in systemic circulation. So, if at all any contaminant or microorganism is present in oral formulation it will not reach easily to blood circulation. Thus, in oral or other such formulations sterility is not an issue of much important but, in parenteral it might become fatal if one should not take this into consideration.

Sterility testing is because very vital factor in case of parenteral products and all official guidelines are clearly mentioned the procedure to perform sterility testing as well as their limits for acceptance.

Products should be tested for sterility given below2:

  • Injectables
  • Readymade injections like oily and aqueous solution or suspension or emulsion.
  • Solids for injection (extemporaneous) like powders containing proteins, harmones, and antibiotics generally which are not stable in storage with aqueous medium.
  • Eye formulations like ointments, lotions, lens, drops etc
  • Immunological products like monoclonal antibodies.
  • Blood related products like whole human blood, serum, fibrinogen, fibrin, plasma expanders etc.
  • Vehicles used in the parenteral formulation like water for injection (WFI), Sterile WFI etc.
  • Implants, surgical materials like catgut, cotton, and other surgical instruments etc.

References-

  1. Remington- The science and practice of pharmacy, Lippincott Williams and Wilkins. Philadelphia. 21st ed, 2005: 776, 802.
  2. Cooper and Gunn's Dispensing Pharmacy, CBS Publisher, Delhi, 12th Ed: 541-572.

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About the Author

P.V.ABHIGNA's picture
Author: P.V.ABHIGNA

Comments

Santosh kumar. JH's picture

Dear Abhigna, Well a good review of various pharmaceutical formulations to be tested for sterility. Do semi-solid dosage forms like suppositories, ointments and creams also need to be sterilized???
P.V.ABHIGNA's picture

Dear Santosh, Yes, Eye Ointments and creams are need to be sterile because eye is very critical and sensitive part of body. Suppositories are need not to be sterile. Regards,

ABHIGNA.P.V.

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