Sterility testing of pharmaceutical preparations

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BACKGROUND

Sterility testing is a testing that confirms that the products are free from the presence of microorganisms.¹ It is important for medical devices, pharmacy preparations, and other materials.² It is a qualitative test that shows the quality of the samples tested.³ It is testing that should be carried out by trained persons.

So the basic objective of the test is to carry the sterility testing of pharmaceutical preparations by membrane filtration and direct inoculation methods.

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REQUIREMENTS

Chemicals:    Fluid thioglycollate medium

        Soybean casein digest medium

Apparatus:     Laminar air flow

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PROCEDURE

Basically following methods are adapted:

1. Membrane filtration
2. Direct inoculation

a. Membrane filtration

In this method the solution of the product is carefully filtered through a hydrophobic edged membrane filter.⁴ The resulting membrane is duly washed to get rid of any antibiotic traces which might get stuck to the surface of the membrane.⁵ Finally the segregated microorganisms are meticulously transferred to a suitable culture media under suitable environmental conditions. There are around 4 microorganisms that are used for positive control tests such as Bacillus cereus, Staphylococcus aureus, Klebsiella aerogenes, Enterobacter species. In this method, the products are filtered through 0.45 or 0.2 micron membrane filter. The filters are then rinsed with appropriate USP fluid to remove inhibitors and then transfer into fluid thioglycollate medium & soybean casein digest medium. The Medias are incubated for around 7-14 days and also checked every day for any presence of microbial growth.⁶ The above Medias are used because of their ability to promote the growth of anaerobic and aerobic microorganisms respectively.

b. Direct inoculation

This is the method of choice for the medical devices and non-filterable pharmaceutical products, which includes solid dosage form, powders, ointments and creams.⁷ In this sterility testing method test articles are directly transferred into fluid thioglycollate medium (FTM) and soybean casein digest medium (SCDM). Both media are incubated for 14 days and checked every day for the presence of microbial growth.⁸

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CONCLUSION

Thus the sterility testing of pharmaceutical products are carried out by some of the above given methods.

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REFERENCES

1. Mehta R.M.;”Sterilization, pharmaceutics- I. Delhi Vallabh Prakashan”. 2002: 227-228.
   
2. Lachman L., Liberman H.A., Kaniz J.L.; ” The theory & practice of industrial pharmacy Bombay, Varghese publication House”. 1986: 673-675
   
3. Akers M.J., Larrimor D.S., Guazzao M.D.; “Parenteral Quality Control, New York” 2006: 1-183
   
4. Van Reis R., Zydney A.; “Bioprocess membrane technology. J Mem Sc”. 2007: 297. 16-50.
   
5. Templin T., Johnston D., Singh V., Tumbleson M.E., Belyea R.L. Rausch K.D.; “Membrane separation of solids from corn processing streams. Biores Tech”. 2006: 97. 1536-1545.
   
6. Ripperger S., Schulz G.; “Microporous membranes in biotechnical applications. Bioprocess Eng.” 1986: 43-49.
   
7. Dewey R., “Inoculation and forewarning. Chapter 15. Psychology: An Introduction. Belmont, CA: Wadsworth Publishing”. 2017
   
8. Compton J., “inoculation theory, and anticipated attacks on credibility. The International Journal of the Image”. 2017:1-9.