STERILITY INDICATORS AND STERILITY TESTING OF PHARMACEUTICAL PRODUCTS

STERILITY INDICATORS

Or

STERILITY TESTING OF PHARMACEUTICAL PRODUCTS

Pharmaceutical preparations require a high standard of sterilization, particularly when talking about parenterals and ophthalmic preparations. Any sort of contamination in these preparations can lead to serious consequences in the health of patient. Therefore, these preparations undergo some tests for the evaluation of sterility.

Three methods are widely used for this purpose:

  1. Direct inoculation method: In this method, a sample is taken out from the preparation and is added to the culture media under aseptic conditions. It is then incubated for a period of 3-5 days. The culture media is then looked for any sort of colony formation. If there is any colony of microorganism present, then batches will be separated and type of microorganism will be identified. Preparations which cannot undergo filtration can be checked using this method. Sterility media includes casein digest medium, fluid thioglycollate medium, etc.

2.Membrane filtration method: Liquid formulations like antibiotics, parenterals and ophthalmics are passed carefully from the hydrophobic-edged membrane filter. This membrane retains the contaminating microbes. The membrane is then carefully washed to remove any traces of antibiotics remains on the membrane. Membrane having 0.45 microns is used in this. The microorganism is then transferred to the culture media under aseptic conditions. After incubation for a few days, the identification of microbes and the possible source of contamination will be identified.

 

3. Pyrogen test: The basic principle behind the pyrogen test is the presence of pyrogens in the aqueous paranterals which on entering into the blood stream of rabbits, increases the temperature of the host. As per IP, the test is passed if the sum of the responses of three rabbits is not more than 1.4oC, and the raise in temperature of the individual rabbit is less than 0.6o if test is failed, then in the next test, 5 rabbits are used in which if sum of responses of eight rabbits does not exceed 3.7oC and temperature of each of the eight rabbits does not raise more than 0.6oC, then the test is considered to be passed.

MCQs

1. Sterility testing can be done by using?

a. Direct inoculation method

b. Membrane filtration method

c. Pyrogen test

d. All of the above

2. Conditions provided for culture in direct inoculation method is/are?

a. Aerobic conditions

b. Anaerobic conditions

c. Both a and b

d. None of the above

3. Membrane filtration method can be used for sterility testing of?

a. Ophthamics

b. Parenterals

c. Antibiotics

d. All of the above

4. Size of pore size of membrane which is used for membrane filtration sterility testing?

a. 1 microns

b. 45 microns

c. 4 microns

d. 100 microns

5. Correct sequence for membrane filtration technique can be?

I. Washing of membranes for removing traces of antibiotics

II. Transfer of microorganism to culture media

III. Passing of formulations from membrane filter

IV. Identification tests of microbs

a. III – I – II – IV

b. III – II – I – IV

c. I – II – III – IV

d. I – III – II – IV

6. Which of the following statements are correct related with the pyrogen test according to IP?

I. 3 rabbits should be used the first time testing of product.

II. Same rabbits can be used once in a week for pyrogen testing

III. Test is passed if the sum of responses of three rabbits is not more than 5oC

IV. If test fails, in the second trial, 5 rabbits should be used for pyrogen testing

a. II, III

b. I, IV

c. II, IV

d. I, III

7. Sequence of true/false for the statements can be?

  • According to IP, first trial for pyrogen testing of product is passed when the sum of the responses of three rabbits is not more than 1.4oC, and the raise in temperature of the individual rabbit is less than 0.6o
  • According to IP, first trial for pyrogen testing of product is passed when the sum of the responses of five rabbits is not more than 2.4oC, and the raise in temperature of the individual rabbit is less than 0.8oC
  • According to IP, second trial for pyrogen testing of product is passed when the sum of the responses of eight rabbits is not more than 4.7oC, and the raise in temperature of the individual rabbit is less than 0.8oC
  • According to IP, second trial for pyrogen testing of product is passed when the sum of the responses of eight rabbits is not more than 3.7oC, and the raise in temperature of the individual rabbit is less than 0.6oC

a. FFTF

b. TFFT

c. FFTT

d. FTTF

 

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ANSWERS

1-d

2-c

3-d

4-b

5-a

6-b

7-b

 

RFERENCES

[1] Black JG, Black LJ. Microbiology: principles and explorations. John Wiley & Sons; 2018 Jan 4.

 

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