Quality Control Test for Parenteral

We perform the quality test on parenteral preparations( injections)

To ensure their quality, whether they are free from any foreign particle or not.

Because injections are directly administered into blood so their quality is very much necessary to avoid any contamination.

 

Types of parenteral tests:

1. Leakage Test
2. Clarity Test
3. Sterility Test
4. Pyrogen

    we will discuss  all of the 4 tests, their requirements and procedures. So first thing first, lets discuss the leakage test.

1      1) Leakage test:

      Leakage test is use to check the sealing of ampules that they are properly sealed or not to   avoid any contamination.

       First of all talk about requirements

     Requirements:

       Beakers, ( vacuum chamber) ,  ampule , dye (1% sodium methylene blue solution)

     Procedure:

    Take the ampule or any parenteral test substance, place it in the vacuum chamber which contain 1% sodium methylene blue.Vacuum cause the dye solution enter into the ampule.

      If the ampule is leaked then methyl blue is entered into the ampule and show the colour which indicates the presence of leakage .If the ampule is not leaked then no colour is shown which indicates that there are no leakage in the ampules.In this test we also check the sterility of the ampules.

     clarity test:

   In clarity test we use the two backgrounds , the black background and the white background.

      Black background:

    Black background is use to check the presence of light particles.

     Procedure:

     Take the ampule place in front of black background.  If the light particles are present then they are more visualized and we detect the presence. 

      White background:

    White background is use to check the presence of dark particles.

      Procedure:

     Take the ampule place in front of white background. If the darker particles are present then they are more visualized as compare to in front of dark background and we detect the presence of that dark particles.

3     Sterility test:

Sterility test is performed to check the   presence of microorganisms in the preparations. Whether microorganisms is present or not.

Sterility test performed by two methods.

1)membrane filtration method (MFM)

2)direct inoculation method ( DIM)

1-membrane filtration method (MFM) :

Membrane filtration method (MFM) is use to check the sterility of the test solution.

Requirements:

Membrane filter, (0.4 micron) , peptic digest solution (PDS) , fluid thioglycate medium (FTM) 100ml of depends upon the particles ,soybeancasin digest medium (SCDM)

Chemicals:

Test solution

Procedure:

Membrane filter paper is soaked with peptic digest solution (PDS) .then we apply test solution on it. When the solution is passes let it dry. wash with peptic digest solution at least three times. Let it dry.

Cut the membrane filter paper in to two equal halves,  now apply the fluid thioglycate medium ( FTM) on one half and soybean casin digest medium (SCDM ) on another half.

Incubate these for seven days. Temperature for fluid thioglycate medium is 30-35 c°. And temperature for soybean casin digest medium is 20-25 c° for 7 days.

After seven days we check both of them.If the growth of microorganisms is occur the product in contaminated .

If there is no growth on any microorganisms the product is sterile.

We are using two mediums because of some bacteria grow in fluid thioglycate medium and some bacteria grow in soybean casin digest medium.

2-direct inoculation method ( DIM) :

In direct inoculation method take fluid thioglycate medium or soybean casin digest medium.  Add test solution,  incubate them for 14 days .

Do the examination if the microorganisms are present the product is contaminated,  if there are no microorganisms the product is sterile.

4)pyrogen test :

Pyrogen test is performed to check the presence of pyrogens.

Pyrogens are part of microbes that causes fever. Also called as fever causing agents. Which change the normal body temperature

Two types of pyrogen tests are performed.

1)      In vivo ( inside the cell)

2)      In vitro ( out side the cell)

1-In vivo:

In vivo testing we use rabbits.

We take three rabbits before 40 minutesof test, keep it calm. Rabbits size shall not be less than 1500 gm.

Check the temperature of the rabbits and let it for 40 minutes. The temperature shall not exceed 39.8 c°.

All are injected with test solution through injection(syringes) in the ear of each rabbit upto 10ml/kg. Left the rabbits for 1 hour , then body temperature is measured.

Repeat it checking its temperature for two more hours. If increased 0.6 c° then it is normal . If temperature increases up to 0.6 c° then its the evidence of presence of pyrogens.

If the collective temperature of all the three rabbits is 1.4 c° then collectively it is called normal temperature.

If the temperature is more than 1.4 c° we consider the presance of pyrogens.

Sometimes we didn’t satisfied with the results . Then we take five more rabbits and repeat the same procedure with all the five rabbits.  If the collective temperature is up to 3.7 c° then it is the evidence of no pyrogen.  But if the temperature exceeds 3.7 c° then the pyrogen is present.

2-in vitro:

Vitro pyrogen test is performed outside the body.

Requirements:

Test solution , enzyme LAL ( limulus amoebocyte lysate ), incubator   vacuum chamber .

LAL( limulus amoebocyte lysate ) obtain from the heart of the crab name “ horse shoe crab “.

First of all LAL is added into the test solution do not shake it , incubate it for 1 hour, temperature required is 30-35 c° . If its give foggy or cloudy appearance then pyrogen is present.

If solution remain clear the it is the evidence of no pyrogen is present in the solution.

Overview:

Quality control test for parenteral usually injections use for intravenous,  intra muscular,  subcutaneous, is performed to ensure the quality of products in order to avoid any contamination which become harmful for the patient in future. A little unconventional product can cause a serious effect.

So it is very necessary to perform all quality test at the best level and ensure the quality of product for the patients care and promotion of health and prevention of any errors.

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