REVIEW - QUALITY CONTROL OF PARENTERAL PRODUCTS

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3)     Leaker Test: - The leaker test is intended to detect incompletely sealed ampules, so that they may be discarded. Tip sealed ampoules are more prone to leak than pull sealed. In addition to that crack my present around seal or at the base of ampule as a result of improper handling leakers are usually detected by producing negative pressure within the incompletely sealed ampule usually into a vaccum chamber while those ampule are submerged into a colored dye solution of 0.5 to 1% methylene blue. Vials and bottles are not subjected to such leaker test because rubber closure is not rigid however bottles are often sealed while vaccum is pulled so that bottle remains evacuated during its shelf life.

The presence of vaccum is detected by striking at the base of bottle sharply with the heel of hand to produce typical water hammer sound. Another test is to apply a spark tester probe outside to the bottle moving form liquid layer into air space a blue spark discharge occur is air space is evacuated.

4) Particulate  matter  testing:-   Particulate  matter  is  primary  concern  in  the parenteral products given by I.V. Route, all parenteral products should be free from insoluble particle. Further U.S.P. states that GMP Requires that all containers be visually inspected and that with visible particle be discarded. It is found that formation of pathologic ganulomes in vital organs of body can be traced to fiber, rubber fragment  and  other  solid  present  in  intravenous  solutions.  The  visual inspection is done by holding the ampule by its neck against highly illuminated screens. White screens for the detection of black particle and black screens for the detection of white particles to detect heavy particles it may be necessary to invert container but care must be exercised to avoid air bubble. The instrumental methods are based on principles of light scattering, light absorption, electrical resistance as in coulter counter. A method which utilizes a video image projection could detects a moving particle without destruction of product unit.

CONCLUSION:
Quality control  should  be  a  fundamental  segment  of parenteral  products  manufacturing.   All  of  the  4  basic  tests  which  are performed  are  essential  and  have  its  own  importance  in  parenteral production. All of these tests ensure that product meet its quality which has been judged to satisfactory also. Each test is unique and provide detailed assement of quality control for parenteral products. 

Medium

Test

Time(Days)

Temperature       

Sterilisation method

FTM

Direct transfer

14

30-35

Aseptic process


Membrane filtration

7

30-35

Terminal sterilisation


Membrane filtration

14

30-35

Aseptic process

SCDM

Direct transfer

 14

20-25

Aseptic process


Membrane filtration

7

20-25

Terminal sterilisation



Membrane filtration



14


20-25


Aseptic process

Table: - Time and Temperature of incubation Requirement for U.S.P. Sterility test.

Container content(ml)

Minimum volume of product(ml)

Minimum volume of medium(ml)

10 or less

1

15

10-50

5

40

50-100

10

80

100-500

One half of contents

N/A

>500

500

N/A

Table:- Sample volume Requirement for Direct transfer method.

*CULTURE MEDIUM EMPLOYED IN STERILITY TEST
1) U.S.P. fluid thioglycollate medium.
2) U.S.P. Soyabean casein digest medium.
3) Polysorbate 80.
4) Brain Heart fusion.
5) Spourlating Agar medium.
6) Saline T.S.
7) U.S.P. soyabean casein digest Agar medium.
8) U.S.P. Antibiotic Agar medium.
9) Potato Dextrose Agar medium.

REFERENCES:
1)  Mehta  R.M,  Sterilization,  pharmaceutics-I.  Delhi:  Vallabh prakashan, 2002. P. 227-228.
2)  Lachman.L,  Liberman  HA,  Kaniz  JL,  Editions,  The  Theory  and  practice  of industrial pharmacy Bombay, Varghese publication House; 1986. P. 673-675.   
3) Akers.MJ, Larrimor DS, Guazzao morton D, Parenteral Quality control, New York, Marcel Deckker; 2006. P. 1-183

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