Module 5 Lesson 3 (Parenterals) Flashcards
Products that are intended to
be administered by injection, infusion, or
implantation into the body.
STERILE PRODUCTS
Sterile dosage forms intended for
administration by ________________under or
through one or more layers of the skin.
Injection
Sterile dosage forms exert their action by directly entering
into the ________ ___________
Systemic Circulation
Finished product must be ______, ___________
& free from extraneous insoluble
materials.
STERILE , Non-pyrogenic
Quality Control of Parenteral
Product
•Pyrogen test
•LAL Test
•Sterility test
•Clarity test/ Test for Particulate
Matter
•Leaker Test
Types of Pyrogen Test
- In Vivo Pyrogen test (RABBIT TEST)
- In Vitro Pyrogen test ( Limulus Amebocyte Lysate Test)
A complex
of pyrogenic
lipopolysaccharide, a
protein and inert lipid
ENDOTOXIN
Test for Bacterial Endotoxin
LAL Test (Limulus Amoebocyte Lysate Test)
Other name of Limulus
polyphemus.
HORSESHOE CRAB
This test depends on the gelling property
of the lysate of amoebocyte of Limulus
polyphemus (Horseshoe Crab)
LAL Test (Limulus Amoebocyte Lysate Test)
POSITIVE form of LAL Test (Limulus Amoebocyte Lysate Test)
A firm gel forms upon inversion
NEGATIVE form of LAL Test (Limulus Amoebocyte Lysate Test)
No gel is formed
An aqueous extract of blood cells from blue blooded horseshoe crab.
Limulus Amebocyte Lysate (LAL)
Used for endotoxin detection
LAL Test
It should be carried out in Aseptic Conditions
STERILITY TEST
2 Methods of Sterility
A. Membrane Filtration Method
B. Direct Inoculation Method
Biological Indicators
Method of Sterilization
• Moist heat (autoclave)
• Dry heat (oven)
• Ethylene oxide
• Radiation
Bacteria used
1. B. stearothermophilus
• B. subtilis
2. B. stearothermophilus
• Both + B. pumilus
Other name of Test for Particulate
Matter
CLARITY TEST
2 Methods of Clarity Test
Visual method
Coulter counter method
It is the most used and relevant method for clarity testing.
VISUAL METHOD
According to this method, the filled containers are examined
against a strong illuminating background with a swirling
motion since moving particles are easier to identify than
stationary particles.
VISUAL METHOD
Dark background- _______ particles
LIGHT
Light background- ________particles
DARK
This is the test that is based on the principle that there
will be an increase in the resistance as a particle
approaches and passes through the orifice (2
electrodes)
COULTER COUNTER METHOD
This method require destruction of the product unit
since an electrolyte is added to the preparation before
its evaluation.
COULTER COUNTER METHOD
Other Methods of Clarity Test
•Membrane Filtration technique
•Light Scattering
Employed to detect incompletely sealed ampoule so that they may be discarded.
LEAKER TEST
To test the package integrity.
LEAKER TEST
4 Types of Leaker Tests
Visual inspection
Bubble test
Dye test
Vacuum ionization
Test that carried out to check the particulate matter in the sample
CLARITY TEST
Filter used for aqueous, oily and weakly alcoholic solutions.
CELLULOSE NITRATE FILTERS
Filter used for strongly alcoholic solutions.
CELLULOSE ACETATE FILTERS
Suitable method for aqueous solutions, oily liquids, ointments and creams.
DIRECT INOCULATION METHOD
No growth means the test is ________.
POSITIVE
What % of dye solution in Leaker Tests?
1% Methylene blue
The test in which the test sample is passed through a sterilized membrane and inoculated into the media for the growth of microorganisms.
Membrane Filtration Method
The test sample is directly inoculated into the media in order to observe the growth of the microorganisms.
DIRECT INOCULATION METHOD
This method do not passed through 0.45mm in membrane filter.
Direct Inoculation Method
This method passed through 0.45mm in membrane filter.
Membrane Filtration Method
Requires membrane filtration unit.
Membrane Filtration Method
Does not require membrane filtration unit.
Direct Inoculation Method
Samples are directly inoculated into the media.
Direct Inoculation Method
2 Types of Filters of Membrane Filtration Method
Cellulose nitrate filters
Cellulose acetate filters
