Module 5 Lesson 3 Flashcards
Are intended to be administered by injection, infusion, or implantation
Sterile products
Forms intended for administration by injection under or through one or more layers of the skin, and exert their action by directly entering into systemic circulation
Sterile dosage forms
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
In vitro pyrogen test
For detection and quantification of pyrogens
- to detect the presence of pyrogens in sterile parenteral products
Pyrogen test
In vivo
Rabbit test
Complex of pyrogenic lipopolysaccharide, a protein and inert lipid
endotoxin
Procedure of rabbit test
Inject to the vein of the ear of each 3 rabbit
Are the metabolic products of gram negative bacteria
pyrogens
LAL test meaning
Limulus amoebocyte lysate test
This test depends on the gelling property of the lysate of amoebocyte of Limulus polyphemus
LAL TEST
Scientific name of horseshoe crab
Limulus polyphemus
are the metabolic products of gram negative bacteria
Pyrogens
Positive Test of LAL Test
A firm gel forms upon invasion
an aqueous extract of blood cells from the blue-blooded horseshoe crab
limulus amebocyte lysate
it is being used for endotoxin detection
LAL (Limulus Amoebocyte lysate)
Should be carried out in Aseptic conditions
sterility test
sterility test 2 Methods
A. Membrane Filtration Method
B. Direct inoculation Method
How can the presence of organism be identified in sterility test
by turbidity in the clear medium
the sample is passed through a sterilized membrane and then inoculated into media for the growth of microorganisms
membrane Filtration
the test sample is directly inoculated into media in order to observe the growth of microorganisms
Direct inoculation
Mediums for Sterility test
Fluid Thioglycollate medium
soybean-casein Digest Medium
use of Fluid Thioglycollate medium
Anaerobic Bacteria
what bacteriaSare for Fluid thioglycollate medium
C. sporogenes
P. aeruginosa
S. aureus
