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
What is the incubation Period for sterility Test Medias
14 days
What is temperature needed for Fluid Thioglycollate medium
30-35°C
Temperature for soybean-casein Digest Medium
22.5 ±2.5°C
use for Soybean-casein Digest Medium
Fungi and Aerobic bacteria
Fungi and Aerobic bacteria
- A. brasilensis
- B. subtiIis
- C. albicans
Fungi and aerobic bacterias
A. brasilensis
B. subtitles
C. albicans
Acceptance criteria of sterility test media
No growth after incubation period
Method of sterilization
Moist heat (autoclave)
Dry heat (oven)
Ethylene oxide
radiation
Unwated mobile isluble foreign matter other than gas bubbles
Particulate matter
2 methods for clarity test
Visual method
Coulter counter method
It is most used and relevant method for clarity testing
Visual method
The filled containers are examined against a strong illuminating background with a swirling motion
Visual method
Light obscuration test
Visual method
A test that is based on the principle that there will be an increase in the resistance as a particle approaches and passes through orifice
Coulter counter method
This method requires destruction of the product unit
Coulter counter method
Other methods
Membrane Filtration technique
Light scattering
Is employed to detect incompletely sealed ampoule so that they may be discarded
Leaker test
It is also to test the package integrity
Leaker test
Reflects its ability to keep the product in ad to keep potential contamination out
Leaker test
4 types leaker test
- Visual inspection
- Bubble test
- Dye test
- Vacuum ionization
dye for leaker test
1% methylene blue
