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products:
Three general areas of quality control are:
Raw material / incoming stock control
Manufacturing / in-process control
Finished product control
B)MembraneFiltrationmethod:
This method basically involves filtration of sample
through membrane filters of porosity 0.45 micron and
diameter about 50 mm. The filtration is assisted under
vacuum or pressure difference.
After filtration, the membrane is washed with a sterile
diluting fluid to remove traces of bacteriostatic agents
etc. and aseptically removed.
The membrane is cut into 2 halves One-half of the
membrane is placed in a suitable volume (usually 100
ml) of FTM, and the other membrane half in SCDM.
INCUBATION-PERIOD
All test containers should be incubated at temperatures
specified by the pharmacopoeia for at least 14 days,
regardless of whether filtration or direct inoculation test
methodology is used.
*Interpretation: If no visible evidence of microbial
growth in culture medium in test tubes is found, then it
is interpreted that the sample representing the lot is
sterile.
Appropriate positive and negative controls must be
included in the sterility testing experiments
SAMPLING
The number of containers tested per batch and
quantity tested from each container should be in
accordance with the pharmacopoeial specification.
Feverresponse
testinrabbits
Why Rabbit?
Reproducible pyrogenic response
Other species not predictable
Similar threshold pyrogenic response to humans
Main test:
Group of 3 rabbits
Preparation and injection of the product:
-Warming the product to 372C
-Dissolving or dilution
-Injection site: ear vein
-The injected volume: about 10 ml per kg of body weight
over 10 min. duration
-Record temperature at 30-min intervals for 3 hours.
-Site of temperature measurement- rectal
Instrument-thermometers/ thermocouples
Disadvantages:
High variability in response.
Difficulty in controlling all factors.
Antipyretic drugs such as aspirin, acetaminophen and
morphine mask pyrogenic effect (i.e.,misleading
results).
Some other drugs have their inherent pyrogenic effect.
LAL test:The test was developed in 1960s by Drs. Bang and Levin and
is based on clotting rection of horseshoe crab blood to
endotoxin.
Limulus- genera of crab
Amebocytes- crab blood cell from which active component is
derived.
Lysate- component is obtained by separating amebocytes from
the plasma and lysing them.
Limuluspolyphemus(horseshoecrab)
Examples of LVPs:
Dextroseinjection: Available in 2 , 5 , 10 , 25 & 50 % w/v solution.
Used for: Fluids replenisher, Electrolyte replenisher
Sodiumchloride&Dextroseinjection:
Contains 0.11 to 0.9 % Sodium chloride and 2.5 to 5.0 % Dextrose
Used for : Fluids replenisher, Electrolyte replenisher, Nutrient
replenisher
SodiumchlorideinjectionIP:
Contains 0.9 % conc., Also known as normal saline solution
Used as : Isotonic vehicle , Fluids replenisher, Electrolyte replenisher
SodiumlactateinjectionIP:
Contains 1.75 to 1.95 % w/v of sodium lactate
Used as : Fluids replenisher, Electrolyte replenisher
MannitolinjectionIP:
Contains 5, 10 , 15, 20 % of mannitol
Used as : Diagnostic aid, Renal function determination , as a diuretic
Mannitol&SodiumchlorideinjectionIP:
Contains 5, 10 , 15, 20 % of mannitol & 0.45 % of Sodium chloride
Used as :As a diuretic
RingersInjection,USP:
Is a sterile solution of sodium chloride, potassium chloride and calcium
chloride in water for injection (WFI).
It is isotonic with physiological fluids
Used as vehicle for other drugs or alone as electrolyte replenisher and plasma
volume expander.
LactatedRingersInjection,USP:
Lactated Ringer's solution is abbreviated as "LR" or "RL". It is also known as
Ringer's lactate solution
Irrigationsolutions:
They are topical solutions used to flush (clean)
open wounds or body cavities.
Although they often labeled using the same terms
for injections, they are never given parenterally.
Container size is usually larger than 1 liter.
Dialysissolutions:
Dialysis is the process in which substances are
separated from one another due to their
differences in diffusibility (distribution) through
the membrane.
The fluids used in dialysis are known as
dialysis fluids.
General uses
Renal failure: to remove waste products and maintain
electrolytes
Transplantation of kidney:
Poisoning cases
Dialysis is a life saving procedure is done either by
haemodialysis or intraperitoneal dialysis.
Composition
IVADMIXTURES
Definition: When two or more sterile products are added to
an IV fluid for their administration, the resulting
combination is known as IV admixture.
In hospitals, prepared by nurses by combining or mixing
drugs to the transfusion fluids.
The drugs may be admixed in one syringe or are
incorporated into bottles of LV transfusion fluids.
Must be prepared under ASEPTIC conditions.