Pyrogen Testing in Pharmaceutical Production
Komal Pareek
T.Y.B.Sc
Indusrial Microbilogy
PYROGEN TEST
PYROGEN TEST
P
YROGEN
: A
CHEMICAL
WHICH
AFFECTS
THE
HYPOTHALAMUS
,
WHICH
REGULATES
THE
BODY
TEMPERATURE
.
PYROGENICITY
Ability to cause a change in body temperature
In humans endotoxins cause an increase in
temperature which is a fever response.
Pyrogenic effect is indirect: the active chemical
agent that causes the temperature change is an
endogenous pyrogen that is released from blood
leucocytes under the influence of endotoxins.
This pyrogen affects the hypothalamus of the
brain which regulates body temperature.
PYROGEN TEST
Pyrogen test defines a process used by drug
manufactures to determine if bacteria toxins are
present in vaccines and drugs that might cause
fever when used on humans.
It determines if microbes or their metabolites are
present in intravenous solutions during the
manufacturing process.
RABBIT PYROGEN TEST
The most common and oldest form of pyrogen
testing consists of injection of drugs into rabbits
to determine if a fever develops.
The rabbit pyrogen testing method surfaced in
the 1940’s after some patients became ill from
intravenous drugs.
The rabbit pyrogen test is commonly conducted
for detecting possible pyrogen contamination in
injectable pharmaceuticals.
HUMAN RESPONSE TO PYROGEN
The human body fights exposure to bacterial
toxins in the environment through the skin.
When contaminated drugs are injected into the
bloodstream, toxins bypass normal defense
mechanisms.
WBC’s begin releasing another form of pyrogen
that causes high fever which might lead to shock
and death.
PYROGEN TEST IN PRODUCTION
PROCESS
As virtually all raw materials involved in a
production process, including factory employees
can be potential sources of pyrogen
contamination in injectable pharmaceuticals.
Hence raw material screening is an important
step in any standard quality control procedure.
In this context early endotoxin detection was
accomplished by injecting rabbits with the
sample and observing the response in their body
temperature.
REASONS
FOR CHOOSING
THIS TEST:
Rabbits have similar
endotoxin tolerance to
humans.
Contrary to LAL test,
rabbit pyrogen test is
sensible to a wide
variety of pyrogenic
materials.
FOR NOT
CHOOSING THE
TEST:
Costly and time
consuming method.
Unable to quantify
endotoxin level.
Pyrogen testing is crucial in ensuring pharmaceutical safety by detecting bacterial toxins that may cause fever in humans. Methods such as the rabbit pyrogen test and human response to pyrogens illustrate the importance of quality control measures in production to prevent contamination. By identifying potential sources of pyrogen contamination and utilizing early detection methods, manufacturers can uphold product quality and safeguard public health.
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Presentation Transcript
PYROGEN TEST Komal Pareek T.Y.B.Sc Indusrial Microbilogy
PYROGEN TEST PYROGEN: A CHEMICAL WHICH AFFECTS THE HYPOTHALAMUS, WHICH REGULATES THE BODY TEMPERATURE.
PYROGENICITY Ability to cause a change in body temperature In humans endotoxins cause an increase in temperature which is a fever response. Pyrogenic effect is indirect: the active chemical agent that causes the temperature change is an endogenous pyrogen that is released from blood leucocytes under the influence of endotoxins. This pyrogen affects the hypothalamus of the brain which regulates body temperature.
PYROGEN TEST Pyrogen test defines a process used by drug manufactures to determine if bacteria toxins are present in vaccines and drugs that might cause fever when used on humans. It determines if microbes or their metabolites are present in intravenous solutions during the manufacturing process.
RABBIT PYROGEN TEST The most common and oldest form of pyrogen testing consists of injection of drugs into rabbits to determine if a fever develops. The rabbit pyrogen testing method surfaced in the 1940 s after some patients became ill from intravenous drugs. The rabbit pyrogen test is commonly conducted for detecting possible pyrogen contamination in injectable pharmaceuticals.
HUMAN RESPONSE TO PYROGEN The human body fights exposure to bacterial toxins in the environment through the skin. When contaminated drugs are injected into the bloodstream, toxins bypass normal defense mechanisms. WBC s begin releasing another form of pyrogen that causes high fever which might lead to shock and death.
PYROGEN TEST IN PRODUCTION PROCESS As virtually all raw materials involved in a production process, including factory employees can be potential sources of pyrogen contamination in injectable pharmaceuticals. Hence raw material screening is an important step in any standard quality control procedure. In this context early endotoxin detection was accomplished by injecting rabbits with the sample and observing the response in their body temperature.
REASONS FOR CHOOSING THIS TEST: Rabbits have similar endotoxin tolerance to humans. Contrary to LAL test, rabbit pyrogen test is sensible to a wide variety of pyrogenic materials. FOR NOT CHOOSING THE TEST: Costly and time consuming method. Unable to quantify endotoxin level.
