Pyrogens test Flashcards
what is a pyrogens ?
chemically polysaccharides
what organisms produce pyrogens?
most usually Gram neg
what are sources of pyrogens in pharmaceutical formulations?
apparatus and containers
Temperature for water injection
70 to 90 degrees celcius.
Purified water temp
ambient temp.
clean room B
A zone for aseptic preparation, filling, and compounding. It’s equivalent to ISO Class 5 at rest and ISO Class 7 in operation
clean room A
highly controlled space used for high-risk operations. It’s the highest level of cleanroom environment and is equivalent to ISO Class 5.
clean room C
A clean area for less critical stages in the manufacturing process. It’s equivalent to ISO Class 7 at rest and ISO Class 8 in operation.
What percentage of contamination is from humans?
70%
what are the control measures of pyrogens in pharmaceutical formulations?
use of high purity water (WFI)
Classification of pyrogens,
exogenous pyrogens.
(e.g., tetanous, shiga, and diphtheria)
endogenous (e.g., produced by our bodies in response to microorganisms, IL-6, IL-1 )
Exogenous pyrogens
microbial
non-microbial
What are properties of pyrogens?
heat stable
water soluble
what are physiological effects of pyrogens?
fever
coagulation
How is depyrogenation performed?
reverse osmosis-multiple
ultrafiltration
baffle distillation
chromatography
ovens dypyrogenation.
Ovens depyrogenation
sterilize glass vials and containers
Ovens depyrogenation prinicle
high temp 650 degrees 1 minute
or
250 degrees for 30 minutes
Baffle distillation
turning water from a liquid to vapour and then back.
Ampoule
single dose (single use)
Vials
multiple dose (multiple use)
pyrogens test (official)
rabbit test (in vivo)- official in all pharmacopoeias.
LAL (Lumulus Amoebocyte lysis ) test ( invitro)
Products to undergo pyrogen test?
devices that come in direct or indirect contant with blood, lymphatic and cerebrospinal fluids.
medical device manufacturers
Pharmaceutical industry.
Rabbit test (invivo)
rabbit type- New Zealand or Belgian white
dose not exceeding 10ml/kg
advantages: similar threshold pyrogenic temperature
disadvantages: time consuming, require skilled animal handlers and technicians.
what are the requirements for rabbit pyrogen test?
health and mature.
individually housed btn 20-23 degrees celcius.
animals must be placed in the boxes 1 hour before the test
