MindMap Gallery Sterility inspection method mind map
A mind map about sterility testing methods, an overview of the basic points of sterile operation in the 20th edition, including concepts, requirements, culture media, etc.
Edited at 2023-12-05 11:33:38One Hundred Years of Solitude is the masterpiece of Gabriel Garcia Marquez. Reading this book begins with making sense of the characters' relationships, which are centered on the Buendía family and tells the story of the family's prosperity and decline, internal relationships and political struggles, self-mixing and rebirth over the course of a hundred years.
One Hundred Years of Solitude is the masterpiece of Gabriel Garcia Marquez. Reading this book begins with making sense of the characters' relationships, which are centered on the Buendía family and tells the story of the family's prosperity and decline, internal relationships and political struggles, self-mixing and rebirth over the course of a hundred years.
Project management is the process of applying specialized knowledge, skills, tools, and methods to project activities so that the project can achieve or exceed the set needs and expectations within the constraints of limited resources. This diagram provides a comprehensive overview of the 8 components of the project management process and can be used as a generic template for direct application.
One Hundred Years of Solitude is the masterpiece of Gabriel Garcia Marquez. Reading this book begins with making sense of the characters' relationships, which are centered on the Buendía family and tells the story of the family's prosperity and decline, internal relationships and political struggles, self-mixing and rebirth over the course of a hundred years.
One Hundred Years of Solitude is the masterpiece of Gabriel Garcia Marquez. Reading this book begins with making sense of the characters' relationships, which are centered on the Buendía family and tells the story of the family's prosperity and decline, internal relationships and political struggles, self-mixing and rebirth over the course of a hundred years.
Project management is the process of applying specialized knowledge, skills, tools, and methods to project activities so that the project can achieve or exceed the set needs and expectations within the constraints of limited resources. This diagram provides a comprehensive overview of the 8 components of the project management process and can be used as a generic template for direct application.
Sterility test
Pharmacopoeia Summary
concept
drug
Biological Products
medical instruments
Raw materials
Other varieties
Pharmacopoeia requirements
Compliance with regulations: It only indicates that no microbial contamination was found in the test product under the inspection conditions.
Require
Sterile conditions
test environment
Routine inspections need to be monitored
One-way flow air area
working desk
controlled environment
Regular confirmation
isolation system
Conduct regular verification according to relevant requirements
Cleanliness confirmation
suspended particles
Plankton
Settlement bacteria
Current national practices for pharmaceutical industry clean rooms/zones
Operation process
Full aseptic operation
Anti-pollution measures
It must not affect the detection of microorganisms
medium
Prepare
Pharmacopoeia prescription
dehydrated medium
Commercial predictive culture medium
in accordance with
store
Sterile airtight container
2~25℃
Avoid light
Verified shelf life
Medium for neutralization or inactivation
Add before sterilization
Add before experiment
Neutralizer inactivator Surfactant
Commonly used culture media
FTM
scope
Main: Anaerobic bacteria
Vice: aerobic bacteria
Element
Tryptone
yeast extract powder
L-cystine
Sodium thioglycolate/thioglycolic acid
Glucose/anhydrous glucose
Agar
water
Newly prepared 0.1% resazurin solution
Sodium chloride
Prepare
Sterilization procedures need to be validated
Adjust ph to slightly alkaline
Add glucose/anhydrous glucose and resazurin
Adjust ph: 25℃ 7.1±0.2
Packaging
Before vaccination: ≤1/3
After culture: ≤1/2
Medium: Oxide layer versus depth comparison
water bath
Time:≤20min
100℃
Cool quickly
Only heat once
pink disappears
nourish
30~35℃
Unless otherwise specified
TSB
scope
Aerobic bacteria
Fungi
Element
Tryptone
Soybean papain hydrolyzate
Dipotassium phosphate
Sodium chloride
water
Glucose/anhydrous glucose
Prepare
Adjust ph: 25℃ 7.3±0.2
Add glucose/anhydrous glucose
nourish
20~25℃
TSA
Element
Tryptone
Soybean papain hydrolyzate
Agar
Sodium chloride
water
Prepare
Adjust ph: 25℃ 7.3±0.2
Add agar
SDA
Element
Animal tissue pepsin hydrolyzate, tryptone equivalent
Glucose 40g
water
Agar
Prepare
Adjust pH: 5.6±0.2 at 25 degrees Celsius
Add glucose and agar
SDB
Element
Animal tissue pepsin hydrolyzate, tryptone equivalent
Glucose 20g
water
Prepare
Adjust pH: 5.6±0.2 at 25 degrees Celsius
add glucose
Potato dextrose agar (PDA)
Adjust ph: 25℃ 5.6±0.2
Can be used instead of SDA for AN passage
0.5 glucose broth medium
Used for sterility testing of antibiotics such as streptomycin sulfate
Suitability test
Sterility test
Take randomly
Each batch ≥5 pieces/bottle
Culture for 14 days
Sensitivity check
strain
Serial Number
SA→26003
PA→10104
BS→63501
CA→98001
AN→98003
CS→and64941
preservation
Confirmation of preservation technology
biological properties
Bacterial liquid preparation
SA.PA.BS
pass on
TSA/TSB
Training time
18~24h
CA
AN
SDA/SDB/PDA→No sodium chloride TSA/TSB/FTM→with sodium chloride