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1) Raw Materials
A) Water
Used in formulations can be a significant source of microbial contamination if not properly treated.
B) Active Pharmaceutical Ingredients (APIs)
May harbor contaminants from their source or during processing.
C) Excipients
Ingredients like fillers, binders, and stabilizers can introduce microbes if not properly handled.
2) Manufacturing Environment as Sources of Microbial Contaminants
A) Air
Airborne contaminants can settle on surfaces and products.
B) Surfaces and Equipment
Inadequately cleaned or sanitized surfaces and equipment can harbor microbes.
C) Personnel
Human operators can introduce contaminants through skin, clothing, or respiratory droplets.
3) Packaging Materials
A) Containers and Closures
Can introduce contaminants if not sterile or if compromised during storage.
B) Packaging Process
Can lead to contamination if not conducted under sterile conditions.
4) Storage and Distribution
A) Storage Conditions
Improper temperature and humidity can promote microbial growth.
B) Transportation
Contaminated transportation environments can introduce or promote the growth of microbes.
5) Handling and Use
A) Consumer Handling
Improper handling by consumers can introduce contaminants.
B) Healthcare Settings
Contaminated environments or improper handling during administration can lead to contamination.
These are all the Sources of Microbial Contaminants
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