Lecture 10 Flashcards
What are the main sources of contamination in the pharmaceutical, biopharma, and healthcare industries?
Raw materials
Water
Personnel
Plant equipment
Packaging components
Air
Post-processing and “in-use” contamination
What are the main sources of raw material contamination in the industry?
Raw materials, especially animal or plant-based, can introduce microbes during manufacturing.
Animal products may be contaminated with human pathogens like Salmonella and E. coli.
Plant materials may carry soil microbes.
Tight specifications and quality control testing are required to manage contamination risks.
How can contamination of raw materials be identified and controlled?
Sources: Animal, plant, synthetic substances, natural earths, and excipients (starch, sugars)
Control Measures:
Risk assessment
Quality control testing
Supplier audits
Proper storage
Sterilization of high-risk materials
How can contamination of water sources be identified and controlled?
Sources: Spoilage organisms and pathogens.
Control Measures:
Water quality monitoring
Use of purified water
Water treatment systems
How can contamination of personnel sources be identified and controlled?
Sources: Microorganisms from skin, hair, and respiratory tract.
Control Measures:
Hygiene training
Health screening
Restricted access
How can contamination of plant and equipment sources be identified and controlled?
Sources: Product residues, biofilm formation, and inadequate cleaning.
Control Measures:
Hygienic design
Regular cleaning and disinfection
Biofilm monitoring
How can contamination of packaging components sources be identified and controlled?
Sources: Contaminated containers and closures, cardboard packaging harbouring mould spores.
Control Measures:
Microbiological testing
Sterilization
Proper storage
How can contamination of air sources be identified and controlled?
Sources: Airborne microorganisms from dust and moisture.
Control Measures:
Air quality monitoring
HEPA filtration
Cleanroom design and control
How can contamination of post processing sources be identified and controlled?
Sources: Occurs during packaging and storage.
Control Measures:
Strict hygiene practices
Environmental controls
How can contamination of in use sources be identified and controlled?
Sources: Products used on multiple patients or IV fluids.
Control Measures:
Patient education
Aseptic techniques
Disposable applicators
What is the relevance of the Aw factor, and how does it relate to raw material contamination control?
Water Activity (Aw): Represents available water for microbial growth; higher Aw indicates more available water and increased contamination risk.
Controlling Aw in raw materials helps prevent microbial contamination.
Example of AW factor
Syrups: Low Aw due to high solute concentrations, preventing microbial growth.
Dry Powders: Naturally low Aw, but can absorb moisture and increase contamination risk.
