Lecture 22 Flashcards
Why is water quality important for medicinal purposes?
Water is a critical utility in compliance with Good Manufacturing Practices (GMPs). It is used in large volumes, meaning surfaces and products may be exposed to bacteria if the system is not well-maintained. Gram-negative bacteria can proliferate during purification and distribution, leading to endotoxin risk. Biofilms in water storage and distribution systems pose major concerns for product quality and safety.
What are the different uses of water in the industry?
As an ingredient
For washing and cleansing
As a cooling agent
For heating
As a solvent and in stock solutions
What contamination problems related to water can affect the industry?
Bacteria can secrete enzymes like proteases and lipases that degrade proteins, affecting product quality.
Spoilage bacteria in process water can reduce product quality and shelf-life.
Biofilms can cause slime production, fouling water systems, clogging pipes, machinery, and filters, leading to costly shutdowns.
Faecal contamination in water can introduce harmful organisms.
Poor water quality can affect the flavour, odour, colour, and turbidity of products.
What are the different types of water used in the pharmaceutical industry?
Drinking Water (Mains Water): Must meet local drinking water standards and is used for washing raw materials.
Purified Water: Made by distillation or reverse osmosis, free from added substances, used in drug production, cleaning, and as a solvent.
Sterile Purified Water: Sterilized purified water used for non-injectable products, but not for injectable drugs due to potential endotoxins.
Water for Injection (WFI): Produced from drinking or purified water, used as an ingredient and in biopharmaceutical processing.
Sterile Water for Injection (SWFI): Packaged sterile WFI, used in sterile drug products.
What are the bacterial endotoxin specifications for Drinking Water & Purified Water
Method: Pour plate
Minimum sample size: 1 mL
Culture media: Plate count agar
Incubation time: 42-72 hours at 30-35°C
What are the bacterial endotoxin specifications for Injection Test
Method: Membrane filtration
Minimum sample size: 100 mL
Culture media: Plate count agar
Incubation time: 48-72 hours at 30-35°C
