Design of Premises [NEW]

What is the goal of designing pharmaceutical premises in terms of microbial contamination?

To produce products fit for quality by minimizing microbial contamination"

What is sterility, and how does it differ from aseptic processing?

Sterility is the complete absence of all organisms in a product; aseptic processing is a procedure to minimize contamination, not a sterilisation method"

Why should all organisms be considered potentially harmful in pharmaceutical production?

All living organisms can damage patients, so they must be excluded, removed, or destroyed with high probability"

What is the significance of Sterility Assurance Level (SAL) in pharmaceutical production?

SAL indicates less than 1 microorganism per 1 million units; it is used to calculate kill rate but has no meaning in aseptic processing"

Why is terminal sterilisation preferred for sterile products?

Terminal sterilisation ensures products are sterilised in their final container, reducing contamination risk"

What are the main sources of contamination controlled by Good Manufacturing Practices (GMP)?

Raw materials, premises and environment, processing equipment, and personnel"

How do natural and synthetic raw materials differ in terms of microbial contamination?

Natural materials have high bioburden; synthetic materials have low contamination due to GMP processes involving heat, acid, or oxidation"

What features of a clean room help control microbial contamination?

Low temperature (16-18°C), controlled humidity, high air pressure, HEPA filters, laminar flow, coved composite flooring, non-shedding paint, sealed windows, good lighting, and controlled entry"

Why is high air pressure used in clean rooms?

To push clean air out and prevent dirty air from entering"

What role do High Efficiency Particulate Air (HEPA) filters play in clean rooms?

They remove microbial particles from the air"

How does the design of flooring and walls in clean rooms reduce contamination?

Single composite coved flooring and non-shedding, cleanable paint prevent particle accumulation"

Why are disposable or stainless steel apparatus preferred in pharmaceutical processing?

Disposable equipment avoids cross-contamination; stainless steel withstands disinfectants and is easier to clean"

What are the personnel requirements to minimize contamination in pharmaceutical premises?

Trained personnel, minimal staff (often two), no infections, cuts, or asthma outbursts, and automation where possible"

What are the hazards of microbial contamination in pharmaceutical products?

Product spoilage and health hazards to patients"

What is product spoilage in the context of microbial contamination?

Breakdown of active compounds (e.g., morphine, penicillin, hydrocortisone) or excipients, potentially producing toxic byproducts"

How does microbial contamination affect liquid formulations like solutions, suspensions, and ointments?

Microbes release enzymes that break down excipients, causing emulsion cracking or pH changes during fermentation"

What are the consequences of excipient breakdown in formulations?

Loss of product integrity, such as emulsions cracking or pH changes"

How can microbial contamination reduce product acceptability?

Breakdown products like amines and H2S cause bad taste and smell"

How do some microbes affect preservatives in pharmaceutical products?

Resistant microbes, like Pseudomonas, produce enzymes that break down preservatives such as phenol"

What types of bacteria pose health hazards in pharmaceutical products?

Primary pathogens (e.g., Salmonella), opportunistic pathogens (e.g., Staphylococcus aureus), and benign bacteria under certain conditions"

How does the patient's health status affect the risk of microbial contamination?

Patients with severe disease or on chemotherapy/steroids are more susceptible to infections"

How does the route of administration impact the risk of microbial contamination?

IV infusions (e.g., TPN) are most dangerous; oral and GIT routes pose less risk"

What are the pharmacopoeial limits for microbial contamination in pharmaceutical products?

Total viable count and absence of specific organisms (e.g., Staphylococcus aureus, Pseudomonas in inhaled products; E.coli, Salmonella in oral products)"

What are the benefits of producing non-sterile drugs in a sterile environment with good GMP?

Allows a larger margin of error and enables proactive contamination control"