Sterility Testing

Bacillus subtilis, Staphylococcus aureus

Clostridium histolyticum, Clostridium sporogenes

Candida albicans, Aspergillus brasiliensis

<p>Membrane filtration method and direct inoculation method</p> Signup and view all the answers

<p>To detect microbial contamination in a drug product</p> Signup and view all the answers

<p>Fever-inducing substances usually derived from microorganisms</p> Signup and view all the answers

<p>Endogenous pyrogens and exogenous pyrogens</p> Signup and view all the answers

<p>Bacterial endotoxin</p> Signup and view all the answers

<p>Water for injection, Infusion fluids</p> Signup and view all the answers

<p>To detect the presence and concentration of bacterial endotoxins in drugs and biological products</p> Signup and view all the answers

<p>To detect the presence of viable forms of microorganisms and ensure the product is free of contamination.</p> Signup and view all the answers

<p>Injections (solutions and suspension), solids for injection, eye drops/ointments/lotions, water for injections, immunological products (vaccines, antisera, diagnostic preparations), implants.</p> Signup and view all the answers

<p>Taking sufficient samples, using sensitive culture media, minimizing accidental contamination through careful supervision of operatives.</p> Signup and view all the answers

<p>Aerobic and anaerobic bacteria, yeasts, and molds.</p> Signup and view all the answers

<p>30-37°C.</p> Signup and view all the answers

<p>30-37°C.</p> Signup and view all the answers

<p>20-25°C.</p> Signup and view all the answers

<p>To ensure drugs delivered to patients are free of contamination.</p> Signup and view all the answers

<p>To initiate and maintain the growth of microorganisms during the test.</p> Signup and view all the answers

<p>To minimize accidental contamination and obtain reliable test results.</p> Signup and view all the answers

<p>Oral tablets</p> Signup and view all the answers

<p>20-25°C</p> Signup and view all the answers

<p>Testing in a sterile environment</p> Signup and view all the answers

<p>Both aerobic and anaerobic bacteria</p> Signup and view all the answers

<p>To ensure drugs are free of contamination</p> Signup and view all the answers

<p>Fungal pyrogen</p> Signup and view all the answers

<p>Eye drops, injections, and implants</p> Signup and view all the answers

<p>30-37°C</p> Signup and view all the answers

<p>To reduce accidental contamination</p> Signup and view all the answers

<p>Both aerobic and anaerobic bacteria</p> Signup and view all the answers

<p>Membrane filtration method</p> Signup and view all the answers

<p>Exogenous pyrogen</p> Signup and view all the answers

<p>To measure the rise in body temperature of rabbits when a preparation is injected intravenously</p> Signup and view all the answers

<p>It is more sensitive for endotoxin</p> Signup and view all the answers

<p>In vitro test</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>All of the above</p> Signup and view all the answers

<p>To detect and quantify endotoxins in drugs and biological products</p> Signup and view all the answers

<p>Exogenous pyrogens</p> Signup and view all the answers

<p>Membrane filtration method and direct inoculation method</p> Signup and view all the answers