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pharmaceutics 2 exam
| Question | Answer |
|---|---|
| what is the goal os aseptic technique | to minimize the introduction of microorganisms |
| can you use heat to kill endotoxins | no, the heat will release endotoxins |
| what ISO class air does the Ante Area provide | ISO class 8 |
| what ISO class does the buffer zone provide | ISO class 7 |
| what ISO class air does the workbench provide | ISO class 5 |
| multi-dose containers must not contain more than ___ mL | 30 |
| what are the 3 main methods of sterilization | 1. Moist heat 2. Dry heat 3. Filtration |
| what are the 2 types of sterility testing | 1. direct inocculation 2. membrane filtration |
| what are the 2 types of endotoxin (pyrogen) testing | 1. Rabbit Test 2. LAL test |
| cannot mix more than ___ different sterile products when preparing immediate-use CSPs | 3 |
| how long after the start of compounding does immediate-use CSPs have to be used | 4 hours |
| what is the BUD for category 1 CSPs | - 12 hours at room temperature or - 24 hours refrigerated |
| what is the difference between a category 1 and category 2 preparation | category 2 is done in a clean room while category 1 is done in a regular room |
| what is the BUD assignment for a category 2 CSP | based on components |
| what is the difference between a category 2 and category 3 preparation | category 3 requires testing for sterility |
| what is the BUD assignment for a category 3 CSP | based on label recommendations and literature |
| are all ophthalmics required to be sterile | yes |
| are nasal preparations required to be sterile | not required |
| nasal preparations are not required to be sterile but... | should be able to inhibit bacterial growth (contain preservatives) |
| are all inhalations required to be sterile | not required |
| which inhalation products are required to be sterile | AQUEOUS solutions and suspensions |
| are all otic products required to be stable | no |
| when might an otic product be stable | when it is a product for the inner ear |
| how does viscosity effect bioavailability of ophthalmics | increases corneal contact time |
| what 2 components must ophthalmic products have | hydrophilic and hydrophobic |
| methylcellulose, hydroxyethylcellulose, hydroxypropyl methylcellulose, and polyvinyl alcohol are examples of | hydrophilic polymers for ophthalmics |
| eyes can tolerate a more _____ pH than ______ | alkaline; acidic |
| NaCl, mannitol, buffer salts, boric acid, glycerin, and propylene glycol are examples of... | tonicity adjusting agents in ophthalmics |
| what are the preservatives for ophthalmics | - benzalkonium chloride - benzelthorium chloride - chlorobutanol - phenylmercuric acetate - phenylmercuric nitrite - thimerosal - EDTA |
| can chlorobutanol be sterilized with heat and why | no, because heat will break down chlorobutanol |
| how can chlorobutanol be sterilized instead | filtration |