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IV Sterile Lec 1
iv sterile studies
| Question | Answer |
|---|---|
| What is a USP/NF 797 Primer | The United States Pharmacopeia and The national Formulary; a book of public pharmacopeia standards |
| What does it Address? | Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. |
| What is Anteroom? | hand hygiene, garbing, staging of necessary products and labeling; ISO Class 8 or better |
| What is a Buffer/clean area? | Primary control; laminar/horizontal flow hood or isolator is located; ISO class 7 or better |
| Primary control | Laminal/horizontal flow hood or an isolator (glove box) ISO class 5 or better |
| Low risk level (Max Storage) | Rm temp:48hrs Fridge:14days Freezer:45days |
| Medium risk level (Max Storage) | Rm temp:30hrs fridge:9days freezer:45days |
| High risk level (Max Storage) | rm temp:24hrs fridge:3days freezer:45days |
| Low risk level products | ISO class 5 or better. using sterile ingre. and components; 3 max commercially sterile products; 3 max entries into a single product |
| Medium risk level products | under low risk conditions;more that 3 sterile products or entries or procedures;multiple patients or times |
| High risk level products | non-sterile ingre. or exposed to ISO 5 for more than an hr;products MUST be sterilized before use |
Created by:
karmabites
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