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IV Sterile Lec 1

iv sterile studies

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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