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USP 797

ISO Requirements

QuestionAnswer
Ante room opens only into positive pressure buffer room ISO 8
Ante room that opens into one or more negative pressure rooms ISO 7
Positive Pressure Buffer Room ISO 7
Negative Pressure Buffer Room ISO 7
Segregated Compounding Area NO Requirements
Containment Segregated Compounding Area NO Requirements
Buffer Room Pressure Gradient 0.020 higher than ante room
Ante Room Pressure Gradient 0.020 higher than general area
Ampule (Allowable in Use Time Opened in ISO Class 5) Use and Discard Remainder
Ampule (Allowable in Use Time Opened Outside ISO Class 5) Use and Discard Remainder
Single Dose Vial (Allowable in Use Time Opened in ISO Class 5) 12 hours
Single Dose Vial (Allowable in Use Time Opened Outside of ISO Class 5) 4 hours for single patient use
Multidose Vial (Allowable in Use Time Opened in ISO Class 5) 28 days unless otherwise specified
Multidose Vial (Allowable in Use Time Opened Outside of ISO Class 5) 28 days unless otherwise specified
BUD Category 1 12 hours room temperature
BUD Category 1 24 hours refrigerated
BUD Category 2-Nonsterile Components 24 hours room temperature
BUD Category 2-Nonsterile Components 4 days refrigerated
BUD Category 2-Nonsterile Components 45 days frozen
BUD Category 2-Sterile Components 4 days room temperature
BUD Category 2-Sterile Components 10 days refrigerated
BUD Category 2-Sterile Components 45 days frozen
BUD Category 3 180 days
Hazardous Buffer Room to Anteroom Pressure Gradient 0.01 to 0.03
Electronic Air Sampling- Category 1 and 2 6 months
Electronic Air Sampling- Category 3 Monthly
Surface Sampling- Category 1 and 2 Monthly
Surface Sampling- Category 3 Weekly
ISO Class 5 Air Sample Action Plan: >1
ISO Class 5 Surface Sample Action Plan: >3
ISO Class 7 Air Sample Action Plan: > 10
ISO Class 7 Surface Sample Action Plan: >5
ISO Class 8 Air Sample Action Plan: >100
ISO Class 8 Surface Sample Action Plan: >50
Created by: lvilla26
 

 



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