1. Introduction to IV Admixture and Aseptic Technique
Pharmacy 721
January 23-27, 2006

2. Objectives
Background and Definitions
Equipment
USP 797
Technique

3. Background
Parenteral: injected through skin or other external boundary tissue, “alongside of” “small intestine”
Uses:
NPO – nothing by mouth
Unstable in GI, 1st pass metabolism
Immediate action needed
Delivery to specific site
Depot form

4. Definitions LVP-large volume parenteral (>100 ml)
“piggy back” – smaller volume (may be up to 250 ml)
D5W (5% dextrose in water)
NS (normal saline) 0.9%NaCl
Compounded Sterile Preparation (CSP)
Continuous infusion vs. intermittent dosing

5. Definitions HEPA filter- High Efficiency Particulate Air
0.3 micron, 99.97%
ISO: International Organization for Standardization
ISO 5: Clean room standards based on particles for cubic meter by particle size
Class 100: number of particles ≥ 5 μm per cubic foot

6. Hood types
Horizontal Laminar Airflow Workbench

7. Hood Types
Vertical Laminar Airflow Workbench (Biosafety)

8. Hood Types
Barrier Isolator

9. USP 797 Risk Levels High (3) Medium (2) Low (1)
Nonsterile ingredients
<ISO class 5
24 hours rt, 3 days cold
Medium (2)
Multiple doses
Complex manipulations
30 hours rt, 7 days cold
Low (1)
Sterile components
ISO Class 5
<3 sterile products
See Tables 32.1 and 32.2 in Thompson

10. Clean room
Video

11. Syringes and Needles Parts of syringe (32.12) Parts of needle (32.12)
Barrel
Plunger
Tip
Parts of needle (32.12)
Bevel
Shaft
Hub

12. Injection technique Critical sites Swabbing Bevel up, angle
Equalize pressure

13. IV Preparation Preparation Cleaning Inspection Manipulation
Calculations
Assembly
Cleaning
Inspection
Expiration dates
Quality
Manipulation

14. References and Resources
USP, Proposed Revisions to USP Chapter <797>
ASHP Self Assessment Tool for Compounding Sterile Preparations
Ockerman AV, U.S. Pharmacist, Compounded Sterile Preparations: An Overview of the New Standards USP <797>
ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, Am J Health-Syst Pharm, 2000;57: