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

Objectives Background and Definitions Equipment USP 797 Technique

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

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

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

Hood types Horizontal Laminar Airflow Workbench

Hood Types Vertical Laminar Airflow Workbench (Biosafety)

Hood Types Barrier Isolator

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

Clean room Video

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

Injection technique Critical sites Swabbing Bevel up, angle Equalize pressure

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

References and Resources USP, Proposed Revisions to USP Chapter <797> http://www.usp.org/healthcareInfo/pharmInfo/revisions797.html ASHP Self Assessment Tool for Compounding Sterile Preparations http://www.ashpbestpracticessat.com/Print_Version_ASHP_797_Assessment.pdf Ockerman AV, U.S. Pharmacist, Compounded Sterile Preparations: An Overview of the New Standards USP <797> http://www.uspharmacist.com/index.asp?show=article&page=8_1252.htm ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, Am J Health-Syst Pharm, 2000;57:1150-69