Sterile Compounding Flashcards
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Questions and Answers

What guidelines should be utilized for sterile compounding?

USP 797

List medications that should be prepared in a sterile manner.

Ophthalmics, Inhalations, Tissue soaks, Implants, Irrigations, IV medications

What is the Ante room?

Space outside the sterile compounding area where the sink and garbing items are located

What is the buffer area?

<p>Cleanroom where sterile compounding takes place</p> Signup and view all the answers

What is a biological safety cabinet?

<p>The hood where low, medium, and high-risk compounding is done</p> Signup and view all the answers

What is CSP?

<p>Compounded sterile preparations</p> Signup and view all the answers

What is garb?

<p>Protective gear required to be in the cleanroom</p> Signup and view all the answers

What is a hazardous drug?

<p>Refers to drugs that can cause cell death, primarily chemo agents</p> Signup and view all the answers

Why is positive pressure used?

<p>To keep contaminated air from entering the hood and contaminating the product</p> Signup and view all the answers

Why is negative pressure used?

<p>To keep contaminated air away from the compounding staff and vent it to the outside</p> Signup and view all the answers

What is ISO classification?

<p>Number of particles permitted per volume of air</p> Signup and view all the answers

ISO classification of all primary engineering controls (PECs)?

<p>ISO 5</p> Signup and view all the answers

ISO classification of the buffer area?

<p>ISO 7</p> Signup and view all the answers

ISO classification of the ante area?

<p>ISO 8</p> Signup and view all the answers

What is a Primary Engineering Control (PEC)?

<p>Refers to the isolator device or the room that provides the ISO class 5 area for compounding CSPs.</p> Signup and view all the answers

List the rooms/areas from ante room to compounding area and their ISO classification.

<p>Ante room (ISO 8), Buffer area (ISO 7), Biological safety cabinet (ISO 5)</p> Signup and view all the answers

What are HEPA filters?

<p>High-efficiency air filters that are &gt;99.97% efficient in removing particles as small as 0.3 microns</p> Signup and view all the answers

What are the CSP risk levels?

<p>Low, low with 12-hour or less BUD, medium, high, or immediate use</p> Signup and view all the answers

Exemptions from USP risk?

<p>Ready to use IVs/premixed, Vial-bag systems</p> Signup and view all the answers

What is 'immediate use' USP classification?

<p>Only for emergency administration, must use within 1 hour and compounded in a clean area</p> Signup and view all the answers

What is 'low risk' USP classification?

<p>Requires an ISO class 5 within an ISO 7 buffer area, ISO 8 ante room, using only sterile ingredients</p> Signup and view all the answers

BUD for low risk for room temp, fridge, frozen?

<p>48 hours, 14 days, 45 days</p> Signup and view all the answers

What is the 'low-risk with 12-hour or less BUD'?

<p>Permits preparation outside of hood but in a segregated compounding area</p> Signup and view all the answers

BUD for room temp, fridge, and frozen 'low-risk with 12-hour or less BUD'?

<p>12 hours, 12 hours, N/A</p> Signup and view all the answers

What is 'medium risk' CSP level?

<p>Individual or small doses of sterile products with complex aseptic manipulations</p> Signup and view all the answers

BUD for medium risk? Room temp; fridge; frozen?

<p>30 hours, 9 days, 45 days</p> Signup and view all the answers

What is 'high-risk' CSP level?

<p>Involves nonsterile ingredients or equipment</p> Signup and view all the answers

BUD for high-risk? Room temp; fridge; frozen?

<p>24 hours, 3 days, 45 days</p> Signup and view all the answers

BUD for 'immediate use' CSP risk level? Room temp; fridge; frozen?

<p>1 hour, N/A, N/A</p> Signup and view all the answers

What type of risk level do batched syringes fall into?

<p>Medium risk</p> Signup and view all the answers

What risk level does parenteral nutrition fall into?

<p>Medium</p> Signup and view all the answers

What risk level is ophthalmics made from sterile products?

<p>Medium</p> Signup and view all the answers

What risk level do small volume injections fall into?

<p>Low-risk</p> Signup and view all the answers

BUD for small volume injections?

<p>48 hours; 14 days; 45 days</p> Signup and view all the answers

What risk level do IV fluids with 3 components fall into?

<p>Low-risk</p> Signup and view all the answers

What risk level do compounds from bulk drug containers fall?

<p>High-risk</p> Signup and view all the answers

What does BUD mean for sterile compounding?

<p>Date or time after which the CSP should not be used</p> Signup and view all the answers

What are the CSP minimum label requirements from USP 797?

<p>Generic name, concentration of active ingredient(s), route, recommended administration rate, storage and handling instructions, preparation date, BUD, name or initials of compounding personnel, auxiliary labels</p> Signup and view all the answers

Additional label requirement for chemotherapy?

<p>'Chemotherapy-- dispose of properly' or similar</p> Signup and view all the answers

Study Notes

Sterile Compounding Guidelines

  • USP 797 outlines the guidelines for sterile compounding.

Medications Requiring Sterile Preparation

  • Include ophthalmics, inhalations, tissue soaks for organ transplants, implants, irrigations, and IV medications.

Compounding Facility Layout

  • Ante room: Area for hand washing and garbing, typically features a sink.
  • Buffer area: A cleanroom where sterile compounding is carried out.

Safety Equipment

  • Biological Safety Cabinet: A hood used for low, medium, and high-risk compounding, located in the cleanroom.

Compounded Sterile Preparations (CSP)

  • Refers to the drug being prepared in a sterile manner.

Garb Requirements

  • Protective gear essential for compliance in the cleanroom, donned in the ante room.

Hazardous Drugs

  • Drugs that can cause cell death, prominently chemotherapy agents.

Air Pressure Control

  • Positive pressure prevents contamination by keeping external air out; used primarily for sterile drug preparations.
  • Negative pressure is utilized for hazardous drugs to contain contaminated air away from staff and exhaust outside.

ISO Classification

  • System defines the number of particles permitted per volume of air; lower numbers indicate cleaner air.
  • ISO classifications:
    • Primary Engineering Controls (PECs) require ISO 5.
    • Buffer area classified as ISO 7.
    • Ante area classified as ISO 8 (ISO 7 if adjacent to a negative pressure cleanroom).

Primary Engineering Control (PEC)

  • Isolator device or room providing an ISO class 5 area for compounding CSPs ensuring high-efficiency particulate air (HEPA) filtration.

HEPA Filters

  • Capable of removing over 99.97% of particles as small as 0.3 microns, facilitating unidirectional airflow to safeguard compounding integrity.

CSP Risk Levels

  • Determined by contamination risk, location, preparation complexity, storage temp:
    • Classifications: low, low with 12-hour BUD, medium, high, and immediate use.

Immediate Use CSPs

  • Prepared for emergency use only within one hour and must be compounded in a clean area.

Low Risk CSPs

  • Require ISO class 5 environment within ISO 7 buffer and ISO 8 ante room.
  • BUD: 48 hours at room temp, 14 days in the fridge, 45 days frozen.

Low Risk with Short BUD

  • Allows compounding outside the hood in a segregated area; max BUD is 12 hours.

Medium Risk CSPs

  • Involves complex manipulations requiring the same environmental controls as low risk.
  • BUD: 30 hours at room temp, 9 days in the fridge, 45 days frozen.

High Risk CSPs

  • Involves nonsterile ingredients, needing strict environmental classifications.
  • BUD: 24 hours at room temp, 3 days in the fridge, 45 days frozen.

BUD Significance

  • Indicates the date/time beyond which CSPs should not be used.

Labeling Requirements for CSPs

  • Minimum label must include generic name, concentration, route, administration rate, handling instructions, preparation date, BUD, compounding personnel name/initials, and auxiliary labels.

Additional Label Requirements for Chemotherapy

  • Labels must note disposal instructions for chemotherapy agents, emphasizing proper disposal methods.

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Test your knowledge on sterile compounding guidelines with these flashcards. Covering important concepts such as USP 797 and the sterile preparation of various medications, this quiz will strengthen your understanding of essential practices in pharmacy. Review crucial definitions to enhance your learning experience.

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