Hand Hygiene and Garbing for Sterile Compounding

This set of flashcards covers the standard operating procedures for hand hygiene, garbing levels, and environmental classifications required for sterile compounding.

The Effective Date for SOP.OH1.09.903, which covers Hand Hygiene and Garbing for Sterile Compounding, is __________.

30NOV2025

An alcohol-containing preparation designed to inactivate microorganisms on the hands is defined as a(n) __________.

Alcohol-based hand rub (ABHR)

An __________ is an ISO Class $8$ or cleaner room that acts as the transition space between the unclassified area and the buffer room.

Anteroom

An ISO Class $7$ or cleaner room where Primary Engineering Controls (PECs) are located is known as a(n) __________.

Buffer room

A __________ is a device or zone within a buffer area that provides an ISO Class $5$ or better environment via unidirectional HEPA-filtered airflow.

LAFS (Laminar Airflow System)

The __________ is a visible line on the floor in the anteroom that separates clean and dirty areas.

Line of Demarcation (LOD)

Before accessing CNC spaces, personnel must remove all cosmetics and exposed __________ (including piercings, necklaces, and earrings).

jewelry

Personnel are prohibited from wearing __________ or nail polish in the compounding environment.

Artificial nails

Approved PPE donned in ISO-classified spaces may be used for a maximum of __________ entry and exit.

$$1$$

During hand hygiene, personnel must wash their hands and forearms for at least __________.

$$30\,\text{seconds}$$

For Level 3 garbing, sterile boots must be donned while moving each leg over the __________.

Line of Demarcation (LOD)

Upon entering the ISO $7$ Fill/Cap (buffer room), personnel must immediately don a __________ pair of sterile gloves aseptically.

second

The abbreviation sIPA stands for sterile __________.

$70\%$ Isopropyl Alcohol

For weekly or monthly cleaning with a sporicidal agent, a(n) __________ can be donned for personal comfort during the process.

positive pressure air respirator (PAPR)

If a breach in sterile garbing occurs in the ISO-$7$ Anteroom, the individual must reapply ABHR, reglove, and replace the __________.

breached garb

The Primary Engineering Control (PEC) is a device or zone that maintains an ISO Class __________ environment for sterile compounding.

$$5$$

Personal outer garments like coats and hats must be replaced with laundered or disposable __________ before entering CNC and ISO-classified spaces.

scrubs

A __________ is a qualified individual formally delegated by the Designated Person to perform specified duties on their behalf.

Appointed Designee