Gowning & Garbing
Before entering the cleanroom, what is the first hand hygiene step required?
Proper hand washing according to procedure.
Name one behavior that increases contamination risk in the cleanroom.
Excessive movement, talking, or touching surfaces.
What does “aseptic” mean?
Free from contamination by microorganisms.
An operator adjusts their goggles inside the cleanroom. What is the issue?
Risk of contaminating gloves and hands.
How many gown sample sites are there when getting qualified? Can you name them?
Gloves should be sanitized how often during operations?
Frequently and whenever contamination is suspected.
Why should slow, deliberate movements be used in classified areas?
To reduce particle generation and to not disrupt first air.
Why are humans considered the largest source of contamination?
Skin shedding, breathing, and movement.
A person leans against a wall after sanitizing gloves. What should they do next?
Re‑sanitize or change gloves.
What checklist can be used to keep aseptic techniques in mind?
V-QMS-0067005: Aseptic Monitoring Checklist
Touching the outside of your gown with bare hands is acceptable if gloves are donned immediately after.
False.
What should you do if you accidentally touch a non‑sterile surface?
Stop, sanitize or replace gloves, and assess impact.
What is one common source of microbial contamination that’s often overlooked?
Gloves, sleeves, or improper behaviors.
An operator notices their sleeve brushed a non‑classified surface. What is the correct action?
Stop, assess, sanitize or regarb per procedure.
How many sample sites are there in the Grade A for each fill room?
Alpha = 11
Bravo = 13
Charlie =12
Delta = 23