Contamination Control & Aseptic Techniques

Winning Cleanroom Behaviors

In the highly regulated environment of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), also known as GXP, maintaining cleanroom behaviors is paramount to ensuring product quality, patient safety, and regulatory compliance. Cleanroom contamination can lead to product defects, invalid test results, and even serious health hazards. Therefore, it is essential that all personnel working in GXP cleanrooms adhere to strict protocols and adopt winning behaviors to minimize the risk of contamination.

This course provides an overview of cleanroom behaviors, highlighting the critical practices and procedures that must be followed to maintain a clean and controlled environment.

CEU Credits: 0.1
Course Code: ELM-739
Duration: 10 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 11/30/2023

Curriculum for this course

Course Introduction
What You'll Learn
Definition and Purpose
Importance in GxP Industries
Cleanroom Knowledge Checks
The Cascade Effect
Zoning and Segregation
Ariflow Management
Entry and Exit Protocols
Process Isolation
Cascade Effect Knowledge Check
Personnel Requirements
Growning Procedures
Personal Hygiene
Controlled Access
Behavior and Discipline
Summary
What We Covered

Test Your Knowledge

Results

v1.1 - Course updated on 10/16/2024 to fix on-screen text to clarify the cleanliness levels associated with the cascade effect
v1.0 - Course released on 02/27/2024.

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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