Interpreting Cleanroom Certification Reports

Learning Objectives

At the conclusion of this activity, pharmacists should be able to: 

1. Discuss the relevant parts of a cleanroom certification report
2. Identify what constitutes an action level for both particle counts and viable sampling
3. Discuss the importance and significance of 0.5 micron sized particles in a cleanroom environment
4. Discuss the concept of “just in time” as related to materials brought into the cleanroom and why it’s important

At the conclusion of this activity, technicians should be able to:

1. Discuss the difference between viable sampling and non-viable sampling or total particle counts
2. Explain why non-viable sampling isn’t the most accurate term
3. Discuss the importance of keeping particle counts in your cleanroom as low as possible
4. Discuss the importance and significance of 0.5 micron sized particles in a cleanroom environment