Interpreting Cleanroom Certification Reports

About the Course

Cleanroom certifications are a process by which our controlled environments are qualified and certified to meet the industry standards. Understanding what is being performed during the certification is important to pharmacists and technicians for maintaining these areas under a state of control.

The main focus of this webinar is to bring clarity to the report and turn it into a usable document to improve the overall quality of your cleanroom environment.

Target Audience

For all pharmacists and other healthcare providers operating in a controlled cleanroom environment.

Statement of Need

Compounding Pharmacists and technicians that operate in a controlled environment need to be able to interpret the data found in a cleanroom certification report in order to maintain the cleanroom in a controlled state.

This activity is designed to increase the competence of pharmacists and technicians in 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

Faculty
Seth DePasquale, R.Ph.

Faculty Disclosure

All planners, speakers, authors, and reviewers involved with content development for continuing education activities provided by Lyceum are expected to disclose any real or perceived conflict of interest related to the content of the activity. Detailed disclosures will be included in participant materials or given prior to the start of the activity. 

The material presented in this course represents information obtained from the scientific literature as well as the clinical experiences of the speakers. In some cases, the presentations might include discussion of investigational agents and/or off-label indications for various agents used in clinical practice. Speakers will inform the audience when they are discussing investigational and/or off-label uses. 

Content review confirmed that the content was developed in a fair, balanced manner free from commercial bias. Disclosure of a relationship is not intended to suggest or condone commercial bias in any presentation, but it is made to provide participants with information that might be of potential importance to their evaluation of a presentation.