Cleanroom Environmental Monitoring

About the Course
This course will provide the learner with the knowledge to properly perform environmental monitoring inside a cleanroom environment.

Target Audience
This course is designed for those working in a compounding controlled environment that need to understand how to do properly perform environmental monitoring and understand its impact on the state of control of the cleanroom.

Statement of Need
Technicians need to have an understanding of how to properly perform environmental monitoring in order to assess the state of the cleanroom and remediate any contamination if necessary.

Learning Objectives:

At the conclusion of this activity Pharmacists should be able to:

1. Discuss two types of sampling that must be included in an environmental monitoring program according to USP 797
2. Explain the relevance of 0.5 and 5 micron sized particles in air sampling
3. Discuss how frequently surface sampling must be performed according to USP <797>
4. Discuss the minimum frequency total particle counts need to be performed according to USP <797>
5. Discuss the point at which an investigation into a contamination should be conducted

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

1. List 3 factors that increase the risk of a compounding procedure
2. List the 3 types of environmental monitoring samples that can be taken
3. Describe the motion used to perform surface sampling
4. Discuss 3 activities that can be assessed using particle counts
5. Discuss the main limitation to viable air sampling

Faculty
Seth DePasquale, R.Ph., BCSCP

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.