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Cleanroom Courses at the University of Florida

ASE Cleanroom Courses

ASE is proud to be an instructor for the University of Florida on November 1, 2017. Registrants are encouraged to email any specific topics that they would like to see addressed to Tammy Mandell: tmandell@cerhb.ufl.edu & David S. Bess, P.E.: David@ASE2000.com.

HVAC Cleanroom Design Concepts for Pharmaceutical Compounding

The Unites States Pharmacopeia is actively revising the standards governing pharmaceutical compounding facilities and will be introducing a new standard focused on hazardous compounding (USP 800) in July 2018. The introduction of this new standard will be accompanied by revisions to the existing USP 797 and USP 795 standards.

Topics covered in this lecture and discussion-based course include, but are not limited to, the following:

  • USP 800 (Hazardous) requirements
  • Existing and proposed USP 797 (Sterile) requirements
  • USP 795 (Non-Sterile) requirements
  • Solutions to handling the humidity issues that are very common in these rooms
  • Common design and maintenance issues

We will have an interactive discussion about these subjects which will allow attendees to discuss their specific challenges.

Registrants are encouraged to email any specific topics that they would like to see addressed to Tammy Mandell: tmandell@cerhb.ufl.edu.

Instructor: David S. Bess, P.E., Advanced Systems Engineering, Inc. http://ase2000.com/

https://xms.dce.ufl.edu/reg/groups/CERHB/course.aspx?c=10019

HVAC Cleanroom Design Concepts for Pharmaceutical cGMP

Topics described and discussed in this lecture-based course include, but are not limited to, the following:

  • Interactive Classroom design of Oral Solid Dosage (Non-Potent)
  • Interactive Classroom design of Oral Solid Dosage (Potent)
  • Design differences between Single Product vs. Multi Product
  • Design differences between Potent and Non Potent
  • Temperature and Humidity requirements
  • ACH vs. Class vs. Application
  • HVAC Risk Assessment
  • Developing Proper User Requirement Specifications
  • FDA vs. EU Requirements
  • Class A, B, C, D and CNC Requirements and Applications
  • Class 100, Class 10,000 and Class 100,000 Requirements and Applications
  • ISO 5, 7 and 8 Requirements and Applications

We will have an interactive discussion about common design and maintenance issues which will allow attendees to address their specific challenges.

Registrants are encouraged to email any specific topics that they would like to see addressed to Tammy Mandell: tmandell@cerhb.ufl.edu.

Instructor: David S. Bess, P.E., Advanced Systems Engineering, Inc. http://ase2000.com/

https://xms.dce.ufl.edu/reg/groups/CERHB/course.aspx?c=10020