Course Offerings

Through lecture and hands-on activities, practice the basics of aseptic operations in a simulated CGMP environment. Topics include microbiology, cleanroom design and control, environmental monitoring, cleaning and disinfection, aseptic gowning, component preparation, solution preparation, sterile filtration, sterilization methods and cleanroom behavior. Topics are correlated to regulatory guidelines.

Course Objectives

Develop an understanding of the role aseptic processing plays in the manufacture of pharmaceuticals.

Gain a basic understanding of microbiology in the context of parenteral drug manufacturing.

Gain hands-on experience with cleaning and disinfection of aseptic processing areas.

Develop an understanding of the principal sterilization methods for aseptic manufacturing.

Gain hands-on experience in aseptic gowning.

Outline of Instruction

Day 1: Microbiology and Cleanrooms

a. Introductions
b. Lecture: Why Aseptic Processing?
c. Overview of CGMPs and GDPs
d. Cleanroom designs and controls (Tour)

e. Lab: Cleaning of Aseptic Areas- Facility cleaning and selected slides (Lecture)

f. Lab- Cleaning the cleanroom/ BSCs

Day 2: Environmental Monitoring
a. Lecture: Microbiology Basics
b. Lecture: Environmental Monitoring
c. Lecture: Microbiology Basics

d. Labs: Environmental Monitoring (Finger Plates, Body Swabs, Contact Plates, Air Sampling for Viables, Air Sampling for Particulates)

e. Lab: Disinfectant Experiment

f. Lab: Component Preparation

Day 3: Sterile product equipment and component preparation sterilization section

a. Lecture: Aseptic Gowning and Cleanroom Behaviors

b. Video: Aseptic Gowning

c. Lab: Filtration in cleanroom

d. Lab: Read Disinfectant plates
Day 4: Lab and Lecture Review (Cleanroom Behaviors and Aseptic Technique Critique, Filtration Results, Gowning)
a. Lab: Solution preparation lecture
b. Lecture: principles of filtration
1 Lab: Review and Discuss Results of Microbiological Data
2 Q&A for AP I
3 Course Evaluations
4 Final Quiz and Course Wrap-up

Contact Hours

24

CEUs

1

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

None

Learning Supplies Needed

Gowning materials, lecture materials, disinfectants, agar plates (finger plates, body swabs, contact plates) Air sampler (viable, and particulate sampling).

Clinical Site/Special Facilities

Capstone or RTP cleanroom facility

Requirements for Successful Completion

90% attendance
Minimum score of 80% on final quiz in two attempts or fewer.

Accreditation/Special Approval Requirements

N/A

Intended Audience

Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel; persons desiring entry into the Biotechnology field

Specific Industry or Business Support Needs

Aseptic Processing Technician, Bioprocess Technician, Gene Therapy Operation Specialist, Lab Technician, QC or QA personnel.

Wake County Need for Industry Positions

https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=9B8/uT7EfbE…

Industry or Job Titles Related to Training Outcomes for Employment

Bioprocess Technician

Lab Technician

Gene Therapy Operation Specialist

Manufacturing Associate

Related Courses

BTC-3300C4

BTC-3200A7

Course Contact Information

Cynthia Lawrence
919-335-1037
[email protected]