Course Offerings

Delve more deeply into the aseptic processing arena with intensive hands-on instruction of aseptic techniques in a simulated cGMP environment. Instruction includes process simulations of closed-system filtrations, hand filling, semi-automated filling, LAF cabinets, BSC's and barrier isolators, and release testing of a final product. Topics of classroom instruction include FDA regulations pertaining to process simulations, review of microbiology including endotoxins, biosafety levels and water system review.

Course Objectives

Gain familiarity with aseptic manufacturing practices and the controls used to provide and maintain the necessary environment for the manufacturing of parenteral products, including process simulations. Aseptic technique will be a primary focus.

Perform aseptic process simulations within LAF's, BSC's and Barrier Isolators.

Compare open-system to closed-system aseptic processes utilizing tube welder, aseptic connections and single-use disposable vessels.

Conduct an investigation into aseptic processing issues and write a CAPA report based on observations.

Outline of Instruction

Day 1 -

a. Classroom: Aseptic Technique Review

b. Classroom: Microenvironments

c. Lab: Micropipetting / Automated Fill Line Demonstration

d. Lab: Aseptic Connections

e. Classroom: Product Release testing

f. Lab: Particulate Release Testing / Steritest

g. Classroom: Regulatory Aspects of Aseptic Processing

Day 2 -

a. Classroom: Process Simulation and Media Fills

b. Lab: Media Fill Aseptic Simulation (Manual)

c. Lab: Cupric sulfate in Isolator / BSC Cell Culture Activity

Day 3 -

a. Classroom: Discussion of Aseptic Technique / gowning from Day 2 Lab

b. Classroom: Biosafety Levels and Precautions

c. Classroom: Endotoxins

d. Video: Endotoxins--Charles River Laboratories

e. Lab: Endotoxins--PTS Unit

f. Classroom: Water Systems

g. Lab: Gram Stains / Serial Dilution of Media in an Isolator

Day 4 -

a. Classroom: Discussion of Aseptic Technique from Day 3 Lab Activities

b. Classroom and Lab: Lyophilization / DSC / Freeze-drying microscopy

c. Classroom: History of Aseptic Processing

d. Classroom: Investigations Utilizing Fish-Bone Analysis

e. Review / Q&A

f. Evaluations

g. Final Written Test and Lab Practicum

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

Micropipettes, Media, Culture, Faculty prepared presentations, Gram stain slides, biosafety cabinet, videos, gowning supplies, Laminar Air Flow Hood, Barrier Isolators, chemical and media supplies.

Clinical Site/Special Facilities

Capstone, or RTP cleanroom facility, labs, and classroom.

Requirements for Successful Completion

90% attendance
Successful completion of lab practicum and final written test.

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

Bioprocess Technician, Manufacturing Associate, QC & QA Validation, Lab technician, Gene Therapy Operation Specialist,

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

Manufacturing Associate

QC & QA Validation

Lab technician

Gene Therapy Operation Specialist

Related Courses

BTC-3200A7

BTC-3300C4

BTC-3300E4

Course Contact Information

Cynthia Lawrence
919-335-1037
[email protected]