Understanding Proper Aseptic Technique and Cleanroom Behavior

Duration: 75 Minutes
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This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why cleanrooms are designed the way they are.
Aseptic Technique and Cleanroom Behavior
Instructor: Danielle DeLucy
Product ID: 508276
Objectives of the Presentation
  • Definition of Aseptic Processing (AP)
  • Terminal Sterilization vs. AP
  • Proper personnel behavior in a cleanroom - keeping human error out of the equation
  • Facility design and how it impacts the product - mitigating risks, reaping reward
  • A review of proper environmental monitoring practices and systems used
  • Aseptic technique and cleanroom behavior
In addition, this course will review how quality systems help define requirements for aseptic technique/cleanrooms, and how to properly maintain these environments.

Why Should you Attend
Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. Most importantly, this activity is critical for the successful manufacture of safe and sterile therapeutics. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.

This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a cleanroom environment. However, this technique is often overlooked by firms and staff leading to sloppy production caused most often by human error. This course is also a good refresher for those personnel that are familiar with the way to properly work in the cleanroom and why cleanrooms are designed for proper contamination control.

Who will Benefit
  • Aseptic operators
  • Aseptic sample handlers
  • Personnel who work in a biological safety cabinet (BSC) and their management
  • Quality assurance counterparts
  • Proper facility design, personnel gowning, and the equipment needed to conduct environmental monitoring are highlighted to give context, so those responsible for these areas are encouraged to attend
  • Manufacturing managers
  • Microbiology Quality Control Professionals
$375
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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