BEST QC Microbiology Training Bioburden, Endotoxin, Sterility Testing Innovative educational programs designed specifically for you.
BEST programs focus on three critical in-process and product release quality control tests:
• Bioburden • Endotoxin • Sterility Testing
BEST is a 3 day innovative educational program designed specifically for you and your laboratory staff. This program will focus on both in-process and product release quality control, including Bioburden, Endotoxin and Sterility Testing. It will provide an overview of relevant methods in each area, however basic technical laboratory skills are assumed as a prerequisite for participation. The course will consist of class presentations and demonstrations of laboratory applications. This program is only available in the US. Program Material Outline
DAY 1 Bioburden Testing Dependable Tests Based on Membrane Filtration
DAY 2 Endotoxin Testing BET Methodology and Background The Bacterial Endotoxin Test (BET) is used for the detection and quantitation of endotoxins from Gram-negative bacteria. Reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. During the second day of training, you will learn:
DAY 3 Sterility Testing A Complete Solution for Reliable Results Sterility Testing is considered the most essential QC Microbiological test for releasing sterile final product. This test is heavily regulated and harmonized across most of the globe. During the third day of training, you will learn about:
Bioburden testing is critical for monitoring water quality and raw materials and for ensuring that manufacturing processes remain in microbiological control. During the first day of the training, you will learn about:
• Advantages and limitations of membrane filtration
• The history of Sterility Testing
• The global harmonized regulations overview • Environmental Monitoring requirements for Sterility Testing
• How to choose the right membrane for your application • The regulations governing Bioburden testing • How to develop a sampling plan for Bioburden testing
• What are endotoxin and BET reagents
• The regulations governing bacterial endotoxin testing
• Deep Dive into USP <71>
• The methodology for bacterial endotoxin tetsing
• Advantages and Limitations of Direct Inoculation Sterility Testing • Advantages and Limitations of Open Funnel Sterility Testing • Advantages and Limitations of Closed System Sterility Testing • Overview of Sterility Testing Media and Rinse Fluids
• How to qualify a chosen BET method
• How to qualify and validate a method
• How to validate samples and how to test them routinely
• How to set alert and action limits
• How to interpret Bioburden test results
• How to analyze and interpret data
• How to troubleshoot membrane filtration issues
• How to address sample interference
• Hands-on session - Pyros Kinetix ® Flex tube reader and Pyros ® eXpress software
• Rapid methods for Bioburden testing
• Most Common Sterility Questions
• Hands-on session using a manifold and Milliflex Plus Pump
• Learn about sustainable recombinant reagents
• Hands-on session - Steritest Equinox
For more information go online to: www.acciusa.com/products-and-services/bet-training-and-support/best-workshop
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