Microbial Control in Pharmaceutical Manufacturing

Operations Quality Assurance
Training
  1. Short description
  2. Objectives
  3. Target group
  4. Program
  5. Questions?
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Management as well as staff must thoroughly understand the concept of pharmaceutical microbiology, and more importantly, live by it. This is key to keeping the probability of consistent batches as high as possible.

Duration
2 days
Profession
Course fee
€ 1595 (excl. VAT)

Short description

This course covers the most important microbiological concepts in the pharmaceutical industry:

  • Microbiological ecology
  • Contamination sources (i.e. employees)
  • Contamination controls (thermal, chemical, engineering, employees)
  • Cleanroom classification and monitoring procedure
  • Microbiological quality control

During this course participants will face the challenge to combat and control the constant threat of microorganisms. Microorganisms are everywhere at all times and the greatest challenge is to keep their introduction and growth under control. This demands a good understanding of microbiological sources and living conditions.
 

Objectives

  1. Have a good understanding of the sources and environmental conditions of microorganisms
  2. Know the purpose of the different contamination control mechanisms and the impact if they do not function properly
  3. Know which activities during the manufacture of sterile and non-sterile products are critical in keeping the introduction of microorganisms under control.

Target group

  1. Staff (analysts, operators) who execute activities in classified areas.
  2. Quality officers, managers, supervisors, who would like to gain a clear and practical insight into the pharmaceutical microbiology.
     

Program

Day 1

 

Theory: Introduction to microbiology, ecology and behavior

What are the most important sources of microbial contamination? How do microorganisms spread, what are the sources of contamination? What are the pharmaceutical risks of bacteria, viruses and fungi?
 

Practice

During the process of manufacturing pharmaceutical drugs, it is vital to control the microorganisms on and within the used materials. Workshop in the D-zone, the area where crucial activities such as cleaning, disinfecting and sterilizing are conducted. What are the critical process parameters for these activities?

Day 2

 

Theory

What is a cleanroom and which standards are used for the various classifications? Methods for environmental monitoring. Why are we interested in particle measurement? Which methods for microbial monitoring are there and what does a positive result mean? Human beings are the worst polluters; critical activities and behavior.
 

Practice

Which measures are taken to ensure the microbiological quality of the finished products? We take a look at the systems that are responsible for clean air and sterile water. We get to know the most important microbiological QC tests. What are the differences between the C and A/B zones? Which samples are taken during the processes in these zones and what are the critical factors?

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Related courses

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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