Microbiology Testing

In the pharmaceutical world they are all around. When they become too many at the wrong time in the wrong place they are subject for broad discussion: the microorganisms!

Duration
2 days
Profession
Quality control and quality assurance
Course fee
€ 1495 (excl. VAT)

Short description

The quality of the product may be in danger but there can also be no impact.  

Because of the many microbiological concepts within a pharmaceutical facility (air quality, surface area, water, product monitoring) it is important to realize what the relationship is between tests carried out in a microbiology laboratory and the quality of the production process. This course is about the relationship between the microbiological quality control of the production area, raw materials, intermediate products and the end products in the pharmaceutical environment, in the broadest sense of the word.  

Growth promotion testing, environmental monitoring, sterility testing, bioburden and endotoxin testing. What do the results really mean? And: How are these methods executed and validated?  

What does a microbiological “Out of Specification” mean for the production process?  

Participants of this course are going to answer these questions using a mix of theory and practical training. After completion of this course the participants will be able to place microbiological results correctly within the context of GMP and patient safety. 

Objectives

  1. Learn the most relevant microbiological tests and their relationship with the (production) process.
  2. Learn why these tests are important for patient safety.
  3. Learn to interpret microbiological results so as to be able to carry out first-rate investigations even when abnormalities occur.



 

Target group

QC-microbiology technicians, quality assurance, quality control teamleaders, managers, and anyone else who wants understand the relationship between microbiological testing and the GMP processes within the pharmaceutical industry.

Program

Day 1

 

09:00h Start

How do microorganisms grow in the laboratory and how do they grow in products and processes?

Explanation of microbial enumeration methods (bioburden quantification, calculation of CFU’s).

Practicum colony-forming unit (CFU) tests.

Read out, interpret and calculate bioburden results in raw materials, water and product samples.

Growth promotion testing of microbial media.

Microbiological identification techniques. Establishment of house-flora.

17:00h End

Day 2

 

9:00h Start

Explanation/theory sterility testing.

Practical sterility testing.

Validation of the colony-forming unit (CFU) quantification and the sterility testing.

Endotoxin tests. Taking samples, sample storage.

Interpretation of results. How to handle abnormalities.

Practical examples.

17:00h End

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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.

Thanks