This document summarizes the production of antibiotics from microorganisms via fermentation. It discusses that antibiotics are derived from microbes and produced at scale using fermentation. The process involves growing the microbes in fermenters, then filtering and purifying the antibiotics from the culture broth. Quality control testing and packaging of the purified antibiotics into primary, secondary, and tertiary containers is also described.

1. 1
PRODUCTION
OF
ANTIBIOTICS
Showmitro Nondi
Department of
Microbiology
Primeasia University

2. 1. Introduction of Antibiotics.
2. Application mood
3. Antibiotics Types
4. Commercial Production of Antibiotics.
5. Process Description
6. Quality control
7. Packaging

3. • Antibiotics are chemical substances that can inhibit the
growth of, and even destroy, harmful microorganisms.
They are derived from special microorganisms or other
living systems, and are produced on an industrial scale
using a fermentation process.
• The first antibiotic was discovered in 1896 by Ernest-
Duchesne and "rediscovered" by Alexander-
Flemming in 1928 from the filamentous fungus
Penicilium-notatum.

4. Antibiotics are used in many forms:
• For bacterial infections on the skin surface, eye, or ear,
an antibiotic may be applied as an ointment or cream.
• If the infection is internal, the antibiotic can be swallowed
or injected directly into the body. The antibiotic is
delivered throughout the body by absorption into the
bloodstream.

6. Inoculum:
• A small amount of material containing bacteria,
viruses, or other microorganisms that is used to start
a culture.
• A high yielding strain (Bacteria) is a prerequisite for
antibiotic production.
• The Inoculum is prepared usually in the form of a spore
suspension, which is transferred into the fermenter.

7. Fermenter / Bioreactor:
• Antibiotic are generally produced in stainless steel fermenters
used in the batch or fed mode, see in figure below.
• Water cooling is often used to maintain the temperature
between 24-26° C.
• Generally, the fermenter is maintained at above atmospheric
pressure which reduces contamination risk and enhances
O2 supply.
• The final stage fermenter is preferably used for antibiotic
production for the longest period.

9.  Initial stages of fermentation are designed for
considerable microbial growth; these are carried out in
seed stage fermenters of smaller size.
 One or more seed stages may be used, depending on the
process and the strain, to produce the maximum amount
of biomass.
Flow Diagram

10. PROCESS DESCRIPTION
• The production fermenter is run in a fed batch mode in
which a nutrient e.g., glucose is added continuously
throughout the fermentation to enhance the duration of
antibiotic production.
• This is accompanied by withdrawal of small volumes of
broth to check increase in volume of the broth in the
fermenter.
• Antifoaming agents are added at the appropriate stage
of fermentation.

11. • Selected microbiological, physical and chemical features
are monitored during the fermentation in order to achieve
proper control.
• At the end of final production stage incubation, the broth
contains only a low concentration (3-35% If the total
solutes in the broth) of the antibiotic.
• Antibiotic recovery is done by separation of cells from
the broth by filtration or centrifugation which is followed
by purification.

12. • Removal of cells:
The first step in product recovery is the separation of
whole cells and other insoluble ingredients from the
culture broth by technique such as filtration and
centrifugation.
• The product needs to be very pure, since it being used
as a therapeutic medical drug, so it is dissolved and then
precipitated as a potassium salt to separate it from other
substances in the medium.

13. COMMERCIAL PFD

14. • Retained Sample
• Analysis of finished
product
• Sampling
• Validation
• Records
• Batch inspection and
sampling
• SOP
• GMP
14
QUALITY CONTROL

15. • Primary packaging
• Secondary packaging
• Tertiary packaging
15
PACKAGING