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Factors Affecting
Microbial
Spoilage Of
Pharma Products
MICROBIOLOGY
MICROBIAL
SPOILAGE
Microbial Spoilage include the contamination
of Pharmaceutical products with the microbes
which lead to spoilage of the product affecting
Drug safety and quality, and is not intended
for use. Shortly Microbial Spoilage is defined
as deterioration of pharmaceutical products by
the contaminant microbe.
Factors affecting microbial spoilage of
pharmaceutical products:-
1. Types and size of contaminant inoculum.
2. Nutritional factors
3. Moisture content: water activity (Aw)
4. Redox potential 5. Storage temperature
6. pH
7. Packaging design
8. Protection of microorganisms within pharmaceutical product
TYPES AND SIZE OF
CONTAMINANT INOCULUM
Low levels of contaminants may not cause appreciable
spoilage however, an unexpected surge in the
contaminant bioburden may present an unacceptable
challenge to the designed formulation.
- Raw materials were unusually contaminated
- A problem of the plant-cleaning protocol
- Gross misuse of product during administration
- Biofilm detached itself from within supplying pipework
NUTRITIONAL FACTORS
Nutritional requirements and metabolic adaptability of
many common spoilage microorganisms enable them to
utilize many formulation components as substrates for
biosynthesis and growth.
- Presence of nutritional material enable or favours
microorganisms to utilize these nutritional material as
energy source and proliferate over pharmaceutical
products
- use of crude vegetable or animal products in a
formulation provides a nutritious environment, more
complex formulations are more supportive for microbial
growth
-Demineralized water also contain some nutritional
material which support the growth of Pseudomonas
bacteria
Moisture Content : water activity
- -Microrganisms readily need water or moisture to
grow. The presence of uncomplexed water in any
formulation supports microbial growth. Greater the
solute concentration, lesser the activity.
-Moisture films over viscous syrups can also increase
water activity and support growth of fungi and yeast.
-With the exception of halophilic bacteria, most
microorganisms grow best in dilute solutions (high
Aw....water activity)
-
The patient
01
Here you could describe
the topic of the section
Jupiter is the biggest
planet in the Solar
System and the fourth-
brightest object
It’s actually a cold place.
It’s full of iron oxide dust,
which gives the planet
its reddish cast
Venus is the second
planet from the Sun. It’s
terribly hot—even hotter
than Mercury
Mars Venus
Jupiter
Review of systems
It’s actually a cold place. It’s
full of iron oxide dust, which
gives the planet its reddish
cast
Mars
Jupiter is the biggest planet in
the Solar System and the
fourth-brightest object
Jupiter
Venus is the second planet
from the Sun. It’s terribly hot—
even hotter than Mercury
Venus
Mercury is the smallest one in
the Solar System—it’s only a
bit larger than the Moon
Mercury
Identifying information
Patient medical history
Age:
Gender:
60
Female
Allergies:
Location:
None
Madrid
It’s a cold place.
It’s full of iron oxide
dust, which gives
the planet its
reddish cast
Sarah Doe
Background:
Planet Mars is
a very cold
place
2017
Planet Saturn is
the ringed one
2018
Jupiter is a
huge gas giant
2019
Planet Venus
has a nice
name
2020
Jupiter is the biggest
70% Jupiter
Mercury is the smallest
20% Mercury
Neptune is the farthest
30% Neptune
Discussion
Dr. Daniel Patt
“Despite being red, Mars is a cold place.
It’s full of iron oxide dust”
Dr. John James
“Jupiter is a gas giant and the biggest
planet in the Solar System”
Discussio
n
summary
Mercury is the closest
planet to the Sun and the
smallest one in the Solar
System—it’s only a bit
larger than the Moon. The
planet’s name has nothing
to do with the liquid metal
Physical examination
Venus
Venus has a
beautiful name
Saturn
Planet Saturn is
the ringed one
Mercury
Mercury is the closest
planet to the Sun and the
smallest one in the Solar
System—it’s only a bit
larger than the Moon
Findings
60 10 20 10
0
10
30
50
40
20
Mercury Jupiter Venus
200
To modify this graph, click on it,
follow the link, change the data
and paste the new graph here,
replacing this one
Comparison
Jupiter Saturn Venus Mars
Eyes
Heart
Brain
Diagnosis
Mercury is the
closest planet to
the Sun and the
smallest one
Mercury
It has a beautiful
name and is the
second planet
from the Sun
Venus
Despite being red,
Mars is a cold
place. It’s full of
iron oxide dust
Mars
Jupiter is a gas
giant and the
biggest planet in
the Solar System
Jupiter
Saturn is a gas
giant and has
rings. It was
named after a god
Saturn
Neptune is the
farthest planet
from the Sun and
the fourth-largest
Neptune
4,498,300
Big numbers catch your
audience’s attention
Treatment
Mercury
The planet’s name has
nothing to do with the
liquid metal, since it was
named after the Roman
messenger god
Venus
Venus has a beautiful
name and is the second
planet from the Sun. It’s
terribly hot—even hotter
than Mercury
Patient monitoring
Week 1
Planet Mars is a
very cold place
Mars
Venu
s
Week 3
Earth is where we
all live on
Mars
Venu
s
Week 2
Planet Saturn is
the ringed one
Mars
Venu
s
Awesome
words
Because keywords
are great for catching
your audience’s
attention
Contraindications & indications
1. Here you can describe the
reason to stop the treatment
2. Here you can describe the
reason to stop the treatment
3. Here you can describe the
reason to stop the treatment
Indications
1. Here you can describe the
reason to stop the treatment
2. Here you can describe the
reason to stop the treatment
3. Here you can describe the
reason to stop the treatment
Contraindications
Post-prevention
Despite being red,
Mars is a cold
place
Mars
It has a nice name,
but it’s very hot
Venus
It’s the biggest in
the Solar System
Jupiter
Neptune is the
farthest planet
Neptune
Saturn is the
ringed planet
Saturn
It’s the closest
planet to the Sun
Mercury
Case timeline
Day 01
Saturn is the
ringed one
Day 02
Mercury is a
small planet
Day 03
Neptune is
far away
Day 04
Mars is a
cold place
Day 05
Jupiter is the
biggest
Week 01
It’s the closest planet to
the Sun and the smallest
Week 02
Earth is the third
planet from the Sun
Conclusion
Mercury is the closest planet to the Sun
and the smallest one in the Solar
System. The planet’s name has nothing
to do with the liquid metal, since it was
named after the Roman messenger god
● AUTHOR (YEAR). Title of the publication. Publisher
● AUTHOR (YEAR). Title of the publication. Publisher
● AUTHOR (YEAR). Title of the publication. Publisher
● AUTHOR (YEAR). Title of the publication. Publisher
● AUTHOR (YEAR). Title of the publication. Publisher
● AUTHOR (YEAR). Title of the publication. Publisher
References
Our team
John James
Planet Venus has a
beautiful name, but
it’s very hot
Jenna Doe
Mars is actually a
cold place. It’s full of
iron oxide dust
Sarah Patt
Neptune is the
fourth-largest planet
in the Solar System
Jenna Doe
It is a gas giant and
the biggest planet in
the Solar System
A picture
is worth a
thousand
words
A picture
always
reinforces the
concept
Images reveal large amounts of
data, so remember: use an
image instead of a long text
Web page
You can replace the image
on the screen with your own
work. Just delete this one,
add yours and center it
properly
CREDITS: This presentation
template was created by Slidesgo,
including icons by Flaticon, and
infographics & images by Freepik
Thanks
Do you have any questions?
addyouremail@freepik.com
+91 620 421 838
yourcompany.com
Please keep this slide for attribution
Alternative icons
Alternative resources
Resources
● Types-cells-back-school-concept
● Microscope-dna-back-school-concept
● View-science-woman
● Two-male-doctors-looking
Vectors Photos
● Virus
Icons

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Diphtheria Clinical Case by Slidesgo [Autosaved] [Autosaved].pptx

  • 2. MICROBIAL SPOILAGE Microbial Spoilage include the contamination of Pharmaceutical products with the microbes which lead to spoilage of the product affecting Drug safety and quality, and is not intended for use. Shortly Microbial Spoilage is defined as deterioration of pharmaceutical products by the contaminant microbe.
  • 3. Factors affecting microbial spoilage of pharmaceutical products:- 1. Types and size of contaminant inoculum. 2. Nutritional factors 3. Moisture content: water activity (Aw) 4. Redox potential 5. Storage temperature 6. pH 7. Packaging design 8. Protection of microorganisms within pharmaceutical product
  • 4. TYPES AND SIZE OF CONTAMINANT INOCULUM Low levels of contaminants may not cause appreciable spoilage however, an unexpected surge in the contaminant bioburden may present an unacceptable challenge to the designed formulation. - Raw materials were unusually contaminated - A problem of the plant-cleaning protocol - Gross misuse of product during administration - Biofilm detached itself from within supplying pipework
  • 5. NUTRITIONAL FACTORS Nutritional requirements and metabolic adaptability of many common spoilage microorganisms enable them to utilize many formulation components as substrates for biosynthesis and growth. - Presence of nutritional material enable or favours microorganisms to utilize these nutritional material as energy source and proliferate over pharmaceutical products - use of crude vegetable or animal products in a formulation provides a nutritious environment, more complex formulations are more supportive for microbial growth -Demineralized water also contain some nutritional material which support the growth of Pseudomonas bacteria
  • 6. Moisture Content : water activity - -Microrganisms readily need water or moisture to grow. The presence of uncomplexed water in any formulation supports microbial growth. Greater the solute concentration, lesser the activity. -Moisture films over viscous syrups can also increase water activity and support growth of fungi and yeast. -With the exception of halophilic bacteria, most microorganisms grow best in dilute solutions (high Aw....water activity) -
  • 7. The patient 01 Here you could describe the topic of the section
  • 8. Jupiter is the biggest planet in the Solar System and the fourth- brightest object It’s actually a cold place. It’s full of iron oxide dust, which gives the planet its reddish cast Venus is the second planet from the Sun. It’s terribly hot—even hotter than Mercury Mars Venus Jupiter Review of systems
  • 9. It’s actually a cold place. It’s full of iron oxide dust, which gives the planet its reddish cast Mars Jupiter is the biggest planet in the Solar System and the fourth-brightest object Jupiter Venus is the second planet from the Sun. It’s terribly hot— even hotter than Mercury Venus Mercury is the smallest one in the Solar System—it’s only a bit larger than the Moon Mercury Identifying information
  • 10. Patient medical history Age: Gender: 60 Female Allergies: Location: None Madrid It’s a cold place. It’s full of iron oxide dust, which gives the planet its reddish cast Sarah Doe Background: Planet Mars is a very cold place 2017 Planet Saturn is the ringed one 2018 Jupiter is a huge gas giant 2019 Planet Venus has a nice name 2020
  • 11. Jupiter is the biggest 70% Jupiter Mercury is the smallest 20% Mercury Neptune is the farthest 30% Neptune
  • 12. Discussion Dr. Daniel Patt “Despite being red, Mars is a cold place. It’s full of iron oxide dust” Dr. John James “Jupiter is a gas giant and the biggest planet in the Solar System”
  • 13. Discussio n summary Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than the Moon. The planet’s name has nothing to do with the liquid metal
  • 14. Physical examination Venus Venus has a beautiful name Saturn Planet Saturn is the ringed one Mercury Mercury is the closest planet to the Sun and the smallest one in the Solar System—it’s only a bit larger than the Moon
  • 15. Findings 60 10 20 10 0 10 30 50 40 20 Mercury Jupiter Venus 200 To modify this graph, click on it, follow the link, change the data and paste the new graph here, replacing this one
  • 16. Comparison Jupiter Saturn Venus Mars Eyes Heart Brain
  • 17. Diagnosis Mercury is the closest planet to the Sun and the smallest one Mercury It has a beautiful name and is the second planet from the Sun Venus Despite being red, Mars is a cold place. It’s full of iron oxide dust Mars Jupiter is a gas giant and the biggest planet in the Solar System Jupiter Saturn is a gas giant and has rings. It was named after a god Saturn Neptune is the farthest planet from the Sun and the fourth-largest Neptune
  • 18. 4,498,300 Big numbers catch your audience’s attention
  • 19. Treatment Mercury The planet’s name has nothing to do with the liquid metal, since it was named after the Roman messenger god Venus Venus has a beautiful name and is the second planet from the Sun. It’s terribly hot—even hotter than Mercury
  • 20. Patient monitoring Week 1 Planet Mars is a very cold place Mars Venu s Week 3 Earth is where we all live on Mars Venu s Week 2 Planet Saturn is the ringed one Mars Venu s
  • 21. Awesome words Because keywords are great for catching your audience’s attention
  • 22. Contraindications & indications 1. Here you can describe the reason to stop the treatment 2. Here you can describe the reason to stop the treatment 3. Here you can describe the reason to stop the treatment Indications 1. Here you can describe the reason to stop the treatment 2. Here you can describe the reason to stop the treatment 3. Here you can describe the reason to stop the treatment Contraindications
  • 23. Post-prevention Despite being red, Mars is a cold place Mars It has a nice name, but it’s very hot Venus It’s the biggest in the Solar System Jupiter Neptune is the farthest planet Neptune Saturn is the ringed planet Saturn It’s the closest planet to the Sun Mercury
  • 24. Case timeline Day 01 Saturn is the ringed one Day 02 Mercury is a small planet Day 03 Neptune is far away Day 04 Mars is a cold place Day 05 Jupiter is the biggest Week 01 It’s the closest planet to the Sun and the smallest Week 02 Earth is the third planet from the Sun
  • 25. Conclusion Mercury is the closest planet to the Sun and the smallest one in the Solar System. The planet’s name has nothing to do with the liquid metal, since it was named after the Roman messenger god
  • 26. ● AUTHOR (YEAR). Title of the publication. Publisher ● AUTHOR (YEAR). Title of the publication. Publisher ● AUTHOR (YEAR). Title of the publication. Publisher ● AUTHOR (YEAR). Title of the publication. Publisher ● AUTHOR (YEAR). Title of the publication. Publisher ● AUTHOR (YEAR). Title of the publication. Publisher References
  • 27. Our team John James Planet Venus has a beautiful name, but it’s very hot Jenna Doe Mars is actually a cold place. It’s full of iron oxide dust Sarah Patt Neptune is the fourth-largest planet in the Solar System Jenna Doe It is a gas giant and the biggest planet in the Solar System
  • 28. A picture is worth a thousand words
  • 29. A picture always reinforces the concept Images reveal large amounts of data, so remember: use an image instead of a long text
  • 30. Web page You can replace the image on the screen with your own work. Just delete this one, add yours and center it properly
  • 31. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik Thanks Do you have any questions? addyouremail@freepik.com +91 620 421 838 yourcompany.com Please keep this slide for attribution
  • 34. Resources ● Types-cells-back-school-concept ● Microscope-dna-back-school-concept ● View-science-woman ● Two-male-doctors-looking Vectors Photos ● Virus Icons