CONTAMINATION AND

INFECTION CONTROL
MR. J.E.JOSE, RMT, MAED, MSMT

Contamination

Spoilage

What you have learned from Chapter 17

Prevention is undoubtedly better than cure in

minimizing the risk of medicament borne infections.

In Manufacture the principles of GMP must be
observed and control measures must be built in at all
stages
Therefore

Therefore
Initial stability tests should show that the proposed

formulation can withstand an appropriate microbial

challenge
Raw materials from an authorized supplier should comply
with in-house microbial specifications
Environmental condition appropriate to the production
process should be subject to regular microbiological
monitoring
End-product analysis should indicate that the product is
mirobiologically suitable for its intended use and conforms
with accepted in-house and international standards

But
Contamination during use is less easily controled

Therefore
Hospital pharmacy: packaging of hospital products

as individual units discourage multidose containers

In other words
Microbial contamination is inevitable in the

phramaceutical production and use

This might lead to

Pharmaceutical product spoilage

Pharmaceutical product neutralization
Microbial Mutation

You as pharmacist need to implement approaches to

minimize if not eliminate this possibilities.

The End
for Chapter 17

Lets Continue
18: LABORATORY EVALUATION OF ANTIMICROBIAL AGENTS
19: CHEMICAL DISINFECTANTS, ANTISEPTICS, AND
PRESERVATIVES
20: NON-ANTIBIOTIC ANTIMICROBIAL AGENTS
21: STERILIZATION PROCEDURES AND STERILITY
ASSURANCE

Factors Affecting the antimicrobial activity of

disinfectants
Innate resistance of the Microorganism
Microbial Density
Disinfectant concentration and exposure time
Physical and chemical factors

Temperature
pH
Divalent cations

Presence of extragenous organic materials

Antibacterial disinfectant efficacy tests

Suspension tests
In-use and simulated use tests
Problematic bacteria

Evaluation of potential chemotherapeutic antimicrobials

Bacteriostatic activity

Disc Tests
Dilution tests
E-Test
Probematic Bacteria

Bactericidal Activity
Fungistatic and fungicidal activity

Evaluating Effectiveness
* Phenol coefficient- compare to phenol (carbolic

acid) =1 higher is more effective, lower is less effective

Use with Staph typhi and Staph aureas standards
Used to research new disinfectants, but has problems
* Filter Paper Method- uses small filter disks
And look for zone of inhibition-shows some
effectiveness but organic matter may interfere with
results
* Use-Dilution test: standard prep of bacteria , coated
on stainless steel and dipped into dilutions of agents,
incubated and observed for no growth* better results
than phenol test

Specific Chemical Antimicrobial Agents

Halogens: Hypochlorous acid Cl, I, Br, Cloramine
Alcohols: denature proteins, skin antiseptics
Phenols: disrupt cell membranes
Oxidizing Agents:H2O2 disenfectant
Alkylating Agents: disrupt nucleic acids and protein

structures, may cause cancer, formaldehyde, ethylene

oxide, glutaraldehyde
Dyes: acridine and methylene blue, crystal violet
Other Agents: plant oils for thyme and clove,
nitrates, sulfites, sodium nitrate

Physical Antimicrobial Agents- Heat Killing

Heat- thermal death point-temperature
DRT or D value-time needed to kill 90% of

organisms
Dry Heat- oxidizes molecules, used for metal objects
and glassware, oils and powders. Dry heat penetrates
more slowly 171C for 1 hr, 160 C for 2 hrs or 121 C for
16 hrs

Physical Antimicrobial Agents- Heat

Killing
Moist Heat- widely used
Autoclave at 15 lb/in pressure for 15-20 minutes,

temp at 121C to kill spores

Hospital autoclave called prevacuum autoclave,
less time to sterilize
Pasteurization - kills pathogens, but not sterile
milk = 71.6 C for 15 sec (flash method), or heat at
92.9 C for 30 min (holding method)
UHT-ultrahigh temp 74-140-74C in 5 sec used to
make coffee creamers

Physical Antimicrobial AgentsCooling, Refrigeration

Refrigeration- foods 5C , Clostridium spores

produce lethal toxins in frig

Freezing- -20C, preserve foods on home and
industry, slows rate of microbes so they do not
spoil food. Frozen foods should not be thawed and
refrozen
Drying- absence of water inhibits enzymes, so it
will preserve foods, drying clothes in dryer or in
sunshine can destroy pathogens
Freeze-drying- lyophilization is drying from a
frozen state to make instant coffee, to preserve
cultures of microbes

Physical Antimicrobial AgentsRadiation

UV-ultraviolet light-40-390nm 200nm is most

effective wavelength for killing by DNA dimers, UV

light for sewage treatment in some areas
Ionizing radiation- X rays and gamma rays, .140nm very short
Microwave radiation-long wavelengths 1mm-1m
Strong visible light- sunlight, 400-700nm due to
UV

Physical Antimicrobial Agentsother Methods

Sonic and Ultrasonic wavesFiltration- passage of material through a filter, use

millipore -membrane filters 25um

Microbes on filter can be transferred to agar
HEPA filters- clean air and capture microbes
Osmotic Pressure- plasmolysis or loss of water
occurs with high concentration of salt, sugar used
in jellies, syrup, pickles

So Can you simplify CH18 21?

Now, a group of 5 will be selected by 1 student

teacher.