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

CONTAMINATION AND INFECTION CONTROL

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

18: LABORATORY EVALUATION OF ANTIMICROBIAL AGENTS

19: CHEMICAL DISINFECTANTS, ANTISEPTICS, AND PRESERVATIVES

20: NON-ANTIBIOTIC ANTIMICROBIAL AGENTS

21: STERILIZATION PROCEDURES AND STERILITY ASSURANCE

Let’s Continue

Factors Affecting the antimicrobial activity of disinfectants

Innate resistance of the MicroorganismMicrobial DensityDisinfectant concentration and exposure timePhysical and chemical factors

Temperature pH Divalent cations

Presence of extragenous organic materials

Antibacterial disinfectant efficacy tests

Suspension testsIn-use and simulated use testsProblematic bacteria

Evaluation of potential chemotherapeutic antimicrobials

Bacteriostatic activity Disc Tests Dilution tests E-Test Probematic Bacteria

Bactericidal ActivityFungistatic 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 standardsUsed to research new disinfectants, but has

problems* Filter Paper Method- uses small filter disksAnd 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 antisepticsPhenols: disrupt cell membranesOxidizing Agents:H2O2 disenfectantAlkylating 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-temperatureDRT or D value-time needed to kill 90% of

organismsDry 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 usedAutoclave at 15 lb/in pressure for 15-20

minutes, temp at 121C to kill sporesHospital autoclave called prevacuum

autoclave, less time to sterilizePasteurization - 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 Agents-Cooling, 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 Agents-Radiation

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, .1-40nm very short

Microwave radiation-long wavelengths 1mm-1m

Strong visible light- sunlight, 400-700nm due to UV

Physical Antimicrobial Agents-other Methods

Sonic and Ultrasonic waves-Filtration- passage of material through a

filter, use millipore -membrane filters 25umMicrobes 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.