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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 .

AND PRESERVATIVES 20: NON-ANTIBIOTIC ANTIMICROBIAL AGENTS 21: STERILIZATION PROCEDURES AND STERILITY ASSURANCE . ANTISEPTICS.Let’s Continue 18: LABORATORY EVALUATION OF ANTIMICROBIAL AGENTS 19: CHEMICAL DISINFECTANTS.

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 .

coated on stainless steel and dipped into dilutions of agents.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 . lower is less effective Use with Staph typhi and Staph aureas standards Used to research new disinfectants. but has problems * Filter Paper Method.compare to phenol (carbolic acid) =1 higher is more effective.Evaluating Effectiveness * Phenol coefficient. incubated and observed for no growth* better results than phenol test .

may cause cancer. nitrates. skin antiseptics Phenols: disrupt cell membranes Oxidizing Agents:H2O2 disenfectant Alkylating Agents: disrupt nucleic acids and protein structures. crystal violet Other Agents: plant oils for thyme and clove. I. glutaraldehyde Dyes: acridine and methylene blue. formaldehyde. sodium nitrate . Br. ethylene oxide. Cloramine Alcohols: denature proteins. sulfites.Specific Chemical Antimicrobial Agents Halogens: Hypochlorous acid Cl.

Dry heat penetrates more slowly 171C for 1 hr.Heat Killing Heat. used for metal objects and glassware.oxidizes molecules. oils and powders.thermal death point-temperature DRT or D value-time needed to kill 90% of organisms Dry Heat.Physical Antimicrobial Agents. 160 C for 2 hrs or 121 C for 16 hrs .

6 C for 15 sec (flash method).Physical Antimicrobial Agents. but not sterile milk = 71.9 C for 30 min (holding method) UHT-ultrahigh temp 74-140-74C in 5 sec used to make coffee creamers .Heat Killing Moist Heat.widely used Autoclave at 15 lb/in pressure for 15-20 minutes. less time to sterilize Pasteurization . or heat at 92. temp at 121C to kill spores Hospital autoclave called prevacuum autoclave.kills pathogens.

-20C. preserve foods on home and industry. so it will preserve foods.lyophilization is drying from a frozen state to make instant coffee. Clostridium spores produce lethal toxins in frig Freezing.absence of water inhibits enzymes. drying clothes in dryer or in sunshine can destroy pathogens Freeze-drying. to preserve cultures of microbes . Refrigeration Refrigeration.foods 5C .Physical Antimicrobial AgentsCooling. Frozen foods should not be thawed and refrozen Drying. slows rate of microbes so they do not spoil food.

140nm very short Microwave radiation-long wavelengths 1mm-1m Strong visible light.sunlight. .Physical Antimicrobial AgentsRadiation UV-ultraviolet light-40-390nm 200nm is most effective wavelength for killing by DNA dimers. 400-700nm due to UV . UV light for sewage treatment in some areas Ionizing radiation.X rays and gamma rays.

plasmolysis or loss of water occurs with high concentration of salt.clean air and capture microbes Osmotic Pressure.passage of material through a filter. pickles . sugar used in jellies. use millipore -membrane filters 25um Microbes on filter can be transferred to agar HEPA filters.Physical Antimicrobial Agentsother Methods Sonic and Ultrasonic wavesFiltration. syrup.

So… Can you simplify CH18 – 21? Now. . a group of 5 will be selected by 1 student teacher.