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Control of microbial contamination.2.pdf
- 1. Control Of microbial contamination in sterileand non sterile Products Presented by : Arslan Ahmad Presented to : Dr.Maria Rasool
- 2. Sterile • Free frombacteria or other living micro-organisms; totally clean. • Sterile products : • These are the dosage form of therapeutic value which is extremely free from viable micro- organisms.
- 3. Categorized as : •Parenteral products • Opthalmic products • Irrigating preparations • Examples include : • Injectable(intravascular,intramascular,s ubcutaneous,Intradermal and intra peritoneal. • Diluents for injectable(water for injections,sterile water,purified water) • Vaccines • Opthalmic preparations(Eye drops,nasal drops)
- 4. Non sterile products •These are the dosage forms which are other than sterile preparation Like Oral and topical preparations • Examples include: • Tablets(compressed,coated,Effervesce nt,etc.) • Ointments • Syrups • Oral suspensions andemulsions • Transdermal/topical patches
- 5. Sources of microbial contamination •External atmosphericair inside the room • Personnel contamination • Surface contamination • Water contamination • Sterilization • a process that destroys or eliminates all forms of microbial life and is carried out in health-care facilities by physical or chemical methods.
- 7. Thermal methods Moisture content Temperatures Period ofexposure As the temprature is increased required to produce a sterile state is decreased. Thermal methods of sterilization ia further subdivided into: Dry heat Moist heat
- 8. Dry heat • Thesubstances which get degraded at a temprature range of approximately 140°C • Contact for 2 hours at 180°C or at 260°C for 45 minutes can produce killingof all kind of bacteria and there spores. • Dry heat Sterilization can be achieved by : • Hot air ovens • Dry heat tunnels
- 9. Moist heat In thermalsterilization rather than dry heat moist heat is considered more efficient. However it should be made into consideration that moist heat cannot terminate pyrogens. Moist heat sterilization can be achieved by Autoclave Air steam mixture
- 10. Non thermal methods of sterilization Itis also known as cold sterilization or non-thermal method of sterilization. Further classified as : Physical method Chemical method Physical Sterilization methods: It can be further classified as: Radiation sterilization Filtration sterilization
- 11. Radiation Sterilization • (a)Ultraviolet light: • For the sterilizationof contamination in atmosphere and on surfaces, ultraviolet light is usually employed. • (b) Ionizing radiations: • These are the radiations of elevated energy which are emittedfrom radioactiveisotopes like caesium-135 (gamma rays) or by highly accelerated electrons at higher velocity (cathode ray & ẞ-ray)
- 12. Chemical methods of sterilization Gas sterilization: Gaseslike formaldehyde and sulfur dioxide are been use from many years for sterilization purpose. These chemicals are very reactive and sometimes are very difficult to remove from surfaces after exposure thus have very limiteduse only.
- 13. Continued… • Few examples: •Alkylating gases: Ethylene oxide, propylene oxide, formaldehyde and ẞ-propiolactone. • Oxidizing gases: hydrogen peroxide, ozone, per- acetic acid and calcium dioxide.
- 14. Control Measures for Microbial Contaminationin Pharmaceutical Products: Environmental Control MISSION CONTROL Housekeeping Disinfection on Surface Control on Air Control on Personnel Compounding Of Products Processing By Automation
- 15. Environmental control STRICT PHYSICAL AND BIOLOGICALENVIRONMENT CONTROL MUSTBE MAINTAINED. HIGH STANDARD OF CLEANLINESS SHOULD BE MAINTAINED IN THE CLEAN-UP AND PACKAGINGAREAS OTHER THAN DAILYROUTINE DISINFECTING PROCEDURES. ENVIRONMENTAL CONTROL COULD MORE EASILYBE ACHIEVED WERE THE MOVEMENTOF SUPPLIES AND PERSONNEL IS SMOOTH AND STRATEGICALLY PLANNED.
- 16. Housekeeping • All theequipment should be thoroughly cleaned at the end of the day so that no pollutant could be recognized after the finished development. • All the housekeeping tools must be selected as per there productivity and liberty from lint generating affinity. They should be reserved for aseptic areas only.
- 17. Disinfection on surface •After complete cleaning procedure all the surfaces of the production unit must go for disinfection at least in aseptic area, by spraying an effective liquid disinfectant followed by wiping on all surfaces and with ultraviolet radiationexposure. • Control on Air: • Use of more than one pre- filter total eliminationof profoundly pollutedair. • HEPA filters are employed.It is 99.97% effectiveto eliminate particles of 0.3µ and bigger size particles.
- 18. Continued... • Laminar airflow principle has upgraded the effectiveness of environmental control of aseptic area to achieve class 100 area. This means there are not more than 100 particles in the air of 100 cubic foot area with0.5µ or more in size. • Control on Personnel: • All the employees must examine for their good health and must be subjected to regular physical examination.
- 19. Continued... • Sterile overalls,hoods, face mask and shoe covers are the different component of apparel worn by a personnel entering in sterile area. • A preparatory procedure must be followed by the personnel while entering in aseptic area. • Processing By Automation: • Machine can be developed to carry out certain procedures and functions more efficiently, accurately and precisely then a human. • Moreover the biggest advantage is the infection caused by human body as a source of biological contamination. 11
- 20. CONCLUSION STERILIZATION AND CONTROLOF MICROBIAL CONTAMINATION IS A CONSTANT PROCESS. STERILIZATION AND DISINFECTION MUSTBE PERFORMED ON DAILYBASIS. PERSONNEL PERFORMANCE AND HANDLING HAS A CRITICAL AND DIRECTIMPACTON CONTAMINATION.