PRINCPLES OF STERILIZATION

Definitions: 1. Sterility is defined as an absolute term - that means absence of all viable forms of life. When individual items have a probability of being non-sterile assurance level (SAL), equal to or better than 10-6. There are basically five methods of sterilization: 1. Heat 2. Gas 3. Radiation 4. Liquid chemical 5. Filtration a sterility

MOIST HEAT STERILZATION Moist heat sterilization is the most efficient biocidal agent. In the pharmaceutical industry it is used for: Surgical dressings Sheets Surgical and diagnostic equipment Containers Closures Aqueous injections Ophthalmic preparations Irrigation fluids I. AUTOCLAVING/STEAM UNDER PRERSSURE Most common sterilization by moist heat requires steam under pressure at temperature range of 121-1340C Principles Moist sterilization requires that the steam used for sterilization must be both Dry and Saturated. Saturated in the sense that the steam in this context is at a phase where it is holding all the water that it can, in the form of transparent vapour.

It does not contain water droplets and therefore it describe as being dry; if it meets an object cooler than itself it condenses. Approximately 80% of the latent energy in dry saturated steam is in the form of latent heat that is released when this forms touches a cooler object and condenses. Condensation is accompanied by an instantaneous contraction of the steam (1600ml ml of steam at 100oC condense to 1ml), creating lowpressure region in which more steam flows. The result is penetration of steam into articles being sterilized. If temperature of dry saturated steam is raised at constant pressure or if temperature is reduced at constant pressure the degree of saturation is reduced and the steam become superheated. Superheated steam condenses less readily than dry saturated steam- less effective sterilant. Wet steam must also be avoided since this will result in reduced penetration of steam in materials and wet the loads. It is important to keep dry is to prevent the steam water droplets soaking towels sheets i.e. porous material. A lengthy drying up period may damage articles. Moist heat sterilization i.e. Autoclaving is performed in an autoclave. The most common conditions for sterilization under pressure include PROCESS TEMPATUR E0C HOLDING TIME (min) FOR STERILZATION 15 10 3 Pressure in PSI (pounds per square inch ) 15 20 30

MOIST HEAT

121 126 134

In any heat sterilization process the articles for sterilization must be first raised to sterilization temperature and this involves heating up stage. Then the objects have to be held at the sterilizing temperature for a sufficient period of time to ensure sterilization and SAL is achieved. This is known as the holding stage. After this the objects must be cooled to temperatures that are safe for handling or the cooling stage.

Moist heat sterilization i.e. Autoclaving is performed in an autoclave. The most common conditions for sterilization under pressure include PROCESS TEMPATUR E0C HOLDING TIME (min) FOR STERILZATION 15 10 3 Pressure in PSI (pounds per square inch ) 15 20 30

MOIST HEAT

121 126 134

Moist heat sterilization is carried out in an autoclave.

There are various types of autoclaves but generally they can be equated to large pressure cookers. Basically they are stainless containers that may be jacketed or nonjacketed with the following features: 1. Pressure gauge 2. Steam outlet and inlet valves 3. Thermometer/ temperature gauge 4. Water heating system/ steam generating system 5. Vacuum pump 6. Safety valve 7. Inlet Door

Basically operation of an autoclave involves i. ii. iii. iv. v. vi. vii. Ensure there is sufficient water in the autoclave to produce required steam usually automatic Load sterilization chamber - Ensure that all products required to be sterilized are accessible Close chamber door Air removal all air must be removed before sterilization can commence Start sterilization cycle (include heating, holding and cooling stages) Remove objects All through the process monitor sterilization temp and pressure

There are various types of autoclaves 1. Simple non-jacketed - small electrically heated sterilizers with simple air expulsion system steam sterilization of unwrapped instruments and utensils used in medical (district hospital) and dental community Disadvantages: Requires personal attention to monitor process Method of air discharge inefficient cannot really monitor that all air has been removed There is no internal thermometer to check coolest part of load There is no mechanism for drying the load 1. Downward displacement autoclaves - These are usually jacketed horizontal or cylindrical in shape. The air is removed by displacement by steam through an automatic air and condensate discharge valve at the base of the autoclave. There are 3 main types: Laboratory autoclaves Hospital - for sterilizing unwrapped surgical instruments used in hospital theaters Fluid sterilizers - autoclaves for sterilizing fluid in sealed containers e.g. infusions injections etc.

2. Porous load autoclaves these autoclaves are used for porous materials such as towels surgical gowns, dressings, swabs, gauzes, sheets etc. The sterilizer is equipped with a vacuum system to ensure a high degree of air removal. To ensure no moisture remains on the sterilized objects. For efficient sterilization a. Keep a daily temp record chart b. Check thermometer daily c. Check air removal system weekly d. Include sterilization control measure each cycle B. DRY HEAT STERILIZATION The value of heat in the form of fire has been known for centuries Examples of Dry heat sterilization are: Incineration Read heat Flaming Hot air oven Dry heat sterilization The equilibrium of heat must be accelerated by forced air circulation using a fan. The slow rate of heat absorption and thus microbial killing by hot air combine to make this process time consuming; That is he total process time including the time taken for the free chamber space to achieve the required temp, the sterilizing time and the cooling. Thus in general dry heat sterilization requires higher temperatures and extended periods of sterilization PROCESS DRY HEAT MOIST HEAT TEMPATURE0C 160 170 180 121 126 134 HOLDING TIME (min) FOR STERILZATION 120 60 30 15 10 3

Due to the high temperatures required for dry heat sterilization can only be used for thermostable, moisture sensitive or moisture impermeable pharmaceutical and medicinal. These include products like; Dry powdered drugs Suspensions of drug in non aqueos solvents Oils, fats waxes, soft hard paraffin silicone Oily injections, implants, ophthalmic ointments, ointment base HOT AIR OVEN It comprises of an electrically heated, insulated chamber fitted with insulated door. The chamber is usually of stainless steel. The inner surfaces are polished to minimize heat loss. Heating arrangements are made around the chamber walls. Heat is delivered to the load primarily by convection and radiation. A fan is fitted for efficient air circulation and heat distribution within the oven. It is also fitted with thermostat to control the temperature. Used for sterilizing glassware that needs to be used dry, for powders, fats, oils and greases that are not penetrable by moist heat. Not recommended for articles such as plastic that would be damaged by the necessary high temperature. The glassware must be dried first before being loaded into a hot oven to avoid cracking. The temperature varies between 160oC- 170oC and duration of 1-2 hours. Ample spacing must be allowed in the oven to permit free circulation of hot air. Containers must be placed on their sides for the same reason to avoid impeding of hot air. Powders, oils, fats and grease must be packed in small quantities or in thin layers to enable penetration of heat.