The document discusses autoclaves and steam sterilization. It defines an autoclave as a large pressure cooker that uses steam under pressure to sterilize. Steam is an effective sterilizing agent because its latent heat allows it to reach high temperatures, and its condensation creates negative pressure drawing it into objects. The document outlines best practices for autoclave operation including removing air pockets, achieving proper steam quality, and validating sterilization cycles.
The document discusses autoclaves and steam sterilization. It defines an autoclave as a large pressure cooker that uses steam under pressure to sterilize. Steam is an effective sterilizing agent because its latent heat allows it to reach high temperatures, and its condensation creates negative pressure drawing it into objects. The document outlines best practices for autoclave operation including removing air pockets, achieving proper steam quality, and validating sterilization cycles.
The document discusses autoclaves and steam sterilization. It defines an autoclave as a large pressure cooker that uses steam under pressure to sterilize. Steam is an effective sterilizing agent because its latent heat allows it to reach high temperatures, and its condensation creates negative pressure drawing it into objects. The document outlines best practices for autoclave operation including removing air pockets, achieving proper steam quality, and validating sterilization cycles.
@Pharmatalks_group Dhaval Surti What is An Autoclave?
• An autoclave is like a large pressure cooker; it operates
by using steam under pressure as the sterilizing agent. High pressures enable steam to reach high temperatures, thus increasing its heat content and killing power. • Autoclave and Steam Sterilizer words are used for same equipment interchangeably • Charles Chamberland invented first real steam sterilizer in 1880. • First steam sterilizer looked like pressure cooker and also worked in same way. How steam kills microorganism?
• Autoclave operates using steam under high pressure as
sterilizing agent. • High pressures enables steam to reach high temperature, thus increasing heat content and killing power. • Most of heating power of steam comes from its latent heat of vaporization. This is the amount of heat required to make water hot. • It takes 80 calories to make 1 litre of water to boil, but 540 calories to convert that boiling water to steam • Therefore steam at 100 C has almost seven times more heat than boiling water How steam kills microorganism?
• Steam is able to penetrate objects with cooler
temperatures because once the steam contacts a cooler surface, it immediately condenses to water, producing a concomitant 1870 fold decrease in steam volume. • This creates a negative pressure at the point of condensation and draws more steam to the area. • Condensations continues to so long as the temperature of the condensing surface is less than that of steam; once temperatures equilibrate, a saturated steam environment is formed. How steam kills microorganism?
• Moist heat is thought to kill microorganisms by
causing coagulation of essential proteins. • When heat is used as sterilizing agent, the vibratory motion of every molecule of a microorganism is increased to levels that induce cleavage of intramolecular hydrogen bonds between proteins. • Death is therefore caused by an accumulation of irreversible damage to all metabolic functions of the organism Role of Air in Steam Sterilization
• Air and steam do not mix readily.
• Air is heavier than steam. • If items to be sterilized are wrapped too tightly than entrapped air cannot escape forming cool pockets inside packages preventing steam from reaching sufficient temperature to kill all microorganisms. • Heat carrying capacity of air is much less than steam • Debris in drain strainer may form air layer which preventing effective operation of steam sterilizer Role of Air in Steam Sterilization Why Air Must Be Removed?
• Air is enemy since the heat power is steam
• Air does not mix readily with steam and sinks to the bottom of chamber • Entrapped air pockets touches the surfaces, impairing killing effect of steam Why Air Must Be Removed? Equilibration Time
• As per EN 285 2016, Equilibration time is
‘period which elapses between the attainment of the sterilization temperature at the reference measurement point and the attainment of the sterilization temperature at all points within the load’. • Equilibration time 15 seconds for the Autoclaves of size less than 800 L • 30 seconds for the Autoclaves of size more than 800 L Usage of Autoclave
• Filling Assemblies includes filling needles and tubing
• Components for filling, filtration etc (vessels, containers, glassware, sampling bottles) • Garments • Rubber stoppers, aluminium seals • Filters, silicone tubing, gloves • Documents and labels • Components for environmental monitoring in aseptic areas • Components for area sanitization like buckets, sponge mops, wipes, sanitization bottles, etc • Accessories like forceps, tools, clamps, bio-breathable papers • And so on… Regulatory Observations
• Inadequate control of autoclave sterilization
cycles • Single door autoclaves instead of double door • The porous load steriliser data did not meet current equilibration requirements • Leak rate and air removal testing was not frequent enough • Sterilizer load patterns were not adequately defined in SOP Advantages of Steam Sterilization
• It is preferred way of destroying
microorganism • It is non-toxic • Kills spores • Inexpensive • Cycles are fast Disadvantages of Steam Sterilization
• Steam can be hazardous certain pieces of
equipment • If steam is not pure than it can get into very small lumens and block them • Pitting or discoloration of metal when come in contact with steam that wasn’t pure • Not suitable for moisture sensitive materials Importance of Steam Quality
• Saturated steam is required for steam
sterilization • Super heated steam causes sterilization failure due to lack of heat transfer to load contents • Unsaturated steam contains water droplets, lacks sufficient heat for steam sterilization and causes wet packs in load • Measures of steam quality are as follows: Importance of Steam Quality
Item Description Limits
Non condensable Air and other gases, which do not ≤ 3.5% gases (NCG) condense under the conditions of steam sterilization and prevent the attainment of sterilization conditions in any part of the load Superheat Steam whose temperature, at any ≤ 25°C given pressure, is higher than that indicated by the equilibration curve for the vaporization of water
Dryness Value The dryness fraction is a measure of 0.90-0.95
the amount of moisture carried by the steam being supplied and used for sterilization Contaminants Clean steam condensate tests as per As per EN 285 EP Leak Test
• (1.3 mBar/min = 0.0195 PSIA/min or 0.039”
Hg/min) • Mark, Sterilizers are prone to leakage because of the nature of the process – pressure/vacuum and hot/cold, all of which stress the valves and sealing systems. Add on to this the complexity and the number of fittings/valves present combined with environmental debris • The EMA requirement to conduct leak rate tests derives from the Orange Guide – Moist Heat 66 – “There should be frequent leak tests on the chamber when a vacuum phase is part of the cycle”. Typical Autoclave Cycle
• Steam sterilization is generally carried out at 121°C
(250°F) for 15 minutes or at 134°C for 3–4 minutes. • Temperatures can be reduced to 115°C, and even as low as 105°C, depending upon the bioburden, integrity, heat resistance, and characteristics of the material being sterilized. This approach is beng mainly used for liquid products terminal sterilized • Low-temperature steam processes (65°–80°C) have been used (e.g., steam-formaldehyde); however, other combinations could also be used. • Load items must be clean, dirty load item may protect bacterial protein resulting in steam non penetrating and non-sterilization. Steam Sterilizer Design Aspects
• Autoclave is composed of autoclave chamber along with
its auxiliary system and equipment 1. A Heating System 2. A Pressure System 3. A Vacuum System 4. A Sensor System 5. A Control Panel 6. A Computer or PLC System 7. An Instrumentation System 8. A Datalogging System 9. Safety Systems Steam Sterilizer Design Aspects Steam Sterilizer Design Aspects Steam Sterilizer Design Aspects Steam Sterilizer Design Aspects Steam Sterilizer Design Aspects
• Critical Parameters are Steam Quality, Steam
Pressure, Temperature and Time • Temperature sensors located in drain and in the chamber. More than one sensors are placed for overall monitoring of chamber temperature and drain temperature • Temperature control can be on drain sensor, OR drain sensor as well as chamber sensor • Automated cycles with data monitoring and alarms Steam Sterilizer Design Aspects Steam Sterilizer Design Aspects Steam Sterilizer Design Aspects Mechanism of Sterilization
• Most of the heating power of steam comes
from its latent heat of vaporization. This is the amount of heat required to convert boiling water to steam. • This amount of heat is large compared to that required to make water hot. For example, it takes 80 calories to make 1 liter of water boil, but 540 calories to convert that boiling water to steam. Therefore, steam at 100º C has almost seven times more heat Mechanism of Sterilization
• Steam is able to penetrate objects with cooler
temperatures because once the steam contacts a cooler surface it immediately condenses to water, producing a concomitant 1,870 fold decrease in steam volume. This creates negative pressure at the point of condensation and draws more steam to the area. Condensations continues so long as the temperature of the condensing surface is less than that of steam. These properties ensure rapid heating of surfaces, good penetration of dense materials, and coagulation of proteins. Why steam is so Effective? Validation of Sterilization Cycle Validation of Sterilization Cycle
Type Goods to be Typical Pre- Air Removal
sterilized vacuum pulses Hard Goods SS Equipment, 1 or more Easy air removal (Non-porous containers, SS (typically 3) and steam load) piping, penetration Glassware Wrapped Goods Garments, 3 or more More difficult air (Porous load) filters, rubber removal/steam stoppers, filters, penetration silicone tubing Liquids Media, terminal None Air overpressure sterilized process, heat products and cool without vacuum Validation of Sterilization Cycle Load items must be clean, dirty load item may protect bacterial protein resulting in Load items must be clean, dirty load item may protect bacterial protein resulting in Microbiological Aspects Microbiological Aspects
• Sterility Assurance Level
The probability of a single viable microorganism being present on a sterilized unit is one in one million after the item has undergone a sterilization process; often called a six log reduction For potential products, desire a SAL of 106 Microbiological Aspects Microbiological Aspects Microbiological Aspects Microbiological Aspects Microbiological Aspects Microbiological Aspects Microbiological Aspects Hope this is of some Help
•This is not all inclusive but
can help/direct to understand more about autoclave •Thank You For Your Time