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Summary Sterilisation methods

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Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images

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  • June 8, 2023
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Sterilisation Methods

Definitions

 Sterility- absence of viable micro-organisms
 Sterilisation- process to achieve sterility
 Sterility assurance level (SAL)- probability that organisms survive (terminally
sterilised products <10-6 and aseptic<10-3 meaning 1 micro-organisms in 10-3
vials)

Sterilisation

 Most preparations sterilised in final packaging
 Injections and IVs
 Sterile fluids
 Implants
 Dressings

Moist Heat Sterilisation

 Using high temperature and pressure (steam)
 Usually done in an autoclave
 121oC/15psi for 15 minutes
 Method of choice for thermostable aqueous preparations
 Causes hydrolysis of proteins
 Heating is effected by: size and shape of container, size of load and porosity and
entrapment of air

MHS for Bottled Fluids

 Autoclave cycle
1. Air removed and steam administered (20-30 minute heat up)
2. Expose (holding phase)
3. Cooling (spray cooled)

MHS Porous Loads

 Wrapped goods and porous materials
1. Air removal (vacuum)
2. Pulses of steam and evacuation in cycles (improve air extraction and steam
penetration)
3. Common conditions 134o for 3 minutes
4. Drying via steam exhaustion and vacuum
5. Restore air pressure and administer sterile air
6. Cycle 35 minutes

MHS Flexible/Semi Ridge Containers

 Products in flexi bags like IVs
1. Air ballasting- proportion of air in chamber to prevent the package from
breaking (no vacuum) and fan to mix steam
2. Heating and holding period
3. Steam stopped by pressure maintained

, 4. Water/cooled air to cool- product not removed until safe temperature and
pressure is reached
5. Can be done at 121o for 15 minutes or as low as 115o for 30 minutes

Advantages

 Terminal process for aqueous solutions
 Wide safety margin
 Kills bacteria and viruses

Disadvantages

 Product must be thermostable
 Cant be used for oil based products

Dry Heat Sterilisation

 No steam so use higher temperature
 160o for 2 hours, 170o for 1 hour or 180o for 30 minutes
 Used for thermostable dry powders, oil based injections, glassware or metal
instruments
 Heat oxidises proteins
 Slower and less efficient than MHS
 Used if paper, cardboard or aluminium
 Avoid packing in many items
 Screw cap containers half unscrewed to prevent bursting but tighten after
cooling

DHS Process

1. Load should all be same size and type
2. Pack the oven evenly spaced and containers are sealed or covered
3. Heat transferred by convection (fan) and radiation (reflect off oven)
4. Air cooling with HEPA filter

Advantages

 Used for substances affected by moisture
 Suitable for assembled apparatus
 Less damage to glass and metal than (MHS)

Disadvantages

 Damages plastic or rubber
 Not suitable for dressings as doesn’t penetrate and causes deterioration

Gaseous Sterilisation

 Ethylene oxide
 Volatile at RTP
 Miscible in water
 Explosive in air so mixed with 10% CO2 or HFCs)
 Toxic, irritant, burns and carcinogenic
Application of Ethylene Oxide

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