Sterilization Processes Sterilization: Process which permits the destruction or elimination of all life forms from the medium or object being sterilized. To sterilize: To subject to sterilization. Sterilized: State of that which has undergone sterilization. Sterile: The state of containing no living micro- organism or virus capable of reproduction.Antonio Matachana, S.A.
Sterilization Processes Sterilization Processes Dry - Hot Air - Poupinel Oven By Phisical HEAT Agents Wet - Steam under pressure - Autoclave Gamma Rays IONISING RADIATION Electrons PLASMA GAS Ethylene Oxide By Chemical GAS Agents Formaldehyde LIQUIDSAntonio Matachana, S.A.
Sterilization Processes DESTRUCTION MECHANISMS Dry heat: By oxidation Wet heat: By protein coagulation Radiation:By altering the protein molecules and nucleic acids Gases: By alkylation Glutaraldehyde Liquids: SporicideAntonio Matachana, S.A.
Sterilization Processes Stages in the process for producing sterile products: • Pre-sterilization • Sterilization • Post-sterilizationAntonio Matachana, S.A.
Sterilization Processes Pre-sterilization This comprises all the operations prior to Sterilization and includes: • Selection of the materials to be sterilized • Cleaning protocols and products and equipment to be used. • Checking and preparation of the materials. • Selection of the method of sterilization to be used, according to the material. • Selection of the type of wrapping. • Method of packaging and preparation. • Positioning of the load in the sterilizer.Antonio Matachana, S.A.
Sterilization Processes Packaging for Sterilization 1. Compatible with the process 2. Microbial barrier 3. Free of toxic elements liable to interfere with the product or process 4. Suitable for aseptic presentation 5. EconomicalAntonio Matachana, S.A.
Sterilization Processes TYPES OF PACKAGING • Paper • Paper / plastic combined • Textile • Unwoven / synthetic fabrics • Containers • OthersAntonio Matachana, S.A.
Sterilization Processes Control of the Sterilization System • PHYSICAL C. – Mechanical components – Graphs – Printer • CHEMICAL C. – Bowie-Dick test (only for steam sterilization) – External controls - Change indicators – Internal controls - Integrators • BIOLOGICAL C. – Spores testAntonio Matachana, S.A.
Sterilization Processes CHEMICAL CONTROLS The chemical controls are elements based on a chemical reaction with one or several of the parameters involved in a sterilization process. They are usually in the form of strips or sheets of paper impregnated with chemical reagent which varies depending on the parameter to be measured, but generally they involve a change in colour. Recommended characteristics: • Very obvious colour change • Non-toxic • Easy to use • CertifiedAntonio Matachana, S.A.
Sterilization Processes BIOLOGICAL CONTROLS The biological controls consist of elements composed of biological preparations containing specific micro-organism spores for each sterilization system. The Pharmacopeia defines the specific types and strains to be used in manufacturing these control elements, as well as the means of recovery for their subsequent analysis.Antonio Matachana, S.A.
Sterilization Processes Biological Controls SELF-CONTAINED TYPE These can be interpreted by the actual user, without requiring the services of an external laboratory. CONVENTIONAL TYPE These require the intervention of a microbiology laboratory for culture and subsequent interpretation. Recommended characteristics: • Reliability • Easy to interpretAntonio Matachana, S.A.
Sterilization ProcessesMANTAINING PRODUCT STERILITYMantaining the integrity of a sterilized object is a complexmatter which depends essentially on three factors. • Effective sterilization – Validacion of the process • Maintenance of sterility – Storage conditions – Quality of packaging • Aseptic handling during final use The CDC stipulates in its recommendations that: In case of doubt concerning the sterility of an object, that object should not be used. Antonio Matachana, S.A.