This modules looks at the validation of a range of sterilisation processes used in the Healthcare industry but places a particular emphasis on steam sterilisation.
Validation-Introduction
What is it? Requirements. Documentation required. Stages. Validation masterplan. Validation protocols. Software Validation.Validation reports. Training requirements. Auditing validation. Common problems.
Air - Control of Microbial Levels.
Control of microbial levels. Filtration- High Efficiency Particulate Air Filtration (HEPA). Viable and non viable counts. Chemical methods- requirements e.g. hydrogen peroxides. UV control bacteriostaticvs bactericidal effects. Cleanrooms and isolation technology. European and Federal Standards.
Calibration
Calibration of key instruments and measurement devices.
Chemical Sterilisation:
Ethylene oxide sterilisation. Peracetic acid . Hydrogen peroxide. Mechanism of action. Applications. Limitations. Design of the steriliser. Cycle conditions. Safety and desorption process. Monitoring the sterilser. Biological , chemical and physical indicators. D values. EN550. EN556.
Moist Heat (Steam) Sterilisation:
Mechanism of action. Applications. Limitations. Design of the autoclave. Types of loads. Monitoring the cycle. Master temperature records (MTRs). Biological, chemical and physical indicators e.g. thermocouples. Validation requirements daily, quarterly and yearly requirements. Steam quality. D and z values. European standard EN 554. ISO 13683. EN 556.
Low temperature steam and Hydrogen peroxide
Mechanism of action. Applications. Limitations. Safety considerations. Monitoring/validating.
Regulatory requirements
Standards and Regulations for Validation of Medical Device Decontamination
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |