Institution Laboratory name Location Head/Responsible person Standard Operating Procedure (SOP) Use and maintenance of an autoclave Code: Version: no. Date: of release Page: 1 of 10 Content 1. Scope 2. Definitions and abbreviations 3. Personnel qualifications 3.1 Medical fitness 3.2 Education and training 4. Procedure 4.1 Principle 4.2 What should be autoclaved? 4.3 Equipment and materials 4.4 Reagents and solutions 4.5 Detailed instructions for use 4.6 Recording and reporting 4.7 Quality control 4.8 Safety precautions 5. Related documents Annex 1. Autoclave logbook Annex 2. Autoclave maintenance logbook Compiled by Examined by Name Approved by Replaced New version Code: Code: Date Signature Laboratory area: No of copies: Reason for change: Institution Laboratory name Location Head/Responsible person Code: Version: no. Date: of release Page: 2 of 10 Standard Operating Procedure (SOP) Use and maintenance of an autoclave 1. Scope The autoclave using saturated steam under pressure is the most efficient means of sterilizing instruments, glassware and media solutions in the general TB diagnostic laboratory, and of decontaminating biological material consisting of infectious waste (= mycobacterial cultures and related infectious material). The current SOP describes the procedure for use of a pressure cooker autoclave with fully manual operation. It must be adapted for other autoclave types with automatic air and condensate discharge. 2. Definitions and abbreviations disinfection A physical or chemical means of killing microorganisms, but not necessarily spores. decontamination Any process for removing and/or killing microorganisms. The same term is also used for removing or neutralizing hazardous chemicals and radioactive materials. sterilization A process that kills and/or removes all classes of microorganisms and spores. inactivation A process rendering an organism inert by application of heat, or other means. Units °C: degrees Celsius 1 kPa (kilopascal) = 0.01 bar 1 kg/cm2 = 98 kPa 1 psi (pounds per square inch or lb/in2) = 6.8947 kPa At sea level, atmospheric pressure is 101 kPa or 1.013 bar or 1 atm or 760 mmHg or 1.03 kg/cm2 or 14.7 psi At sea level, 121°C is obtained at 115 kPa or 1.06 kg/cm2 or 15 psi. Conversion table Pa Pa 1 bar 105 bar 10 5 -5 atm 9.87 x 10 mmHg -6 0.0075 kg/cm2 psi –5 1.02 x 10 1.45 x 10–4 1 0.987 750 1.0197 14.5 atm 1.01 x 10 1.013 1 760 1.03 14.7 mmHg 133.3 1.33 x 10–3 1.32 x 10–3 1 1.36 x 10–3 1.93 x 10–2 kg/cm2 9.8 x 104 0.98 0.97 735 1 14.22 psi 6895 0.069 0.068 51.7 0.07 1 Institution Laboratory name Location Head/Responsible person Standard Operating Procedure (SOP) Use and maintenance of an autoclave Code: Version: no. Date: of release Page: 3 of 10 3. Personnel qualifications 3.1 Medical fitness In accordance with national laws and practices, arrangements should be made for appropriate health surveillance of TB laboratory workers:     before enrolment in the TB laboratory; at regular intervals thereafter; after any biohazard incident; at the onset of TB symptoms. Ideally, individual medical records shall be kept for up to 10 years following the end of occupational exposure. Laboratory workers should be educated about the symptoms of TB and provided with ready access to free medical care if symptoms arise. Confidential HIV counselling and testing should be offered to laboratory workers. Options for reassignment of HIV-positive or immuno-suppressed individuals away from the high-risk areas of the TB laboratory should be considered. All cases of disease or death identified in accordance with national laws and/or practice as resulting from occupational exposure to biological agents shall be notified to the competent authority. 3.2 Education and training Education and training must be given on the following topics:           potential risks to health (symptoms of TB disease and transmission); hygiene requirements; wearing and use of protective equipment and clothing; handling of potentially infectious materials; prevention of incidents and steps to be taken by workers in the case of incidents (biohazard incidents, chemical, electrical and fire hazards); good laboratory practice; organization of work flow from clean to dirty areas; use of chemical and biological indicators; waste management; use of equipment (operation, identification of malfunctions, maintenance). The training shall be:    

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