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Kris Traver and Nitin Jain

Standard Operating Procedures. Kris Traver and Nitin Jain. Goals and Objectives. To understand: The purpose of having SOP’s and how they affect the daily workings of laboratories. To discuss: What is an SOP Purpose of SOP Components of SOP Identification process of SOP.

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Kris Traver and Nitin Jain

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  1. Standard Operating Procedures Kris Traver and Nitin Jain

  2. Goals and Objectives • To understand: • The purpose of having SOP’s and how they affect the daily workings of laboratories. • To discuss: • What is an SOP • Purpose of SOP • Components of SOP • Identification process of SOP

  3. What is an SOP? • SOP’s are written instructions that document a routine or repetitive activity followed by an organization. • They addresses all requirements to perform laboratory procedures safely. • SOPs will fail if they are not followed, therefore, the use of SOPs needs to be reviewed and re-enforced by management.

  4. The Purpose of SOP’s • SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. • They document the way activities are to be performed to maintain consistency with technical operations and to support data quality. • They describe the analytical processes, and processes for maintaining, calibrating, and using equipment. • SOP’s maintain quality control and quality assurance processes and ensure compliance with governmental regulations. • SOPs are usually specific to the organization or facility

  5. Components of an SOP • SOPs must address: • Process Identification • Controls • Equipment Checks • Potentially Hazardous Situations • Waste Management • Any Requirements for Obtaining Authorization

  6. The Process Identification Section • The chemicals, process or equipment involved are identified. Including: • The stock chemicals • The chemicals produced in the process • The intermediates • The final compounds and wastes involved and also such factors as use of catalysts, inert compounds, heat, cold, and varied operating pressures which are involved in the process.

  7. The Controls Section • This section lists required methods to control potential exposures. • Three types of controls • Engineering controls • Administrative controls • Personal protective equipment (PPE)

  8. Engineering Controls • Engineering controls involve specific information on the environments involved in the procedure to maintain safety. • Engineering controls state: • Work environment (ventilated area, fume hood, ext.) • Storage of toxic materials • Restricting access to the area protect from hazards or potentially explosive situations.

  9. Administrative Controls • Involve maintaining standards and mandatory laboratory practices including: • substituting pre-formulated liquids instead of powders to be weighed and prepared • hygiene practices such as hand washing • procedures for removal and disposal of contaminated PPE

  10. Personal Protective Equipment (PPE) • This section covers information on the types of PPE to use such as gloves, lab coats, etc. The type of PPE must be specified, such as the type of glove.

  11. Equipment Checks and Potentially Hazardous Situations • The Equipment checks sectiondescribes ways to verify that equipment is operating correctly prior to using hazardous chemicals. • The Hazardous situations section provides guidance for handling spills and identifying if a spill is causing a hazardous situation. This also provides guidance when purchasing a chemical, as to the maximum size of container.

  12. Waste Management and Particularly Hazardous Substances • Waste management section identifies safe disposal methods for routinely generated wastes, including waste treatment ways to make handling safer. • Particularly hazardous substances section provides additional details if hazardous substances are used. Details should address: • using specific containment device(fume hoods or glove boxes) • authorizations for using the particularly hazardous substances • describing additional procedures for decontamination and safely handling contaminated waste materials

  13. Authorizations • Include requirements for obtaining authorization before being allowed to perform the procedure, operation or activity. • This section may include: • special training prior to using equipment/chemicals • completing a medical examination before using certain equipment

  14. Guidelines For Writing an SOP • Use clear, simple, direct wording in short sentences • Write procedures as chronological sequences • Use ‘shall’ or ‘must’ for mandatory actions and ‘should’ for advisory actions • Procedures should reflect current practice • If any section is not applicable to the procedure, include “N/A” under the heading –DO NOT leave blanks.

  15. References • http://en.wikipedia.org/wiki/Standard_operating_procedure • www.microbial.uninelb.edu • http://engineering.tamu.edu • www.epa.gov • www.ehs.washington.edu

  16. Questions??????

  17. Happy Halloween

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