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SAFER TECHNOLOGIES AND EQUIPMENT. By T.S.Sudhir. TYPE OF CHEMICAL HAZARD. FLAMABLE - SOLVENTS TOXIC – CARCINOGENIC…. HAZARDOUS – LIKE Na metal. CORROSIVE – Chlorine/ Thionyl chloride. REASON FOR HAZARD. STORAGE REACTIONS HANDLING FAILURES OF EQUIPMENTS

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Type of chemical hazard
TYPE OF CHEMICAL HAZARD

  • FLAMABLE - SOLVENTS

  • TOXIC – CARCINOGENIC….

  • HAZARDOUS – LIKE Na metal.

  • CORROSIVE – Chlorine/ Thionyl chloride


Reason for hazard
REASON FOR HAZARD

  • STORAGE

  • REACTIONS

  • HANDLING

  • FAILURES OF EQUIPMENTS

  • PIPES/PUMPS/STORAGE TANKS - LEAKAGES


How to avoid reduce
HOW TO AVOID/REDUCE?

  • MINIMIZATION

    • Reducing hazardous inventories

    • Reactor sizes

    • Pipe diameters.

      Can lessen the consequences of potential mishaps

  • CHANGE MANUFACTURING TECHNOLOGY – TO ELIMINATE HAZARDS

    The result will be a safer and a cost-effective plant design


  • Principles of green chemistry
    PRINCIPLES OF GREEN CHEMISTRY

    • P Prevents wastes

    • R Renewable materials

    • O Omit derivatization steps

    • D Degradable chemical products

    • U Use safe synthetic methods

    • C Catalytic reagents

    • T Temperature & pressure ambient

    • I In-process monitoring

    • V Very few auxiliary substances

    • I I-factor, maximize feed input product

    • T Toxicity- low of chemical products

    • Y Yes then it is safe

    • Y Yes it's safe


    Safer technologies steps
    SAFER TECHNOLOGIES STEPS

    • Possible replacement of solvents.

    • Alternate green chemistry

    • Short reaction steps or combined reactions.

    • Recycle and reduce ingredients-solvents

    • Reduce storage of hazardous chemicals

    • Gas vs. Liquid transport – e.g.. Chlorine gas


    Principles of green engineering
    PRINCIPLES OF GREEN ENGINEERING

    • I Inherently non-hazardous and safe

    • M Minimize material diversity

    • P Prevention instead of treatment

    • R Renewable material and energy inputs

    • O Output-led design

    • V Very simple

    • E Efficiently use mass, energy, space & time

    • M Meet the need

    • E Easy to separate by design

    • N Networks for exchange of local mass & energy

    • T Test the life-cycle of the design

    • S Sustainability throughout the produce life-cycle


    Inherent safety
    INHERENT SAFETY

    • “Inherent" as "existing in something as a permanent and inseparable element, quality, or attribute.

    • " A chemical process is described as inherently safer if it reduces or eliminates one or more process hazards,

    • This is accomplished through changes that are permanent and inseparable from the basic process technology.

    • We cannot change hazards.

    • We can alter the materials or their conditions to reduce or eliminate them.

    • Reducing the quantity of a hazardous material or energy through process intensification is one important way of increasing the inherent safety of a CPI process.


    Strategies inherently safer process design
    STRATEGIES - INHERENTLY SAFER PROCESS DESIGN

    • Minimize the size of process equipment.

    • Substitute a less-hazardous substance

    • Less hazardous process step.

    • Moderate storage or processing conditions.

    • Simplify process and plant design.

    • Alternate equipments.

    • Plant area segregation and separation.


    Safer plant equipment design
    SAFER PLANT EQUIPMENT DESIGN

    • Intense mixing & mass transfer- e.g. Nitration

    • Rapid heat transfer – Exothermic reactions

    • Proper designed equipments.- safety/Rupture disc/scrubbing etc.

    • Reduce storage and handling.

    • In situ generation of small quantities of reactants than storage and transfer.

    • Multiple operation in single equipment – reduces all other paraphernalia's like pumps/pipes/storage etc.

    • Innovative energy sources Energy sources such as lasers, ultraviolet light, microwaves, or ultrasound can be used in a controlled fashion in a chemical reaction or physical unit operation to increase efficiency.


    Guide for risk assessment
    GUIDE FOR RISK ASSESSMENT

    • International Conference on Harmonization Q 9 guidelines.

    • Tools for use of Risk assessment

      The Risk assessment is carried out by a Team using the format SOP drafted for the purpose in line with ICHQ9 guide lines. The cGMP compliance, process flow, Equipment, services in use and the personnel involved are verified. The assessment is based on Failure Mode and Effect Analysis (FMEA).


    Guide for risk assessment1

    Initiate

    Quality Risk Management Process

    Risk Assessment

    Risk Identification

    Risk Analysis

    Risk Evaluation

    unacceptable

    R

    n

    i

    s

    o

    k

    i

    t

    a

    M

    c

    Risk Control

    a

    i

    n

    n

    u

    a

    g

    m

    Risk Reduction

    e

    m

    m

    o

    e

    C

    n

    t

    k

    t

    s

    Risk Acceptance

    o

    i

    o

    R

    l

    s

    Output / Result of the

    Quality Risk Management Process

    Risk Review

    Review Events

    GUIDE FOR RISK ASSESSMENT


    Guide for risk assessment2
    GUIDE FOR RISK ASSESSMENT

    Potential threat

    - chemical reaction

    - manufacturing issues

    - facilities and equipment

    hazard

    Failure

    System defect

    - technical breakdown

    - not detected

    - human breakdown

    - insufficiently prevented

    - extrinsic effect

    - emerges by degree

    Anything that has the potential to harm patients, product quality or the business (loss, interruption, image)