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Micro Risk

Micro Risk. Why do we clean so often? Does the cleaning make the product safer?. Why should we look at this?. 49% of time is used in cleaning and preparing the line Output very low for effort (cost higher than necessary) Water use is high Water costs on way in and way out (Double Whammy)

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Micro Risk

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  1. Micro Risk Why do we clean so often? Does the cleaning make the product safer? Process Improvement & Product Services September 2013

  2. Why should we look at this? • 49% of time is used in cleaning and preparing the line • Output very low for effort (cost higher than necessary) • Water use is high • Water costs on way in and way out (Double Whammy) • Extra chemicals are used during the clean • Other companies in the same industry run for periods up to 48 hours without washing between batches Process Improvement & Product Services September 2013

  3. Example for another company Process Improvement & Product Services September 2013

  4. Perceived Risk • High raw material microbiological load • High microbial load in air • Remaining load due to inadequate cleaning routine • Viable organisms in the finished product due to above • Post Process Contamination Process Improvement & Product Services September 2013

  5. Risk Management • Raw material • Organisms to be managed • Microbiological testing • Adequacy of sampling • Segregation / rejection • Product impact • Processing time and temperature • Kill rate • Safety margin Process Improvement & Product Services September 2013

  6. Risk Management • Air • Filtration (Level) • Humidity reduction (What is the standard?) • Air changes (How many) • GMP (What checks?) • Fogging (Frequency and adequacy measurement) • Microbiological testing (Standard Level/ Trends) Process Improvement & Product Services September 2013

  7. Risk Management • Cleaning Routine • Frequency • Standards • Chemicals • Microbiological testing Process Improvement & Product Services September 2013

  8. Risk Management • Post Process Contamination • Connection Manipulation • Equipment storage • Equipment condition • Manipulation during filling • Manipulation during testing • Customer manipulation Process Improvement & Product Services September 2013

  9. Risk Level • Where is the biggest risk? • Which controls are weakest? • Which controls can be reduced? • Do we need extra controls? Process Improvement & Product Services September 2013

  10. Shipping Handling Review Findings • Pressure gauge and equipment stored in bag • Should be in sterilants solution at all times • Spray in use was not alcohol • Spray not marked • Frequency of change unknown • Valves not protected from dust in store and at customer Process Improvement & Product Services September 2013

  11. Priority Actions • Revise shipping control standards and procedures • Revise shipping equipment management • Review putting cap onto nitrogen valves • To avoid dust in storage • To avoid dust during shipping • To avoid dust at customer • Implement check system • Consider frequency of audit • Consider customer handling procedures Process Improvement & Product Services September 2013

  12. Next Actions • Confirm process kill capability at normal time temperature (QA) • Check fruit contamination levels (QA) • Increase run length by one batch (next week) (Ops) • Test product over period of time (1 month?) QA • Maintain controls (QA & Ops) • Check finished product impacts (QA) • Increase batch run length by further batch • Target to be able to run all lines 16 hours on same product within 3 months? (Ops & QA) Process Improvement & Product Services September 2013

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