Micro Risk Why do we clean so often? Does the cleaning make the product safer? Process Improvement & Product Services September 20131

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 20132

Example for another company Process Improvement & Product Services September 20133

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 20134

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 20135

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 20136

Risk Management  Cleaning Routine  Frequency  Standards  Chemicals  Microbiological testing Process Improvement & Product Services September 20137

Risk Management  Post Process Contamination  Connection Manipulation  Equipment storage  Equipment condition  Manipulation during filling  Manipulation during testing  Customer manipulation Process Improvement & Product Services September 20138

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 20139

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

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

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