KAIZEN IN QC MICROBIOLOGY

1. KAIZEN IN QC MICROBIOLOGY SEPTEMBER 2013

2. Project: POTABLE WATER SAMPLING FREQUENCY REDUCTION Production units : Gemba :QCM Lab Location : campus Actions Taken During Kaizen Status : Before Kaizen Evidence on the possible risk involved in reducing the testing frequency was gathered and recommendation of any control measure required on the risk identified for 31 potable water sampling points located at SFP, IFP, PFP and other facility was identified. 31 potable water sampling points tested for Total viable count and pathogens {number of tests-6] once in 15 days

3. Risk assessment being performed by assessing the mode of failure with control measures. Risk rating being evaluated by multiplying the risk level (severity) with available control measures. Based on the assessment sampling points was recommended for a sampling frequency of once a month Results & Benefits Summary Process Map Before & After Kaizen

4. Project :BMR REVISION Location : campus Gemba :QCM Lab Production units : NA Status : Before Kaizen Actions Taken During Kaizen Park BMR’s revised Campus BMR’s - 16 numbers Reduction in number of pages, consolidation of raw material entry, media preparation activity for SF and IF combined, number of signatures reduced. Repetitive text removed Expected to be complete by 15/09/2013 Biological BMR’s -7 numbers Documentation time reduced by 60%; Preprinting of entries, number of signatures reduced BMR is lengthy and time consuming to fill them Repetitive entries Signatures required in many place Media preparation activity stage wise Sterilization chart pasted in BMR -duplication of autoclave log book Process Map Before & After Kaizen Results & Benefits Summary Cost savings for paper & printing – to be estimated Reduction in Autoclave cycle therefore savings of power Manual entries reduced, thereby reducing errors, time. Eg – Tacrolimus Seed inoculum development checklist will be reduced from 27 pages to about 16-17 pages Before After Lengthy BMR Reduced pages Media preparation separate for each stage Combined media preparation for all stages Reduced documentation

5. Project :CLOSED INOCULATION PROCEDURE FOR FERMENTERS Gemba :QCM Lab Location : campus Production units : SFP, IFP Actions Taken During Kaizen Status : Before Kaizen Small Molecules & Biologicals- Inoculation of fermenters was done using inoculation needle, which was essentially an open setup which required flaming before inoculating the fermenter Introduction of closed system, comprising of male and female connectors which are connected in a sterile manner, no exposure to the surrounding environment Biological- Replaced the glass transfer flask with the Heavy duty vacuum bottle with sterile connectors since inoculum volume is less Results & Benefits Summary • Inoculum which is the basis for the start up for fermentation is not exposed to the external non clean environment • Removal of flame- safety aspect • Presence of sterile filter assures sterility

6. Process Map Before & After Kaizen

7. Project :REPLACEMENT OF COTTON PLUGS WITH SCREW CAPS Gemba :QCM Lab Location : campus Production units : NA Actions Taken During Kaizen Status : Before Kaizen • Cotton plugs were used for all the flasks and bottles used • Cost for Cotton usage annually – 55508 INR Replaced the cotton with the screw cap bottles Results & Benefits Summary Process Map Before & After Kaizen • Cost savings 1st year – 35252 INR • Cost savings 2nd year onwards -  ~ 1 lakh INR • choking of the return air grills of the Biosafety cabinet with cotton fibers is avoided

8. Project :FILTER INTEGRITY TESTING TRANSFERRED TO PRODUCTION Gemba :QCM Lab Location : campus Production units : SFP Actions Taken During Kaizen Status : Before Kaizen • QC Microbiology was testing integrity of filters used in the fermentation as well as downstream process in production • Total Number of filters tested -450 in five months • Documentation involved • One analyst used to be completely deputed for this activity Transferred the filter integrity testing to production since it does not involve any microbiology science Training of production personnel Results & Benefits Summary Reduced one man power requirement which resulted in saving 1.98 Lakhs Documentation reduced

9. Project :HARMONIZATION OF PCG SOP’s Gemba :QCM Lab Location : campus Production units : NA Actions Taken During Kaizen Status : Before Kaizen 20 SOP’s for the MCB and WCB were being maintained Procedure was common but the documents were maintained strain wise SOP’s reduced to 3 numbers Strain details entered in Annexure Results & Benefits Summary SOP preparation for new strains can be avoided Change controls reduced Maintenance of documents becomes simpler and easier to track

10. Project :STOP IN USAGE OF FLAME IN BIOSAFETY CABINETS Gemba :QCM Lab Location : campus/PARK Production units : NA Actions Taken During Kaizen Status : Before Kaizen Used flame for all the aseptic activities handled in the BSC Complete removal of usage of flame inside the BSC Results & Benefits Summary Process Map Before & After Kaizen • Safety compliance • No disturbance in the air flow, no turbulence caused because there will be no heat generated in the cabinet • Usage of gas cylinders reduced

11. QC MICROBIOLOGY Thank you Contact Information: Kaizen Institute India Pvt Ltd. Ahmedabad – Pune Email: india@kaizen.com Tel: +91-79-2640 7756 / +91-9225527911 Website: in.kaizen.com