SEPTEMBER 2013
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Project: POTABLE WATER SAMPLING FREQUENCY REDUCTION Production units :
Gemba :QCM Lab
Status : Before Kaizen
Location : campus Actions Taken During Kaizen
Evidence on the possible risk involved in 31 potable water sampling points tested for Total viable count and pathogens {number of tests-6] once in 15 days
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.
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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 Previous
After kaizen
Total sampling points analyzed = 31 points analyzed for every 15 days
Total sampling points analyzed = 31 points analyzed for every one month
Media Cost : for each analysis 160/- Rs. 160 * 31 (sampling points) = 4960/- * 2 (monthly twice) = 9920/-
4960/- per month Process Map Before & After Kaizen
Filter paper: For Each analysis 10/- Rs 10* 155(no. of filter papers for 31 sampling points) = 1550/- (for 15 days) * 2 = 3100/- per month
1550/- per month
Man Power : For each analysis 20minutes 20 * 31 (sampling points) = 620 minutes for 15 days 620 * 2 = 1240 minutes per month or 20.6 hr.
10.3 hours per month
HDPE Sampling Bottles : For each analysis 1 bottle per sampling point = 12/- per bottle 12 * 31 = 372/- Rs. For 15 days , 372*2 = 744/-
372/- per month
Total Cost = 1,65,168/Total Time = 247.2 hr. per year
Total Cost = 82,584/Total Time = 123.6 hr. per year
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Project :BMR REVISION Production units : NA
Location : campus
Gemba :QCM Lab
Status : Before Kaizen
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
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
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
Process Map Before & After Kaizen Before
After
Lengthy BMR
Reduced pages
Media preparation separate for each stage
Combined media preparation for all stages
4 Reduced documentation
Project :CLOSED INOCULATION PROCEDURE FOR FERMENTERS Production units : SFP, IFP
Gemba :QCM Lab
Location : campus 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
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Process Map Before & After Kaizen
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Project :REPLACEMENT OF COTTON PLUGS WITH SCREW CAPS Production units : NA
Gemba :QCM Lab
Status : Before Kaizen
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Cotton plugs were used for all the flasks and bottles used
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Cost for Cotton usage annually – 55508 INR
Results & Benefits Summary
• • •
Location : campus Actions Taken During Kaizen
Replaced the cotton with the screw cap bottles
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
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Project :FILTER INTEGRITY TESTING TRANSFERRED TO PRODUCTION Production units : SFP
Gemba :QCM Lab
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
Location : campus Actions Taken During Kaizen
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
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Project :HARMONIZATION OF PCG SOP’s Production units : NA
Gemba :QCM Lab
Status : Before Kaizen
20 SOP’s for the MCB and WCB were being maintained Procedure was common but the documents were maintained strain wise
Location : campus Actions Taken During Kaizen
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
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Project :STOP IN USAGE OF FLAME IN BIOSAFETY CABINETS Production units : NA
Gemba :QCM Lab
Status : Before Kaizen
Used flame for all the aseptic activities handled in the BSC
Results & Benefits Summary
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Safety compliance
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No disturbance in the air flow, no turbulence caused because there will be no heat generated in the cabinet
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Usage of gas cylinders reduced
Location : campus/PARK Actions Taken During Kaizen
Complete removal of usage of flame inside the BSC
Process Map Before & After Kaizen
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QC MICROBIOLOGY
Thank you
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