The document describes several kaizen projects undertaken by the QC Microbiology department to improve processes. One project reduced the frequency of potable water sampling from once every 15 days to once a month, saving over Rs. 80,000 annually in testing costs and technician time. Another harmonized standard operating procedures for microbial cell banks, reducing the number of documents from 20 to 3. A further project eliminated the use of open flames inside biosafety cabinets, improving safety and airflow.

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SEPTEMBER 2013

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Project: POTABLE WATER SAMPLING FREQUENCY REDUCTION
Production units : Gemba :QCM Lab Location : campus
Status : Before Kaizen
31 potable water sampling points tested for Total
viable count and pathogens {number of tests-6] once
in 15 days
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.
Actions Taken During Kaizen

3. 3
Results & Benefits Summary
Process Map Before & After Kaizen
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
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
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

4. 4
Project :BMR REVISION
Production units : NA Gemba :QCM Lab Location : campus
Status : Before Kaizen Actions Taken During Kaizen
Results & Benefits Summary Process Map Before & After 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
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
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
Lengthy BMR
Media preparation
separate for each
stage
After
Reduced pages
Combined media
preparation for all
stages
Reduced
documentation

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Project :CLOSED INOCULATION PROCEDURE FOR FERMENTERS
Production units : SFP, IFP Gemba :QCM Lab Location : campus
Status : Before Kaizen Actions Taken During Kaizen
Results & Benefits Summary
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
• 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

7. 7
Project :REPLACEMENT OF COTTON PLUGS WITH SCREW CAPS
Production units : NA Gemba :QCM Lab Location : campus
Status : Before Kaizen Actions Taken During Kaizen
Results & Benefits Summary Process Map Before & After 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
• 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. 8
Project :FILTER INTEGRITY TESTING TRANSFERRED TO PRODUCTION
Production units : SFP Gemba :QCM Lab Location : campus
Status : Before Kaizen Actions Taken During Kaizen
Results & Benefits Summary
• 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
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 Location : campus
Status : Before Kaizen Actions Taken During Kaizen
Results & Benefits Summary
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
SOP preparation for new strains can be avoided
Change controls reduced
Maintenance of documents becomes simpler and
easier to track

10. 10
Project :STOP IN USAGE OF FLAME IN BIOSAFETY CABINETS
Production units : NA Gemba :QCM Lab Location : campus/PARK
Status : Before Kaizen Actions Taken During Kaizen
Results & Benefits Summary
Used flame for all the aseptic activities
handled in the BSC
Complete removal of usage of flame inside the
BSC
• 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
Process Map Before & After Kaizen

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Thank you
QC MICROBIOLOGY