KAIZEN IN QC MICROBIOLOGY

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KAIZEN IN QC MICROBIOLOGY

• SEPTEMBER 2013

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Project POTABLE WATER SAMPLING FREQUENCY
REDUCTION
Production units
Gemba QCM Lab
Location campus
Status Before Kaizen
Actions Taken During 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
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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
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 , 3722 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
Process Map Before After Kaizen
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Project BMR REVISION
Location campus
Gemba QCM Lab
Production units NA
Status Before Kaizen
Actions Taken During Kaizen
Park BMRs revised Campus BMRs - 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 BMRs -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
Results Benefits Summary
Process Map Before After Kaizen
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
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Project CLOSED INOCULATION PROCEDURE FOR
FERMENTERS
Gemba QCM Lab
Location campus
Production units SFP, IFP
Status Before Kaizen
Actions Taken During 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
Gemba QCM Lab
Location campus
Production units NA
Status Before Kaizen
Actions Taken During 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

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Project FILTER INTEGRITY TESTING TRANSFERRED TO
PRODUCTION
Gemba QCM Lab
Location campus
Production units SFP
Status Before Kaizen
Actions Taken During 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
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Project HARMONIZATION OF PCG SOPs
Gemba QCM Lab
Location campus
Production units NA
Status Before Kaizen
Actions Taken During Kaizen
20 SOPs for the MCB and WCB were being
maintained Procedure was common but the documents
were maintained strain wise
SOPs 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
Gemba QCM Lab
Location campus/PARK
Production units NA
Status Before Kaizen
Actions Taken During 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

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QC MICROBIOLOGY
Thank you
Contact Information Kaizen Institute India Pvt
Ltd. Ahmedabad Pune Email india_at_kaizen.com Tel
91-79-2640 7756 / 91-9225527911 Website
in.kaizen.com