Kaizen in Qc Microbiology – Kaizen Institute India
In this documents we are revealing Kaizen Institute role in QC MicorBiology for various Jobs. To find more details check out: http://in.kaizen.com/
In this documents we are revealing Kaizen Institute role in QC MicorBiology for various Jobs. To find more details check out: http://in.kaizen.com/
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SEPTEMBER 2013<br />
1
Project: POTABLE WATER SAMPLING FREQUENCY REDUCTION<br />
Production units : Gemba :QCM Lab Location : campus<br />
Status : Before <strong>Kaizen</strong><br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
31 potable water sampl<strong>in</strong>g po<strong>in</strong>ts tested for Total<br />
viable count and pathogens {number of tests-6] once<br />
<strong>in</strong> 15 days<br />
Evidence on the possible risk <strong>in</strong>volved <strong>in</strong><br />
reduc<strong>in</strong>g the test<strong>in</strong>g frequency was gathered and<br />
recommendation of any control measure<br />
required on the risk identified for 31 potable<br />
water sampl<strong>in</strong>g po<strong>in</strong>ts located at SFP, IFP, PFP<br />
and other facility was identified.<br />
2
Risk assessment be<strong>in</strong>g performed by assess<strong>in</strong>g the mode of failure with control measures.<br />
Risk rat<strong>in</strong>g be<strong>in</strong>g evaluated by multiply<strong>in</strong>g the risk level (severity) with available control measures.<br />
Based on the assessment sampl<strong>in</strong>g po<strong>in</strong>ts was recommended for a sampl<strong>in</strong>g frequency of once a month<br />
Results & Benefits Summary<br />
Previous<br />
Total sampl<strong>in</strong>g po<strong>in</strong>ts analyzed = 31 po<strong>in</strong>ts analyzed for every 15<br />
days<br />
Media Cost : for each analysis 160/- Rs.<br />
160 * 31 (sampl<strong>in</strong>g po<strong>in</strong>ts) = 4960/- * 2 (monthly twice) = 9920/-<br />
Filter paper: For Each analysis 10/- Rs<br />
10* 155(no. of filter papers for 31 sampl<strong>in</strong>g po<strong>in</strong>ts) = 1550/- (for 15<br />
days) * 2 = 3100/- per month<br />
Man Power : For each analysis 20m<strong>in</strong>utes<br />
20 * 31 (sampl<strong>in</strong>g po<strong>in</strong>ts) = 620 m<strong>in</strong>utes for 15 days<br />
620 * 2 = 1240 m<strong>in</strong>utes per month or 20.6 hr.<br />
HDPE Sampl<strong>in</strong>g Bottles : For each analysis 1 bottle per sampl<strong>in</strong>g<br />
po<strong>in</strong>t = 12/- per bottle<br />
12 * 31 = 372/- Rs. For 15 days , 372*2 = 744/-<br />
Total Cost = 1,65,168/-<br />
Total Time = 247.2 hr. per year<br />
After kaizen<br />
Total sampl<strong>in</strong>g po<strong>in</strong>ts analyzed = 31 po<strong>in</strong>ts analyzed<br />
for every one month<br />
4960/- per month<br />
Process Map Before & After <strong>Kaizen</strong><br />
1550/- per month<br />
10.3 hours per month<br />
372/- per month<br />
Total Cost = 82,584/-<br />
Total Time = 123.6 hr. per year<br />
3
Project :BMR REVISION<br />
Production units : NA Gemba :QCM Lab Location : campus<br />
Status : Before <strong>Kaizen</strong><br />
BMR is lengthy and time consum<strong>in</strong>g to fill them<br />
Repetitive entries<br />
Signatures required <strong>in</strong> many place<br />
Media preparation activity stage wise<br />
Sterilization chart pasted <strong>in</strong> BMR -duplication of<br />
autoclave log book<br />
Results & Benefits Summary<br />
Park BMR’s revised<br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
Campus BMR’s - 16 numbers<br />
Reduction <strong>in</strong> number of pages, consolidation of raw<br />
material entry, media preparation activity for SF and IF<br />
comb<strong>in</strong>ed, number of signatures reduced. Repetitive text<br />
removed<br />
Expected to be complete by 15/09/2013<br />
Biological BMR’s -7 numbers<br />
Documentation time reduced by 60%; Prepr<strong>in</strong>t<strong>in</strong>g of<br />
entries, number of signatures reduced<br />
Process Map Before & After <strong>Kaizen</strong><br />
Cost sav<strong>in</strong>gs for paper & pr<strong>in</strong>t<strong>in</strong>g <strong>–</strong> to be estimated<br />
Before<br />
After<br />
Reduction <strong>in</strong> Autoclave cycle therefore sav<strong>in</strong>gs of<br />
power<br />
Lengthy BMR<br />
Reduced pages<br />
Manual entries reduced, thereby reduc<strong>in</strong>g errors, time.<br />
Eg <strong>–</strong> Tacrolimus Seed <strong>in</strong>oculum development checklist<br />
will be reduced from 27 pages to about 16-17 pages<br />
Media preparation<br />
separate for each<br />
stage<br />
Comb<strong>in</strong>ed media<br />
preparation for all<br />
stages<br />
Reduced<br />
documentation<br />
4
Project :CLOSED INOCULATION PROCEDURE FOR FERMENTERS<br />
Production units : SFP, IFP Gemba :QCM Lab Location : campus<br />
Status : Before <strong>Kaizen</strong><br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
Small Molecules & Biologicals- Inoculation of fermenters<br />
was done us<strong>in</strong>g <strong>in</strong>oculation needle, which was<br />
essentially an open setup which required flam<strong>in</strong>g before<br />
<strong>in</strong>oculat<strong>in</strong>g the fermenter<br />
Introduction of closed system, compris<strong>in</strong>g of male<br />
and female connectors which are connected <strong>in</strong> a<br />
sterile manner, no exposure to the surround<strong>in</strong>g<br />
environment<br />
Biological- Replaced the glass transfer flask with the<br />
Heavy duty vacuum bottle with sterile connectors<br />
s<strong>in</strong>ce <strong>in</strong>oculum volume is less<br />
Results & Benefits Summary<br />
• Inoculum which is the basis for the start up for fermentation is not exposed to the<br />
external non clean environment<br />
• Removal of flame- safety aspect<br />
• Presence of sterile filter assures sterility<br />
5
Process Map Before & After <strong>Kaizen</strong><br />
6
Project :REPLACEMENT OF COTTON PLUGS WITH SCREW CAPS<br />
Production units : NA Gemba :QCM Lab Location : campus<br />
Status : Before <strong>Kaizen</strong><br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
• Cotton plugs were used for all the flasks<br />
and bottles used<br />
Replaced the cotton with the screw cap<br />
bottles<br />
• Cost for Cotton usage annually <strong>–</strong> 55508<br />
INR<br />
Results & Benefits Summary<br />
Process Map Before & After <strong>Kaizen</strong><br />
• Cost sav<strong>in</strong>gs 1 st year <strong>–</strong> 35252 INR<br />
• Cost sav<strong>in</strong>gs 2 nd year onwards - ~ 1 lakh<br />
INR<br />
• chok<strong>in</strong>g of the return air grills of the<br />
Biosafety cab<strong>in</strong>et with cotton fibers is<br />
avoided<br />
7
Project :FILTER INTEGRITY TESTING TRANSFERRED TO PRODUCTION<br />
Production units : SFP Gemba :QCM Lab Location : campus<br />
Status : Before <strong>Kaizen</strong><br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
• QC <strong>Microbiology</strong> was test<strong>in</strong>g <strong>in</strong>tegrity of filters<br />
used <strong>in</strong> the fermentation as well as downstream<br />
process <strong>in</strong> production<br />
• Total Number of filters tested -450 <strong>in</strong> five months<br />
• Documentation <strong>in</strong>volved<br />
• One analyst used to be completely deputed for<br />
this activity<br />
Transferred the filter <strong>in</strong>tegrity test<strong>in</strong>g to production s<strong>in</strong>ce it<br />
does not <strong>in</strong>volve any microbiology science<br />
Tra<strong>in</strong><strong>in</strong>g of production personnel<br />
Results & Benefits Summary<br />
Reduced one man power requirement which resulted <strong>in</strong><br />
sav<strong>in</strong>g 1.98 Lakhs<br />
Documentation reduced<br />
8
Project :HARMONIZATION OF PCG SOP’s<br />
Production units : NA Gemba :QCM Lab Location : campus<br />
Status : Before <strong>Kaizen</strong><br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
20 SOP’s for the MCB and WCB were be<strong>in</strong>g<br />
ma<strong>in</strong>ta<strong>in</strong>ed<br />
Procedure was common but the documents<br />
were ma<strong>in</strong>ta<strong>in</strong>ed stra<strong>in</strong> wise<br />
SOP’s reduced to 3 numbers<br />
Stra<strong>in</strong> details entered <strong>in</strong> Annexure<br />
Results & Benefits Summary<br />
SOP preparation for new stra<strong>in</strong>s can be avoided<br />
Change controls reduced<br />
Ma<strong>in</strong>tenance of documents becomes simpler and<br />
easier to track<br />
9
Project :STOP IN USAGE OF FLAME IN BIOSAFETY CABINETS<br />
Production units : NA Gemba :QCM Lab Location : campus/PARK<br />
Status : Before <strong>Kaizen</strong><br />
Actions Taken Dur<strong>in</strong>g <strong>Kaizen</strong><br />
Used flame for all the aseptic activities<br />
handled <strong>in</strong> the BSC<br />
Complete removal of usage of flame <strong>in</strong>side the<br />
BSC<br />
Results & Benefits Summary<br />
Process Map Before & After <strong>Kaizen</strong><br />
• Safety compliance<br />
• No disturbance <strong>in</strong> the air flow, no<br />
turbulence caused because there will be<br />
no heat generated <strong>in</strong> the cab<strong>in</strong>et<br />
• Usage of gas cyl<strong>in</strong>ders reduced<br />
10
QC MICROBIOLOGY<br />
Thank you<br />
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