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MICROBIOLOGICAL RESULTS

                                                                                STILL WAITING?
                                       Benefits:
                                       Continuous monitoring detects
                                       biological contamination of WFI or
                                       purified water in real time
                                       Significantly lowers costs by reducing
                                       product loss and product recalls due
JMAR INTRODUCES                        to contamination
                                       Monitors effectiveness of water
                                       purification processes
• CONSTANT WATER QUALITY AWARENESS     Automated system offeres low
                                       mainenance and low cost of ownership
• REAL-TIME BIOBURDEN MEASUREMENT
                                       Features:
• INCREASED PROCESS CONTROL            Total sytem flow 100ml/min

• ONLINE MINUTE BY MINUTE ANALYSIS     Inspection volume rate ~ 1 ml per
                                       minute (1.4 liters per day)
• IMMEDIATE MEASURABLE ROI             Requires no consumables or reagents
                                       for detection
• LOW ENERGY CONSUMPTION (300 WATTS)
                                       Automatic cleaning


                                                                                WAITING FOR MICROBIOLOGICAL
                                         KBERG CONSULTANTS                      TEST RESULTS FOR WFI AND
                                        STEWART JASON KOHNBERG
                                                                                PURIFIED WATER IS NOW
                                       4234 MASSEY PRESERVE TRAIL
                                          RALEIGH, NC 27616 USA                 A THING OF THE PAST
                                             PHONE (910)232-0342
                                             STEW@KBERG.INFO
                                              WWW.KBERG.INFO
REAL-TIME RESULTS, REAL SAVINGS

Sample Business Senerio
                                                                         YEAR
                                                                                                                                                     BioSentry’s real-time results equal real savings for
                       BENEFIT DRIVERS
                                                                    0             1
                                                                                                                                                     pharmaceutical manufacturers.         The real-time
Reduction in Lot rejections (assumes impovement by 1 bactch)                   $400,000
                                                                                            REAL-TIME RESULTS, REAL SAVINGS
Reduction in investigation cycle time from process excursions                                                                                        data provided by BioSentry has the potential to
(manpower and Lab resources)                                                    $50,000
Loss of productivity due to line down time
                                                                                            Returning Real-Time Results                              increase productivity, reduce        nished product
(assumes 1 batch produced)                                                     $400,000
                                                                                            No longer does the pharmaceutical industry have          release time, as well as lower lot rejection rates.
Reduction in cycle time during production line restart after
maintenance                                                                     $50,000
                                                                                            to wait for microbiological test results for WFI and     While BioSentry does not replace conventional
Loss of productivity during production line restart
(assumes 1 batch produced)                                                     $400,000
                                                                                            puri ed water. BioSentry not only reduces the wait       methods of testing , its advanced monitoring
Reduction in rework, reprocessing, and repeat testing                           $30,000
Total Annual Benefits                                                         $1,330,000    for microbial contamination results, it eliminates it.   technologies can reduce the number of overall
Implementation lter                                                                   60%   With real-time, on-line capabilities                     conventional tests needed every year resulting in
Total Benefits Realized                                                        $798,000
                                                                                            BioSentry allows users to                                substantial consumable cost and labor savings for
Initial Investment                                                  0             1
Initial investment (assume 3 unitis to support operstions)       $120,000              $0   monitor the biological activity                          manufacture rs.
Implementation Costs (Quali cation and regulatory costs)         $100,000              $0
Ongoing support costs                                                             $5,000
                                                                                            of a water source from
                                                                         $0
                                                                                                                                                     BioSentry’ s compact, reagent free, and energy
Training costs                                                    $10,000         $5,000    anywhere in the world
Other costs                                                              $0            $0                                                            e cient design saves on operating costs around
                                                                                            at any time of day.
Total Costs                                                      $230,000       $10,000
                                                                                                                                                     the clock.     Its multiple purchase incentives,
ROI Measures
Cost of capital                                                         12%
                                                                                            Whether you are across the                               comprehensive training, and dedicated support
Net present value                                               $2,312,057                  lab or across the globe,                                 team make keep initial costs low and result in a
Return on investment                                                             298%
                                                                                            BioSentry will alert you                                 quick return of investment.
Payback (in years)                                                   0.29
                                                                                            the moment contamination occurs.
                                                                                                                                                     If you would like to learn more about BioSentry, or
                                                                                            Returning Real Savings                                   discuss exactly how BioSentry can save you
                                                                                            Pharmaceutical manufacturers are nally able to           money, please contact us at (858)946-6800 or visit
                                                                                            integrate the power of state-of-the-art technology       us on the web at www.jmar.com.
                                                                                            with long standing scienti c methods to assure
                                                                                            continuous water purity. JMAR’s BioSentry is the
                                                                                            only rapid microbiological method (RMM) of detec-
                                                                                            tion that o ers real-time, on-line, monitoring for
                                                                                            microorganisms in process water.


                             KBERG CONSULTANTS
                                 (910)232-0342
                                www.kberg.info

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Pharma Kberg

  • 1. MICROBIOLOGICAL RESULTS STILL WAITING? Benefits: Continuous monitoring detects biological contamination of WFI or purified water in real time Significantly lowers costs by reducing product loss and product recalls due JMAR INTRODUCES to contamination Monitors effectiveness of water purification processes • CONSTANT WATER QUALITY AWARENESS Automated system offeres low mainenance and low cost of ownership • REAL-TIME BIOBURDEN MEASUREMENT Features: • INCREASED PROCESS CONTROL Total sytem flow 100ml/min • ONLINE MINUTE BY MINUTE ANALYSIS Inspection volume rate ~ 1 ml per minute (1.4 liters per day) • IMMEDIATE MEASURABLE ROI Requires no consumables or reagents for detection • LOW ENERGY CONSUMPTION (300 WATTS) Automatic cleaning WAITING FOR MICROBIOLOGICAL KBERG CONSULTANTS TEST RESULTS FOR WFI AND STEWART JASON KOHNBERG PURIFIED WATER IS NOW 4234 MASSEY PRESERVE TRAIL RALEIGH, NC 27616 USA A THING OF THE PAST PHONE (910)232-0342 STEW@KBERG.INFO WWW.KBERG.INFO
  • 2. REAL-TIME RESULTS, REAL SAVINGS Sample Business Senerio YEAR BioSentry’s real-time results equal real savings for BENEFIT DRIVERS 0 1 pharmaceutical manufacturers. The real-time Reduction in Lot rejections (assumes impovement by 1 bactch) $400,000 REAL-TIME RESULTS, REAL SAVINGS Reduction in investigation cycle time from process excursions data provided by BioSentry has the potential to (manpower and Lab resources) $50,000 Loss of productivity due to line down time Returning Real-Time Results increase productivity, reduce nished product (assumes 1 batch produced) $400,000 No longer does the pharmaceutical industry have release time, as well as lower lot rejection rates. Reduction in cycle time during production line restart after maintenance $50,000 to wait for microbiological test results for WFI and While BioSentry does not replace conventional Loss of productivity during production line restart (assumes 1 batch produced) $400,000 puri ed water. BioSentry not only reduces the wait methods of testing , its advanced monitoring Reduction in rework, reprocessing, and repeat testing $30,000 Total Annual Benefits $1,330,000 for microbial contamination results, it eliminates it. technologies can reduce the number of overall Implementation lter 60% With real-time, on-line capabilities conventional tests needed every year resulting in Total Benefits Realized $798,000 BioSentry allows users to substantial consumable cost and labor savings for Initial Investment 0 1 Initial investment (assume 3 unitis to support operstions) $120,000 $0 monitor the biological activity manufacture rs. Implementation Costs (Quali cation and regulatory costs) $100,000 $0 Ongoing support costs $5,000 of a water source from $0 BioSentry’ s compact, reagent free, and energy Training costs $10,000 $5,000 anywhere in the world Other costs $0 $0 e cient design saves on operating costs around at any time of day. Total Costs $230,000 $10,000 the clock. Its multiple purchase incentives, ROI Measures Cost of capital 12% Whether you are across the comprehensive training, and dedicated support Net present value $2,312,057 lab or across the globe, team make keep initial costs low and result in a Return on investment 298% BioSentry will alert you quick return of investment. Payback (in years) 0.29 the moment contamination occurs. If you would like to learn more about BioSentry, or Returning Real Savings discuss exactly how BioSentry can save you Pharmaceutical manufacturers are nally able to money, please contact us at (858)946-6800 or visit integrate the power of state-of-the-art technology us on the web at www.jmar.com. with long standing scienti c methods to assure continuous water purity. JMAR’s BioSentry is the only rapid microbiological method (RMM) of detec- tion that o ers real-time, on-line, monitoring for microorganisms in process water. KBERG CONSULTANTS (910)232-0342 www.kberg.info