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000-637 exam Dumps Source : Requirements Management with employ Cases - Part 2

Test Code : 000-637
Test denomination : Requirements Management with employ Cases - Part 2
Vendor denomination : IBM
: 111 real Questions

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IBM IBM Requirements Management with

IBM Takes purpose at Nutanix With Multicloud manager | killexams.com real Questions and Pass4sure dumps

foreign company Machines(NYSE: IBM) has built an $18.5 billion cloud industry by passage of focusing on the needs of its shoppers. About 80% of mission-critical workloads and sensitive statistics nonetheless elope on on-premises hardware as a result of efficiency or regulatory necessities, in response to Ovum. IBM's hefty hub of attention on deepest cloud and hybrid cloud makes experience in that context.

a further statistic riding IBM's cloud method: eighty five% of companies are the employ of a yoke of cloud ambiance, in response to IBM's Institute for company cost. whereas Amazon net services and Microsoft Azure dominate the marketplace for public cloud infrastructure, many organizations are spreading workloads across distinctive public clouds and on-premises hardware, instead of going utter in on a sole public cloud. Managing these multi-cloud workloads can acquire complicated fast.

IBM's Global  hub for Watson IoT in Munich, Germany.© IBM IBM's global middle for Watson IoT in Munich, Germany. A multi-cloud world

it really is the position IBM is available in. The industry announced on Monday its Multicloud supervisor, a solution that makes it practicable for valued clientele to control complex multi-cloud workloads. The gadget offers a dashboard interface for managing container-primarily based functions spread throughout diverse cloud environments, even those of IBM's opponents, as well as on-premises hardware.

The reply is optimized for IBM's cloud, however the enterprise notably mentioned assist for Amazon internet functions, Microsoft Azure, and crimson Hat's private cloud. "With its open source approach to managing facts and apps across distinctive clouds, the IBM Multicloud manager will allow companies to scale their many cloud investments and unleash the plenary company cost of the cloud," spoke of IBM Hybrid Cloud senior vice chairman Arvind Krishna within the press release epigram the product.

while IBM claims that Multicloud manager is the "world's first multicloud administration technology," it really is now not completely correct. Managing workloads across diverse clouds is the bread and butter of Nutanix(NASDAQ: NTNX), a corporation that offers software that "melds inner most, public and allotted cloud working environments and offers a sole element of control to maneuver IT infrastructure and applications at any scale."

Nutanix generated $1.sixteen billion of income in fiscal 2018, with most of that coming from application and assist, which grew by forty seven% in comparison to 2017. there is a tall and turning out to be market for multi-cloud management, and IBM's Multicloud supervisor is the business's endeavor to seize a chunk of that pie.

IBM's key capabilities over Nutanix should be its giant trove of customer relationships. IBM counts as customers giant firms and governments, a few of which contain been the employ of IBM solutions for decades. As those groups tiptoe into the cloud, IBM's Multicloud manager will be smartly located to assist simplify the technique.

IBM's Multicloud Manager dashboard.© IBM IBM's Multicloud supervisor dashboard. company agnosticism

IBM has its personal public cloud, so why is the company helping Amazon, Microsoft, and other rivals with its Multicloud manager? because at its core, IBM is an organization that solves complications for its consumers. and often an IBM-most efficient solution would not reduce it.

returned within the Nineteen Nineties, when outsider CEO Lou Gerstner was brought in to hold the enterprise from cave in, some of the pillars of the enterprise's turnaround was manufacturer agnosticism. Gerstner wanted IBM's capabilities company to be a one-cease shop in a position to building built-in solutions for its customers. however that required sometimes favoring opponents' products. Gerstner wrote in his book, Who Says Elephants can't Dance?:

To be really a success, they might contain to carry out things that might shake the location to its roots. for example, the features unit would should be in a position to recommend the products of Microsoft, HP, solar, and utter different essential IBM rivals if that, basically, changed into the superior solution for the customer. Of route, they might contain to hold and service these items as well.

With Multicloud supervisor, that manufacturer-agnostic approach is terribly plenty alive and smartly at IBM. It won't assist IBM win public cloud market share from Amazon and Microsoft, but it surely will unencumber a turning out to be marketplace for multi-cloud management.

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John Mackey, CEO of whole meals Market, an Amazon subsidiary, is a member of The Motley fool's board of directors. Teresa Kersten is an worker of LinkedIn and is a member of The Motley fool's board of administrators. LinkedIn is owned by using Microsoft. Timothy green owns shares of IBM. The Motley fool owns shares of and recommends Amazon. The Motley fool recommends Nutanix. The Motley fool has a disclosure policy.


Whirlpool signs IBM as cloud administration partner | killexams.com real Questions and Pass4sure dumps

Whirlpool organization has grew to become to IBM to aid it control its bevy of global digital operations within the cloud.

The Benton Harbor-based appliance maker said last month it's going to employ IBM Cloud “to control and provide 24/7 access to the business’s vital enterprise purposes,” including commercial enterprise aid planning, client relationship management and enterprise warehousing.

Whirlpool plans to leverage the “flexibility and scalability” of the IBM Cloud to elope Whirlpool’s SAP HANA environments, including around-the-clock insights into its 70 global manufacturing websites, its distribution and obtain contact with facilities and a yoke of other programs to deliver “worldwide entry and increased efficiencies.”

SAP HANA is a database administration gadget developed with the aid of Walldorf, Germany-primarily based SAP.

“Whirlpool corporation is a manufacturing chief, and they contain moved their travail to the cloud aggressively,” said Mike Berendsen, VP of IT, Whirlpool employer. “This collaboration with IBM will continue to enable us to leverage the capabilities of SAP on HANA, as they continue to be a tech-ahead company within the items they design and their international travail environments.”

IBM currently added a unique SAP-licensed managed applications providing for SAP HANA workloads. it's an built-in approach for hardware, utility and features, and the industry observed it's the first to present “this degree of cloud help” for workloads of up to 24 terabytes by using IBM punch programs and IBM Storage. IBM referred to the method will provide “even the biggest shoppers” the skill they should control analytics in the cloud.

IBM talked about its innovation turned into “key” to gaining Whirlpool as a shopper, because the enterprise has enterprise necessities that pressure “very huge” HANA platforms exceeding “generally attainable” cloud capacities for HANA.

“The introduction of rising technologies has offered businesses fancy Whirlpool industry enterprise with an entire unique platform to innovate on,” spoke of note Slaga, international expertise features customary supervisor, IBM features for Managed purposes. “Prior solutions often lacked the skill to scale to meet the needs of customers fancy Whirlpool and required significant customization, which could oblige up prices.

“With this solution, we’re featuring Whirlpool employer the skill to scale its HANA atmosphere to hold up on method.”

below the brand unique partnership, Whirlpool now has alternatives to expand its SAP HANA portfolio and “can hub of attention on what’s most necessary to its company,” IBM observed.

Whirlpool

Whirlpool supplier (NYSE: WHR) is an appliance manufacturer with ninety two,000 employees and 70 manufacturing and expertise analysis facilities everywhere.

The company markets the manufacturers Whirlpool, KitchenAid, Maytag, Consul, Brastemp, Amana, Bauknecht, Jenn-Air, Indesit and other necessary brand names.

The company mentioned 2017 sales of $21 billion.

IBM capabilities

centered in 1995, IBM features is the professional services arm of Armonk, long island-primarily based IBM.

The division makes employ of advanced know-how to uphold clients in the reduction of can suffuse and chance, achieve compliance, accelerate speed to market, create unique income streams and establish a “security-prosperous and legit” infrastructure that’s in a position for AI and hybrid cloud.

It offers a number of functions: functions capabilities; company procedure, operations, resiliency, approach and design; cloud, digital office, community and safety services; and know-how uphold and consulting.


New statistics management options for bright Simulations | killexams.com real Questions and Pass4sure dumps

The mode in extreme performance supercomputer design has advanced – from proposing highest compute competence for advanced scalable science purposes, to capability computing employing effective, competitively priced computing vigour for fixing a miniature number of tremendous issues or a huge variety of miniature problems. The subsequent technology of supercomputers can be optimized for workflow computing, utilizing system utility and hardware infrastructure to time table and coordinate an ensemble of functions solving problems too advanced to even be modeled with a sole utility. Whereas common HPC is dominated by batch scheduled jobs running to completion or failure, workflow computing requires frameworks that can be used to permit runtime interactions between applications and clients. IBM developed the IBM facts broking service [open sourced at github.com/IBM/data-broker] to facilitate the runtime alternate of facts between functions deployed in a workflow.

One rising category of workflow, is ingenious Simulation in which computing device learning suggestions are used to inform complex simulations to execute extra effectively and in the reduction of time to solution. IBM and Lawrence Livermore country wide Laboratory partnered to develop an bright simulation workflow to extra correctly schedule and execute multi-scale simulations of phone membrane fashions primary to getting to know RAS-initiated cancers.

As a Part of this task, the IBM facts broker become deployed on the Sierra supercomputer at very huge scale and used to trade statistics between multi-scale simulations written in C and numerous laptop gaining lore of and analytics applications written in Python.  in the course of standing up this workflow, the groups developed a stronger understanding of bandwidth and latency necessities in creating an most reliable workflow solution at scale. As paraphernalia screw ups are a fact in any giant scale cluster, the value of saving and restoring a stateful workflow is critical. historically, checkpoint/restart mechanisms had been censorious to long operating simulations, but they are equally vital to stateful workflow computing options.

figure 1: File I/O versus records broker for Workflows statistics alternate

   figure 1 contrasts the IBM data broker approach with average Posix file I/O. youngsters file I/O can moreover be used to exchange facts at runtime, the lower latency and higher bandwidth requirements of a posh workflow including simulation and AI obtain the data broker reply a far better answer.

The IBM information broker became conceived with several fundamental design desires:

  • primary programming interface for purposes to obtain employ of to position and acquire statistics from a allotted facts shop
  • Leverage an information shop that resided in memory, SSD, or difficult disk and steer transparent of the latency and bandwidth constraints of changing data in a workflow the employ of Posix file I/O
  • guide for outlining and managing discrete namespaces
  • capable of leveraging each utility or hardware accelerated object stores
  • access throughout on premise and exterior systems including public clouds
  • figure 2: IBM statistics broking service structure

    determine 2 shows the extreme stage architecture of the statistics broker. The picture highlights a person library that offers that client API at present supporting both C/C++ and Python. moreover, a system library allows assist of distinctive backend key-cost outlets devoid of recompiling the utility. The existing version supports Redis and GasNet with prototyping of hardware accelerated backend.

    figure 3: IBM statistics broking service Namespaces

    applications, as shown in device 3, employ the client API to form connections with the backend key-cost store and create/spoil, connect/detach to namespaces shared by using one or more of the purposes in the workflow.  The functions employ an light key-value API to place/get records to/from the records broking service. The statistics broking service device library interfaces with the backend allotted key-value hold to locate the records throughout the dispensed statistics save. for example, when Redis is used as a data store, the proper hash slot is computed from a CRC16(key) modulo 216 . different backend statistics retailers may additionally employ different algorithms to ration keys. in any case, the IBM information broker abstracts the region of the hash slot and key from the application.

    The IBM statistics broking service remains in early building ranges and extra feature is being brought to deliver a higher store/restore gadget in addition to prick back latency of records exchanges. The prefatory travail has been open sourced at github.com/IBM/information-broking service.

    talk over with IBM subsequent week at SC18 (sales space #3433) in Dallas, Texas, to learn about main-facet HPC and AI solutions. Register right here for technical briefings and consumer neighborhood classes.

    With contributions from Carlos Costa, Claudia Misale  and Lars Scheidenbach

    IBM Cognitive and Cloud options

    information Centric systems

    IBM T. J. Watson analysis




    Killexams.com 000-637 Dumps and real Questions

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    000-637 exam Dumps Source : Requirements Management with employ Cases - Part 2

    Test Code : 000-637
    Test denomination : Requirements Management with employ Cases - Part 2
    Vendor denomination : IBM
    : 111 real Questions

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    Oracle Cloud Unveils unique HPC Offerings to uphold Mission censorious Workloads | killexams.com real questions and Pass4sure dumps

    Oracle now provides a complete set of solutions for any tall performance computing workload, built to present the best performance at the lowest cost in the cloud

    REDWOOD SHORES, Calif., Nov. 12, 2018 /PRNewswire/ -- Oracle today announced availability of unique bare metal Oracle Cloud Infrastructure compute instances to succor enterprises elope various performance sensitive workloads, such as simulated intelligence (AI) or engineering simulations, in the cloud. These unique instances are Part of Oracle's unique "Clustered Network," which gives customers access to a low latency and tall bandwidth RDMA network. Oracle now provides large organizations with a complete set of solutions for any tall performance computing (HPC) workload, enabling businesses to capitalize on the benefits of modern cloud computing while enjoying performance comparable to on-premises compute clusters at a cost that makes sense for their businesses. 

    Oracle Logo (PRNewsfoto/Oracle)

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    Countless enterprises contain considered a transition to the cloud for years for their legacy HPC workloads, but were unable to carry out so due to the want of tall performant cloud offerings or economics that would obtain it too expensive to elope in the cloud. Organizations contain struggled to find a cloud that can uphold unique workload requirements while realizing cost efficiencies and flexibility that meet industry goals and overall technology vision. With today's news, organizations finally contain a low-cost path to extend their on-premises HPC workloads to the cloud without sacrificing performance.

    "HPC has been underserved in the cloud due to want of tall performance networking (RDMA) and unappealing price/performance. We've listened to their customers and over the last few years Oracle has focused on improving tall performance bare-metal offerings, such as Clustered Networking, to provide on-premise customers with the options they exigency to extend their HPC workloads to the cloud," said Vinay Kumar, vice president, Product Management & Strategy, Oracle Cloud Infrastructure. "Our growing collaboration with trusted vendors helps Oracle Cloud Infrastructure continue to expand and present the best performance at the lowest cost for the workloads that customers really exigency to extend into the cloud."

    With Oracle's Clustered Network offering at the data hub level, Oracle has opened up an entirely unique set of use-cases and workloads that enterprises can harness the power of cloud computing for, ranging from car crash simulations in automotive and DNA sequencing in healthcare to reservoir simulation for oil exploration. Organizations can now deploy additional use-cases previously out of their reach, such as using data from their Oracle Database and cutting-edge NVIDIA(R) Tesla(R) GPUs to elope Neural Network AI training and instantly adding value to their data.

    The unique offering is powered by high-frequency Intel® Xeon® Scalable processors and Mellanox's tall performance network interface controllers. For more than 25 years, Oracle and Intel contain worked closely to bring innovative, scalable, and secure enterprise-class solutions to its customers. This unique addition completes Oracle's comprehensive set of infrastructure solutions for the plenary compass of both CPU- and NVIDIA GPU-based HPC workloads, providing customers with streamlined and lower cost access to specialized offerings in the cloud. Oracle Cloud Infrastructure now provides a complete compass of HPC workloads, including the only bare metal Infrastructure-as-a-Service (IaaS) offering on the market with RDMA.

    Story Continues

    These unique HPC instances with Clustered Networking are offered across Oracle regions in the US and EU at $0.075 per core hour, a 49 percent pay-as-you-go savings compared to other cloud providers on the market.

    Additionally, these capabilities will moreover be expanded for Oracle's recently announced uphold for NVIDIA HGX-2 platform on Oracle Cloud Infrastructure. Customers will be able to seize odds of clustered networking as Part of the next generation of NVIDIA Tensor Core GPUs, opening up large scale GPU workloads such as AI and deep learning.

    Industry Quotes

    "HPC is censorious for more employ cases, complex workloads, and data-intensive computing than ever before. Access to HPC capabilities in the cloud enables users to carry out more by extending into the public cloud while providing unique HPC and AI users a platform to develop and test unique classes of HPC and AI algorithms," said Lisa Davis, vice president of Intel's Data hub Group and General Manager of Digital Transformation and Scale Solutions. "We are working with Oracle to enable leading HPC offerings that seize odds of the advanced performance, efficiency and scale delivered by Intel® Xeon® Scalable processors across HPC and AI workloads, utter while benefiting from the agility and flexibility of Oracle's next generation, enterprise-grade cloud offering."

    "As organizations glimpse to ensure they linger ahead of the competition, they are looking for more efficient services to enable higher performing workloads. This requires swiftly data communication between CPUs, GPUs and storage, in the cloud," said Michael Kagan, CTO, Mellanox Technologies. "Over the past 10 years they contain provided advanced RDMA enabled networking solutions to Oracle for a variety of its products and are pleased to extend this to Oracle Cloud Infrastructure to succor maximize performance and efficiency in the cloud."

    "With the massive explosion of data, you exigency larger clusters of GPUs to process and train the data being produced. HGX-2 on Oracle is the perfect meet for this problem," said Ian Buck, vice president of Accelerated Computing, NVIDIA. "HGX-2 on Oracle combines cutting-edge V100 Tensor Core GPUs and NVSwitch along with competence to scale across multiple HGX-2s using Clustered Networking to resolve the biggest computing challenges."

    Supporting Resources

    About Oracle Cloud Infrastructure Oracle Cloud Infrastructure is an enterprise Infrastructure as a Service (IaaS) platform. Companies of utter sizes confidence on Oracle Cloud to elope enterprise and cloud endemic applications with mission-critical performance and core-to-edge security. By running both traditional and unique workloads on a comprehensive cloud that includes compute, storage, networking, database, and containers, Oracle Cloud Infrastructure can dramatically augment operational efficiency and lower total cost of ownership. For more information, visit https://cloud.oracle.com/iaas. 

    About OracleThe Oracle Cloud offers complete SaaS application suites for ERP, HCM and CX, plus best-in-class database Platform as a Service (PaaS) and Infrastructure as a Service (IaaS) from data centers throughout the Americas, Europe and Asia. For more information about Oracle (ORCL), gladden visit us at www.oracle.com.

    TrademarksOracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

    Future Product DisclaimerThe preceding is intended to silhouette their universal product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, timing, and pricing of any features or functionality described for Oracle's products may change and remains at the sole discretion of Oracle Corporation.

     

    View original content to download multimedia:http://www.prnewswire.com/news-releases/oracle-cloud-unveils-new-hpc-offerings-to-support-mission-critical-workloads-300747806.html


    New Data Management Techniques for bright Simulations | killexams.com real questions and Pass4sure dumps

    The trend in tall performance supercomputer design has evolved – from providing maximum compute capability for complex scalable science applications, to capacity computing utilizing efficient, cost-effective computing power for solving a miniature number of large problems or a large number of miniature problems. The next generation of supercomputers will be optimized for workflow computing, utilizing system software and hardware infrastructure to schedule and coordinate an ensemble of applications solving problems too complex to even be modeled with a sole application. Whereas traditional HPC is dominated by batch scheduled jobs running to completion or failure, workflow computing requires frameworks that can be used to enable runtime interactions between applications and users. IBM developed the IBM Data Broker [open sourced at github.com/IBM/data-broker] to facilitate the runtime exchange of data between applications deployed in a workflow.

    One emerging ilk of workflow, is bright Simulation in which machine learning techniques are used to inform complex simulations to execute more efficiently and reduce time to solution. IBM and Lawrence Livermore National Laboratory partnered to develop an bright simulation workflow to more efficiently schedule and execute multi-scale simulations of cell membrane models apposite to studying RAS-initiated cancers.

    As Part of this project, the IBM Data Broker was deployed on the Sierra supercomputer at very large scale and used to exchange data between multi-scale simulations written in C and multiple machine learning and analytics applications written in Python.  In the course of standing up this workflow, the teams developed a better understanding of bandwidth and latency requirements in creating an optimal workflow solution at scale. As system failures are a reality in any large scale cluster, the import of saving and restoring a stateful workflow is critical. Traditionally, checkpoint/restart mechanisms were necessary to long running simulations, but they are equally necessary to stateful workflow computing solutions.

    Figure 1: File I/O versus Data Broker for Workflows Data Exchange

       Figure 1 contrasts the IBM Data Broker approach with traditional Posix file I/O. Although file I/O can be used to exchange data at runtime, the lower latency and higher bandwidth requirements of a complex workflow including simulation and AI obtain the Data Broker solution a better solution.

    The IBM Data Broker was conceived with several fundamental design goals:

  • Simple programming interface for applications to employ to effect and acquire data from a distributed data store
  • Leverage a data store that resided in memory, SSD, or difficult disk and avoid the latency and bandwidth constraints of exchanging data in a workflow using Posix file I/O
  • Support for defining and managing multiple namespaces
  • Capable of leveraging both software or hardware accelerated object stores
  • Access across on premise and external systems including public clouds
  • Figure 2: IBM Data Broker Architecture

    Figure 2 shows the tall level architecture of the Data Broker. The picture highlights a user library that provides that client API currently supporting both C/C++ and Python. In addition, a system library enables uphold of different backend key-value stores without recompiling the application. The current version supports Redis and GasNet with prototyping of hardware accelerated backend.

    Figure 3: IBM Data Broker Namespaces

    Applications, as shown in device 3, employ the client API to form connections with the backend key-value store and create/destroy, attach/detach to namespaces shared by one or more of the applications in the workflow.  The applications employ a simple key-value API to put/get data to/from the Data Broker. The Data Broker system library interfaces with the backend distributed key-value store to locate the data across the distributed data store. For example, when Redis is used as a data store, the reform hash slot is computed from a CRC16(key) modulo 216 . Other backend data stores may employ different algorithms to ration keys. In any case, the IBM Data Broker abstracts the location of the hash slot and key from the application.

    The IBM Data Broker is noiseless in early development stages and additional function is being added to provide a more robust save/restore system as well as reduce latency of data exchanges. The initial travail has been open sourced at github.com/IBM/data-broker.

    Visit IBM next week at SC18 (booth #3433) in Dallas, Texas, to learn about leading-edge HPC and AI solutions. Register here for technical briefings and user group sessions.

    With contributions from Carlos Costa, Claudia Misale  and Lars Scheidenbach

    IBM Cognitive and Cloud Solutions

    Data Centric Systems

    IBM T. J. Watson Research


    A Better Approach To Pharmaceutical Water Testing — User Requirements For An Online Water Bioburden Analyzer | killexams.com real questions and Pass4sure dumps

    By Online Water Bioburden Analyzer Workgroup

    Pharmaceutical water testing is comprised of several components; among which are appearance, total organic carbon, conductivity, bioburden, and endotoxin testing to ensure product attribute and patient safety. Currently, conductivity and total organic carbon (TOC) are the only attributes routinely performed with online testing.

    Bioburden and endotoxin testing traditionally contain been performed retrospectively, and only through adequate validation and historical data is adequate confidence developed. Online water bioburden analyzers (OWBAs) contain the potential to purge sampling and testing errors via reduced manipulations, while providing increased product safety and process control by making statistically significant real-time data available.

    Online monitoring provides early warning of system upsets and provides process engineers and attribute groups the competence to ensure the water used for manufacturing is of adequate attribute prior to use.

    The OWBA must contain the capability and flexibility to be used for purified water (PW), water for injection (WFI), cleaning verification, etc.

    The prescribed limits of 100 colony forming unit (CFU)/mL for PW and 10 CFU/100 mL (0.1 CFU/mL) for WFI are capricious values used to measure the bioburden levels of water quality. Current water monitoring, composed of daily samples, provides only snapshots for identifying changes in water system stability and therefore cannot be reliably used for meaningful trending analysis. The EU monograph for WFI requires a minimum of 200 mL volume samples for testing.

    The challenge of developing a unique measurement technology is the measurement unit. Due to the historical, regulatory, and legal significance of the terms CFU, total viable import (TVC), and cell, an alternate unit that does not limit technology development needed to be identified. The OWBA Workgroup has suggested the term auto-fluorescence unit (AFU) as a unique unit to enable a unified approach to understanding and discussing the measurement system. However, other technologies that determine microbe equivalents can moreover be acceptable. Current OWBA technologies in development confidence on fluorescence. The concept of microbe equivalents therefore may moreover be expressed in auto-fluorescence units (AFUs).

    The development of the OBWA provides the competence to monitor low-level microbial content. The OWBA ideally will measure at the compendial levels. Regardless, the system needs to provide a stable baseline used to ensure process control. Furthermore, the OWBA could be used to demonstrate the health and suitability of water systems.

    USP <1231> Pharmaceutical Water Testing Requirements

    The U.S. Pharmacopeia requires that water used for pharmaceutical purposes meet the following specifications.

    Table 1: Specifications for Water Purity

    Online Water Bioburden Analyzer User Requirement Specifications (URS)

    The following sections silhouette the minimum user requirements for an OWBA as specified by the OWBA Workgroup.

    Bioburden I Microorganism Testing

  • Limit of Detection (LOD): 1 AFU / mL
  • Limit of Quantitation (LOQ): 10 AFU / mL (proportional to 10CFU/100mL)
  • Limit of Linearity: 10,000 AFU / mL
  • Range: 1 to 10,000 AFU / mL
  • Note: The current WFI microbial requirement is NMT 10 CFU/100 mL. The acceptance level would be determined based on the technology and would not necessarily be expressed as colony-forming units. (LOD, LOQ, and compass may be demonstrated through stable baseline analysis of signal-to-noise ratios.)

    Calibration

  • Precision: <50% at LOQ 1 AFU and <25% at 5 LOQs AFU
  • Accuracy: ± 30% of measurement of 6 replicates at 5 LOQs AFU
  • pH Range: 4.0 to 8.0
  • Analysis Modes:
  • Online (continuous) or
  • Periodic testing frequency (e.g. circa one sample every 4 minutes)
  • Daily (once per day at designated time)
  • System Suitability - Desirable Attributes

    The analyzer should be capable of performing periodic verification of operational performance. Suitability standards should limn the potential contamination or simulated spikes. The suitability standard should be a surrogate for microbial contamination. The employ of live or killed microorganisms is not acceptable.

  • Ozone Compatibility: Maximum 300 ppb as 03
  • External stream Rate (line or sample stream rate): Maximum 50 mL/min
  • System Supply /Temperature Range: 10°  to 95° C, although the sample will be transmitted in non-insulated lines
  • Sample Pressure: Up to 100 psig with spikes to 150 psig. (e.g., water hammer magnitude)
  • Potential Interferences: System provides robust analyses even in the presence of reasonable amounts of residual sanitizer, rouge, gasket particulates, and particulate up to 25 µm
  • Calibration Stability: Source I detector stable for six months
  • Display Readout: Three significant digits with trending plot of at least 4 hours data
  • The unit should be designed to obviate reverse flow.
  • Instrument

  • Power: 100-260 VAC, 50/60 Hz
  • Installation I Overvoltage
  • Category II (protects against transients present in Category II power)
  • Safety Certifications: UL/cUL and CE
  • Normal Operating Environment:
  • Ambient Temperature: 2° to 40° C (35° to 104° F)
  • Maximum Relative Humidity: Up to 95%, non-condensing
  • Maximum Altitude: 2000 m (6500 ft)
  • IP Rating: Environmental IP 35 or NEMA equivalent
  • Equipment can be sanitized with caustics, free of crevices, manufactured from non-shedding, non-corroding materials
  • Inputs: At least one isolated binary input
  • Outputs:
  • At least one isolated 4-20mA output,
  • 10-100 Mb Ethernet,
  • one USB 2.0 port, and
  • one warning output
  • Communications Protocol:
  • 802.11 a/b/g/n WiFi Capability
  • Interface scripts for Plant Distributed Control System (e.g. Delta V)
  • Fully CFR 21 Part 11 compliant (data records, audit trails, user rights assignment, etc.)
  • LIMS connectivity, bidirectional capability to provide input I output.
  • Display: Backlit Quarter-VGA touchscreen display
  • Consumables To be Supplied With Original Purchase Order (System May employ Reagents If Needed)

  • Consumable reserves for 90 days operation
  • Reagents adequate for 45 days of unattended operation
  • Suitable temperature storage for reagents
  • Low reagent alarms
  • Supplier agreement for spare parts / consumables
  • 1 year of operation (may be held at vendor with 24-hour availability based on company practices)
  • 60-day notification of supplier change for spare parts / consumables
  • Additional Design Considerations (Points To account For The System)

  • System pipework, connections, and internal stream paths should be of sanitary design able to be routinely sanitized, in accordance with ISPE well-behaved drill guidance
  • Vibration tolerant
  • Capable of excursion sample collection (filtration, IV bag, or sample bottle) or of sending a signal that could be used to trigger a sample collector
  • Self-sanitizing or simple method to sanitize fluid path
  • Two modes of use:
  • Bench-top portability — competence for unit to be moved to individual points of employ or used on a bench top
  • Internal power for portable operation or potential battery cart with system for 120 minutes operation
  • System may contain manifolds or multiplex capability to monitor several points simultaneously
  • Customer Requirement Considerations (Points To account For System Design And Support)

    Potential customers for a device that uses alternative methodologies contain defined expectations that must be satisfied in order to contain the device accepted by a regulatory authority. These requirements are broadly outlined below for the benefit and insight of instrument developers and vendors. For further information, consult PDA Technical Report 33, USP <1223>, and EU 5.1.6.

    USP <1223> User Requirements

    Determining the precise technical requirements necessary for an alternative microbiological method is essential before one can select the commandeer technology and paraphernalia that meet the apposite assay requirements. Therefore, it is suggested that organizations wishing to develop and validate a candidate alternative method produce a user requirement specification (URS) document. This document should include utter censorious functions of the technology, censorious user interface requirements, space requirements, environmental requirements, operational requirements, and utter other necessary characteristics of an alternative method for the intended use. These requirements will be specific to the company or organization, as well as to the alternative method's intended use, and therefore the requirements should be generated by the user.

    In generating the URS document, three divorce components of the alternative microbiological method validation must be considered:

    1. Instrument qualification. Most alternative microbiological methods will depend on specific equipment. This analytical paraphernalia is subject to industry standard instrument qualification requirements (see USP <1058> for further information).

    2. Validation of alternate technologies. The basic rationale for using an alternative methodology is to ameliorate on some aspect of the existing technology of the current compendial method without sacrificing essential characteristics of that technology (e.g., plate import and membrane filtration). The current technology for compendial microbiology methods consists of detection of the growth of viable microorganisms on (or in) a nutrient medium. The alternative technology must be at least equivalent to the current technology in terms of performance for the intended use. Much of the technical uphold for equivalence may approach from the peer-reviewed scientific literature or from a prior regulatory submission (e.g., a vendor submitted the Drug Master File to the FDA, or prior submission from a company on this technology), but this must be confirmed, as commandeer for the intended use.

    Method suitability. This consideration must address both the technology's suitability to the specific test and the want of product inhibition and enhancement on the test results.

    a. Suitability of the technology to the specific test. Many compendial microbiological tests contain mandated test requirements. An example of this would be sample plans consisting of the quantity of material to be tested (e.g., 10 g or 20 units of a specific volume). Because the test results are frequently used to determine compliance with finished product specifications, and the specifications are contingent on sample volume or quantity, the alternative technology must be able to answer sample volume requirements as required in the universal test method. The employ of a lesser volume or sample size is not recommended and would exigency to be fully justified by the user on a case-by-case basis. The alternative technology is considered suitable if it can meet utter censorious parameters of the compendial test.

    b. Inhibition and enhancement. Specific products may meddle or enhance the signal of different measurement technologies to the specific signal of interest (see USP <1227>). This component of alternative microbiological method validation (i.e., suitability) must be demonstrated for each product tested.

    Summary

    These requirements were developed by the Online Water Bioburden Analyzer Workgroup to record the characteristics of the technology/method required by end-user for routine water sample testing. This group recognizes that methods based on the colony-forming unit are unlikely to achieve continuous and real-time detection of viable microorganism from water systems. Alternative microbial detection methods such as those based on fluorescent biomarkers contain the possibility of achieving continuous and real-time detection; therefore the group identified censorious performance characteristics that are minimally required to meet the end-users’ needs. These characteristics, such as validation parameters for bioburden testing, calibration, system suitability, instrument operation, and data laboratory information management system (LIMS) interface contain been assembled into this URS document. Additional system design features to be considered by technology/method developers are moreover included.

    Note: This document provides a design specification for a potential water analyzer; but is not to be considered an endorsement, uphold or purchase agreement with any vendor or the authors.

    An earlier URS version was published by members of this group in 2013 (“Novel Concept for Online Water Bioburden Analysis: Key Considerations, Applications, and industry Benefits for Microbiological Risk Reduction,” Anthony Cundell, Oliver Gordon, Nick Haycocks, Joe Johnston, Michelle Luebke, Neil Lewis, Jeanne Mateffy, and Jeffrey W. Weber, American Pharmaceutical Review. July 2015.) and served as a starting point for this updated and refined set of performance characteristics to be considered by the end-users and technology/method developers.



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    References :


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