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500-205 | SP Optical Technology Systems Engineer Representative

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500-205 - SP Optical Technology Systems Engineer Representative - braindump

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Exam Name SP Optical Technology Systems Engineer Representative
Questions 50 Q & A
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Test Number : 500-205
Test Name : SP Optical Technology Systems Engineer Representative
Vendor Name : Cisco
Q&A : 50 Dumps Questions

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SP Optical Technology Systems Engineer Representative certification

Monitoring movements Pharmaceutical Freeze Drying with Tunable Diode Laser Absorption Spectroscopy | 500-205 Dumps and Real test Questions with VCE Practice Test

The water content in prescription drugs is extraordinarily essential to the finished product, please supply an outline of how the water content influences pharmaceutical product satisfactory?

Freeze drying is a long and costly fill/finish operation it is required for many pharmaceutical and biotechnology items to make certain product stability, efficacy and lengthy shelf lifestyles earlier than distribution to patients.

one of the most key parameters affecting product pleasant is residual moisture (RM) content. The RM is typically decreased to a degree with the intention to now not guide chemical reactions (or biological increase).

RM is reduced to handle chemical and real degradation techniques. youngsters most drug items are dried to RM values of <1%, one of the crucial new biotechnology products can also require an intermediate RM value, 2-5%, to maximise product stability, security and efficacy.

despite the significance of RM, there is presently no true-time display screen capable of determining RM during the secondary drying part of lyophilization.

What impact would too a great deal, or too little water have on a comprehensive pharmaceutical product?

The impact of residual moisture on product balance has been studied for a lot of items.  In most cases lower degrees of residual water improves steadiness and the manufacturer needs to steadiness multiplied drying times that outcomes in lessen water degrees with a discount in technique efficiency and extra processing complications to obtain and keep the extremely low degrees of residual moisture.

In some instances, lessen ranges of residual water can lead to a discount in product balance, primarily for protein-based mostly products and vaccines. It has been stated that a minimal level of residual water is required for conformational balance and over-drying can result in a loss in product great and steadiness.

What does physical Sciences Inc. offer to video display and manipulate water removing?

physical Sciences Inc. has developed a Tunable Diode Laser Absorption Spectroscopy (TDLAS) based water vapor mass circulate cost monitor, referred to as the LyoFlux®, that provides continuous measurements of the water removing cost right through pharmaceutical freeze-drying operations.

The sensor uses a non-intrusive, near IR optical absorption approach to video display the water vapor attention and gasoline flow velocity within the duct connecting the lyophilizer product chamber and condenser.

These measurements are utilized in mixture with the duct move-sectional area to calculate the instantaneous water vapor mass movement rate (grams/second) within the duct. These measurements may also be integrated to supply a continual, precise-time resolution of the whole volume of water removed throughout the freeze-drying method.

We be aware that the determination of product RM is a bit harder to check. The end user can't without difficulty subtract the integrated TDLAS measurements of water eliminated all the way through freeze-drying from the total amount of water brought to the batch of vials undergoing freeze-drying.

here is since the total strong content of the formulations is customarily in the 5% - 10% range. Measuring RM of the final solid following drying would require a dimension error of 0.05% - 0.1% for a product RM content material of 1%.

here is beyond the capability of the TDLAS sensor, and definitely most analytical gadgets. In collaboration with the college of Connecticut, TDLAS-based determination of RM has been tested based on correlating the TDLAS measured water vapor concentration on the conclusion of basic drying to Karl Fisher primarily based RM measurements.

The construction of the correlation curve for a selected product is performed as soon as in a laboratory scale freeze-dryer and then has been used for subsequent laboratory and pilot scale experiments. This correlation curve well-nigh erases the measurement error amassed during primary drying and enables correct integration of the measurements all over secondary drying to predict product RM during secondary drying with a valuable measurement accuracy of +/-0.5%.

What aspects does PSI present to make certain a professional freeze-drying system?

The LyoFlux® sensor offers actual-time facts that can be used to correctly strengthen and monitor freeze drying procedures.  Use of the sensor helps procedure engineers keep time and cash in establishing their cycles and helps fast disposition of product through production engineers following a method disruption.

PSI, via an extended and productive collaboration with the institution of Connecticut, has confirmed numerous functions of the LyoFlux® know-how for monitoring freeze-drying tactics including the choice of:

  • primary and secondary drying endpoints
  • Vial warmth transfer coefficients, Kv
  • Product temperature at the backside center of the vial, Tb
  • Product temperature on the sublimation interface, To
  • continual choice of the ice and dryer layer thicknesses
  • Product resistance to drying, Rp
  • The highest lyophilizer gadget means: mass movement as a feature of power
  • Residual moisture content
  • lots of the pharmaceutical business conclusion clients have also tested these measurements and extra applications of the know-how, including the construction of great through Design (QbD) competencies and design areas.

    lower back within the late 1990’s and early 2000’s a couple of vital papers have been posted that demonstrated that by utilizing gravimetric determinations of mass move and the well-approved regular state model of warmth and mass transfer of vial-primarily based freeze-drying, a product, vial and dryer specific procedure design space may be calculated and graphically displayed that provided lyophilization technique engineers with a comprehensive overview of the drying method.

    This strategy calculated shelf and product temperature isotherms of the water vapor mass move cost as a feature of technique power. When mixed with the capabilities of the device capability limit, additionally displayed as mass circulation as a characteristic of technique drive, the graphical output supplied a QbD primarily based formula of developing the lyophilization process design. in addition, the process engineer could predict how the product temperature would respond to feasible technique shocks in drive and shelf temperature.

    The simplest issue with the gravimetric primarily based strategy changed into that the statistics required to calculate the abilities and design spaces would require weeks to months to attain. that's as a result of gravimetric based mostly experiments required for the records collection needed to be run in constant state.

    These facts had been used to examine the important thing parameters together with the drive based values of Kv, the perpetually altering value of Rp (as a function of dry layer thickness) and the drive stylish machine ability limits.

    Use of the TDLAS sensor to purchase the same information capacity that experiments not had to be run at a fixed set of situations (e.g. power) and this shortened the facts collection period to approximately 1-2 weeks. the use of the TDLAS sensor to Excellerate the manner design area may have the highest have an effect on on pharmaceutical freeze-drying system construction.

    The LyoFlux sensor from PSI are additionally accessible to be fitted into SP Scientific freeze-dryers, please provide a top level view of your partnership and the way this collaboration helps both groups reside on the cutting edge of freeze-drying.

    PSI has had a relationship with SP Scientific from the preliminary experiments that established the feasibility of the TDLAS measurements in a Lyostar 2 freeze dryer returned in 2004. all through the previous ~5-years, this relationship has been reinforced and is now producing product advancements and new items that without delay advantage our pharmaceutical valued clientele.

    This collaboration has enabled efficient software of the TDLAS technology to distinctive scale lyophilizers, such because the miniature LyoCapsule and the greater LyoConstellation S20 pilot scale dryer.

    we now have correctly Tested correct mass circulation measurements and importantly, accurate determinations of batch usual product temperatures when the mass flow measurements have been combined with the warmth and mass switch mannequin of freeze drying. as a result, these tools allow more swift process development and scale-up, sooner or later permitting end clients to streamline their approaches and get their products to the market faster.

    A key improvement has been the building of application that enables direct communication between the freeze-dryer and the TDLAS sensor. This conversation provides the sensor with continual measurements of the freeze dryer product chamber pressure, shelf temperature and the product temperature information.

    The pressure and shelf temperature values offered to the sensor get rid of the want for consumer inputs to the sensor during the lyophilization manner and permit really self reliant operation of the sensor 24/7/365.  here is a big improvement to the end consumer, saving time, resulting in fewer facts assortment error and proposing a single location for taking pictures and plotting the manner information for subsequent analysis.

    system recipes are enter into the dryer and the user initiates the freeze-drying cycle, from this aspect the process runs with out operator intervention to follow this technology. on the applicable instances in the manner the dryer opens and closes the isolation valve to check measurement offset values and initiates sensor integration of the mass move measurements.

    The TDLAS sensor measurements and all the ensuing heat and mass transfer model records items calculated using the sensor and freeze dryer information are transferred to the lyophilizer handle computing device for storage the use of the dryer records historian. This ensures a standard time stamp for all of the facts and less difficult reveal and processing by the conclusion user.

    The collaboration between SP Scientific and PSI continues us each on the innovative of freeze-drying technology via allowing us to work together on research and building projects. The establishment of verbal exchange (and handle) between the sensor and the freeze-dryer has additionally provided the foundation for more advanced purposes of the sensor expertise. PSI and SP Scientific currently achieved a collaborative R&D effort that has created the TDLAS smart Freeze Dryer know-how.

    The TDLAS sensible FD allows for the building of a freeze-drying cycle the usage of a single scan. It combines the existing Manometric Temperature measurement (MTM) primarily based smart algorithm with TDLAS determinations of the water vapor mass circulation to create a new product that overcomes the obstacles of the common MTM based mostly product.

    The wise™ freeze drying know-how immediately generates a freeze-drying cycle in accordance with consumer inputs of product qualities and vial dimensions, combined with non-intrusive TDLAS-primarily based in-method product temperature measurements and a pseudo-constant state warmth and mass switch model of freeze drying in vials.

    This development allows the software of the smart FD technology for a a good deal wider latitude of product formulations, including excessive weight percentage amorphous organic items, on both laboratory and pilot scale freeze dryers, assisting each system development and scale-up.

    PSI and SP Scientific proceed to explore additional applications and automation of cycle building with the top-rated purpose of sensor-based mostly cycle manage. We respect that automated cycle handle would require decades of extra R&D and business trying out, however success of this intention is without delay in-line with the FDA system Analytical know-how (PAT) and first-class by using Design (QbD) initiatives.

    What elements assist your shoppers in expanding their understanding and robustness of the movements freeze-drying method?

    The fresh building and rollout of sensor and freeze dryer application packages enable direct conversation and manage between the sensor and the lyophilizer are critical advancements for our consumers. The communique (and control) capability significantly improves person application of the sensor know-how, decreasing the competencies for conclusion-consumer error in applying the LyoFlux® sensor.

    The statistics sharing between the two techniques also makes it possible for true-time and accurate calculation of the warmth and mass transfer mannequin information products and storage of the information on the freeze-dryer. Our aim is to at last dispose of the sensor consumer interface, getting ready the mixed system for application in a producing environment.

    this could supply end users with a rich library of information for each and every batch of the product it is freeze-dried. currently these true time facts units supply method construction scientists with the tips essential to increase their figuring out of the drying procedure, existence cycle management, and permit building of robust procedures the use of first-rate by Design ideas. in the future this facts should be purchasable to enable greater fast liberate of lyophilized product and extra quick disposition of product following technique deviations.

    How does the TDLAS sensor integrate with other freeze dryer scales in the manufacturing procedure to make sure a wise approach to production and a respectable excellent of the product?

    The LyoFlux® sensor is applicable to all dimension freeze dryers as long as we are able to insert an optical spool in between the freeze dryer product chamber and the condenser. PSI has established software on dryers starting from the SP Scientific LyoCapsule® miniature, seven, 20mL vial lyophilizer, which has a 2-inch spool, as much as a manufacturing scale lyophilizer which has a 30-inch diameter spool.

    The sensor manage electronics, statistics acquisition and processing algorithm are commonplace for all dimension dryers. A fiber optic and digital sign umbilical cable connects the sensor control unit to the freeze dryer optical spool.

    a typical optical platform is used for all spools, hence the only trade with dryer scale is the size of the spool and the area of the optical ports. as a result of we're the usage of absorption spectroscopy, longer absorption pathlengths associated with bigger spools supply better sign to noise ratios.

    so far our most usual setting up has been on the SP Scientific Lyostar 3 laboratory scale freeze-dryer, however we now have fielded many fresh inquiries for competencies installations on higher dryers.

    We trust that this shows a natural evolution of the product software from the laboratory to manufacturing scale. It may be taking place at this time as a result of frequent industrial potential of the know-how and the a lot of publications describing software of the sensor, including a e-book via the FDA.

    businesses that undertake the LyoFlux® know-how for monitoring their techniques on all scale freeze dryers can have usual statistics units from development via scale-up to manufacturing.  This should still influence in more desirable technique understanding, doubtless quicker time to market and more effective assessment of product satisfactory in the experience of manner disruptions.

    What’s next for real Sciences Inc?

    physical Sciences Inc. continues to work with both our tutorial and industrial collaborators to strengthen subsequent era sensors, and to enrich application of the TDLAS know-how, with the eventual intention of using the LyoFlux® sensor and different PAT sensors for true-time system manage.

    PSI is at the moment participating with tuition and industrial partners to practice the TDLAS expertise and technique models for more advantageous lyophilization process building and scale-up. This includes the building of a brand new aseptic, pilot scale lyophilization facility to enable testing of new sensors and system construction fashions in an environment that's representative of a producing facility.

    this may help the pharmaceutical industry and the training of the subsequent generation scientists and process engineers on lyophilization procedure building and scale-up. This facility, which is expected to come online in Fall 2019, could be purchasable as a user facility to each academia and trade. In summary, we're still actively pursuing a large number of R&D initiatives to increase the sensor and its application.

    the place can clients find more tips? About invoice Kessler

    bill Kessler received his undergraduate and graduate levels in chemistry from Boston institution, performing extremely-high-decision gas spectroscopy. His analysis focused upon multi-photon excitation of aligned ionic states.

    In 1986 invoice joined real Sciences Inc. in Andover, Massachusetts as a body of workers scientist. His work at PSI has spanned a large number of disciplines including combustion, atmospheric, and chemical laser research. invoice’s center of attention shifted to the building of diode laser-based mostly sensors and sensor networks which leveraged the tools created by way of the optical telecommunication industry for industrial sensor applications.

    In December 2000 bill became a founding member of the PSI-spinout business, Confluent Photonics Corp., concentrated on constructing excessive index distinction optical waveguides for optical telecommunications. invoice served as the Director of purposes Engineering while at CPC and its associate, the MIT Lincoln Laboratory, developed silicon-on-insulator waveguide tapers for efficient laser supply coupling to single mode photonic circuits.

    He again to PSI to pursue the construction and application of advanced optical sensors for pharmaceutical system monitoring and control. bill is now the vp of the applied Optics business enterprise within PSI and is the technical lead for the tunable diode laser absorption spectroscopy primarily based LyoFlux® product. He oversees two further business instruments, the Biomedical Optics know-how and Aerothermal gadget groups.

    Contact guidance: [email protected], 978-738-8253


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