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500-210 | SP Optical Technology Field Engineer Representative

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Test Number : 500-210
Test Name : SP Optical Technology Field Engineer Representative
Vendor Name : Cisco
Q&A : 50 Dumps Questions

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SP Optical Technology Field Engineer Representative certification

Monitoring pursuits Pharmaceutical Freeze Drying with Tunable Diode Laser Absorption Spectroscopy | 500-210 Dumps and Real exam Questions with VCE Practice Test

The water content in prescription drugs is extremely critical to the comprehensive product, please give an overview of how the water content material influences pharmaceutical product quality?

Freeze drying is an extended and high priced fill/finish operation it's required for many pharmaceutical and biotechnology products to be sure product balance, efficacy and long shelf lifestyles previous to distribution to sufferers.

one of the key parameters affecting product nice is residual moisture (RM) content. The RM is typically lowered to a degree to be able to no longer help chemical reactions (or biological increase).

RM is reduced to manage chemical and real degradation processes. however most drug items are dried to RM values of <1%, probably the most new biotechnology items can also require an intermediate RM cost, 2-5%, to maximize product steadiness, safety and efficacy.

regardless of the value of RM, there's at present no real-time display screen able to picking RM all over the secondary drying phase of lyophilization.

What effect would too an awful lot, or too little water have on a entire pharmaceutical product?

The impact of residual moisture on product stability has been studied for numerous products.  In most cases reduce stages of residual water improves steadiness and the manufacturer must balance elevated drying instances that influence in lessen water tiers with a discount in system efficiency and additional processing issues to achieve and keep the extraordinarily low tiers of residual moisture.

In some circumstances, decrease levels of residual water can result in a reduction in product steadiness, exceptionally for protein-based products and vaccines. It has been said that a minimum stage of residual water is required for conformational balance and over-drying can result in a loss in product best and steadiness.

What does physical Sciences Inc. present to computer screen and manage water removing?

actual Sciences Inc. has developed a Tunable Diode Laser Absorption Spectroscopy (TDLAS) based mostly water vapor mass move fee computer screen, called the LyoFlux®, that provides continual measurements of the water removing price during pharmaceutical freeze-drying operations.

The sensor makes use of a non-intrusive, close IR optical absorption approach to monitor the water vapor concentration and gasoline circulate pace within the duct connecting the lyophilizer product chamber and condenser.

These measurements are utilized in aggregate with the duct go-sectional enviornment to calculate the instantaneous water vapor mass circulation price (grams/2nd) within the duct. These measurements can be built-in to supply a continual, true-time choice of the entire volume of water removed during the freeze-drying technique.

We notice that the choice of product RM is a little harder to investigate. The end consumer cannot conveniently subtract the integrated TDLAS measurements of water eliminated all over freeze-drying from the full amount of water introduced to the batch of vials present process freeze-drying.

here is because the complete solid content of the formulations is typically in the 5% - 10% range. Measuring RM of the closing strong following drying would require a dimension error of 0.05% - 0.1% for a product RM content of 1%.

this is beyond the potential of the TDLAS sensor, and definitely most analytical contraptions. In collaboration with the school of Connecticut, TDLAS-based determination of RM has been Checked in keeping with correlating the TDLAS measured water vapor awareness at the end of fundamental drying to Karl Fisher primarily based RM measurements.

The development of the correlation curve for a selected product is carried out once in a laboratory scale freeze-dryer after which has been used for subsequent laboratory and pilot scale experiments. This correlation curve pretty much erases the dimension error accrued throughout basic drying and enables accurate integration of the measurements all over secondary drying to foretell product RM throughout secondary drying with a helpful size accuracy of +/-0.5%.

What features does PSI offer to make sure a reputable freeze-drying system?

The LyoFlux® sensor provides true-time statistics that may also be used to efficiently increase and display screen freeze drying strategies.  Use of the sensor helps system engineers keep time and cash in developing their cycles and helps rapid disposition of product by means of creation engineers following a manner disruption.

PSI, via a long and productive collaboration with the school of Connecticut, has established a large number of purposes of the LyoFlux® know-how for monitoring freeze-drying methods including the resolution of:

  • primary and secondary drying endpoints
  • Vial heat switch coefficients, Kv
  • Product temperature on the bottom core 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 optimum lyophilizer gadget capacity: mass movement as a function of drive
  • Residual moisture content
  • most of the pharmaceutical trade end users have also demonstrated these measurements and additional functions of the expertise, including the building of satisfactory via Design (QbD) talents and design areas.

    returned within the late 1990’s and early 2000’s a few essential papers were published that proven that through the use of gravimetric determinations of mass movement and the well-authorised consistent state model of warmth and mass switch of vial-based freeze-drying, a product, vial and dryer particular technique design space could be calculated and graphically displayed that offered lyophilization procedure engineers with a finished overview of the drying technique.

    This strategy calculated shelf and product temperature isotherms of the water vapor mass circulation fee as a function of manner force. When mixed with the expertise of the machine means limit, also displayed as mass flow as a feature of system pressure, the graphical output supplied a QbD primarily based components of setting up the lyophilization technique design. furthermore, the system engineer could predict how the product temperature would reply to feasible technique shocks in power and shelf temperature.

    The handiest difficulty with the gravimetric based mostly approach changed into that the information required to calculate the abilities and design areas would require weeks to months to acquire. that is because gravimetric based mostly experiments required for the statistics collection needed to be run in regular state.

    These facts had been used to verify the important thing parameters together with the force elegant values of Kv, the normally altering price of Rp (as a feature of dry layer thickness) and the power stylish device means limits.

    Use of the TDLAS sensor to acquire the identical information skill that experiments no longer had to be run at a fixed set of conditions (e.g. drive) and this shortened the records collection duration to about 1-2 weeks. using the TDLAS sensor to enhance the manner design space could have the optimum have an effect on on pharmaceutical freeze-drying manner construction.

    The LyoFlux sensor from PSI are also available to be outfitted into SP Scientific freeze-dryers, please supply an outline of your partnership and the way this collaboration helps each corporations stay at the innovative of freeze-drying.

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

    This collaboration has enabled effective utility of the TDLAS know-how to different scale lyophilizers, such as the miniature LyoCapsule and the higher LyoConstellation S20 pilot scale dryer.

    we've effectively validated correct mass circulate measurements and importantly, accurate determinations of batch average product temperatures when the mass stream measurements were combined with the heat and mass switch model of freeze drying. therefore, these equipment enable more quick process building and scale-up, finally permitting conclusion clients to streamline their procedures and get their items to the market faster.

    A key improvement has been the development of application that enables direct conversation between the freeze-dryer and the TDLAS sensor. This communique gives the sensor with continuous measurements of the freeze dryer product chamber power, shelf temperature and the product temperature facts.

    The drive and shelf temperature values provided to the sensor eliminate the want for consumer inputs to the sensor during the lyophilization technique and permit truly autonomous operation of the sensor 24/7/365.  here is a large improvement to the end user, saving time, resulting in fewer facts collection mistakes and proposing a single place for capturing and plotting the manner information for subsequent analysis.

    technique recipes are enter into the dryer and the person initiates the freeze-drying cycle, from this aspect the method runs without operator intervention to practice this know-how. at the applicable instances in the system the dryer opens and closes the isolation valve to verify size offset values and initiates sensor integration of the mass circulate measurements.

    The TDLAS sensor measurements and all the resulting heat and mass transfer mannequin statistics products calculated the use of the sensor and freeze dryer data are transferred to the lyophilizer control laptop for storage the use of the dryer records historian. This ensures a standard time stamp for all of the records and less difficult monitor and processing with the aid of the end person.

    The collaboration between SP Scientific and PSI continues us both on the leading edge of freeze-drying know-how by way of enabling us to work collectively on research and development tasks. The establishment of conversation (and handle) between the sensor and the freeze-dryer has additionally offered the foundation for extra advanced applications of the sensor know-how. PSI and SP Scientific these days completed a collaborative R&D effort that has created the TDLAS smart Freeze Dryer technology.

    The TDLAS wise FD allows for the development of a freeze-drying cycle the use of a single test. It combines the present Manometric Temperature dimension (MTM) primarily based smart algorithm with TDLAS determinations of the water vapor mass flow to create a new product that overcomes the boundaries of the usual MTM primarily based product.

    The sensible™ freeze drying know-how automatically generates a freeze-drying cycle in keeping with user inputs of product qualities and vial dimensions, combined with non-intrusive TDLAS-primarily based in-technique product temperature measurements and a pseudo-consistent state heat and mass switch model of freeze drying in vials.

    This construction permits the utility of the smart FD technology for a much wider latitude of product formulations, including high weight percent amorphous organic items, on each laboratory and pilot scale freeze dryers, supporting both process development and scale-up.

    PSI and SP Scientific continue to discover additional functions and automation of cycle construction with the finest purpose of sensor-based cycle handle. We appreciate that automatic cycle control would require decades of additional R&D and business testing, however success of this aim is directly in-line with the FDA procedure Analytical know-how (PAT) and nice through Design (QbD) initiatives.

    What elements assist your purchasers in expanding their realizing and robustness of the events freeze-drying procedure?

    The contemporary development and rollout of sensor and freeze dryer utility applications allow direct communication and handle between the sensor and the lyophilizer are vital advancements for our clients. The communication (and manage) potential drastically improves consumer application of the sensor expertise, reducing the potential for end-consumer error in making use of the LyoFlux® sensor.

    The data sharing between the two programs also makes it possible for real-time and correct calculation of the heat and mass switch model records products and storage of the data on the freeze-dryer. Our aim is to ultimately get rid of the sensor user interface, making ready the mixed device for utility in a producing atmosphere.

    this may supply conclusion clients with a rich library of information for every batch of the product it is freeze-dried. at the moment these true time facts units provide manner building scientists with the information essential to increase their figuring out of the drying procedure, lifestyles cycle administration, and enable development of strong methods using nice through Design concepts. in the future this information might be purchasable to allow greater rapid unencumber of lyophilized product and extra speedy disposition of product following manner deviations.

    How does the TDLAS sensor integrate with different freeze dryer scales in the manufacturing technique to be sure a smart approach to construction and a legit nice of the product?

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

    The sensor manage electronics, records acquisition and processing algorithm are standard for all size 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 simplest trade with dryer scale is the size of the spool and the vicinity of the optical ports. because we're the use of absorption spectroscopy, longer absorption pathlengths associated with higher spools deliver better signal to noise ratios.

    to this point our most general 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 bigger dryers.

    We agree with that this suggests a natural evolution of the product utility from the laboratory to manufacturing scale. It could be occurring at the present due to common industrial abilities of the know-how and the numerous publications describing utility of the sensor, including a book by way of the FDA.

    businesses that adopt the LyoFlux® expertise for monitoring their tactics on all scale freeze dryers could have general facts sets from development through scale-up to manufacturing.  This may still effect in more suitable manner understanding, probably quicker time to market and greater productive evaluation of product fine within the adventure of procedure disruptions.

    What’s next for real Sciences Inc?

    physical Sciences Inc. continues to work with both our academic and industrial collaborators to enhance next generation sensors, and to Improve software of the TDLAS expertise, with the eventual purpose of the use of the LyoFlux® sensor and other PAT sensors for actual-time procedure handle.

    PSI is at the moment taking part with college and industrial companions to practice the TDLAS expertise and method models for superior lyophilization technique construction and scale-up. This includes the construction of a new aseptic, pilot scale lyophilization facility to allow checking out of new sensors and manner building models in an environment that's representative of a producing facility.

    this will guide the pharmaceutical industry and the working towards of the next technology scientists and manner engineers on lyophilization process development and scale-up. This facility, which is expected to return on-line in Fall 2019, could be accessible as a person facility to each academia and trade. In summary, we are nonetheless actively pursuing a large number of R&D tasks to develop the sensor and its application.

    where can clients discover greater information? About invoice Kessler

    bill Kessler obtained his undergraduate and graduate levels in chemistry from Boston college, performing ultra-high-resolution fuel spectroscopy. His analysis focused upon multi-photon excitation of aligned ionic states.

    In 1986 invoice joined real Sciences Inc. in Andover, Massachusetts as a group of workers scientist. His work at PSI has spanned numerous disciplines including combustion, atmospheric, and chemical laser research. invoice’s focal point shifted to the development of diode laser-primarily based sensors and sensor networks which leveraged the tools created through the optical telecommunication trade for industrial sensor functions.

    In December 2000 invoice grew to be a founding member of the PSI-spinout company, Confluent Photonics Corp., focused on setting up excessive index distinction optical waveguides for optical telecommunications. invoice served because the Director of applications Engineering while at CPC and its partner, the MIT Lincoln Laboratory, developed silicon-on-insulator waveguide tapers for productive laser source coupling to single mode photonic circuits.

    He back to PSI to pursue the building and application of advanced optical sensors for pharmaceutical method monitoring and manage. invoice is now the vice chairman of the utilized Optics enterprise enterprise inside PSI and is the technical lead for the tunable diode laser absorption spectroscopy primarily based LyoFlux® product. He oversees two further enterprise instruments, the Biomedical Optics know-how and Aerothermal system agencies.

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

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