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Test Code : 500-205
Test Name : SP Optical Technology Systems Engineer Representative
Vendor Name : Cisco
: 50 Real Questions

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SP Optical Technology Systems Engineer Representative education

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

The water content material in pharmaceuticals is extremely important to the accomplished product, please provide a top level view of how the water content material influences pharmaceutical product great?

Freeze drying is a long and high priced fill/finish operation it is required for a lot of pharmaceutical and biotechnology products to ensure product balance, efficacy and long shelf lifestyles earlier than distribution to sufferers.

one of the crucial key parameters affecting product best is residual moisture (RM) content. The RM is typically decreased to a degree in order to now not guide chemical reactions (or organic growth).

RM is decreased to control chemical and physical degradation techniques. youngsters most drug items are dried to RM values of <1%, one of the most new biotechnology products can also require an intermediate RM cost, 2-5%, to maximize product steadiness, safety and efficacy.

despite the significance of RM, there's at the moment no real-time computer screen capable of making a choice on RM all through the secondary drying phase of lyophilization.

What effect would too much, or too little water have on a entire pharmaceutical product?

The effect of residual moisture on product steadiness has been studied for a large number of products.  In most situations reduce stages of residual water improves balance and the company should stability accelerated drying times that result in lessen water ranges with a reduction in manner efficiency and extra processing complications to achieve and hold the extraordinarily low tiers of residual moisture.

In some situations, lessen degrees of residual water can cause a discount in product stability, above all for protein-based items and vaccines. It has been said that a minimum stage of residual water is required for conformational balance and over-drying can lead to a loss in product quality and stability.

What does actual Sciences Inc. present to computer screen and manage water elimination?

physical Sciences Inc. has developed a Tunable Diode Laser Absorption Spectroscopy (TDLAS) primarily based water vapor mass stream expense display screen, known as the LyoFlux®, that provides continuous measurements of the water elimination rate during pharmaceutical freeze-drying operations.

The sensor uses a non-intrusive, near IR optical absorption method to monitor the water vapor attention and fuel circulate speed in the duct connecting the lyophilizer product chamber and condenser.

These measurements are used in mixture with the duct pass-sectional enviornment to calculate the instantaneous water vapor mass circulate cost (grams/second) within the duct. These measurements can also be built-in to deliver a continual, actual-time choice of the overall quantity of water eliminated all the way through the freeze-drying process.

We note that the determination of product RM is a little more durable to investigate. The conclusion user can not readily subtract the integrated TDLAS measurements of water removed all the way through freeze-drying from the whole quantity of water introduced to the batch of vials present process freeze-drying.

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

here's beyond the ability of the TDLAS sensor, and in reality most analytical contraptions. In collaboration with the university of Connecticut, TDLAS-primarily based choice of RM has been established in accordance with correlating the TDLAS measured water vapor awareness at the end of primary drying to Karl Fisher based mostly RM measurements.

The development of the correlation curve for a specific product is performed once in a laboratory scale freeze-dryer after which has been used for subsequent laboratory and pilot scale experiments. This correlation curve almost erases the size error gathered all the way through basic drying and enables accurate integration of the measurements right through secondary drying to foretell product RM during secondary drying with a effective measurement accuracy of +/-0.5%.

What facets does PSI offer to be sure a official freeze-drying system?

The LyoFlux® sensor gives true-time data that will also be used to efficiently develop and computer screen freeze drying strategies.  Use of the sensor helps manner engineers shop time and cash in developing their cycles and supports rapid disposition of product with the aid of construction engineers following a technique disruption.

PSI, through an extended and productive collaboration with the tuition of Connecticut, has tested numerous applications of the LyoFlux® expertise for monitoring freeze-drying processes together with the determination of:

  • simple and secondary drying endpoints
  • Vial warmth transfer coefficients, Kv
  • Product temperature at the bottom center of the vial, Tb
  • Product temperature at the sublimation interface, To
  • continual decision of the ice and dryer layer thicknesses
  • Product resistance to drying, Rp
  • The optimum lyophilizer gadget potential: mass circulation as a feature of power
  • Residual moisture content material
  • lots of the pharmaceutical industry conclusion users have also tested these measurements and extra functions of the technology, together with the building of great with the aid of Design (QbD) advantage and design areas.

    back in the late 1990’s and early 2000’s a few vital papers were published that validated that by utilizing gravimetric determinations of mass stream and the well-authorised constant state mannequin of warmth and mass transfer of vial-primarily based freeze-drying, a product, vial and dryer specific procedure design house could be calculated and graphically displayed that offered lyophilization procedure engineers with a finished overview of the drying manner.

    This strategy calculated shelf and product temperature isotherms of the water vapor mass circulation rate as a function of procedure power. When mixed with the potential of the gadget capability limit, also displayed as mass flow as a characteristic of procedure force, the graphical output offered a QbD based system of establishing the lyophilization method design. furthermore, the method engineer might predict how the product temperature would reply to possible technique shocks in force and shelf temperature.

    The only issue with the gravimetric primarily based strategy became that the facts required to calculate the talents and design areas would require weeks to months to obtain. it truly is because gravimetric primarily based experiments required for the information assortment needed to be run in regular state.

    These information had been used to investigate the important thing parameters including the force stylish values of Kv, the always altering value of Rp (as a feature of dry layer thickness) and the power stylish machine ability limits.

    Use of the TDLAS sensor to acquire the same statistics capability that experiments not needed to be run at a fixed set of circumstances (e.g. drive) and this shortened the records assortment length to about 1-2 weeks. the use of the TDLAS sensor to enhance the method design space can have the maximum have an impact on on pharmaceutical freeze-drying system building.

    The LyoFlux sensor from PSI are additionally obtainable to be equipped into SP Scientific freeze-dryers, please give an overview of your partnership and how this collaboration helps each agencies live at the cutting edge of freeze-drying.

    PSI has had a relationship with SP Scientific from the initial experiments that established the feasibility of the TDLAS measurements in a Lyostar 2 freeze dryer returned in 2004. all over the past ~5-years, this relationship has been strengthened and is now producing product improvements and new products that directly improvement their pharmaceutical shoppers.

    This collaboration has enabled effective utility of the TDLAS expertise to distinctive scale lyophilizers, such because the miniature LyoCapsule and the greater LyoConstellation S20 pilot scale dryer.

    we've efficaciously established accurate mass stream measurements and importantly, accurate determinations of batch regular product temperatures when the mass flow measurements were mixed with the warmth and mass switch model of freeze drying. therefore, these equipment permit more rapid system construction and scale-up, in the end enabling end clients to streamline their procedures and get their products to the market quicker.

    A key development has been the building of application that allows direct communication between the freeze-dryer and the TDLAS sensor. This communique provides the sensor with continual measurements of the freeze dryer product chamber pressure, shelf temperature and the product temperature data.

    The drive and shelf temperature values provided to the sensor eradicate the want for person inputs to the sensor all over the lyophilization method and permit actually independent operation of the sensor 24/7/365.  here is a large improvement to the end user, saving time, resulting in fewer data collection mistakes and offering a single vicinity for taking pictures and plotting the system facts for subsequent evaluation.

    method recipes are enter into the dryer and the user initiates the freeze-drying cycle, from this aspect the method runs with out operator intervention to practice this expertise. on the appropriate instances within the procedure the dryer opens and closes the isolation valve to investigate measurement offset values and initiates sensor integration of the mass flow measurements.

    The TDLAS sensor measurements and the entire resulting warmth and mass switch model information products calculated the use of the sensor and freeze dryer statistics are transferred to the lyophilizer manage desktop for storage using the dryer facts historian. This ensures a typical time stamp for all of the information and easier display and processing with the aid of the end person.

    The collaboration between SP Scientific and PSI maintains us each at the innovative of freeze-drying technology by means of permitting us to work together on analysis and building initiatives. The establishment of conversation (and control) between the sensor and the freeze-dryer has additionally provided the groundwork for extra advanced functions of the sensor expertise. PSI and SP Scientific lately achieved a collaborative R&D effort that has created the TDLAS sensible Freeze Dryer technology.

    The TDLAS wise FD allows for the building of a freeze-drying cycle the use of a single experiment. It combines the existing Manometric Temperature size (MTM) based wise algorithm with TDLAS determinations of the water vapor mass circulate to create a new product that overcomes the limitations of the usual MTM based product.

    The smart™ freeze drying know-how instantly generates a freeze-drying cycle based on consumer inputs of product traits and vial dimensions, mixed with non-intrusive TDLAS-based mostly in-system product temperature measurements and a pseudo-steady state warmth and mass switch model of freeze drying in vials.

    This construction makes it possible for the application of the wise FD expertise for a an awful lot wider latitude of product formulations, including high weight percentage amorphous organic products, on each laboratory and pilot scale freeze dryers, assisting both procedure development and scale-up.

    PSI and SP Scientific continue to discover further applications and automation of cycle construction with the ultimate aim of sensor-based cycle control. They admire that computerized cycle control would require many years of extra R&D and business checking out, however success of this intention is without delay in-line with the FDA process Analytical technology (PAT) and exceptional with the aid of Design (QbD) initiatives.

    What aspects aid your purchasers in expanding their figuring out and robustness of the movements freeze-drying procedure?

    The recent development and rollout of sensor and freeze dryer utility packages allow direct communication and control between the sensor and the lyophilizer are vital improvements for their customers. The communication (and control) skill vastly improves user software of the sensor technology, cutting back the capabilities for end-person error in making use of the LyoFlux® sensor.

    The data sharing between the two systems additionally enables precise-time and accurate calculation of the warmth and mass transfer mannequin facts items and storage of the information on the freeze-dryer. Their goal is to ultimately dispose of the sensor user interface, getting ready the mixed equipment for software in a manufacturing atmosphere.

    this can deliver conclusion clients with a wealthy library of statistics for each and every batch of the product it truly is freeze-dried. currently these actual time records sets supply process development scientists with the tips vital to raise their understanding of the drying manner, lifestyles cycle management, and enable building of robust procedures the use of quality by means of Design principles. sooner or later this records may be purchasable to permit extra speedy free up of lyophilized product and extra fast disposition of product following manner deviations.

    How does the TDLAS sensor integrate with different freeze dryer scales in the manufacturing manner to ensure a sensible method to creation and a reputable pleasant of the product?

    The LyoFlux® sensor is applicable to all dimension freeze dryers so long as they will insert an optical spool in between the freeze dryer product chamber and the condenser. PSI has verified utility 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 control electronics, information acquisition and processing algorithm are ordinary for all measurement dryers. A fiber optic and digital sign umbilical cable connects the sensor manage unit to the freeze dryer optical spool.

    a common optical platform is used for all spools, thus the most effective change with dryer scale is the measurement of the spool and the place of the optical ports. because they are using absorption spectroscopy, longer absorption pathlengths associated with greater spools give larger signal to noise ratios.

    to this point their most average setting up has been on the SP Scientific Lyostar 3 laboratory scale freeze-dryer, but they now have fielded many recent inquiries for talents installations on better dryers.

    We agree with that this indicates a herbal evolution of the product software from the laboratory to manufacturing scale. It may well be occurring at the present as a result of frequent industrial talents of the know-how and the a large number of publications describing software of the sensor, including a e-book by means of the FDA.

    agencies that adopt the LyoFlux® technology for monitoring their processes on all scale freeze dryers will have general data sets from construction through scale-as much as manufacturing.  This should still outcome in more suitable system figuring out, probably sooner time to market and extra efficient evaluation of product exceptional in the experience of method disruptions.

    What’s subsequent for actual Sciences Inc?

    physical Sciences Inc. continues to work with each their educational and industrial collaborators to strengthen next era sensors, and to enrich application of the TDLAS know-how, with the eventual goal of the usage of the LyoFlux® sensor and different PAT sensors for actual-time process control.

    PSI is at the moment participating with university and industrial partners to follow the TDLAS expertise and procedure fashions for more advantageous lyophilization procedure development and scale-up. This comprises the development of a new aseptic, pilot scale lyophilization facility to allow testing of recent sensors and process construction models in an atmosphere it's consultant of a producing facility.

    this may guide the pharmaceutical business and the practicing of the next era scientists and system engineers on lyophilization method development and scale-up. This facility, which is expected to come back online in Fall 2019, might be accessible as a consumer facility to each academia and trade. In summary, we're nevertheless actively pursuing a lot of R&D projects to boost the sensor and its software.

    the place can clients locate extra assistance? About bill Kessler

    bill Kessler received his undergraduate and graduate degrees in chemistry from Boston institution, performing extremely-excessive-resolution fuel spectroscopy. His research concentrated upon multi-photon excitation of aligned ionic states.

    In 1986 bill joined physical Sciences Inc. in Andover, Massachusetts as a body of workers scientist. His work at PSI has spanned numerous disciplines together with combustion, atmospheric, and chemical laser research. invoice’s focal point shifted to the development of diode laser-based sensors and sensor networks which leveraged the equipment created with the aid of the optical telecommunication trade for industrial sensor applications.

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

    He back to PSI to pursue the building and application of superior optical sensors for pharmaceutical method monitoring and handle. invoice is now the vp of the applied Optics company commercial enterprise within PSI and is the technical lead for the tunable diode laser absorption spectroscopy primarily based LyoFlux® product. He oversees two additional business devices, the Biomedical Optics technology and Aerothermal system corporations.

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

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