Application Notes & Case Studies
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Seeq For Operators - Find Production Settings
1/20/2021
Process operators are responsible for making production target settings when changing product grades. Typically, operators use a written logbook to record production settings, and when they make grade changes, they reference the logbook. While the logbook may contain information about finished product quality or other process KPIs, they do not get the full context about the last production run. Seeq for operators allows you to create conditions for the production runs of product grades. Easily navigate to past production runs to find past production settings. View the relationship between the production settings and key process KPIs, like quality or production rate.
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Loss Monitoring And Categorization
1/20/2021
All manufacturing industries suffer a variety of different performance losses including production losses, product quality losses, energy losses, raw materials losses, environmental/regulatory losses and others. These losses can negatively impact profitability, environmental stewardship, and even license to operate. A manufacturer needed a way to gain insight into the leading causes of production losses, finding those times when equipment was not running at capacity and categorizing the loss by reason.
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Asset Utilization (OEE) Monitoring
1/20/2021
In order to raise efficiency and production standards, it is important to be able to analyze the performance of batch processes and identify time spent in each of the different process phases. Increased visibility into unproductive process time (for example during cleaning and maintenance and shift v shift differences in manual re-cleaning events) is necessary in order to enable users to take actions to reduce them. With the ability to increase production opportunities when reducing waiting times, overall profitability can also increase.
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Streamlining Delivery Device Manufacturing
1/20/2021
A leading European pharma company needed a highly resistant glass cartridges that could be easily integrated with a pen injector used in a range of treatments. Stevanato Group combined its glass expertise with proven testing methods and statistical analysis to establish a viable solution. Read more about how custom drug delivery systems process can be simplified through organizations which provide a centralized product and service offering that minimizes the risk and burden for pharma partners.
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A Streamlined Scientific Approach To Primary Packaging Solutions For Biologics
1/20/2021
A particular challenge during the selection of the appropriate primary packaging for an injectable drug product when it comes to biologics is the issue of sensitivity. By some estimates, 20-30% of drug formulations now have sensitivity issues – reacting to one or more elements of their primary packaging and losing their stability. Stevanato Group has developed a product line to address these issues.
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Real-time Characterization Of Mammalian Cell Culture Bioprocesses By Magnetic Sector MS
1/19/2021
The complexity of mammalian cell culture processes for biopharmaceutical manufacturing has resulted in the rapid development of Process Analytical Technology (PAT) tools aimed at improving batch-to-batch reproducibility through the implementation of real-time process monitoring techniques. In this paper mammalian cell culture processes were characterized upon the analysis of the exhaust-gas composition achieved through the on-line integration of a magnetic sector MS analyser with benchtop bioreactors.
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A Practical Guide To Aerosol Particle Counter Matching
1/15/2021
A common question related to aerosol particle counters is how well particle counting results should match each other. An example of when this becomes important is new particle counters being added to an existing fleet. The new instruments could be supplied from the original manufacturer or from a new vendor. This short application note provides a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.
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Clinical Supply Global Optimization: Managing Complex Global Drug Distribution And Expiry
1/12/2021
A global top-ten pharmaceutical company was sponsoring a complex, 8-year Phase III trial across 43 countries. The Sponsor was under intense pressure to reduce trial costs and leverage internal resources. Ultimately, study sites began to run out of medication. They realized that the trial could be better managed if it was outsourced.
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Dilution Of High Active Surfactants
1/11/2021
High Active Surfactants and water are of widely differing viscosities. If surfactants are pumped into the water in the vessel, they are not easily blended by conventional agitators. This can lead to globules of surfactant remaining undiluted or being partially diluted. Dilution is best carried out using a high shear in-line mixer.
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Mixing And Blending Of Carbopol
1/10/2021
Carbopol® is a water soluble polymer, used as an emulsifying, stabilizing, suspending, thickening in many industries and is also used as gelling agent in hand sanitizer gels and other products. Challenges of Carbopol include dusting problems, the formation of agglomerates which are not readily dispersed, and poor flow properties to name a few. The correct mixer can avoid these problems.