Life Science, Phamaceutical & Biotechnology 

ANALYTICAL Solutions for LIFE SCIENCE, PHAMACEUTICAL & BIOTECHNOLOGY 

The pharmaceutical, life science and biotechnology industries continue to be an essential element of healthcare systems worldwide.  Implementing the most innovative, cutting-edge technologies gives pharmaceutical manufacturers the tools needed to gain position in the marketplace. Over the years, the pharmaceutical and biotechnology industries continue to be an essential element of healthcare systems worldwide.  Today’s manufacturers need to know about the latest Process Analytical Technologies (PAT). Implementing the most innovative, cutting-edge technologies gives pharmaceutical manufacturers the tools needed to gain position in the marketplace.

Our Cavity Ring-Down Spectroscopy (CRDS) Technology is a standard bearer for a growing number of major research centers and national metrology institutes around the globe. Now our CRDS gas analyzers are in 22 national metrology institutes worldwide. They serve as transfer standards and for research into such issues as global warming and acid rain, and prized for their proven precision, excellent stability, rapid response, and dynamic range (four+ orders of magnitude).

For the first time, powerful advanced spectroscopy is available at a popular price for a host of applications, from quality assurance to cylinder filling, as well as welding, medical, industrial and high-purity gas production; bulk delivery and distribution transfer points; and more. Say goodbye to cumbersome, complex, costly and labor-intensive mid-20th century technology. Gone is the need for calibration, spare parts, cramped ranges, and worries about drift and downtime. The speed alone will make you gasp. Plus, it’s a joy to start-up and to operate.  Look at our Spark™ H2O for effortless trace moisture detection as low as 3 ppb.

The extremely versatile T-I Max™ CEM is used for continuous emissions monitoring of gas concentrations for target compounds, both for compliance and process control.  It is an ideal, proven solution for MATS HCl compliance needs.

Our CRDS Analyzers Deliver

  • Industry leading measuring capability of ppt to ppm level of moisture and more
  • Versatile, robust & affordable performance
  • Fast, accurate, online monitoring with no calibration or maintenance requirements

APPLICATIONS

  • Lyophilization
  • QA/QC for Medical Gases
  • Packaging Permeability

Process Insights:  We are revolutionizing measurement everywhere!

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Fermentation Control

 In the fermentation process, growing bacteria and production of drugs occurs.  Fermentation has three stages:  Primary fermentation, Secondary fermentation (Optional), and Bottle or keg conditioning and carbonation.  The fermentation process is used for the production of biomass, enzymes, chemicals and pharmaceuticals. Cell types used in these culture processes were traditionally yeasts, fungi and bacteria.  Fermentation is a process breaks down large organic molecules via the action of microorganisms into simpler ones like yeast enzymes converting sugars and starches into alcohol, while proteins are converted to peptides/amino acids.  It is important to reduce production costs and optimize yields by improving fermentation conditions.  

The Quadrupole Mass Spectrometer is used to provide full, fast and precise analysis of the incoming air and the off-gas from the fermenter. The results are used to calculate the Respiratory Quotient (RQ), a major parameter in controlling growth and health of the bacteria. In different stages of a batch fermentation process, the RQ value changes, thus allowing for optimum and efficient drug production. The additional analysis of minor concentrations of by-products allows for rapid process adjustment to avoid undesired reactions.

We can provide fast and accurate analysis for control with our MGA™ 1200CS for Oxygen Uptake Rate (OUR), Carbon Dioxide Evolution Rate (CER), Respiratory Quotient (RQ) and fermentation end point.  As well as easily monitor fermenter bioreactor off-gas composition analysis with our quadrupole mass spectrometer, EXTREL™ MAX300-LG.

  • Fast and accurate analysis for control with our MGA 1200CS for Oxygen Uptake Rate (OUR), Carbon Dioxide Evolution Rate (CER), Respiratory Quotient (RQ) and fermentation end point
  • Continuous monitoring to improve yield / quality and reduce waste – single species or multi-component analysis (e.g. CO2, O2, N2, Ar, H2O, CO, H2, He, hydrocarbons, alcohols, aldehydes, sulfurs, etc.)
  • Easily monitor fermenter bioreactor off-gas composition analysis with our MAX300-LG
  • Active Pharmaceutical Ingredients (API) and biomolecule production

OTHER APPLICATIONS

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THERMOGRAVIMETRIC / materials science

Thermogravimetric analysis (TGA) is a powerful approach to the study of the thermal behavior of solid and liquid samples.  The interface of TGA with a quadrupole mass spectrometer allows the researcher to characterize and quantify the compounds in the off gas in real-time along with each mass loss.  Additional information about sample composition and thermal behavior can be obtained by analyzing the gases that leave the material as it is heated. This allows the researcher to determine not only the temperature at which a mass loss occurs, but also the molecular structures involved. Evolved Gas Analysis (EGA) is commonly carried out via a variety of analytical techniques, but in all cases the integrity of the gas stream must be protected. It must be kept hot and moved quickly to the gas analyzer to prevent condensation and chemical interactions

Our MAX300-EGA evolved gas analyzer comes equipped to import a Start-of-Heating signal from the TGA for easy data synchronization and features a chemically inert transfer line specially designed keep the sample hot and under vacuum all the way to the ionizer, to guard against condensation or chemical interaction.

Material Science TGA-MS Applications

  • Polymers
  • Elastomers
  • Thermoplastics
  • QA/QC

The MAX300-EGA is capable of scanning from 1-500 amu and features our EXTREL 19 mm mass filter for high analytical repeatability and long-term stability. The Questor5 software allows the system to perform qualitative analysis for sample characterization, or quantitative analysis, measuring concentrations from 100% down to 10 ppb. In addition to the transfer line, a MAX300-EGA is equipped to import a start-of-heating signal from the TGA and can be configured to perform calculations and trend data or output the data for viewing and manipulation on a different platform.

PROCESS & PURE WATER QUALITY ANALYSIS 

The requirements for water analysis in pharmaceutical manufacturing, biotechnology and life science is high. Besides ensuring high product quality, process safety and reliability are among the most important objectives.  Pharmaceutical water in particular places high demands on the accuracy of online analysis, since the water quality of e.g. water for injection is decisive for the product quality. For the compliance of the water quality there are standards as well as pharmaceutical standards (pharmacopoeia), which define the requirements for such pharmaceutical water, such as water for injection (WFI) and ultra-pure water (UPW). 

The United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) recognize TOC as a required test for purified water and water for injection.  The U.S. Food and Drug Administration (FDA) has many regulations to protect the health of the public.  These regulations are needed to ensure no cross-contamination between product production and cleaning procedures.

In pharma industry the production of Purified Water (PW) and the maximum TOC (total organic carbon) level is defined by more than one authority. We understand the pharmaceutical water limits.  Our LAR Online TOC Water Quality Analyzers measures accurately total organic carbon (TOC), chemical oxygen demand (COD), and biological oxygen demand (BOD) to meet these standards.

Glove Box Analysis

Glove boxes are widely used in ultra-pure environments without O2, H2O, and dust.  This includes lithium-ion batteries and materials, semiconductors, pharmaceutical, super capacitors, special lamps, laser welding, brazing, material synthesis, and OLED, MOCVD.  Continuous measurement of oxygen levels in glove boxes is necessary for pure environments and controlled atmospheres. Even though the glove box environment is intended to be closed.  Yet small amounts of oxygen can seep through the glove ports. Glove box oxygen deficiency monitors are designed for these enclosures using nitrogen or cryogenics.

OUR SOLUTIONS FLYERS

Process Analytical Technology (PAT)

Process Analytical Technology (PAT) is a manufacturing methodology for high value chemicals and pharmaceuticals.  PAT is defined by the US FDA as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect critical quality attributes (CQA).

  • Inline and online process NIR Spectrometers, NIR-O and ClearView db, are ideal for continuous PAT Monitoring

Breath Analysis

The fast-acquisition breath analysis configuration of our EXTREL™ MAX300-LG™ quadrupole mass spectrometer was designed in collaboration with leaders in the field of respiratory research. Mass spectrometry is the ideal gas analysis technique for many respiratory applications, and the MAX300-LG measures all compounds in the sample, requires minimal sample flow, and delivers data updates very fast.  Researchers focusing on the physiological or biomedical study of respiration and metabolism can use breath analysis data to reveal underlying processes within complex biological systems.  The high repeatability provided by the MAX300-LG ensures that calculated metabolic parameters derived from the gas analysis, like the respiratory quotient (RQ), are accurate and precise Quantitative Analysis of O2, CO2, N2, H2O, and trace volatiles. 

It can measure all compounds in the sample with 400 full updates per breath.  The mass spectrometer analyzes all compounds in the sample with very high precision. In addition, the analyzer has the flexibility to measure trace volatiles such as formaldehyde, acetic acid, ammonia, and hydrocarbons for the purpose of diagnostic evaluation.  The Respiratory Quotient (RQ). Nitrogen is not absorbed during respiration, so the ratio of the volumetric % of N2 in the inspired and expired sample is used to develop an RQ equation in which measured sample flow is not necessary. All O2, CO2, and N2 terms above are measurements of volume %. 

Our MAX300-LG, laboratory gas analyzer, features a fast acquisition software and inlet configuration designed specifically to produce the full breath-to-breath quantitative profile. It provides high precision measurements of all components in the breath sample, with up to 50 updates for each compound per second. The complete sample composition allows the researcher to calculate metabolic parameters, like the RQ, without the need for integrating additional flow measurements.

  • Measurement rate:  up to 5 milliseconds per compound
  • Minimum Sample flow < 0.04 atm cc/sec
  • Sample transit times as fast as 0.1 secon

Solvent Drying & Recovery

Drying is the process of removing the presence of solvents (i.e. water or other liquids) in a formulation with the presence of heat. The final product is a dry solid mass or powders.  Solvent drying process can occur in a number of process vessels, including tray dryers, vacuum dryers, and rotary dryers.  Measure organic solvent concentrations in the active pharmaceutical ingredient (API) refers’ to the biologically active component of a drug product i.e. tablet, capsule. It’s the primary ingredient.  Substances dried in pharmaceutical industries are classified in three groups: 1) Granular material 2) Pastelike Material 3) Solution and suspensions.

Pharmaceutical manufacturers are well aware of the industry statistics that at least 25% of time and energy can be saved by terminating the active pharmaceutical ingredient drying process at its true endpoint. However, actually determining the true endpoint has always been an obstacle. To avoid interrupting the process (traditional methods to determine the drying process involved sampling and analyzing the product in a lab) and possible contamination of an entire batch, many producers choose to overextend the drying process. Today’s engineers can solve this problem by using our MAX300-RTG 2.0 Industrial Gas Analyzer or the MAX300-LG Laboratory Gas Analyzer. Both can monitor the atmosphere composition above the drying material. Because the headspace is in close relationship with the concentration of solvents in the material, the true drying process end point can be determined by analyzing the headspace vapors. Our quadrupole mass spectrometers allow you the ability to view the concentration profiles of solvents over time, pinpointing the exact moment the drying is complete.  With its dual detector and dynamic auto ranging capabilities, the MAX300 has a detection range of 100% to 10 parts per billion.  

The MAX300 detection capabilities are beneficial for dynamic processes such as solvent drying, in which it is desirable to analyze a component over a large concentration range. Figure 1 illustrates the dynamic range, accuracy and response time of theMAX300
over a complete drying process.  The Dual Faraday and Electron Multiplier Detector and its auto ranging capabilities enable the MAX300 to achieve a continuous dynamic range of 100% down to 10 parts per billion.  Its flexibility lends itself to batch processing with its abilityto quickly and easily change the analysis method in order to monitor different solvents.

  • Accurate endpoint determination to improve product yield and production efficiency, and minimize waste
  • Easily switch streams to monitor multiple chambers using the same, or different solvents
  • Optimized sampling for ambient pressures, vacuum drying, and lyophilizers
  • Trace moisture analysis and multi-species analysis of solvents, such as IPA, MEK, DCM, ethyl acetate, styrene, acetonitrile, etc

Evolved Gas Monitoring

Evolved gas analysis (EGA) is a method used to study the gas evolved from a heated sample that undergoes decomposition or desorption, the effluent of analytical equipment and chemical processes.  Understanding the dynamic composition of the gases released by thermal analysis or continuous flow systems can provide insight into the mechanisms at work within the experiment.  When energy or a reagent is added to a reaction, changes to the off-gas can occur instantaneously. Our MAX300-EGA has the speed and sensitivity to detect even small shifts in the evolved fraction as they occur.  Characterize unknown samples, quantify solvent compositions, pinpoint reaction kinetics.  The heated transfer line can interface with a wide array of equipment, and signals and data can be imported into the mass spectrometer for trending and calculation or exported for manipulation on another platform.  

Thermogravimetric analysis (TGA) is a powerful technique that has been used for many years to characterize solid and liquid samples. The mass of the sample material is monitored while it is heated. By using a high precision balance and carefully controlling the heating process, researchers are able to plot mass loss as a function of temperature.  TGA is widely used in the study of polymers, pharmaceuticals and petrochemicals to determine degradation temperatures, characterize thermal decomposition, and monitor solvent and moisture content.

  • Connects to thermal gravimetric analyzers (TGA) for off-gas monitoring
  • Quality control in reaction monitoring, natural product analysis and synthesis studies
  • Microreactor off-gas and head-space analysis
  • Single species or multi-component analysis (e.g. CO2, O2, N2, Ar, H2O, CO, H2 He, hydrocarbons, alcohols, aldehydes, sulfurs, etc.)
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