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Process Analytical Technology, PAT - BioPharmaTechnology

PAT / Spatially Resolved Spectroscopy / Raman Spectroscopy / Hyperspectral Imaging / UV/VIS / NIR Synthesis / Clean-In-Place / Suspended Solids / Dissolution Testing / Residual solvent / Purity / Cell Density Plating Density / Glycosylation / In-Line Acceptance / Uniformity / Solvent Recycling


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Knowledge Bases :

I. Process analytical technology (PAT)
II. Industrial processes
III. PAT tools
    Spatially Resolved Spectroscopy
    Raman Spectroscopy
   Hyperspectral Imaging

Applications :

IV. Pharmaceutical
V. Biotechnology
VI. Food / Agriculture
VII. Chemical

I. Process Analytical Technology, PAT


The long-term goals of PAT are to: reduce production cycling time, prevent rejection of batches, enable real time release, increase automation and control, improve energy and material use, facilitate continuous processing.

Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (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).

The concept actually aims at understanding the processes by defining their CPPs, and accordingly monitoring them in a timely manner (preferably in-line or on-line) and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects.

II. Industrial Processes


The long-term goals of PAT are to: reduce production cycling time, prevent rejection of batches, enable real time release, increase automation and control, improve energy and material use, facilitate continuous processing.

Industrial processes are procedures involving chemical, physical, electrical or mechanical steps to aid in the manufacturing of an item or items, usually carried out on a very large scale. Industrial processes are the key components of heavy industry..

Chemical processes by main basic material
Certain chemical process yield important basic materials for society, e.g., (
cement, steel, aluminum, and fertilizer). However, these chemical reactions contribute to climate change by emitting carbon dioxide, a greenhouse gas, through chemical reactions, as well as through the combustion of fossil fuels to generate the high temperatures needed to reach the activation energies of the chemical reactions.

III. PAT tools


Fundamental to process analytical technology (PAT) initiatives are the basics of multivariate analysis (MVDA) and design of experiments (DoE). This is because analysis of the process data is a key to understand the process and keep it under multivariate statistical control.

PAT tools

In order to implement a successful PAT project, a combination of three main PAT tools is essential:

  • Multivariate data acquisition and data analysis tools: usually advanced software packages which aid in design of experiments, collection of raw data and statistically analyzing this data in order to determine what parameters are CPP.
  • Process analytical chemistry (PAC) tools: in-line and on-line analytical instruments used to measure those parameters that have been defined as CPP. These include mainly near infrared spectroscopy (NIRS); but also include biosensors, Raman spectroscopy, fiber optics and others.
  • Continuous improvement and/or knowledge management tools: paper systems or software packages which accumulate Quality Control data acquired over time for specific processes with the aim of defining process weaknesses and implementing and monitoring process improvement initiatives. These products may be the same or separated from the statistical analysis tools above.


Intensity distribution of the diffused light when one select only the part coming out in reflection at a distance from the source.

Spatially offset Raman spectroscopy (SORS) is a variant of Raman spectroscopy that allows highly accurate chemical analysis of objects beneath obscuring surfaces, such as tissue, coatings and bottles. Examples of uses include analysis of: bone beneath skin,tablets inside plastic bottles,explosives inside containers[4] and counterfeit tablets inside blister packs. There have also been advancements in the development of deep non-invasive medical diagnosis using SORS with the hopes of being able to detect breast tumors.


Energy-level diagram showing the states involved in Raman spectra.

Raman spectroscopy (/ˈrɑːmən/); (named after Indian physicist C. V. Raman) is a spectroscopic technique typically used to determine vibrational modes of molecules, although rotational and other low-frequency modes of systems may also be observed. Raman spectroscopy is commonly used in chemistry to provide a structural fingerprint by which molecules can be identified.

Raman spectroscopy relies upon inelastic scattering of photons, known as Raman scattering. A source of monochromatic light, usually from a laser in the visible, near infrared, or near ultraviolet range is used, although X-rays can also be used. The laser light interacts with molecular vibrations, phonons or other excitations in the system, resulting in the energy of the laser photons being shifted up or down. The shift in energy gives information about the vibrational modes in the system. Infrared spectroscopy typically yields similar yet complementary information.


Two-dimensional projection of a hyperspectral cube

Hyperspectral imaging, like other spectral imaging, collects and processes information from across the electromagnetic spectrum.[1] The goal of hyperspectral imaging is to obtain the spectrum for each pixel in the image of a scene, with the purpose of finding objects, identifying materials, or detecting processes. There are three general branches of spectral imagers. There are push broom scanners and the related whisk broom scanners (spatial scanning), which read images over time, band sequential scanners (spectral scanning), which acquire images of an area at different wavelengths, and snapshot hyperspectral imaging, which uses a staring array to generate an image in an instant.


Beckman DU640 UV/Vis spectrophotometer

UV spectroscopy or UV–visible spectrophotometry (UV–Vis or UV/Vis) refers to absorption spectroscopy or reflectance spectroscopy in part of the ultraviolet and the full, adjacent visible regions of the electromagnetic spectrum. This means it uses light in the visible and adjacent ranges. The absorption or reflectance in the visible range directly affects the perceived color of the chemicals involved. In this region of the spectrum, atoms and molecules undergo electronic transitions.


A pseudocolor image of two people taken in long-wavelength infrared (body-temperature thermal) radiation.

Infrared (IR), sometimes called infrared light, is electromagnetic radiation (EMR) with wavelengths longer than those of visible light. It is therefore invisible to the human eye. IR is generally understood to encompass wavelengths from around 1 millimeter (300 GHz) to the nominal red edge of the visible spectrum, around 700 nanometers (430 THz)[verification needed] (although the longer IR wavelengths are often designated rather as terahertz radiation). Black-body radiation from objects near room temperature is almost all at infrared wavelengths. As a form of electromagnetic radiation, IR propagates energy and momentum, with properties corresponding to both those of a wave and of a particle, the photon.

IV. Pharmaceutical


The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms.[1][2] Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%.





Suspended Solids

Dissolution Testing

Residual solvent



V. Biotechnology


Biotechnology is "the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term biotechnology was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms.

Culture Composition / Concentration

Cell Density / Plating Density

Globules Size

Glycosylation of Proteins / Antibodies


VI. Food / Agriculture

Food is any substance consumed to provide nutritional support for an organism. Food is usually of plant, animal, or fungal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism and assimilated by the organism's cells to provide energy, maintain life, or stimulate growth.

In-Line Acceptance


Color Quality Scale (CQS)


VII. Chemical


A chemical substance is a form of matter having constant chemical composition and characteristic properties.[1][2] Some references add that chemical substance cannot be separated into its constituent elements by physical separation methods, i.e., without breaking chemical bonds.[3] Chemical substances can be simple substances,[4] chemical compounds, or alloys. Chemical elements may or may not be included in the definition, depending on expert viewpoint.

Blends / Mixing Composition

Contaminants / Residual products

Fault analysis

Industrial Water

Solvent Recycling

Key Words :
#Spectroscopy #Spatially #Raman #HyperSpectralImaging #UV/VIS #NIR #Pharmaceutical #Synthesis #Crystallization #Clean-In-Place #Suspension #Dissolution #ResidualSolvent #Purity #Biotechnology #CellCulture #CellDensity #Food #Agriculture #In-Line Acceptance #Uniformity #CQS #Humidity (Moisture)  

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