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Particulate Contamination Analysis and Control

Particulate Contamination Analysis and Control

Identification, analysis and mitigation of particulate contamination risks.

“Particulate contaminants in products can have a massive impact on the production efficiency, quality standards and the integrity of a brand. Therefore, it is extremely critical to recognise and eliminate the risk of particulate contamination in your production, operation and supply chains.”

Particulate contamination

Contamination sensitive products and product components produced for the transportation, microelectronics (ICs, circuit boards, semiconductors), healthcare, pharmaceuticals, and medical devices industries require a standardized quality control to efficiently increase performance, reliability, and brand integrity. Particulate and molecular contaminants are one of the biggest challenges faced across various industries. Contaminants can be in the form of microscopic particulate matters and can pose various toxicological threats to the consumers. These contaminants often include inanimate or inorganic substances that can act as performance detractor for the products concerned. The investigation of contaminants requires the identification of particulate as well as molecular contaminants and the determination of various contamination sources is also required in the investigation. The objective of this process is to provide insights and to minimalize the impact of the contaminants on the product quality, efficacy and reliability. This step-by-step approach requires the collaboration of both the investigators and the client to understand the manufacturing process in-depth and to identify the potential root causes as well as to work on finding a remedy of the aforementioned problems to optimize the production, supply, and distribution chains specifically to avoid any of these issues. Validation techniques are incorporated that ascertain the level of cleanliness via the incorporation of a quantitative approach followed by optical or electron microscopic analysis to isolate the particles critical to the validation and a focused approach to solving the problem. Without optical or electron microscopy at the helm, it’s often difficult to isolate the particulate contamination problem that is prevalent in most industries and leads to difficulties in upholding the industrial quality standards without it.

Our approach

At NISHKA Research Pvt. Ltd., our team of experts can provide insights and reliable counsel by applying their in-depth knowledge and experience to provide solutions to your problems. Whether you need to monitor surface particulate contaminants or require an in-depth analysis using microscopy and advanced computer imaging analysis and solutions for the same, NISHKA is the one-stop solution for all your needs. We can provide superior analytical results and help you to be compliant with the regulatory requirements by working closely with you to provide the necessary contamination control actions. Our strategic approach to identify contaminants includes microscopy and computer imaging assessment to provide forensic traceability followed by a thorough analysis of the particulate contaminants. We offer both standardized and rapid deployment services for the analysis of particulate contaminants using the following techniques:

  • Microscopy: Light (and Polarised Light) Microscopy, SEM /EDX, ATR-FTIR Microscopy, Confocal Raman and Confocal Laser Scanning Microscopy and Transmission Electron Microscopy (TEM)
  • Molecular Spectroscopy: including Nuclear Magnetic Resonance Spectroscopy (NMR) and Pyrolysis Mass Spectroscopy.
  • Surface analysis using X-ray photoelectron spectroscopy or XPS
  • Thermal analysis such as DSC

Sampling and sample preparation

Whether your contaminants are present in the form of particulate contamination: inanimate and inorganic, like residual remains from a manufacturing process or organic, like bacteria, fungi, spores, flakes of shed skin, or cell fragments; or in the form of molecular contamination: either organic and inorganic films, such as the residue from additives during manufacturing, the experts at NISHKA apply the most suitable techniques to collect the samples to avoid any case of cross-contamination and we also provide the service of sample collection from your sites.

Visual characterization
Optical and Electron Microscopy techniques can be used to reveal specific information such as morphology, size, consistency, colour, shape, and the nature of the contaminants (organic or inorganic). Light microscopy can be used to rapidly identify the unique features of the particle, for further investigation, using low magnification viewing. Our team of experts documents the visual findings in a digital format to further study the visual appearance of the particulate matter.
Chemical identification
Our experts use microscope-based techniques such as Scanning Electron Microscopy alongside Energy-Dispersive X-Ray Spectroscopy on isolated particles to obtain the chemical composition of the particle. We also apply spectroscopy techniques to identify the unknown particulate matter. The spectroscopy techniques that we deploy include infrared (ATR-FTIR), FTIR Imaging, Raman Imaging and confocal Raman imaging alongside some other supporting techniques such as TDS-GC/MS, GC/MS, MS/LC, MALDI-MS and NMR. Raman spectroscopy, in particular, is very helpful in the analysis of particulate matter in glass vials, polymers containers whilst being non-destructive.
Contamination root cause analysis and control

At NISHKA, Our team of experts provides a full analytical review of the findings and empowers you to identify and mitigate the risks of contamination in your production, supply, engineering and distribution chains. We provide solutions tailored to tend to your contamination problem and to implement preventive measures for the future too.

CASE STUDY: Contaminant Particle Isolated on a Swab (Manufacturing Industry)

CASE STUDY: Fibre Contaminants In Healthcare Products

Unlock the Potential with Nishka Research. Schedule a consultation to explore our comprehensive solutions and drive innovation, quality, and success.

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Nishka Research

NISHKA has been helping customers unlock their full potential and realize their true value for more than 13 years by providing innovative and bespoke solutions to ensure the highest standards.
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Nishka Research Pvt. Ltd.

Regus Business Center,
4th floor, Gumidelli Commercial Complex,
1-10-39 to 44, Old Airport Road, Begumpet,
Hyderabad-500016
India

Phone : +91 40 29303155

Mobile : +91 7842798518

Send Mail : [email protected]
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