Particle Counts Testing

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Particle Counts Testing Service

Particle Count Testing is a critical process for maintaining the cleanliness, safety, and regulatory compliance of controlled environments such as cleanrooms, pharmaceutical laboratories, manufacturing facilities, and medical device production units.

Validair Engineers is a trusted name in delivering high-quality Particle Count Testing Services in India, ensuring accuracy, compliance, and reliability for critical environments. Our experienced professionals conduct detailed examinations of all required parameters, using advanced instruments and the latest technology to achieve precise results. We employ state-of-the-art equipment such as AAS, DSC, FTIR, GC, GCMS, HPLC, HPTLC, IR, ICP, ICPMS, ICPAES, ICPOES, LCMS, NMR, XRD, WXRD, XRF, WXRF, and advanced spectrometers. Each service is tailored to meet specific client requirements, ensuring GMP and ISO compliance. With Validair Engineers, industries benefit from efficient, reliable, and cost-effective particle count testing solutions.

What is Particle Counts Testing Service?

Particle Count Testing is a precise scientific process used to measure and monitor the number and size of airborne particles within a controlled environment. These particles can include microscopic dust, microbial contaminants, chemical vapors, and pollutants. Excessive levels of airborne particles can negatively impact product quality, cause equipment contamination, and pose health risks to personnel. This makes particle monitoring essential in critical industries such as pharmaceuticals, healthcare, aerospace, electronics, and food production, where maintaining a clean and contamination-free environment is vital for safety, reliability and regulatory compliance.

Importance of Particle Counts Testing Service

  • Regulatory Compliance: Industries such as pharmaceuticals and biotechnology must comply with strict guidelines like ISO 14644, EU GMP Annex 1, and FDA regulations. Failing to meet particle count thresholds can result in non-compliance, product recalls, and legal consequences.
  • Product Quality Assurance: Particle contamination can compromise product integrity. In semiconductor manufacturing or medical device production, even minor particle contamination can cause defects or malfunctions. Particle Counts Testing helps maintain product reliability.
  • Workplace Safety: Inhalation of microscopic airborne particles can lead to respiratory issues or other health risks. Maintaining a clean environment through routine Particle Counts Testing Service helps safeguard employee well-being.

How Does Particle Counts Testing Work?

  • Site Evaluation: We start with a comprehensive evaluation of your cleanroom or controlled environment, noting the classification, operational conditions, and any critical zones.
  • Selection of Monitoring Points: Sampling locations are selected as per ISO 14644-1 requirements, considering airflow patterns, process operations, and high-risk areas.
  • Data Recording: The number of particles detected is recorded in real time and compared to industry standards or specific cleanroom classifications.

Exploring The Methods Of Particle Count Testing

There are several methods used for particle count analysis, each employing different principles and techniques to determine the concentration and size distribution of particles in a fluid sample. The main types of methods used for a precise particle count test include:

  • Optical Particle Counting (OPC): Uses light scattering to detect and count particles in a sample based on size and concentration.
  • Coulter Counter: Utilizes electrical impedance to count and size particles passing through a small aperture.
  • Gravimetric Analysis: Captures particles on a filter membrane, measuring weight change to determine concentration.
  • Flow Cytometry: Uses laser beams and light scattering to identify and count particles, commonly used in medical research.
  • Coulter Multisizer: Measures and counts particles over a wide size range using electrical impedance.

Each method has specific advantages and limitations, and selection depends on particle size range, accuracy, sample type, and required detail. Maintaining clean and contamination-free environments is critical to product quality, regulatory compliance, and workplace safety. Through professional Particle Counts Testing Service, Validair Engineers helps organizations achieve and maintain the required standards of cleanliness in their controlled environments.

For more information about our Particle Counts Testing Service, or to schedule a consultation, Contact Validair Engineers today.

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