Contract analysis on particle characterization

Nanomol Technologies provides its clients with high added value services on particle characterization techniques.

Deep knowledge and understanding on particle size and shape analysis by “Laser Diffraction (LD), Optical and Electron Microscopy and Dynamic Light Scattering (DLS)” techniques are complemented by a vast experience to characterize any kind of material such as APIs (raw materials), product intermediates and final formulations. This contract analysis unit is fully GMP compliant for the characterization of APIs.

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Services

Our contract analysis unit offers the following services for the characterization of a wide variety of products according to customer requirements — includes cGMP:

  1. Analysis of API particle properties including size, shape, stability, density, either for R+D samples or batch release samples under GMP compliance.
  2. Particle Size Distribution (PSD) determination by single or combination of techniques (Laser Diffraction, Microscopy, Dynamic Light Scattering).
  1. Consultancy on particle characterization of materials both at micro and nano scale.
  2. Method development and validation according to ICH guidelines.
  3. Transference of methods.
  1. Comparative studies of samples (test vs. reference samples; different suppliers; micronized samples) concerning particle and solid state properties.
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Analysis

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Particle Size Distribution and Granulometry by Laser Diffraction

Our highly qualified team make use of our vast expertise and instruments for Particle Size Distribution (PSD) determination to provide the following analytical services:

  1. Analytical method development and optimization.
  2. Analytical method validation in compliance with GMP standards. Routine measurements according to validated methods.
  3. Transfer of analytical methods for PSD determination.
  4. Routine measurements of any type of products from raw materials to final forms, adapted to customer requirements.
  5. Training courses on demand.

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Particle Morphology Characterization by Automated Optical Microscopy and Image Analysis

We are also experts in Particle Morphology characterization. We make use of an “Automated Optical Microscope” and “Image Analysis” to fully characterize size and shape parameters of particulate matter and provide the following services:

  1. Comparative studies to evaluate and quantify shape (circularity, elongation, aspect ratio, roughness, agglomeration) or size (CE diameter, length, width, max. distance or max. Feret diameter, perimeter) differences between particulate samples — powdered or in suspension.
  2. Detection and quantification of agglomerates, oversized particles or contaminant particles. Size measurement of non-spherical particles such as needle-shaped crystals.
  3. Accuracy evaluation and support to PSD method optimization in measurements obtained by Laser Diffraction or other techniques.
  4. Correlation studies of product behavior and dissolution / pharmacological properties with morphological or particle size parameters.
  5. Straightforward measurements on agglomerated / granulated / compacted samples with preservation of original solid state.

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Analysis of nanoparticles

Our services also focus on the characterization of nanoparticles. We determine Nanoparticle Size and Z-Potential of colloidal suspensions by “Dynamic Light Scattering” and “Laser Doppler Micro-Electrophoresis”, respectively. We can complement these techniques by the determination of Nanoparticle Size Distribution and concentration by “Nanoparticle Tracking Analysis”.

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Complementary analytical services

Our package of services related to solid state and liquid colloidal/suspension formulations analysis is complemented by:

  1. Characterization and monitoring of destabilization phenomena of suspensions (floculation, sedimentation, agglomeration, aggregation and coalescence) by “Multiple Light Scattering” and accelerated stability studies.
  2. Particle size and morphology characterization by “Electron Microscopy” techniques (SEM, CRIO—TEM).
  3. Density determination of powders by “He Pycnometry” (real density) and “Autotap” (tapped density).
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Quality

Nanomol Technologies works with high-quality standards, having implemented a Good Manufacturing Practices (GMP) Quality System. Nanomol Technologies has been already qualified by its costumers as cGMP contract analysis service for the characterization of APIs. This successful process matches the next objective of obtaining the GMP certification for particle analysis of finished and intermediate pharmaceuticals, applying for both human and veterinary medicinal products. By these quality policies, Nanomol Technologies contract analysis unit:

  1. Is fully adapted to customer requirements.
  2. Analyses particles from APIs, and also particles from intermediate products and final pharmaceutical forms.
  1. Analyses particles from any product coming from food, cosmetic, chemical and construction sectors. The GMP quality system ensures our services are provided with the highest quality.
  1. Applies USP429, Eur. Ph. 2.9.31 and ISO13320 guidelines for PSD method developments, validations and transfers.

All staff in Nanomol laboratories is trained to work properly and in accordance with the GMP requirements with the objective of obtaining fully reliable and traceable results from robust analytical methodologies. The company has a Quality Assurance Department which is in charge of the maintenance and improvement of the quality in the complete analysis process, from the reception of the samples to their treatment as waste.

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Expertise and equipment

We have the right expertise and equipments when the following particle properties become Critical Quality Attributes:

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Particle Size Distribution (PSD)

Particle size is the most important physical property of particulate samples. Particle size has a direct influence on material properties such as reactivity or dissolution rate, stability in suspension, efficacy of delivery in drug delivery systems, texture and feel of food ingredients, appearance in powder coatings and inks, etc.

Measuring particle size and understanding how it affects your products and processes can be critical to the success of many manufacturing businesses, therefore these parameters can become Critical Quality Attributes (CQAs).

We are experts on the use of the world’s most widely used particle size analysers, Malvern Mastersizer Laser Diffraction instrument. We are equipped by the latest generation version of this instrument, Mastersizer 3000, a particle size analyser that delivers accurate particle size distributions for both wet and dry dispersions, over the nanometer to millimeter particle size ranges.

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Particle Shape

As well as particle size, the shape of constituent particles can also have a significant impact on the performance or processing of particulate materials. Particle shape in addition to particle size measurements are extremely useful in order to gain a better understanding of any particle-based product (pharmaceutical actives, drug delivery systems, ceramic filters, food ingredients).

In Nanomol Technologies we are also equipped by Malvern Morphologi G3S, an automated image analysis tool being a high-resolution direct technique for characterizing particles from around 0.5 micron up to several millimetres in size. Individual particle images are captured from dispersed samples and analysed to determine their particle size, particle shape and other physical properties. Statistically representative distributions of parameters can be constructed by measuring tens to hundreds of thousands of particles per measurement. These size and shape morphological parameters are Circle equivalent (CE) diameter, length, width, perimeter, area, maximal distance, sphere equivalent (SE) volume, fiber total length, fiber width, aspect ratio, circularity, convexity, elongation, high sensitivity (HS) circularity and solidity.

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Properties at The Nanoscale

We are experts and advanced users of nanoparticles characterization tools for analysing:

  1. Size, zeta potential and concentration of nanoparticles in suspension using Dynamic Light Scattering (DLS) instruments such as Malvern Zetasizer.
  2. Stability of particles and colloids in suspension with Multiple Light Scattering — Identification and rapid quantification of sedimentation phenomena, flocculation and creaming.
  3. Particle morphological parameters by optical and electron microscopy techniques.