Particle Analytical stages workshop on particle size determination

Hørsholm, Denmark: – Particle Analytical, the Danish-based particle properties specialist, says its upcoming workshop on particle size determination will focus on avoiding potentially disastrous pitfalls that can disrupt production of pharmaceutical powders.

The half-day workshop will be held at Copenhagen’s landmark AC Bella Sky Hotel during the afternoon of March 1, 2017.

The workshop will explore the intricacies of determining particle size accurately within pharmaceutical analysis of powders.

Importance of accurate particle size determination

Particle size forms by far the most important physical property of particulate samples. Particle size determinations are routinely carried out across a wide range of industries to provide critical parameters in the manufacture of pharmaceutical products. Particle size has a direct influence on material properties such as reactivity, dissolution rate, stability, flowability and handling.

“Particle size distribution should be known – and controlled,” says Particle Analytical CEO, Søren Lund Kristensen, who will help facilitate the workshop.

“This is necessary not only to protect patients but also to avoid unpleasant surprises during manufacture,” emphasizes Kristensen.

Surprises and pitfalls

“Measurement of particle size is not an exact technique and a ‘true” value does not exist. There is a wide range of analytical techniques for determining particle size; these all have their strengths and weaknesses. In order to develop and validate analytical methods for determination of particle size, it is necessary to correlate several methods.”

“In this course we will give you an overview of methods and regulatory requirements. Based on real life examples, we will go through commonly observed pitfalls in particle size determination that should be avoided,” said Kristensen.

This course identifies the studies needed to characterize the physico-chemical properties of drug substances in tablet development, with special focus on particle sizes.

Powdered solids focus

The course is designed primarily for those concerned with products developed or manufactured from powdered solids in the pharmaceutical industries, including scientists and technologists, introducing various methods used for characterization. The workshop will also meet the needs of regulatory and quality personnel, who need to understand the development process.

The primary purpose of the course is to review the various properties of powdered solids in relation to development and manufacture of the products of the pharmaceutical industry. In particular, it will discuss experimental techniques and equipment for evaluating important properties of powders, relating these to underlying principles and common industrial problems.

Key topics

Topics for the workshop will include:

• Regulatory requirements for powder characterization (PA)
• Linking material properties to formulation/processing behavior, stability and bioavailability
• Identifying potential Critical Product Attributes related to the drug substance: Real life examples
• Established techniques for powder characterization (Malvern & PA)
• Development of analytical methods for powder characterization (Malvern & PA)
• Benefits of accurate particle size measurement

“We intend that by the end of the workshop, our guests will possess an informed overview of requirement for powder characterization – and be able to avoid most common pitfalls in determination of particle sizes,” said Kristensen.

Those attending the workshop will receive a Particle Analytical certificate of participation.

Places for the workshop are still available. Those interested in attending should email Particle Analytical (see link below).

About Particle Analytical

Particle Analytical ApS is a contract laboratory (CRO) that specializes in analysis of physical parameters of particles, powders or emulsions, using a range of advanced techniques.

Founded in year 2000, the laboratory has become one of Denmark’s most rapidly expanding companies, twice winning the national ‘Growth Gazelle’ award.

It is one of the few laboratories in Europe to offer a complete range of services dedicated to analysis of powders, including particle size, and all physical chemical properties. These services are primarily focused on the pharmaceutical industry, where particle and powder analysis are essential in controlling compound properties during development, both with regard to production process and behavior in vivo.

Unique analysis services include determination of refraction index, fast compatibility screenings of excipients and determination of the crystalline proportions of samples.

Particle Analytical’s leading-edge capabilities include laser diffraction, XRD, thermal analysis, dynamic light scattering, microscopy, BET, dynamic vapor sorption, density measurement and air permeability. The laboratory is fully certificated as cGMP compliant by the Danish authorities and is also registered with the US Food & Drug Administration (FDA).

Particle Analytical services can either be used in routine analysis, separately to solve specific problems, or in parallel to larger drug development programs. These services include particle size determination, examination of physical properties, polymorph screening, method development and validation.