HMR Enhances Particle Size Analysis Capabilities: Why Pharmacopeial-Compliant Testing Matters
At HMR Labs, we are proud to highlight our enhanced capabilities in particle size analysis, supported by the recent installation of the advanced Malvern Mastersizer 3000+ Ultra System!
After a significant investment in state-of-the-art instrumentation over the past year, this system Is just one example of our commitment to offering the highest quality pharmaceutical analysis services.
The Malvern Mastersizer 3000+ enables particle size analysis by laser diffraction and is fully compliant with USP <429>, Ph.Eur. 2.9.31 and JP 3.06 general chapters
As a commonly outsourced technique, in this blog, we will explore the importance of particle size analysis and how our advanced equipment will enhance our testing capabilities, ultimately driving your pharmaceutical success.
Particle size analysis is essential for ensuring quality in pharmaceutical testing.
At the heart of product safety and compliance, particle size analysis provides valuable insights that help uncover the bioavailability of pharmaceutical drugs.
Not only is particle size mandated by various regulatory bodies, but it is also a critical aspect of drug formulation. It offers insights into dissolution rates, powder flowability, packing density, stability and more.
Particle size testing is inherently tied to patient safety and product effectiveness. This is why HMR Labs is excited to expand its independent testing capabilities. With investment in new equipment, particularly the Malvern Mastersizer 3000+, we can offer the very best in quality control through advanced and compliant methodologies for laser diffraction measurement of particle size.
Why Particle Size Analysis Matters?
In an evolving pharmaceutical testing landscape, methodologies are continuing to expand to address the range of INDs (Investigational New Drugs) and ensure their safety, quality and efficacy,
Particle size analysis is a critical quality control tool in the pharmaceutical testing industry to characterise APIs and excipients. As with other testing categories, particle size analysis is governed by strict regulatory guidelines, with protocols set by European, American, Chinese, Japanese and other pharmacopoeias.
Early methods of particle size analysis included sieving, a process from the pre-1950s used to separate coarse powders. ‘The possibility of making microscopic analysis completely automatic occupied much attention’ post-1950s, according to an article published by M.J.Groves from the Department of Pharmacy, Chelsea College, London.
Optical microscopy gradually entered the landscape, but limitations quickly became apparent due to time, manual operations and incompatibility with smaller particles (<1mm). From the mid-20th century onwards, advances have been seen in automation as well as liquid-based methods, culminating in the promising and proven pathway of laser diffraction.
The Malvern Mastersizer 3000+ is an industry standard for particle size analysis by laser diffraction, offering fast, reliable and highly accurate measurement data relating to particle size distribution.
In the pharmaceutical sector, particle size provides crucial data which informs decision-making during the drug discovery and development journey. Data collected can span drug formulation, reformulation and excipient characterisation. Through these insights, API dosage forms can be optimised for targeted release and controlled drug delivery.
Working with nanometre to millimetre measurements in laser diffraction is ideal for powdered APIs. Particle size data from HMR Labs can feed into your dissolution rate analysis, drug solubility testing, bioavailability assessments and batch-to-batch manufacturing analysis.
Challenges Faced by Those Managing Particle Size Testing
Choosing between conducting in-house analysis or opting for a provider with extensive particle size instrumentation can be a difficult decision. Particle size analysis is a quality control tool in drug development and manufacturing and so it must be governed by pharmacopeial protocols.
Moreover, the data collected must adhere to 21 CFR Part 11 and other equivalent regulations, including GMP (Good Manufacturing Practice) standards, which span ICH, EMA, WHO and other quality expectations.
External CROs, like us, are already audited by many authorities to ensure consistent compliance. Seeking this certification and assurance internally, can often require more resources than expected.
To conduct particle size analysis requires advanced equipment and internal expertise to interpret and manage standardised methodologies laid out by USP <429>, Ph.Eur. 2.9.31 and JP 3.06. This is often where resources and costs are impacted most, with training of personnel, capital investments and compliance of both reducing the time spent investigating particle size.
Risking standardised methodologies or inexperienced personnel can lead to inconsistencies in testing and variability in results, compromising their accuracy and any decision-making based on them.
A common challenge for those conducting in-house particle size analysis is the proper interpretation and method development knowledge required to expand on detailed pharmacopeial testing. The specific parameters of particle size analysis will depend on the sample and materials. If the developed method is not properly validated by a knowledgeable pharmaceutical analyst or scientist, this could lead to unreliable results.
Introducing the Malvern Mastersizer 3000+
The Malvern Mastersizer 3000+ Ultra System was selected by our team of scientific project leaders due to its precision, performance and automation. Not only can we generate client data quickly and accurately, but it helps us maintain a gold standard in compliance.
We invested in an innovative system that can conduct laser diffraction-based particle size analysis across various client samples, from powders, suspensions, emulsions and sprays.
Whether it’s tablets and capsules, injectables and oral suspensions, lipid-based drug delivery systems or inhalation products, particle size analysis is relevant and crucial for all aspects of drug formulations, particle distributions, dosage optimisation, and dissolution investigations.
The Malvern Mastersizer 3000+ is fully compliant with Ph.Eur.2.9.31 since it deploys both Mie Theory and Fraunhofer Approximation to cover both models of light scattering, accounting for absorption, refraction and scattering effects.
Housing advanced laser diffraction technology, and offering a broad range of particle measurements, the Malvern Mastersizer 3000+ is a gold standard instrument. At HMR Labs, we have already seen the value it has brought to development projects through auditable reports and records helping our clients with their pre-IND applications.
Ph.Eur.2.9.31 General Chapters: Methodology Expectations
Methodologies aligned with Ph.Eur.2.9.31 are achievable through our particle size analysis capabilities, enhanced by our recent investment in the Malvern Mastersizer 3000+. In accordance with these testing methodologies, we can provide data and reportable insights on:
Stability:
Poor control over particle size can lead to sedimentation in suspensions, segregation in solid dosage forms and accelerated degradation of APIs. With our analysis and testing, HMR Labs can guide you on how to adjust formulations to improve product lifespan and drug potency.
Safety and Compliance:
As a method that plays a wider role in evaluating safety and quality of pharmaceuticals, efficacy can often be affected by particle size. Avoiding ineffective dosages is crucial to prevent regulatory rejection.
Manufacturing:
Large scale manufacturing is the future for many developers. Particle size analysis at the benchtop level can improve blending, compression, waste management, and general manufacturing, working towards high-volume production. A good understanding of particle size will help avoid batch failures, disruptions to production and compatibility issues with machinery.
Your Partner for Pharmacopeial-Compliant Testing
In summary, particle size analysis is critical in the pharmaceutical industry for ensuring product quality, safety, and compliance, making it a valuable service provided by our independent testing labs.
The Malvern Mastersizer 3000+ is a significant step in our continued commitment to offering the best in precision and analysis. Avoid the expense and complexity of in-house testing and take advantage of regulatory confidence with our adherence to USP <429>, Ph.Eur. 2.9.31 and JP 3.06 being second to none.