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Pharmaceutical Characterization

Micromeritics Predictive Materials Science Solutions for the Identification and Control of Critical Quality Attributes

LINKS: 

- Pharmaceutical Solutions Brochure » 
 
- Preformulations »

- Formulations and Drug Delivery »   

- Process Design and Pilot Scale Up »

Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Achieving QbD requires an in-depth understanding of physicochemical properties that predict processability, in vivo, and in vitro performance. Early identification of Critical Quality Attributes (CQA) of excipients and active pharmaceutical ingredients (API) and their impact on a formulation is a key component of QbD. Micromeritics’ instruments and contract analytical services offer solutions for the early identification of CQA’s, continuous process monitoring, and verification, which are the foundation of QbD.

To date, chemical analysis has received the greatest level of emphasis and deployment within a QbD architecture. The need for robust product and process design to ensure lot-to-lot consistency has led to an increased focus on the importance of material characterization. Historically, particle size has been the dominant physical characteristic control parameter for release. But now, properties such as surface morphology, porosity, particle shape, density, and surface energy are additionally utilized as predictive tools to reduce possible manufacturing failures by predicting scale-up effects on the final product. This effort improves the overall efficiency of a manufacturing process and cuts the cost of waste due to batch rejection, reprocessing, or testing failures.

QbD Quantitive Measurements of CQA's in Solid Dosage Form Unit Operations:

Links:
- Interactive Brochure »
- PDF Brochure » 
- Porosity, Density and Surface Area »

Links: 
- Interactive Brochure »  
- PDF Brochure »
- Particle Size, Material Segregation-Flow, Vapor Sorption » 

Link to Part 1Link to Part 2Link to Part 3Link to Part 4Link to Part 1

Material Sciences Contract Research

Understanding physiochemical properties of drug substances, excipients and finished products is crucial. In today’s age of Process Analytical Technology (PAT) and Quality by Design (QbD), regulatory authorities look favorably upon drug developer partnerships with Contract Research Organizations (CROs) that have specific areas of expertise in material characterization.

Backed by Micromeritics with 50 years of experience, Micromeritics Pharmaceutical Servicescan be trusted as your materials characterization solution for pharmaceutical materials, medical devices, nutraceutic and other FDA-regulated products. Through the use of advanced analytical testing systems, MPS provides solutions for the optimization of your drug development and production processes.

Early identification and understanding of Critical Quality Attributes (CQAs) are essential steps in the process. From a QbD perspective, scientists, researchers, and regulators look for consistency, both in physical and chemical attributes. MPS is here to help you define, specify, and control the critical quality attributes of your materials.

Our areas of expertise include particle size distribution analysis (micrometer and nano particles), particle shape and morphology, surface area, surface energy, vapor sorption, porosity, density, thermal analysis, and material flow properties.

Micromeritics Material Science Solutions:

  • Streamlining Pharmaceutical Development
  • Identification/Evaluation of API, Excipient, and Blended Material Critical Quality Attributes
  • Providing Predictive Tools and Lab Services for Implementing QbD and PAT initiatives in line with ICH Q6A, Q8, Q9, and Q10 Guidelines
  • Using Materials Science to Model and Predict Material Behavior
  • Characterization Solutions for Robust Quality Control
  • Raw Material Qualification
  • Assessing Lot-to-Lot Variability
  • Assistance in Quality Investigations and CAPAs (Corrective and Preventative Actions)

In addition to Material Science Solutions, Micromeritics Provides Products and Services for the Following USP General Chapters:

  • USP <267> Porosimetry by Mercury Intrusion
  • USP <429> Laser Diffraction Measurement of Particle Size
  • USP <699> Density of Solids-Gas Pycnometry
  • USP <788> Particulate Matter in Injections
  • USP <789> Particulate Matter in Ophthalmic Solutions
  • USP <846> Specific Surface Area
  • USP <1174> Powder Flow
  • USP <1241> Water Solid Interactions in Pharmaceutical Systems

Method Development / Validation

  • Method Development Services for all analytical tests
  • Method Validation Services for all analytical tests
  • Method transfer documentation
  • Secure Method and Validation storage for future projects

 

MPS is a DEA-licensed, FDA-registered, cGMP/GLP-compliant contract lab service organization

Analytical Services
  • Particle Size, Particle Shape (Light Scattering, Dynamic Light Scattering, Electrical Sensing Zone, Dynamic Image Analysis, Microscopy)
  • Surface Area(Gas Adsorption, BET)
  • Density (True, Apparent, Bulk, TAP, Carr index)
  • Porosity (Gas Adsorption, Mercury Porosimetry)
  • Thermal Analysis (DSC/TGA)
  • Dynamic Vapor Sorption (DVS)
  • Volumetric Vapor Sorption
  • Surface Energy (IGC)
  • Surface Energy (Volumetric Gas Adsorption-Density Functional Theory)
  • Zeta Potential

 

Links:

HOME - Pharmaceutical Characterization

Preformulations »

Formulations and Drug Delivery »

Process Design and Pilot Scale Up »

 

QbD Quantitive Measurements of CQAS in Solid Dosage Form Unit Operations...

.. for Porosity | Density | Surface Area »

.. for Particle Size | Material Segregation-Flow | Vapor Sorption »

M.P.S. - Micromeritics Pharmaceutical Services »




Particulate Systems Instruments   

OEM laboratory instruments












AccuPyc 1340 - Roller Compaction Test   

AccuPyc 1340 - Roller Compaction Test Page









SediGraph III Plus 2017   

Particle Sizing Analyzer - Sedimentation technique









AutoPore IV 2017   

Mercury Porosimetry Analyzer




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Using a SpinTester to Accurately Predict Hang-Up Issues In Process Equipment


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