Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
|Articles|May 2, 2017
- Pharmaceutical Technology-05-02-2017
- Volume 41
- Issue 5
Sanitary Lab Mixer
The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems.
The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems. The OptimaBlend Fluidizing Blenders mechanically fluidize the product ensuring an efficient and gentle mixing process regardless of density, shape, or size. The new 1.5-ft³ sanitary lab mixer, from Eirich Machines American Process Systems product line, features the same fluidizing mixing technology as their larger production mixers. This lab-size mixer is suitable for lab work, R&D, and small-scale production.
Articles in this issue
over 9 years ago
The Complexity of IDMPover 9 years ago
Transforming Regulatory Data Managementover 9 years ago
Optimizing Yields on Modern Tablet Pressesover 9 years ago
Robots Package Parenteral Productsover 9 years ago
Combination Products Raise New Manufacturing Challengesover 9 years ago
Engaging with Interest Groups or Industry Associationsover 9 years ago
CMOs and CROs Have Different Trajectoriesover 9 years ago
Catalysis, Flow Chemistry Impact API Manufacturingover 9 years ago
Keeping an Eye on Qualityover 9 years ago
MACRA and Value-Based ContractsRelated to this article
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
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