PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
|Articles|December 2, 2019
- Pharmaceutical Technology-12-02-2019
- Volume 43
- Issue 12
Triple Shaft Mixer with Powder Induction Manifold
The latest 600-gallon VersaMix Model VM-600 from Ross is qualified for high-speed subsurface powder induction with a proprietary Ross Solids/Liquid Injection Manifold (SLIM).
The latest 600-gallon VersaMix Model VM-600 from Ross is qualified for high-speed subsurface powder induction with a proprietary Ross Solids/Liquid Injection Manifold (SLIM). The SLIM incorporates powder and liquid phases into the rotor-stator mix head, which rotates at 3600 RPM.
Available in laboratory sizes up to 4000 gallons, the mixer uses a dual-post triple-shaft design for the processing of substantial powder phases along with an anchor agitator to move the product from the high shear rotor stator head to a high-speed dispersing head, which deagglomerates any remaining fisheyes. The SLIM feature also enables the device to mix large batches and accelerate loading phases.
Articles in this issue
almost 7 years ago
Applying Lessons Learned from the Semiconductor Industryalmost 7 years ago
Visualization Enhances Facility Designalmost 7 years ago
Bio Diol and IEX Columnsalmost 7 years ago
Two-step Disposable Autoinjectoralmost 7 years ago
Cube Plus for Pharmaceutical Manufacturingalmost 7 years ago
Fighting the Good Fightalmost 7 years ago
Managing Excipient Interactionsalmost 7 years ago
‘Polling’ All the Wayalmost 7 years ago
The Challenges for Regulators in the Digital Agealmost 7 years ago
Tackling Solubility in Drug DevelopmentRelated to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
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