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Pharmaceutical Technology-02-02-2017
Pharmaceutical Technology
A Risk-Based Approach to Stainless Steel Equipment Maintenance
February 02, 2017
Features
41
2
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
Pumping Fluids in Biopharmaceutical Processing
February 02, 2017
Features
41
2
Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.
Moving Forward with Adaptive Licensing
February 02, 2017
Regulatory Watch
41
2
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
Collaboration Key to Meeting Excipient GMP Requirements
February 02, 2017
Features
41
2
Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
Regulatory Reform Is Not That Simple
February 02, 2017
From The Editor
41
2
Reducing regulatory roadblocks requires more than the stroke of a pen.
Mass Spec Sheds New Light on Biologics Drug Development
February 02, 2017
Cover Story
41
2
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
Evaluating E&L Studies for Single-Use Systems
February 02, 2017
Features
41
2
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs
February 02, 2017
Features
41
2
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
Ensuring Sterility in Small-Scale Production
February 02, 2017
Ask the Expert
41
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Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
Viewpoint: Challenges and Opportunities for CDMOs
February 02, 2017
Outsourcing Outlook
41
2
The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
User Fees Needed to Help FDA Manage its Full Plate
February 02, 2017
Regulatory Watch
41
2
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
Cold Chain: Zeroing In on the Last Mile
February 02, 2017
Supply Chain
41
2
Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving novel therapies.
Last-mile temperature control
February 02, 2017
Supply Chain
41
2
An example of a new cold chain temperature-controlled shipping technology is Cocoon, which was commercialized in November 2016 and designed for use with pallet-sized shippers.
Advancements in Extrusion-Spheronization
February 02, 2017
Formulation
41
2
More agile techniques are improving the development of multiparticulate drug-delivery systems.
Establishing Blend Uniformity Acceptance Criteria for Oral Solid-Dosage Forms
February 02, 2017
Peer-Reviewed Research
41
2
This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
Fluid Imaging System for R&D and Quality Control Applications
February 02, 2017
Product Spotlight
41
2
The FlowCam 8100 particle imaging and analysis system from Fluid Imaging Technologies features a camera that can capture images at up to 120 frames per second and high-resolution digital images of individual particles and microorganisms measured in real-time based on their actual size and shape.
Explosion Proof Mixer and Discharge System
February 02, 2017
Product Spotlight
41
2
The 10-gallon Double Planetary Mixer and Discharge System from Ross, Charles & Son has heavy-duty helical mixing blades, designed for high-viscosity pastes, gels, and putty-like materials.
Updated Firmware Improves Traceability
February 02, 2017
Product Spotlight
41
2
The firmware version 2.20 for the Excellence Moisture Analyzers HX204 and HS153 from Mettler Toledo includes enhanced user-rights assignment capabilities.
Pharmaceutical Analyzer Uses Focus Tracking Technology
February 02, 2017
Product Spotlight
41
2
The RA802 Pharmaceutical Analyzer from Renishaw is a compact benchtop Raman imaging system that enables users to formulate tablets by speeding up the analysis of tablet composition and structure.
Pharmaceutical Technology, February 2017 Issue (PDF)
February 02, 2017
Issue PDF
41
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Click the title above to open the Pharmaceutical Technology February 2017 issue in an interactive PDF format.