Pharmaceutical Technology-02-02-2017

Pharmaceutical Technology

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

Features
Pharmaceutical Technology

February 02, 2017

Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.

Regulatory Watch
Pharmaceutical Technology

February 02, 2017

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

Pharmaceutical Technology

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

From The Editor
Pharmaceutical Technology

February 02, 2017

Reducing regulatory roadblocks requires more than the stroke of a pen.

Pharmaceutical Technology

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.

Pharmaceutical Technology

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Ask the Expert
Pharmaceutical Technology

February 02, 2017

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

Outsourcing Outlook
Pharmaceutical Technology

February 02, 2017

The outlook for the CMO and CDMO industry may be affected by ever-changing politics.

Regulatory Watch
Pharmaceutical Technology

February 02, 2017

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

Pharmaceutical Technology
Supply Chain

February 02, 2017

Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving novel therapies.

Supply Chain
Pharmaceutical Technology

February 02, 2017

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.

Pharmaceutical Technology
Formulation

February 02, 2017

More agile techniques are improving the development of multiparticulate drug-delivery systems.

Pharmaceutical Technology

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology
Product Spotlight

February 02, 2017

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.

Pharmaceutical Technology
Product Spotlight

February 02, 2017

The firmware version 2.20 for the Excellence Moisture Analyzers HX204 and HS153 from Mettler Toledo includes enhanced user-rights assignment capabilities.

Pharmaceutical Technology

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.

Issue PDF
Pharmaceutical Technology

February 02, 2017

Click the title above to open the Pharmaceutical Technology February 2017 issue in an interactive PDF format.