Pharmaceutical Technology-06-02-2018

Flow imaging microscopy can be used to identify particulates and their sources.

New approaches enable more patient-centric drug design that offers improved outcomes.

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA and Congress seek to limit the production and distribution of pain medicines.

New and expanded facilities point to the continuing growth of the biopharmaceutical industry.

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

Ross Charles’ 300-gallon process vessel is suitable for 5-psi internal pressure at 300 °F and is agitated by a disperser blade driven to 1150 rpm by a 75HP explosion-proof motor.

The ÄKTA pilot 600 from GE Healthcare is a lightweight bench-top chromatography system suited to streamline both GMP and non-GMP everyday operations.

Endress+Hauser’s Field Xpert SMT70 is a tablet PC suited for commissioning and maintaining field instruments in hazardous and non-hazardous locations.

Leistritz has added a continuous twin screw extrusion system that continuously mixes and conditions gel-mass formulations designed to replace previous upstream batch processing methodologies.

Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.

Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.

Drugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.

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Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.

The CUREfilm technology delivers drugs through a dissolvable strip that can be applied in the oral cavity or onto the skin.