Laboratory Equipment and Instruments

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

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.

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.

Analytical products for improved bio/pharmaceutical development.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.

Agilent’s new facility in Folsom, California includes laboratory, order fulfilment, and warehousing space.

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

Visual inspection of parenteral vials is the first step in a root cause investigation.

The Chinese facility was cited for data integrity violations.

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

A vessel for the Hanson Research Vision G2 series of dissolution testers is designed to provide more consistent vessel-to-vessel dissolution test results.

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Process analytical technology paved the way for continuous manufacturing.

SPECTRO XEPOS spectrometers handle rapid screening elemental analysis and support product quality control at-line for the manufacture of pharmaceuticals.

Live Track focus tracking technology on the Renishaw inVia Qontor Raman microscope enables the analysis of samples with uneven, curved, or rough surfaces.

The Litesizer 500 from Anton Paar determines particle size, zeta potential, and molecular mass by using light-scattering technology.

The Metrohm 917 Karl Fischer Coulometer is a stand-alone coulometer for routine water analysis.

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia .