Analytics

The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

A case study presents important lessons for using average and individual results, as well as user requirements, when qualifying a laboratory refrigerator.

The past several months have seen new product releases and updates made to already available laboratory equipment.

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.

In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems.

The portable Flexible Screw Conveyor from Flexicon can be tilted and rolled to serve multiple functions.

The LogTag UTRID-16 Data Logger System from CiK Solutions GmbH includes a built-in USB connector, automatic PDF report generation, and six-level multi-alarm display.

Ross Engineering’s ASME tanks are custom built to serve a wide range of applications and processing requirements.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Endress+Hauser’s Memosens CPS171D pH electrode for hygienic and sterile biopharmaceutical processing provides stable measurements even after multiple cleaning and sterilization cycles.

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.

A venture between GEA and Siemens aims to familiarize more pharmaceutical companies with more modern control and continuous processing.

Solid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.

This article looks at five of the most common hurdles in packaging and labelling artwork and how to avoid them.