PharmTech Products

There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

The IH-TMS Tool Management System from I Holland monitors tool rotations, tooling inventory, and maintenance.

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

High Speed Dispersers from Ross feature a National Electrical Manufacturers Association (NEMA) 7&9 Operator Panel and grounding systems.

The Class 100 cleanroom oven from Grieve is used for a variety of heat processes such as sterilizing, depyrogenation, curing, and drying workloads.

National Bulk Equipment’s material handling system for non-free flowing materials can be specified to meet cGMP cleanability standards.

Biocorp’s Easylog smart sensor for insulin delivery devices enhances compliance.

Honeywell Process Solutions’ Honeywell Pulse app brings notifications, real-time plant performance data, and analytics directly to mobile devices.

The Vacuum De-aeration Apparatus from Copley Scientific is used in semisolid pharmaceutical testing for de-gassing the medium used in vertical diffusion cells (VDCs) to measure the drug release profile of semisolid products.

The Ross X-Series is a clean-in-place (CIP) ready ultra-high shear mixer for inline emulsification, particle size reduction, and homogenization.

The Kimtech Pure A4 Sleeve Protector from Kimberly-Clark Professional features barrier protection that shields workers and the garment from hazardous chemicals and biologics.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

The Alfa Laval Safety Valve, a true spring-loaded safety valve, is designed to protect both equipment and people.

Sensaphone's monitoring system provides low-cost, 24/7 remote monitoring of unattended freezers and coolers.

An ultraviolet light (UV) spectrophotometer system from Hanson Research automatically handles samples for pharmaceutical dissolution and diffusion testing.

The Prominence-i LC-2030 LT is a new model of Shimadzu’s i-Series integrated high-performance liquid chromatograph and ultra high-performance liquid chromatograph systems.

The Ross AMK Kneader Extruder combines the technologies of a double-arm mixer with an extrusion screw.

The BioClamp Plastic Tri-Clamp, from BioPure Technology, part of the Watson-Marlow Fluid Technology Group, is a patented plastic union tri-clamp meant to reduce distortion on polymeric fittings when subjected to heat.

The DF30Plus, a new version of Aptar Pharma’s aerosol metering valve for pressurized metered dose inhalers (pMDIs), incorporates an elastomeric cyclic-olefin-copolymer (COC) neck gasket.

AdvantaPure’s TPE tubing with pre-sealed ends can be used in sampling or storage to save time.

Rockwell Automation’s updated PlantPAx DCS enhances automation and control.

Millipore Express PHF hydrophilic, sterilizing-grade filters from EMD Millipore offer faster flow rates to speed the process or reduce the process footprint.

KnowItAll spectroscopy software from Bio-Rad Laboratories corrects differences in spectra data.

The ReactoMate Datum controlled lab reactor system accommodates a range of vessel sizes.

Charles River offers the Endosafe nexgen-PTS endotoxin testing system.