PharmTech Products

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

The penetrometer PNR 12 from Anton Paar, used for quality monitoring, features the Pharma Qualification Package--Smart PNR 12, which fulfills GMP and United States Pharmacopeia (USP) regulations and can be used to perform qualification processes.

The NEMA 4X Operator Stations, from Ross, Charles & Son, include a 15-inch color touchscreen with Ethernet communications and emergency stop button with hermetically sealed contact block.

The FlexPro 50, from Groninger, is a modular filling and closing system designed to process vials, cartridges, and syringes, as well as vials in bulk and trays.

The Optima AUC from Beckman Coulter Life Sciences is an ultracentrifuge that determines molecular weight, size shape, and polydispersity.

Instruments are introduced for elemental impurity analysis and materials identification.

Texture analyzers can be used to evaluate wall hardness and elasticity of softgel capsules.

A program for calibration and routine testing of weighing instruments ensures accurate results.

Ross VersaMix Multi-Shaft Mixers are designed for sanitary and high-purity applications.

Peristaltic cased pump for upstream and downstream biopharmaceutical applications from Watson Marlow Fluid Technology Group.

The Anritsu Capsule Checkweigher from MG America achieves high throughput of up to 230,000 capsules per hour.

The Flexi-Cap Protect from Schreiner MediPharm.

MG America’s Anritsu Capsule Checkweigher delivers accuracy at high speeds.

Watson-Marlow Fluid Technology Group’s 530 peristaltic pump includes an enhanced operator and control system interface.

A new body type for diaphragm valves from Burkert Fluid Control Systems offers advantages for hygienic environments.

The Dara Moduline is a compact modular solution for filling vials, syringes, and cartridges.

Steriline’s enhanced robotic aseptic vial filler and capper line includes RA-V4 Rotary Vial Washing Machine, a depyrogenation tunnel, the RVFCM50 Robotic Vial Filling and Capping Machine with Isolator, and an EDM-C External Decontaminating Machine.

The Planeta 200 Capsule Filler’s modular design can be configured for a variety of production requirements.

AdvantaPure’s BioClosure container closures are intended to save time and money on inventoried parts, assembly, and cleaning validations.

Optima introduces OPTIMA H4 and the Multiuse series for multiple filling operations.

Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.

The syriQ Rigid Cap (SRC) and SCHOTT TopPac Rigid Cap (TRC) closure systems from Schott use an intuitive twist-off mechanism for ease of use and container closure integrity.

The Spark 20M multimode microplate reader has the ability to read 6- to 1536-well microplates and includes a high-frequency xenon flash lamp that can be combined with detection modules.

The Dionex Integrion High-Pressure Ion Chromatography system from Thermo Scientific includes high-pressure capability and electrochemical detection.

The Zeiss Smartproof 5 wide-field confocal microscope is designed for applications in quality assurance and quality control, production, and R&D laboratories.

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.