Point-of-Use Filtration

Product: SFE filter cartridges with -222 O-ring adapters

Application: Small-batch processing of liquids and gases

Features: New high-performance, small-flow–element filter cartridges with optional -222 O-ring adapters come in 2.5-in. (6.4-cm) or 5-in. (12.7-cm) lengths. They are designed for point-of-use filtration and small-batch processing of liquids and gases with flow requirements <3 gpm (11 L/min) or 60 scfm (102 Nm³/hr). These pleated small-area filters provide excellent chemical compatibility and low extractables. They offer a range of media and 0.04–99.00 µm filtration ratings for prefilters in glass and polypropylene microfiber and membranes in PES, PVDF, polypropylene, and PTFE.

Contact Meissner Filtration Products, Inc. www.meissner.com

Single-Use Tubing

Product: DAFPA sets

Applications: Aseptic or sterile processing

Features: Flexicon offers single-use tubing sets, each supplied complete with a validation package. The DAFPA (disposable aseptic fluid path) sets come double-bagged and gamma-irradiated ready for use. Various tubing set configurations are available. All include the required pharmaceutical-grade silicone tubing for pumps and, depending on the application, a sterile filter, aseptic quick-connect fittings, prefillable product bag, and/or filling nozzle.

Watson-Marlow Pumps Group www.wmflexicon.com

Chromatography Columns

Product: PROCHROM columns

Applications: Low- to medium-pressure chromatography

Features: Prochrom columns come in 800–2,000 mm diameters and function at 0–20 bar pressures. These columns implement a dynamic axial compression (DAC) method with a smart piston attached to a hydraulic jack. The piston is used to pack and unpack a column while keeping the stationary phase under dynamic (and adjustable) compression, ensuring efficiency and bed stability at any scale. The piston is automatically adjusted with swelling or shrinkage of the stationary phase to maintain a constant compression over time.

Contact Novasep www.novasep.com

Laboratory Sterilization

Product: Vigilair Room Surface sterilization system

Application: Surface sterilization

Features: The Vigilair Room Surface sterilization system (RSS) showed =5 log reduction of target pathogens when compared with other cleaning procedures at the Memorial Sloan-Kettering Cancer Center. This system uses ultraviolet energy (UV-C) to deactivate microorganisms that contaminate surfaces. UV-C emitters are strategically placed to bathe an entire laboratory with germicidal UV-C energy. Controls turn those off when a predetermined UV dose is achieved and prevents workers from being accidentally exposed.

Contact: Vigilair Systems www.vigilairsystems.com

PAT and QbD Software

Product: xPAT software

Applications: Collection, analysis, and management of processes and data

Features: xPat could help companies implement quality by design (QbD) through their products’ entire lifecycles. The software system collects, analyses, and manages processes and the data they generate to provide a comprehensive PAT package, which can help manufacturers implementing PAT to improve the quality and safety of their products. This Windows-based software takes data gathered by analytical instruments and analyzes it to assess the state of a process. It then feeds that information to a control system. The software can be used in conjunction with other tools.

Contact ABB Inc. www.abb.com

E-Learning

Literature: Drug Development Clearly Explained

Features: A new set of rapid-learning tools helps scientists and businesspeople learn the key points of drug development from laboratory to market rapidly, easily, and cost effectively. A 248-page e-book, Drug Development Clearly Explained, is hyperlinked to an 1,800-page guideline appendix and Internet reference and contains key points and quiz questions. The short summary e-book, Drug Development Summarized (available also in Japanese), is a 48-page, one-hour narrated PowerPoint presentation with a self-assessment quiz. A one-day Alladex course follows the development of a drug from laboratory to market interspersed with key points slides and discussion.

Contact Alladex www.alladex.com

Specialized Dose Forms

Service: Melt-extrusion blending

Applications: Blending of active ingredients and polymers

Features: Foster Pharma has changed its name to Delivery Science. It specializes in melt-extrusion blending of active ingredients and polymers and provides contract process development, scale-up, and manufacturing services in a CGMP cleanroom environment. The company serves start-up through top-tier companies in pharmaceutical and combination medical device markets. Services include blending active pharmaceutical ingredients (APIs) for oral, implantable, subcutaneous, transmucosal, and transdermal dose forms.

Contact Foster Pharma www.fostercorporation.com

Advanced Measurement

Product: Cubis premium balances

Application: Precision weighing

Features: The Cubis series of premium balances features a modular design that can be custom-configured and adapted to the changing requirements of different applications. From simple weighing to management of complex sequences using a user-password management feature, these balances advanced weighing requirements at the most sophisticated level. With finely graduated weighing capacities of ≤12 kg and 0.01-mg to 0.1-g readabilities, these are especially suited to laboratory weighing applications.

Contact Sartorius www.sartorius.com

Mycoplasma Control Filters

Product: Flourodyne EX EDT filters

Application: Bioprocess filtering

Features: Fluorodyne EX EDT filters have new hybrid sterilizing grade membranes for highest throughput and mycoplasma control. They incorporate MachV for high dirt retention, Ultipleat folds for enhanced surface area, and a narrow

core for increased speed. Their 0.1 µm sterilizing layer rated > 10 log reduction of Acholoplasma laidlawii at 107 cfu per mL. Laser barcodes simplify data capture. The filters are available in sheet, cartridge, and capsule formats.

Contact Pall Life Sciences www.pall.com

IEX Chromatography

Product: BioPro series columns

Application: Ion-exchange chromatography for proteins

Features: YMC-BioPro series ion-exchange chromatography columns for proteins and peptides are based on a new hydrophilic polymer with low nonspecific adsorption. They come in QA and SP chemistries and are based on 5-µm porous (QA and SP) or nonporous (QA-F and SP-F) hydrophilic polymer beads. Porous materials offer excellent binding capacities with high efficiencies and low operating pressures in 50 × 4.6 mm columns. Nonporous particles offer high efficiencies, exceptional resolution, and low operating pressures in 30 × 4.6 mm and 100 × 4.6 mm columns.

Contact YMC Separation Technology www.ymc.co.jp; www.ymcamerica.com; www.ymc.de

Job/Candidate Search

Service: ISPE Career Exchange

Features: ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, will expand its global online Career Exchange center to include a pilot network of local websites that serve pharmaceutical science and manufacturing professionals and employers. The network has pilot sites for a Boston-area chapter and a Singapore ISPE affiliate. It will ultimately expand to include worldwide ISPE affiliates and chapters after an initial testing period. Job-seekers and employers outside the pilot areas can access a multitude of global opportunities and reach candidates worldwide.

Contact ISPE www.ispe.org/careerexchange

On-Line Analysis

Product: SIMCA Batch On-Line software, version 3.3

Applications: Batch process monitoring

Features: The SIMCA Batch On-Line (SBOL) program is a multivariate analysis software that performs on-line batch process monitoring and control. It also provides an easy way to interpret batch “fingerprint” for a running batch. The software is compatible with SIMCA-P+, version 12. It allows comparison between a running batch and a training-set batch, allows plotting of two process variables on the same chart, and has improved memory use and catch-up functionality.

Contact Umetrics www.umetrics.com