Products, Services, and Literature October 2008

Mixing Options

Product: PSU-20 microcompressor

Application: Biotechnology/biopharmaceutical development and academic research

Features: A new bench-top heavy-duty platform shaker provides three mixing functions (orbital motion, reciprocation, and vibration) and the flexibility of a range of interchangeable platforms. It includes a high-capacity, four-level “hotel” format platform to minimize its footprint. The mixing functions are fully programmable and can be set for continuous or timed operation from one minute to 96 hours to achieve optimum mixing in a single mode or in different combinations of the three functions. The unit comes with interchangeable platforms to accommodate different sized flasks, beakers, Petri dishes, and other laboratory vessels. It measures 140 × 485 × 520 mm and features a loading capacity of 15kg, a two-line 16-character LCD display, and a powerful but quiet motor.

Contact Grant www.grant.co.uk

Small Batch Filling

Product: FPC50 filling machine

Application: Clinical trials and scale-up

Features: The FPC50 is a compact, operator-friendly, fully automated filling and plugging system that offers accuracy and flexibility for aseptic filling, capping in clinical trials, and scale-up applications. The system can use a changeover of the single-use fluid path, which includes pharmaceutical-grade silicone tubing and plastic filling needles to adapt to multiple batch processes or different product fill volumes. The system is equipped with an automated precision turntable infeed, an in-line filling station, and a rubber plug closure applicator that can fill and cap vials at rates up to 25 vpm.

Contact: Watson-Marlow Flexicon www.flexiconamerica.com

Separation/Purification Catalog

Literature: Pall Life Sciences OEM media guide

Applications: Filtration, separation, and purification

Features: Pall’s new 140-page catalog presents the company’s comprehensive line of OEM products — membrane, media, and separation materials — for diagnostics, research, and health-care applications. Each application section contains detailed information about the materials and how to select the optimal one in specialty markets. Complete product information about each membrane is provided, including target applications, product specifications, sealing mechanism recommendations, performance data, and ordering information. Sealing guidelines, chemical compatibility recommendations, and market summary charts are included.

Contact: Pall Corporation www.pall.com.

Increased Service Options

Product: e-Clinical Solutions

Applications: Clinical trials

Features: ClinPhone plc, a clinical technology organization, has been acquired and is being combined with Perceptive Informatics, Parexel’s wholly owned technology subsidiary. The combined company will offer clients and service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. These include ClinPhone Interactive Voice and Web Response Systems (IVRS/IWRS); Perceptive Medical Imaging; DataLabs, an Electronic Data Capture (EDC) and clinical data management system; and Clinical Trial Management Systems (CTMS) including IMPACT enterprise CTMS solution; TrialWorks CTMS solution for small and mid-size companies, and Electronic Patient Reported Outcomes (ePRO).

Contact: PAREXEL www.parexel.com

Steam Testing Service

Product: Steam-in-place testing

Application: Sterilization, fluid flow

Features: A new steam-in-place (SIP) testing service for hose assemblies is available from Saint-Gobain. During SIP sterilization, hoses are exposed to severe conditions that can adversely affect the service life of the product. SGPPL tests hoses with automated equipment that reproduces the processes end users use on their production lines. This service enables customers to obtain information on the effects of their specific sterilization protocol and operating conditions on the company’s hose assemblies. The company develops, manufactures, and assembles a full line of silicone and fluoropolymer lined hoses for pharmaceutical and biotech applications.

Contact: Saint-Gobain www.saint-gobain.com

Genderless Connection

Product: Disposable aseptic connectors

Applications: Biopharmaceutical production (especially with disposables)

Features: ReadyMateT genderless disposable aseptic connectors (DAC) for biopharmaceutical production offer a safe, economic, and simple connection option for assembly components, such as media bags and tubing for upstream and downstream applications. They decrease parts inventories and eliminate the need for unique operator skills, specialized equipment, calibration, or servicing. The validated closure mechanism provides users with the flexibility to quickly establish aseptic connections in noncontrolled environments. Connectors come in a range of tube sizes, from 0.24” to 0.75” (6.4–19.1 mm), are designed to work under high flow pressures, and can be gamma sterilized or autoclaved.

Contact: GE Healthcare www.gehealthcare.com

Flow-Rate Measurement

Product: FlowCal 5000 digital liquid flow meter

Applications: HPLC instrument calibration and qualification

Features: The FlowCal 5000 is designed for chemists, metrologists, and validation/qualification specialists responsible for HPLC instrument calibration and qualification. The digital flow meter measures flows accurately to 1.0% of the reading, with guaranteed linearity from 0.05 to 25.00 mL/min. No user calibration is required; it’s supplied calibrated at 1.0 (±1.0%) mL/min, and calibration at multiple points is available. The instrument substantially reduces HPLC pump troubleshooting time, and leaking piston seals or check valves are easily diagnosed. The unit comes with a carrying case with foam inserts, a cleaning kit, a universal mounting kit, and an optional miniature thermal printer.

Contact: Tovatech www.tovatech.com

Cell Culture Analysis

Product: Photometric biochemistry analyzer

Application: Analysis of cell culture chemistry

Features: CuBiAn is a fully automated, membrane-free chemical analyzer that measures key parameters in cell culture media. All assays are prepared, incubated, and measured by the instrument. Pipetting, sample predilution, and temperature control are all automated to provide significant assay ranges. The analyzer can detect IgGs (by immunoturbidometry) and 11 different metabolites (by photometric enzyme assays) in a single sample and sequence. Key parameters measured are IgG (human, humanized), glucose, lactate, ammonia, glutamine, glutamate, inorganic phosphate, LDH, total protein, and Na⁺, K⁺, Cl^–. Barcode detection of samples and reagents ensure traceable analysis results. The unit requires low sample volumes and provides 90 results/hour.

Contact: innovates www.innovatis.com

Multiuse Closures

Product: Container closures and stoppers

Applications: Aseptic and sterile environments

Features: These closures and stoppers are biologically safe for pharmaceutical, biotech, biomedical, and laboratory environments to assure aseptic fluid transfer, sealing, filling, and sampling. The pure, platinum-cured silicone is free of animal-derived ingredients and meets USP Class VI and FDA standards. Closures are designed for carboys, flexible container systems, solution and media bottles, and other vessels. They work equally well with stainless steel, glass, and plastic and are injection-molded in a clean room environment, which provides finished products with smooth, gap-free surfaces for a true seal. These closures and stoppers resist temperatures from –100 °F (–73.3 °C) to 400 °F (204.4 °C) as well as cracking, particle migration, and attack from a variety of chemicals. They are sterilizable by autoclave or gamma radiation.

Contact: AdvantaPure www.advantapure.com

Syringe Protection

Product: V-OVS NS needle shield

Applications: Injectable products

Features: The V-OVS NS needle shield is designed for glassbarrel syringes with staked needles and features a patented tamper-evident closure for product integrity. The syringe it comes on is activated by separating the syringe cap from the ring in a steady, axial movement (as with other needle shields). The ready-to-use closure protects sterilization processes in the area of the needle while providing an aseptic seal for the filled system. These syringes can be processed on existing aseptic production equipment without the need for major modification — and process flows remain unchanged. The units are recommended for anticounterfeiting and patient-friendliness programs.

Contact: Vetter Pharma-Fertigung GmbH & Co. KG www.vetter-pharma.com