BPI Contributor

November 1, 2008

6 Min Read

Stainless Steel Sanitary Fittings


Product: Swagelok Sanitary Fittings

Features: Offered in up to 12-in. diameters in a variety of configurations, Swagelok sanitary fittings are available to meet ASME-BPE and 3-A standards, as well as ISO 2852 requirements. They feature polished and unpolished inside- and outside-diameter surface finishes. Swagelok sanitary fittings are typically used in biopharmaceutical and food, beverage, and dairy process systems, such as water and fermentation. The vacuum annealed, cold form tubular fittings minimize the likelihood of stress corrosion cracking. Tolerances, angularity, squareness, ovality and polish finishes are monitored by statistical quality control. The fittings are offered with Kwik-Clamp, tube butt weld, acme threaded and plain bevel set, and specialty end connections, and available in 304 and 316L stainless steel construction. Many machined sanitary fittings can be provided in alloy C-276, titanium, and alloy 6-moly on special order.

Contact Swagelok www.swagelok.com

Disposable Connection


Product: Kleenpak sterile connectors

Applications: Fluid transfer

Features: The disposable Kleenpak connector from Pall Life Sciences allows for dry connection of two separate sterile fluid pathways while maintaining the sterile integrity of both. Connections can be made in seconds anywhere — even outside a controlled-air environment. Applications include transfer of inoculums to reactors, sampling during fermentation or cell culture, connection of small sterile equipment to large equipment (e.g., bioreactors), handling of bulk material in a nonsterile environment, and connections from tanks to filling lines.

Contact Pall Corporation www.pall.com/allegro

Eco-Friendly Lab Freezers


Product: Ultralow-temperature (-86 °C) laboratory freezers

Application: Long- and short-term storage of culture samples

Features: New Brunswick Scientific’s Innova and Premium line freezers consume roughly half the power that other freezers of similar size do, potentially saving thousands of dollars in energy bills over the life of each one. Innova models feature specialized low-temperature seals on inner and outer doors and ice-proof inner door latches to prevent cold air loss. Use of heavy-duty compressors that reduce cycle times and a single powerful fan in place of a traditional two-fan system further improve energy savings. By reducing energy consumption, these ecologically friendly freezers not only save money, but reduce CO2 emissions by an average of 5,671 kg over a 10-year period.

Contact New Brunswick Scientific www.nbs.com/bi2

Safer Syringe

Product: Crystal Zenith RU prefillable syringe system

Applications: Packaging and administration of macromolecular therapeutics

Features: The market’s first silicone-free, ready-to-use prefillable syringe system offers pharmaceutical and biopharmaceutical companies a total system solution that can mitigate the risks associated with glass syringes. Its 1-mL Luer lock system is suited for packaging and administering large-molecule biopharmaceuticals and vaccines. The syringe barrel is made from a break-resistant material that helps reduce product loss during filling, shipping, storage, and administration. It is transparent and drainable, can be autoclaved at 121 °C, and tolerates freeze drying and liquid-N2 exposure. The system includes a piston and nozzle cap with a proprietary lubricating barrier film on all drug-contact surfaces, so there is no need to apply free silicone oil.

Contact West westpharma.com

Flow-Rate Measurement

Product: FlowCal 5000 liquid flowmeter

Applications: HPLC IQ, OQ, PQ, and calibration

Features: The FlowCal 5000 is designed for chemists, metrologists, and validation specialists responsible for HPLC instrument calibration and qualification. Flow-rate measurement with this instrument is easier, faster, and more accurate than using a timer while manually collecting fluid for gravimetric or volumetric measurement. The digital flowmeter measures flows accurately to 1.0% of the reading with guaranteed linearity of 0.05–25.00 mL/min. No user calibration is required; the instrument is supplied calibrated at 1.0 mL/min (±1.0%), and calibration at multiple points is available.

Contact Tovatech www.tovatech.com/liquid_flow_meter.html

High Capacity Resins

Product: Toyopearl GigaCap ion-exchange resins

Applications: Protein purification (downstream processing)

Features: Toyopearl GigaCap ion-exchange resins were designed for the capture and large-scale purification of antibodies and other therapeutic proteins. These resins have higher dynamic binding capacities than, and the fastest elution mass transfer kinetics of any other currently available comparable resin. Based on the proven polymer technology of the product line, the resins provide users with an opportunity to increase process throughput both through the use of higher loads for a given column configuration and the added benefit of a significantly enriched target elution stream in a greatly reduced total liquid volume. These resins come in two cation-exchange functionalities (Toyopearl GigaCap S-650M and Toyopearl GigaCap CM-650M) and one anion exchanger (Toyopearl GigaCap Q-650M).

Contact Tosoh Bioscience LLC www.tosoh.com

Reusable Cartridge Filters

Product: Solvex solvent filters

Applications: Filtration of solvent-based APIs

Features: Solvex cartridge filters provide customers with validated, robust, and cost-efficient sterile filtration for solvent-based active pharmaceutical ingredients (APIs). The cartridges are suitable for filtration of a wide variety of organic solvents and scalable to meet changing process needs. The robust design of these filter cartridges promotes a consistent, repeatable manufacturing process characterized by high-capacity, low extractables, and resistance to thermal and hydraulic stress. These cartridge filters can be reused multiple times, promoting an economical filtration process. They are available in 10-, 20-, and 30-inch sizes and can be steamed in place up to 135 °C.

Contact Millipore Corporation www.millipore.com

Allegro™ 2D Systems

Product: Allegro™ 2D Systems

Applications include: Cell culture media preparation and storage; Buffer preparation and storage; Chromatography fraction collection; Intermediate product storage; Bulk product storage prior to filling; Sampling.

Features: Pall Allegro 2D systems provide a high degree of flexibility for your process design. With volumes from 50 mL to 50 L, Allegro 2D systems are ideally suited for a wide range of applications from upstream to formulation and filling.

Contact Pall Corporation www.pall.com/allegro

Syringe Prefilling

Service: Contract packaging

Applications: Sterile liquid pharmaceuticals in prefilled syringes

Features: IDT Biologika has expanded its capability for packaging sterile liquid dosage pharmaceuticals in prefilled syringes. The company’s fully integrated services range from formulation development and clinical manufacturing through large-scale commercial production, packaging, quality control, and logistics. The company operats one of Europe’s integrated pharmaceutical and biological development and manufacturing facilities for sterile liquid dosage forms. It has experience in technically sophisticated projects — such as biopharmaceuticals, lyophilized compounds, narcotics, and “biosimilars.” Its facilities are EMEA- and FDA-inspected, and most were built within the past five years.

Contact IDT Biologika GmbH www.idt-biologika.de

Separation and Purification

Product: Protein separation columns

Applications: Protein separation and analysis

Features: Ethylene-bridged hybrid (BEH) protein separation technology columns are specifically designed to address today’s protein separation and analysis challenges. Benefits of this innovative column chemistry include excellent protein recoveries and extreme pH and temperature tolerance. These columns are effective with mass-spectrometric compatible eluents for LC/MS, and they are quality-control tested with diverse protein standards. Columns come with 3.5-µm (HPLC) and 1.7-µm (UPLC) particles. LC/MS analysis of monocolonal antibody fragments can be performed on the BEH300 C4 column.

Contact Waters www.waters.com

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