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Tubing/Hose Clamps



Product: Overmolded Tri-Clamp ends

Applications: Sanitary fluid management, single-use processing

Features: AdvantaPure Overmolded Tri-Clamp ends for PVC, TPE, and TPR tubing and hoses are injection molded from USP Class VI Hytrel material or polypropylene in Tri-Clamp and Mini Tri-Clamp styles. A smooth transition from tubing to clamp reduces bacteria entrapment potential for cleaner connections. The clamp materials are mated thermally (no leachable adhesives) to PVC, TPR, or TPE hoses and certified free of animal-derived ingredients. Miniature through1.5-in. Tri-Clamp sizes are available, as well as made-to-order assemblies, with documented quality control.

Contact New Age Industries

www.advantapure.com

Automation Guide



Literature: GAMP Good Practice Guide: Calibration Management

Applications: Analytical laboratories

Features: For its second edition, ISPE’s GAMP guide to calibration management provides insight into a risk-based approach to validation and regulatory compliance. The guide provides guidance for setting up calibration management systems in analytical laboratories that support GMP development and manufacturing. It describes the principles of calibration and provides a structured approach to formal criticality assessment, management, documentation, and corrective actions. The widened scope includes related industries and analytical instrumentation.

Contact International Society for Pharmaceutical Engineering

www.ispe.org

HIC Membranes



Product: Sartobind phenyl membranes

Applications: Downstream processing (purification and polishing) of therapeutic proteins

Features: This is the first membrane adsorber for hydrophobic-interaction chromatography (HIC). The hydrophobic phenyl ligand is covalently attached to a >3-µm cellulose membrane. Target molecules bind to the membrane at buffer conditions like those for conventional HIC columns, but flow rates can be increased by at least 10-fold, ensuring faster processing with less buffer consumption.

Contact Sartorius Stedim Biotech

www.sartorius-stedim.com

Polymerase Chain Reaction

Product: CFX96 optical reaction module

Applications: qPCR genetic analysis for cell line development/characterization

Features: This module converts a C1000 thermal cycler into a powerful and precise real-time PCR detection system. Factory calibration minimizes set-up time. Data are collected from all wells during multiple data acquisition modes. A thermal gradient feature optimizes reactions in a single run. CFX Manager software provides tools for performing normalized gene expression analysis. Users can configure the system to run without a computer, run up to four systems from one computer, or integrate with an automation system for higher throughput.

Contact Bio-Rad Laboratories

www.bio-rad.com

Low-pH Chromatography

Product: Single-use AxiChrom column bed supports

Applications: Acidic/corrosive chromatography conditions

Features: GE Healthcare’s extended AxiChrom column platform now includes disposable plastic bed supports. For multipurpose plants, a column tube swing-out facilitates bed support exchange for large and small columns. High chloride concentrations and low pH levels can corrode metals. These plastic bed supports offer the same level of regulatory compliance as the columns themselves, meeting the requirements of USP Class VI as described in USP <88> and 21 CFR Part 177. The supports comply with EMEA/410/01 Rev. 2 as free from animal-derived components.

Contact GE Healthcare

www.gelifesciences.com

Clinical Supply

Service: Contract fill and finish with automated systems

Applications: Clinical trial materials quality control

Features: Catalent Pharma Solutions installed electronic verification applications at its clinical supply services facilities in Philadelphia, PA, and Schorndorf, Germany. The automated scan-and-assemble system in Philadelphia eliminates randomized schedules and manual employee checks on the labels of each patient kit. It was designed and validated to support large, global phase 3 clinical trials and will be deployed at all Catalent packaging sites. The German facility uses a label-check station (LCS) to check for errors and discharge defectives before products are labeled.

Contact Catalent Pharma Solutions

www.catalent.com

Sterile Disconnection



Product: Kleenpak sterile disconnectors

Applications: Single-us
e and hybrid fluid management and process systems

Features: Kleenpak sterile disconnectors provide secure, sterile disconnection of flexible tubing assemblies even in uncontrolled environments, maintaining sterility of fluid paths before and after disconnection. Each disconnector consists of joined male and female units to fit tubing 13-mm (0.5-in.) ID tubing. They can be autoclaved ≤130 °C or gamma irradiated ≤50 kGy. Pall Life Sciences can customize Allegro single-use systems with these disconnectors.

Contact Pall Life Sciences

www.pall.com

Small-Scale TFF



Product: KrosFlow Research IIi tangential-flow filtration system

Applications: R&D scale microfiltration and ultrafiltration processing of proteins, cells, viruses, and other macromolecules

Features: The KrosFlo Research IIi TFF system comes with a digital pressure monitor integrated into its peristaltic pump, both functions controlled by the same PLC/HMI. Four pressure measurements are displayed: feed, retentate, permeate, and transmembrane pressure. A high-pressure pump shutoff helps maintain membrane integrity. An automatic backpressure valve accessory can be used to maintain process pressures without fluid contact.

Contact Spectrum Laboratories, Inc.

www.spectrumlabs.com

Small-Scale Filling



Product: 520Di dispensing pump

Applications: Vial/bottle filling for vaccines and diagnostics; filtration, fermentation, and dispensing

Features: This peristaltic pump accepts a range of tubing materials up to 9.6 mm ID for 4 µL/m to 3.5 L/min flow rates and pressures ≤100 psi. A ramp- and-drip feature allows soft start and graduated dosing to reduce splashing and foaming. Users can recalibrate without disturbing batch flow. The brushless DC motor has a 3,500:1 speed range and a 1,000,000:1 flow range. A number of different pump-heads can be fitted for user needs.

Contact Watson-Marlow Pumps Group

www.watson-marlow.com

Process Automation

Service: PlantPAx system

Applications: Automated system monitoring and control

Features: Rockwell Automation’s PlantPAx system release 2.0 has new features for high availability, device integration and asset management, design productivity, batch and sequencing control, and operations productivity. A new focused program will help equipment manufacturers and skid builders reduce overall costs and minimize time to market while simplifying integration of their equipment into users’ process systems. The system is available in the first quarter of 2011.

Contact Rockwell Automation

www.rockwellautomation.com

Titration Specialists

Service: Good Titration Practice program

Applications: Research, analytical, and development laboratories

Features: Mettler Toledo’s Good Titration Practice program covers the entire life cycle of its titration systems. The program covers evaluation and selection of appropriate analytical instrumentation, installation and qualification of chosen systems, and routine operation. The company offers comprehensive support and services through GTPSecure packages: EduPacs packages for education, IPacs packages for initial qualification, EQPacs packages for equipment qualification package, and preventive maintenance packages to minimize risk of equipment failure.

Contact Mettler Toledo

www.mt.com/GTP

Research Tool

Service: SciFinder

Applications: Chemical research and chemical synthesis development

Features: CAS has added time-saving advancements and usability improvements to its SciFinder research and discovery tool. CAS chemists incorporated new features that enable researchers to view experimental procedures in context with their reactions. Users can search structures using SMILES and InChI strings and rank reactions by relevance. The feature is designed to bring the most relevant reactions to the top of a user’s answer set, improving retrieval quality and speed.

Contact Chemical Abstracts Service

www.cas.org/products/scifindr

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