Products & Services

A bundled solution is designed to help building automation systems comply with 21 CFR Part 11. Built around this company's Apogee system, the platform also comes with a comprehensive series of services focusing on the procedural elements of compliance, including automated audit trails, electronic signatures and data security. Procedural elements include Part 11 gap analysis, compliance remediation and ongoing consultation.

To address long-term needs, the company also provides a compliance team to oversee ongoing developments, and to guide and support customers in the progressive applications of its compliance solution. The solution also meets the rigorous facility requirements of 21 CFR Parts 210 and 211.

Siemens Building Technologies, Inc.

http://www.sbt.siemens.com

Software provider now offers web-based services with its CATSWeb tracking system, designed to allow companies to simplify quality systems and integration while meeting 21 CFR Part 11 requirements. The new package can be used in an Internet or intranet environment, and can handle issues ranging from product quality and FDA compliance to safety, according to the company. The system can use any Web service, regardless of platform, location or data format without an integration server. In addition, users can extend functionality by adding their own web services for assisted data entry, data lookup or calculation, custom business rules and validation routines, or drill-down links to analytic information.

AssurX, Inc.

408-778-1376

http://www.assurx.com

Despite the importance of new product development, many companies still approach it randomly. According to some estimates, 41% of new product concepts will ultimately fail. Given the competitive pressures of the pharmaceutical and biotech industries, more companies are using product lifecycle management (PLM) software to help streamline the product development process and ensure its effectiveness.

Latest release of PLM package Accolade is focused on improving the impact of gate- or phase-based product developments. Accolade 5.0 organizes documents, resources and metrics; facilitates team communication; and provides access to the internal and external information and expertise necessary to inform decision-making throughout the product lifecycle. The software's latest version offers more than three dozen new or enhanced features, including industry-specific research centers that support assessment of product ideas, increase the quality of critical "go/kill" portfolio management decisions, and ensure that resources are aligned with strategic priorities. In addition, this version of the software has been designed specifically to comply with 21 CFR Part 11 and other regulatory standards.

Sopheon Corp.

952-851-7585

http://www.sopheon.com

Pure-Chem family of valves has been designed to address ultrapure fluid-transfer requirements, its manufacturer says. The inert, solenoid-operated devices are used for measuring, transferring and dispensing ingredients. The valves are offered as stand-alone components or in manifold-ready form. The stand-alone version features both two-way normally open and two-way normally closed versions as well as simple tube connectors for quick attachment. A less inert Pure-Chem isolation valve is also available for processes with less stringent purity requirements.

Bio-Chem Valve, Inc.

973-263-3001

http://www.bio-chemvalve.com

The ZC Powder Disperser is designed to incorporate and disperse hard-to-wet gums into a liquid stream in a single pass. The device's design allows for intense shearing of the gums prior to hydration, producing homogenous dispersions that are free of lumps and fish-eyes. Its manufacturer says that the unit will typically reduce batch times by 70% and result in powder savings of up to 30%. Three sanitary-designed models are available with 3A and USDA approval, offering throughputs from 3 to 120 gpm.

Quadro Engineering, Inc.

519-884-9660

http://www.quadro.com

Dynamic in-line mixer has been designed to achieve intensive mixing at short residence time, allowing small quantities of additives to be mixed continuously. The new mixers are particularly useful when an ingredient must be added just before the next step in a process or before filling takes place, according to its manufacturer. The standard model includes electropolished internals and is easy to clean or steam in place. In addition, it can be easily installed within existing piping and can be customized to meet specific requirements.