Help for Facilities Grappling with 21 CFR Part 11
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.
Web Services for Quality Tracking
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.
PLM Sharpens Pharmaceutical Development
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.
Inert Valves Meet Highest Purity Standards
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.
One-Pass Gum Dispersion
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.
Intense Mixing for Small Quantities
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.
MPE Group USA, Jongia Div.
Finishing & Packaging
Nonchemical Sterilization Process for Nonwovens
E-Beam offers a non-chemical process for the bioreduction and sterilization of nonwovens, permitting manufacturers and packagers to assure product integrity without the use of alcohol or chemical additives. The process is suitable for clean room wipes and other products.
E-Beam Services, Inc.
Package Analyzer Doesn't Need An Operator
PBI-Dansensor analyzer allows manufacturers and packagers of pharmaceutical vials, parenterals, transdermals and medical devices to obtain accurate readings of package oxygen. Unlike gas chromatographs, which require 30 to 40 h of operation for a test and depend upon operator skill level, these devices allow for fast accurate readings at low cost, according to the manufacturer. The device has also been designed to operate without regular calibration. In addition, the devices require as little as 2 cc of air for analysis.
PBI-Dansensor America Inc.
Peristaltic Pumps Improve Filling Accuracy
New peristaltic pump is designed to achieve highly accurate filling and faster clean-up validation. With the Multi Filling System, according to the manufacturer, sterile product comes into contact only with the device's medical-grade silicone tubing and filling needle. Once filing is completed, the tubing can be cleaned easily or disposed of. The filling unit is available in a range of sizes from stand-alone models for smaller facilities, to systems with up to 16 drives and filling needles controlled by one master control. Filling volumes range from 0.1 ml to over 1 L.
Flexicon America, Inc.
Encapsulation Services Offered
This company is now a licensee of microsphere and encapsulation systems developed by the German company, Brace GmbH. The technology allows for microspheres to be formed, or capsules to be made via sol-gel processing, mixture with binders or melt processing. The spheres feature tightly controlled particle size distribution for pharmaceutical and other applications, and can be made in sizes ranging from 50 to 100 microns up to 5-8 mm in diameter.
Harper Technology Development Center
Facilities & Support
Hand-held Wand Wipes Out Contaminants
SterilWand hand-held device uses the company's patented UVC technology to decontaminate surfaces, ridding them of mold, bacteria or viruses. The user slowly passes the device over surface areas. The company also offers installed UVC devices to decontaminate air-conditioning coils, ductwork and other HVAC components.
Expanded Series of Tank-Cleaning Nozzles
Line of tank and vessel cleaning nozzles has been redesigned and expanded, allowing use for a wide variety of tank sizes and cleaning tasks. The company's "whirling nozzle" now features a double-race bearing for flexible mounting, all 316-L stainless steel construction, and improved vertical coverage. It can also fit through smaller openings than previous versions, according to the manufacturer. Meanwhile, the company's AccuClean nozzle features more compact gearbox, wider spray coverage, and improved self-cleaning capabilities. Lechler, Inc.
Dehumidifier Offers Cost Savings
Multiple Small Plate (MSP) dehumidification technology offers up to 50% reduction in energy costs, lowering capital costs and speeding return on investment, according to the manufacturer. The system allows warm, humid air to pass through plate air-to-air heat exchangers for pre-cooling. This pre-cooled air then passes over ordinary refrigeration coils for final cooling and dehumidification. Smaller compressors are used, requiring half the power of conventional technology via hot gas reheat coil evaporatorsMSP Technology, LLC
Silicone-Jacketed Hose Improves Safety
Made of steel-overbraided polytetrafluoroethylene (PTFE) covered with pure silicone, hose is designed to maintain cleanliness while protecting users from high temperatures. The jacketing prevents particle entrapment, which can be a problem with nonjacketed hosing. Temperature range is "275F to 500 (-171C to 260C), and is especially suitable for high-temperature sanitary applications, according to the manufacturer.
New Age Industries Inc.