Novx Corporation, a leading supplier of cleanroom environment monitoring solutions, electrostatic charge (ESC/ESD) auditing, monitoring and training equipment plus other-related services, introduces the Applications Engineering Group (AEG). AEG was created to provide consulting and certification services, strategic development of ESD event detection products and services, EMI-related process control and product development and E78 testing. AEG is already working with many customers to define their applications and control requirements and providing process equipment compliance certification (E78). AEG works in parallel with the Novx Engineering Department to develop hardware and software solutions to meet the needs and new applications discovered working with customers better than any other in the industries we serve. Novx provides engineering services for most industries where ESD/EMI is a critical problem. Some of the industries include but are not limited to aerospace, disk-drive, flat-panel, electronics, pharmaceutical, military, semiconductor and many more.

Novx engineers and technicians are experienced across a broad range of industries and manufacturing processes. Technical evaluations can include specific tool evaluation, testing, certification, detailed manufacturing process analysis and research or manufacturing facility assessments. Formal reports based upon investigations are comprehensive and include advanced analysis methods to provide clients with the maximum usefulness in managing interference issues in their process or facility.

Services
Applications Engineering (Tool/Process): Engineering assistance provided to client engineering staff to resolve ESD or related contamination problems.

E78 Auditing (Process/Facility/Tool): Specialized ESD audit and facility (equipment end-user) tool verification services for SEMI E78-1102.

ESD/EMI/RFI/ELF Investigation (Process/Facility/Tool): Investigations for ESD/EMI/RFI/ELF to determine causes of product damage, tool or process interrupt and lockup.

ESC/ESD Materials and Products Qualification (Lab): The application of standard ESDA and other specialized tests for material ESC/ESD characteristics, independent electrostatic control products evaluation
ESC/ESD Surveys (Process/Facility): A survey of a facility and/or process to determine scope of work based upon sampling of production or process elements.

S20.20 Program Assistance: Can be provided at all levels from devising customized ESC/ESD programs for specific facilities and areas, training production staff and technicians in ESC/ESD safety and metrology issues, to assisting a customer in moving to full S20.20 Standard compliance

Ionization Evaluation (Tool/Room/Process): Application of standard and specialized tests for ionizer effectiveness for a specific product or process

Sensor Installation and Verification (Process/Facility): Installation, evaluation and verification of interference sensors to determine area coverage, sensitivity, gain settings and data collection methods

On-site Technical Training: Training for engineering and/or production staff on specific methods, tools and protocols for ESC/ESD control.

Installed Tool Interference Auditing: Verification of critical environmental interference potential for proposed tool installation sites or for tools experiencing possible interference problems.

Benefits
Formal compliance program development
Enhanced process metrics
Better yield control
New manufacturing process development
Third-party solution validation
Specification development
Rapid interference identification
Solution path identification

Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food and Drug Administration (FDA) today issued a final report that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.

The report describes the accomplishments and plans for the future resulting from FDA’s completed assessment of the current good manufacturing practice (CGMP) regulations, current practices, and the new tools in manufacturing science that will enable a progression to controls based on quality systems and risk management.

“Americans must have confidence in the quality of their medications even as we face more sophisticated technology and manufacturing processes,” HHS Secretary Thompson said. “This final report provides clear guidance for both FDA and manufacturers to implement a risk-based quality assessment system that will ensure that the drug supply in the United States is of consistently high quality.”

“The accomplishments and next steps announced demonstrate FDA’s commitment and continued progress toward modernizing the regulation of manufacturing and product quality for both human and veterinary drugs as well as biological products,” said FDA Acting Commissioner Dr. Lester M. Crawford. “FDA’s CGMP Steering Committee has completed its two-year assessment of existing CGMP programs, and the agency has begun to implement a new scientific and risk-based approach to pharmaceutical manufacturing and product quality.”

FDA’s initiative has focused on its current regulation of pharmaceutical quality, encompassing veterinary and human drugs, and select human biological drug products such as vaccines. The report issued today addresses FDA’s findings, which put the agency on a path to develop the product quality regulatory system of the future. The report describes specific steps the agency is taking to achieve this system. Some of these include:

The formation of a Council on Pharmaceutical Quality that will be charged with policy development and continuing change management, including the ongoing implementation of certain quality management systems within FDA relating to pharmaceutical quality regulation;

A first step in establishing a new risk-based pharmaceutical quality assessment system is to replace the current chemistry, manufacturing and controls (CMC) review system, in the Office of New Drug Chemistry within the Center for Drug Evaluation and Research;

The issuance of a draft guidance on the role of quality systems in the pharmaceutical current good manufacturing practice regulations to ensure agency regulatory practices encourage similar progress in the pharmaceutical industry as well as enabling manufacturers to tailor their quality system to fit their specific manufacturing environment;

More systematic risk-based approaches to inspectional oversight of pharmaceutical manufacturing, beginning with pilot implementation of a risk-based model for prioritizing domestic manufacturing sites for many human drug CGMP inspections;

The issuance of a final guidance on aseptic processing used in the manufacturing of sterile drugs, encouraging the adoption of modern science and technology and risk-based approaches;

The issuance of a final guidance on Process Analytical Technology (PAT) ¿ a framework for allowing regulatory processes to more readily adopt state-of-the-art technological advances in drug development, production and quality;

The publishing of a draft guidance on good manufacturing practice for combination products, (i.e., products combining components from two or more of these regulatory categories: drug, device, or biological product);

Continued active collaboration with the International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), leading to the implementation of an internationally harmonized plan for a pharmaceutical quality system based on an integrated approach to risk management and science;

FDA’s decision to seek membership in the Pharmaceutical Inspection Cooperation Scheme–a cooperative agreement among national health regulatory authorities whose purpose includes leading international development, implementation, and maintenance of harmonized CGMP standards and Quality Systems of world-wide pharmaceutical inspectorates.

In addition, the following accomplishments underscore the agency’s commitment to realizing the specific goals of this initiative:

A proposed rule amending Part 11, Electronic Records, Electronic Signatures ¿ Scope and Application is expected to be published for public comment in 2005;

A draft guidance on the use of computerized systems in clinical trials, once finalized, will replace the guidance of the same name issued in April 1999;

The implementation of a technical dispute resolution process for CGMP disputes;

The upcoming finalization of guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to chemical entities, protein drug products and biological products;

Improved integration of the preapproval and CGMP inspection programs through training, certification, and Center detail opportunities for the 26 candidates, who have just completed their first level of training, chosen for the Pharmaceutical Inspectorate;

The implementation of a revised Charter by the Team Biologics Operations Group that adopts a quality systems management framework, improves processes for communication and coordination between headquarters and the district offices, and further integrates product specialists into the program.

Making improvements in the way we regulate pharmaceutical manufacturing and product quality is necessary to require the use of the best scientific data available, to develop quality standards, and to use efficient systems and practices that will provide clear and consistent decisions and communications for the regulated industry and the American public.

The progress that is being made reflects the agency’s commitment to the consistent adoption of risk management principles and a strong, robust inspection and enforcement program centered on the protection of the public health of all Americans.

More information on this major initiative, as well as the final report, is available online at http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

AdvantaPure is pleased to announce its International Distribution Network, offering customers in North and South America, Europe, Asia, and Australia quick access to the company’s products. The Network allows nearly worldwide coverage of AdvantaPure’s sanitary tubing, hose, fittings, and assemblies for markets such as pharmaceutical, biomedical, food, beverage, dairy, cosmetic, chemical, and others involving high purity applications.

“It’s exciting to be able to offer our products on an international basis,” says John Stover, Director of Sales. “Customers can get the hose they need more quickly and at less shipping expense and travel time. The Network also speeds worldwide introduction of new products, such as Hose Track, our Hose Lifecycle Analysis System.”

AdvantaPure distributors included in the Network are found in the United States and Puerto Rico, Canada, Brazil, Belgium, Sweden, Finland, Japan, Korea, and Malaysia. Additional distributors are continually researched and added to the Network to enhance worldwide coverage.

Distributor selection is based on a number of factors including current market knowledge and reach, staff, length of time in business, other product lines carried, warehouse size, hose assembly capabilities, geographic coverage area, and other branch locations. Chosen distributors receive in-depth training, sales and marketing materials, and attentive service from knowledgeable AdvantaPure team members.