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  • Seals of Approval
    share of design challenges opportunities, Coyle calls them particularly regarding the customization of the filling equipment to meet the needs of product and process. Foremost among these challenges was devising a means to ensure that particles of budesonide, Pulmicort s active ingredient
  • Orr on Engineering: Practical Realities in Product Design
    Orr on engineering: Prose of documentation, passion of design The engineering cycle roughly consists of requirements capture, conceptual design, detailed design, prototyping and refinement, design approval, production- process design, production, and deployment and support. This linear list is neat
  • Transformers supplier -FDA Section 510 (k) Approval
    Medical Original Equipment Manufacturers (OEMs) are required to. submit an FDA Section 510 (k) application when they plan to market. a new equipment design. Section 510 (k) of the U.S. Food, Drug and. Cosmetic Act allows the FDA to determine whether the device is. equivalent to similar equipment
  • Quality by Design in the Design Space
    . Monitoring the parameters of drug attributes results to less process and ultimately, less product variability. The advantage of the design space is it provides a wider range within which material attributes can vary in the future without supplemental FDA approval, said Chen. QbD also helps make
  • Part and Mold Design (.pdf)
    equipment. These factors, coupled with other design concerns - such as agency approval, processing parameters, and part consolidation - are discussed in this chapter
  • Rapid Prototyping Accelerates The Design Process
    techniques in the final stages of product development and the transition to manufacturing. But the greatest potential for 3D modeling lies earlier in the design process where superior designs are conceived and the roots of development delays are put down. Properly used, rapid prototyping can
  • Medical Device Link . An Update on EMC Compliance Issues Manufacturers should take note of recent developments in the EMC regulatory arena to ensure that their devices make it through the approval process.
    Recent reports of medical device malfunctions caused by interference from licensed radio-frequency sources have underscored the importance of ensuring electromagnetic compatibility (EMC) in the design, production, and use of electronic medical apparatus. FDA issued a public health advisory
  • Medical Device Link . Design considerations for IVD clinical trials:
    Cheryl L. Hayden and Michael L. Feldstein An IVD clinical trial represents a major investment for the sponsoring company; consequently, it is important to maximize the utility of the trial. One way to accomplish this is to design the trial protocol to include several time-staggered end points
  • American Lifts Help Indianapolis Motor Speedway Raise Winners to New Heights
    ? Not for American Lifts! With this concept in mind, American lifts went to work designing and manufacturing the T1-90-500 scissors lift to fit the specifications. IMS gave final design approval in February and the lift was shipped in May. The speed in which this schedule was accomplished can only work
  • Standard and Custom Designed Countercurrent Packed Scrubbers (SPT Series) (.pdf)
    Pre-engineered standard models provide low initial cost since design, engineering and drafting times are reduced. Drawings for the standard scrubbers can be forwarded quickly for customer approval and delivery time can be dramatically improved. SPT are used in a variety of industrial applications.

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