White Papers
5 Must Have Strategies for Total Enterprise Quality
October 24, 2012 2:22 pm | by InfinityQSThis free white paper, 5 Must Have Strategies for Enterprise Quality, shows how quality can take a more prominent, enterprise-scale role. Learn more today about • The trend towards centralizing quality data • Best practices for collecting and integrating multiple data sources • How to monitor and analyze quality real-time • Workflow management to ensure data integrity • Reporting needs of users at all levels
Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory
October 19, 2012 9:54 am | by ShimadzuTotal Organic Carbon (TOC) analyzers are utilized across a wide range of industries for such measures as process and water quality control, experimental research, and EPA compliance. Within the pharmaceutical industry, they serve vital roles in the manufacturing process. From inspections of the water used in drug manufacture (ultrapure water) to evaluation of cleaning effectiveness (cleaning validation), TOC analyzers are essential instruments in the pharmaceutical laboratory to ensure compliance with applicable regulations. This paper examines their use and presents some application data.
How to Avoid FDA 483s for Temperature, Humidity and other Controlled Environments
October 17, 2012 3:10 pm | by VaisalaThis article shows excerpts from recent 483s issued for deviations in tracking and recording environmental parameters in various applications, then outlines ten best practices of a 483 response, providing a checklist to make the 15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.
The Benefits of Investigating Surface Treatments Earlier In the Design Process
October 11, 2012 4:19 pm | by General MagnaplateToo often the coating of parts is an afterthought for design engineers. Rather than being a part of the discussion in the early stages of design, designers try to solve problems with coatings at the point of manufacturing – or even after manufacturing. While each type of surface treatment (anodizing, electroplating, thermal spray etc.) provides its own unique set of properties and benefits, each of these processes also has limitations that should be addressed early on in the design process to ensure optimal performance
Choosing the Proper Equipment for Pharmaceutical Stability Room Humidity and Temperature Mapping
October 5, 2012 8:57 am | by RotronicPharmaceutical and Biotechnology companies are under a great deal of pressure to comply with regulatory requirements from the inception of a product to its final destination. One such aspect of the regulatory process is stability testing. Stability testing allows drug manufactures to expose the product to conditions that might occur in the supply chain, as well as provide for stress testing for determination of shelf life. Stability testing relies on three important parameters: 1) Control Constancy 2) Uniformity 3) Sensor accuracy Clay Hile of Parameter Generation and Control and Greg Gowaski of ROTRONIC discuss the important points of stability testing.
The Top Five Mistakes in Prepping for Outsourced Prototyping
September 24, 2012 10:54 am | by Screaming CircuitsMost companies outsource prototyping because they have resource constraints. In some cases this is a strategic decision, but in many cases, it is simply the only way to meet the latest product development deadline. While many prototype houses can accommodate a “throw it over the transom” approach, taking a more strategic approach can save time, money and most importantly, help your team develop a higher quality product.
Eliminating Static Electric Dangers is not Rocket Science
September 6, 2012 7:04 am | by Newson GaleA Newson Gale White Paper, “You Don’t Have To Be a Rocket Scientist” is a concise engineering guide for the person responsible for protecting plant equipment and personnel from the hazards associated with the potential for static discharge. It provides a step-by-step audit procedure to evaluate the potential for a manufacturing or handling process to produce a static electric charge, how best to deal with it when flammable or combustible atmospheres also occur, and the content and scope of applicable engineering standards and guidelines.
White Paper: Effective ICH Q8 Pharmaceutical Development Reports
August 17, 2012 7:27 am | by DPTThe International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development.
FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains
August 16, 2012 8:57 am | by VaisalaThe Vaisala CCL100 Cold Chain temperature logger might be simple and easy, but the regulations governing cold chain monitoring are complex. Read this new Application Note, "FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains" for help demystifying these regulations. This paper discusses a scientific approach to cold chain management, overview of ICH guidance, three key FDA regulations, and examples of cold chain 483 observations.
Future Ready ST100 Air to Gas Flow Measurement
August 9, 2012 6:44 am | by FCIEngineers are continuously challenged to meet plant productivity and operating objectives as well as ensure regulatory compliance. FCI's White Paper, “Advancing Thermal Mass Flow Meters for 21st Century Process and Plant Needs”, explains a future-ready approach to air/gas flow measurement using breakthrough FCI's ST100 Series Flow Meters.
Why is it Raining Inside My Environmental Test Chamber?
August 8, 2012 11:54 am | by TestoAccurately measuring moisture levels in an environmental chamber is both a surprisingly difficult and frustrating exercise. Many times the chamber’s instrumentation refuses to agree with handheld instrumentation. And there are instances when moisture generation inside the chamber gets so out of control, it can be literally “raining” inside. This white paper summarizes the various sensor designs, their typical problems, and some operational challenges of environmental chambers to be aware of.
Light Up the Visual Factory
July 26, 2012 12:02 pm | by Banner EngineeringLighting Solutions for Lean Manufacturing: Increase Efficiency, Reduce Costs & Improve Quality
10 Ways To Reduce Time In Product Development
June 28, 2012 12:49 pm | by Duane BensonThe biggest challenge for design teams is meeting tight timelines with smaller internal teams. This paper looks at ways to leverage readily available industry resources to reduce design, prototyping and debug time.
Solvent Considerations in Solid-Dose Manufacturing
June 21, 2012 5:09 am | by NorwichPharmaceutical companies are moving away from all-inclusive, in-house operations and partnering with Contract Development and Manufacturing Organizations (CDMOs) for solvent-based solid-dose manufacturing. When researching CDMOs, important considerations about the organization’s capabilities and processes should be assessed. Although the considerations reviewed in this white paper are not intended to replace the quality assurance standards that companies have in place, they provide a guide to increase the confidence you have in your manufacturing partner.
Early ERP Adoption Is Key To Your Growth
June 18, 2012 4:57 am | by CDC SoftwareWhen moving into the commercialization phase, many basic business applications tend to quickly reach their limitations. Forward thinking manufacturers address these key business processes and requirements early on, in order to minimize growing pains while keeping up with exponential increases in production and federal regulations.
