In the November/December issue of Pharmaceutical Processing we profile Metrics’ clinical trial materials manufacturing facility located in Greenville, North Carolina. This issue also includes our annual CMO/CSO reader survey and our directory of service providers. Two articles on pure water discuss compendial water system maintenance and monitoring considerations, and automated and continuous TOC monitoring of ultra-pure water cycles.
The September 2013 issue of Pharmaceutical Processing features a profile of LSNE, a Bedford, NH-...
The two-day Pharmapack Conference is your opportunity to examine packaging design, materials and compliance strategies which will lead your company to reach innovative and cost effective solutions. The program includes 20+ presentations covering ePedigree, serialization, track and trace, materials, patient compliance, sustainability and cost control.
INTERPHEX Puerto Rico is the island’s leading tradeshow for the pharmaceutical and biotech manufacturing industries.
INTERPHEX (International Pharmaceutical Expo) is the single source for complete biopharmaceutical & pharmaceutical manufacturing solutions to confidently process, fill and finish life-enhancing drugs.
The theme for the meeting is “Biopharmaceutical and Sterile Pharmaceutical Manufacturing – Embracing Innovation to Meet Global Challenges.“ Manufacturing technologies are changing rapidly in response to new regulations, requirements and capabilities. The industry is changing at a fast pace by adapting these technologies while evolving in the global economy.
Pittcon is the world’s largest annual premier conference and exposition on laboratory science. It is organized by The Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, a Pennsylvania not-for-profit educational corporation which is comprised of the Spectroscopy Society of Pittsburgh (SSP) and the Society for Analytical Chemists of Pittsburgh (SACP).
A clinical trials facility was at risk of losing temperature data to monitoring equipment failure. They installed a monitoring system that identified an equipment failure, saving hundreds of thousands worth of research. “[The monitoring system] saved the costs of the study’s products ... These studies enhance lives, so the samples and products involved in the trials need to be safeguarded, accurately and reliably.”
When a powder processing operation involves multiple components, providing protection against static spark ignition of flammable or explosive atmospheres can be daunting. A recently updated “Applications Spotlight” section of the Newson Gale website provides detailed information explaining how various types of processing equipment can be reliably protected by an integrated system based on their Earth-Rite® Multipoint controller. Read more here
When a processing operation involves multiple components, providing protection against static spark ignition of flammable or explosive ambients can be daunting. A recently updated “Applications Spotlight” section of the Newson Gale website provides detailed information how various types of processing equipment can be reliably protected by an integrated system based on their Earth-Rite® Multipoint controller.
10 articles on how to reduce the risks of failed inspections, poor quality management systems, and bad measurement practicesSeptember 26, 2013 9:08 am | by Vaisala White Papers
Download this combined PDF of 10 Must-read Articles: “Quality, Metrology, and cGMP/FDA Regulations: 10 articles on how to reduce the risks of failed inspections, poor quality management systems, and bad measurement practices” Let our subject matter experts show you how to attain and maintain GxP-compliant environmental monitoring and validation applications. Get PDF
Supply chain planning involves functions such as demand forecasting and planning, distribution inventory planning, and plant capacity planning and scheduling. The right mix of strategy, education, and systems can have a very high impact on a pharmaceutical manufacturer’s overall operations—and ultimately its bottom line.
Analysis for Polysorbate 80 Using New High Performance Liquid Chromatography (HPLC) Method with Charged Aerosol Detection (CAD)September 11, 2013 4:51 pm | by Impact Analytical White Papers
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) is a common nonionic surfactant, emulsifier and solubilizer that is used in a wide variety of industries and applications. A well-developed analytical method is crucial for accurately quantitating polysorbates. Due to the chemical structure and chemical properties of polysorbate 80, it cannot be accurately quantitated by analytical methods such gas chromatography or liquid chromatography with ultraviolet absorption. This whitepaper discusses how a new analytical method using High Performance Liquid Chromatography (HPLC) with Charged Aerosol Detection (CAD) accurately quantitates polysorbate 80 in a pharmaceutical formulation.
New Infographic: How to Use GAMP to Validate an Enterprise Software for a Continuous Monitoring SystemSeptember 3, 2013 9:44 am | by Vaisala White Papers
This new infographic created by Vaisala’s validation engineers describes 10 Points of a GAMP-based validation that ensure an environmental monitoring system will function as expected. It refers to the 3 most common types of continuous monitoring systems, and outlines the validation steps and extent of validation effort for each.
Bulk ingredients for pharmaceutical products are shipped and handled almost exclusively on wood pallets. When the ingredients are needed for use in production, however, the wood pallets have to be removed. This means drug manufacturers must find a way to safely transfer bulk ingredients—whether in cartons, super sacks, bulk boxes, drums tubs or bags—onto a captive, production-dedicated plastic pallet used only within the processing area. The safest transfer solution maintains the load’s integrity, prevents potential contamination from the transport pallet and protects workers from possible injury, all while operating at a speed that does not inhibit production rates.
With new demands by the biopharmaceutical industry comes new facility design offerings, which claim to be “flexible facilities,” “modular facilities” or facilities that are capable of “manufacturing on demand.” In this white paper, many types of facility design offerings are reviewed, specifically those labeled modular, flexible, or both.
Qualifying Cold Chains, Writing Performance Qualifications and the Parenteral Drug Association Technical Report 39July 31, 2013 3:51 pm | by Vaisala White Papers
NEW Application Note: Qualifying Cold Chains, Writing Performance Qualifications and the Parenteral Drug Association Technical Report 39. This application note gives a brief overview of the Parenteral Drug Association’s technical report 39. After the overview of TR39, we use the guidelines described in the report to provide several best practices for writing a performance qualification protocol. Get the application note now.