This white paper reviews the OSHA National Emphasis Program for combustible dust, the NFPA standards that address explosion hazards, how to identify these hazards, and equipment used for explosion protection. It will also examine the most common shortfalls to compliance and how to avoid them.
The Computrac® Vapor Pro® Rx is an excellent alternative to Karl Fischer titration offering equivalent results, easier usage, and faster test times than the Karl Fischer when testing lyophilization closures. The instrument is highly durable, and since it uses no solvents or reagents, it is a greener alternative to Karl Fischer analysis.
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.
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.
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.
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.
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.
New Application Note on GxP Maintenance: Not only must an environmental monitoring system be integrated into your organization’s overall Quality Management System, its compliance must be maintained over time. This Application Note: “Care & Feeding of an Environmental Monitoring System” is a primer on maintaining continual compliance by focusing on five primary areas where your monitoring system must be supported by your Quality System: 1. SOPs 2. Training 3. Validation 4. Change Control 5. Calibration
Vaisala recommends a nine-point process for successful mapping of a GxP-compliant warehouse or storage space. These nine steps will ensure that you take into consideration the most important elements of validation, especially understanding where temperature and humidity pose risks to product quality.
Download this new Application Note: "Matching Environmental Monitoring & Mapping to FDA/ICH Guidance for Better Stability Studies" and learn how to minimize the risk of data gaps. If your data is incomplete as a result of infrastructure failures during environmental mapping or monitoring applications, your testing may not comply with FDA/ICH guidelines. Learn how redundant monitoring devices reduce the risk of incomplete records. Get this PDF…
This peer-reviewed paper (published in the Journal of Validation Technology) focuses on two sensors used in thermal mapping: thermocouples and thermistors, and describes advantages and disadvantages of both, concluding that thermistor-equipped data loggers can be used in regulated environments.