ASPEX is the leading provider of integrated microanalysis systems for the automatic detection, characterization and documentation of raw materials and foreign particulate matter present in research and pharmaceutical manufacturing processes, enabling the user to understand and control the purity of the process. ASPEX systems are installed at pharmaceutical and medical device companies worldwide for process control initiatives related to raw materials and finished products, including inhalable drugs and implantable medical devices.
ICS offers a custom designed Lyo Transfer Cart that is a self-contained, battery powered, enclosure designed for transport of pharmaceutical products through uncontrolled space. Most commonly, the lyo transfer cart is used to transfer product vials from the fill suite through uncontrolled hallway space to the lyophilizer suite.
In a process plant, the general function of a control valve is to restrict the opening of the valve so it affects the flow or pressure of the liquid or gas that is passing through it. In any given application, an installed valve has one fundamental variable – the position of the moving element, which could be a profiled ball, plug, or sleeve in the valve. That single moving element determines the exposed orifice that allows greater or lesser flow through the valve, which in turn provides the control of the process.
A description of the technology used in FRABA's POSITAL line of magnetic absolute encoders (MAGNETOCODE) to ensure that the full absolute position (angular position + turn-count) is always accurate, even after a power failure or shutdown of the control system. The solution involves technology that generates the power needed to record position data without the need for backup batteries.
This white paper presents a practical and compliance-focused approach to root cause and corrective actions that will help pharmaceutical manufacturers transform their CAPA efforts into effective, efficient, and sustainable quality systems that meet ICH Q10, ISO, and U.S. FDA requirements.
Many pump systems cannot stand up to the stringent demands of beverage production, filling and dispense applications. Repeatability is a crucial requirement, and most beverage production applications also demand high speed for line efficiency, and adjustable speed for overall line flexibility to serve different container sizes and product consistencies.
Today’s leading medical device manufacturers often demand more than off-the-shelf flow control, fluid handling and transfer equipment. To meet the technical, performance and regulatory requirements of their new designs, custom solutions are often needed – custom pumps, custom enclosures, custom controls, and more.
Recombinant protein technology provides a wealth of commercial opportunities. However, recombinant protein production is time-consuming, costly, and subject to technical pitfalls. Common challenges include protein aggregation and lengthy purification and refolding processes.
Following publication of the December 2008 FDA Guidance for Industry Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, assessment of cardiovascular safety has become a critical focus during the development of new antidiabetic therapies for Type 2 diabetes mellitus (T2DM).
Recent studies covering plants in the U.S., UK and Germany show that controlling static electricity build-up is the key to preventing combustible cloud explosions.
A comprehensive battery of tests including filter integrity, downflow, bleed airflow, light intensity and noise level was carried out to verify the performance of the Esco Pharmacon Downflow booth.
As pharmaceutical product coding regulations change, and as the threat of counterfeiting increases, drug companies are looking for better methods of product identification. Coding and marking are keys to accurate, reliable product identification, which can combat counterfeiting and prevent errors in administering drugs to patients.
This report shows how untreated quality issues at even a single investigator site can negatively impact the results of an entire study. It identifies the elements that every trial should deem mandatory in order to avoid unnecessary failure.
Rockwell Automation announces the availability of the Converged Plantwide Ethernet (CPwE) Design and Implementation Guide (DIG) 2.0 to help manufacturers converge their industrial and enterprise-level networks.
The 10-step Guide is designed to help the wide range of pharmaceutical processors, blood and tissue banks, clinical laboratories, medical device manufacturers, research hospitals, and other GxP facilities who may receive public criticism warning letters respond quickly and appropriately within the permitted 15-day window.