– The new range of WMArchitect single-use solutions is designed to streamline the process, safeguard products, and reduce regulatory burden for biopharmaceutical companies
– With an open architecture approach, WMArchitect offers both standard, ready-to-use single-use assemblies as well as customised…

What is the current state of how GxP industry performs temperature mapping?

Current Good Manufacturing Practice (CGMP), according to the FDA's Code of Federal Regulations Title 21, requires that environments used to manufacture or process drug products be validated to ensure a high degree of quality…

– Fluid bed Solidlab 2 Plus: efficient development of batch and continuous manufacturing processes
– TPR 200 Plus: flexible tablet press with containment for small to medium-sized batches
– Automated product feeder “APD Feeder”: optimal determination of process parameters for tablet presses

At this year’s…

Based on decades of experience and numerous in-house designs for demanding handling tasks, PIA now offers individually configurable tray and palletizer platforms as stand-alone automation solutions for medical technology. They can be used in the feeding as well as in the removal and are designed GMP…

THE GUARDTECH GROUP are expanding their Service Department to meet the needs of a fast-growing new customer base.

A new year restructure saw Guardtech Cleanrooms repositioned to sit alongside new acquisition Cleanroom Solutions and existing businesses Isopod (rapid cleanrooms) and CleanCube (mobile s…

Manufacturers of medical technology products worldwide have to meet ever higher demands and stricter regulatory requirements of the FDA and MDR. Since the introduction of the MDR final cleaning and packaging have been critical elements of the product. This leads to a considerable economical effort f…

Für alle manuellen Prozesse – so auch für die manuell umgesetzten Wischverfahren größerer Flächen – steht die Frage im Raum, ob ein vom Menschen durchgeführter Prozess reproduzierbar und damit validierbar sein kann.

Unter Validierung versteht man die Erbringung eines dokumentierten Beweises, dass ein Prozess…

Neu bei CiK Solutions ist der Edelstahl-Datenlogger Tecnosoft Pressure Disk. Der kosteneffektive Datenlogger zur Druck- und Temperaturmessung ist insbesondere für die Validierung von Autoklaven und Sterilisationsprozessen geeignet.

Extrem hohe Präzision und Genauigkeit von ± 0,1°C zeichnen diesen D…

Since its entry in the U.S. market in 2008, the healthcare company Fresenius Kabi has grown to become a leading provider of generic injectable drugs. In the U.S., the company focuses on the development of generic pharmaceutical products, IV solutions and pumps, transfusion devices and cellular thera…

Egal ob in der Medizin-, Pharma- oder Halbleiterproduktion: Für viele Branchen wird das Produzieren und Fertigen von Bauteilen in einem sauberen bzw. partikelfreien Umfeld immer wichtiger. Die Hauptanwendung der Spetec Reinraum-Werkbank bzw. Mini-Environment liegt im Bereich der optischen, elektron…