A major global player in vaccine manufacturing has just ordered two additional membrane-based “cold” WFI systems for one of its European sites. This facility will soon have had six (6!) of these systems installed in the past four years. What is so remarkable about this? …more
Hot WFI storage and distribution is now a standard option for our Pharmatec flagship model MWFI membrane-based “cold” WFI generation system. Syntegon is pleased to announce the successful commissioning of this system configuration at a major, global vaccine manufacturer.
Lead engineers Andre Nebel and Nick Eilenberger proudly share that the MWFI modularization project is right on track. Three base configurations have been defined to cover the complete output range. Customers need only specify the number and size of options to match the final system configuration to their exact needs.
“Processing and packaging for a better life” – Especially in the current situation, we´re keeping up with our mission. The Covid-19 pandemic is challenging manufacturers of medicines: They have to respond fast to changing demands and supply key medicines across borders. Simultaneously, the preparation for new vaccines and therapeutics is ongoing. …more
Syntegon is happy to introduce the MIH-IV – a manual inspection system that provides an optimal environment for the inspection of infusion (IV) bags. …more
Barrier systems such as isolators or RABS play a fundamental role in the protection of people and products in pharmaceutical production. Only tenths of a millimeter thick gloves are the most crucial interface in these hermetically sealed units. To ensure that barrier systems are sterile, and processes remain safe, a thorough and regular inspection of the glove integrity is vital. The regulatory requirements for gloves are strict. However, they also leave plenty of choice for suitable test methods. Many facility operators face the question as to which method is suited best for which system.
Self-administration of drugs on the rise
PCI Pharma Services relies on RRA assembly machine from Bosch Packaging Technology
The injectable drug delivery market has experienced a huge change in recent years. Due to drastic changes in lifestyle and the accompanying increase in chronic diseases such as diabetes, the demand for injectable drugs has been growing for decades. This transformation relates not only to the quantity, but also to the way in which injectable drugs are delivered today.
Drinking water is the basis for producing water for pharmaceutical purposes in all national pharmacopoeias. What was long prohibited in the EU has been a reality for the past two years. …more
There are many things to consider when transferring products and materials into barrier systems. It begins with categorizing the pharmaceutical product and defining the aseptic environment. How is my product categorized? What processes and procedures are commonly used? What are the major challenges in product and component supply? These and many other questions are a first baseline to start with.
Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing risks that affect the quality of a medicinal product. An efficiently implemented quality risk management system (QRM) ensures the quality of products throughout the entire life cycles and is an enabler of the Pharmaceutical Quality System (PQS). …more
