Whenever feasible, regulatory agencies require injectable products to be terminally sterilized. Due to somewhat fragile molecules and compounds, this aseptic process may render the intended product to be adversely impacted and not endure the stress that moist-heat processes may subject them to. However, for those products that are more compatible to the heat and exposure, …more
You asked and Syntegon listened. Three new, free isolator-focused webinars are in the works, focused on crowdsourced topics that are important to you. Matthias Angelmaier, global product manager for barrier systems, isolator and process technology and Dr. Laura Moody, North American product manager for primary packaging, will keep the conversation going with a new variety of subjects: qualification & validation, project management of complex isolator lines and material transfer into barrier systems. On April 14th, …more
Developing and manufacturing hard-shell capsules with low fill-weights can be an especially challenging task. However, recent innovations provide the tools to make the job of manufacturing such products much easier, while also providing assurance that the capsules you make meet your stringent quality requirements. Whether you need to fill just API into capsules for clinical trials, need to manufacture a low-fill capsule product for dry powder inhalation, or simply have a product formulation that requires low fill-weight, the tools available today can make the job much simpler. …more
Syntegon is pleased to be participating in two presentations at the upcoming 2021 ISPE Aseptic Conference, presented virtually March 15-17th. On Day 1,Global Product Manager for Isolator Technology Matthias Angelmaier will join speakers from Bavarian Nordic and IPS to discuss “Vaccines for the World – Insights into Design and Execution of a BSL2 Fill-Finish Facility”. Later that afternoon, …more
COVID-19 is currently challenging our technical professionals in terms of traveling for set-ups and the commissioning of the delivered equipment to our customers worldwide. However, our customers are also suffering from travel restrictions, which make it difficult to carry out a joint Factory Acceptance Tests (FAT) on the manufacturer’s site. A FAT is a process to approve that the equipment aligns with the specifications made for design and functions, before it is dispatched to our customers.
Fluid bed processing has long been used in the Pharmaceutical, Nutraceutical, and Chemical industries as a way to enhance the characteristics of powders, dry products, or apply an active compound or functional coating to the surface of particles or beads, with the objective of controlling release of the product. …more
Join Syntegon at the 2021 Virtual Pharma Expo series event, focused on Pharmaceutical Packaging: Aseptic Fill/Finish, Sterile Manufacturing. On Wednesday, February 24 at 9:30am EST, Senior Product Manager Klaus Ullherr will be presenting …more
The pharmaceutical and nutraceutical industries are constantly looking for ways to develop robust and efficient processes across their oral solid dosage (OSD) portfolios. Producing a quality tablet or capsule should start much earlier than when the tablet press or capsule hopper is filled with powder or granules. …more