Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.
Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.
This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.
Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.
Stability of your weighing balance is paramount when it comes to collecting reliable data for project. As the old adage goes, “Anything that can go wrong will go wrong.”. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success. The purpose of this paper is to inspire thought and dialogue regarding those “not so obvious” sources of balance stability issues. Below, you may find 10 prompt questions that will hopefully guide one in resolving those pesky head-scratchers.
Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.
This video shows ATC's patented Mass Extraction technology in a container closure integrtiy testing example of system verification and system testing.
Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.
Read how Resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.
The Powder Cell is a unique instrument for the study of dry granular flows, especially in the fluidized or near fluidized state.
Anton Paar’s range of Abbemat refractometers embody over forty years of technical expertise. They are built with care and precision using the highest quality materials. Abbemat refractometers measure the refractive index and concentration of liquids, gels and solids. These truly universal refractometers cover a broad range of applications in all industries. Depending on the accuracy, temperature range and level of automation you require, a model is available to suit your application and your budget. An Abbemat is a secure investment for the future, providing reliable and accurate results for years to come.
Used Nicolet Magna 560 IR spectromerter.
With thousands of methods developed, validated, and/or transferred in support of IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.