When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome with the aid of a skilled facilitator... right?
The growing adoption of single-use technologies in all process steps of cGMP clinical and commercial production requires enhanced assurance of quality supply. 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.
Printing errors in pharmaceutical packaging are unfortunately inevitable. By integrating both on-line and off-line inspection systems, you improve the potential for cost savings by reducing the time and materials lost to avoidable errors, ultimately protecting not just your own bottom line but also your customer’s brand, not to mention their long-lasting satisfaction.
Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.
A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.
Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.
Using checkweighers for 100% inline product control of bottles, jars and tubes.