FDA reports 22 recalls for particulate as of September 14, 2014. Particulate do matter, as pointed out by John Johnson, NSF Health Sciences.1
Particulate in parenteral is an issue of safety, but impact manufacturers in many other ways.
- Perceived quality
- Cost of recall
- Cost of reprocessing
- Increased regulatory surveillance
Now, with the advent of USP <787> Subvisible ParticulateMatter in Protein Injections, manufacturers are asked do more; not just testing for particulate, but characterization of it. So it behooves manufacturers to eliminate particulate sources wherever possible.
One source of contamination we are knowledgeable about is that found in rigid storage and transport containers. Any container made by an extrusion blow molding process is prone to having a substantial particulate burden. Still, a tough rigid container is highly desirable when biopharmaceutical substance can have a value well in excess of $100,000 per liter.
Providing containers to meet current drug standards is our business. PharmaTainer bottles and carboys offer security, traceability, UPS <788> certification and much more. Here is a look at some of our particulate testing data for 20L PharmaTainer TM Carboys.
PharmaTainer products will reduce your risk of container failure due to leaks, breaks and contamination as well as providing an unrivaled level of traceability in your production process. While you are here at our website, check out our slide show: PharmaTainers – a Slide Show Tour.pdf and see additional information about our sterile storage bottles, carboys and Octopus™ custom manifold assemblies at downloads/literature
Would you like a sample of our product? Request a sample here.
1 John Johnson (2014) Do Particulates Matter? The Journal, no. 29, summer