August 21st, 2019
New approaches to fluid control enhance pharma manufacturing
By Meagan Parrish, Senior Editor
For orginal article visit pharmamanufacturing.com
It’s no secret that in pharma, consistency is king. When it comes to fluid handling, manufacturers need components that will churn out reliable and safe results. But there are also opportunities to maximize this critical area of operations to boost speed, increase efficiency and control costs.
As pharma companies look for ways to optimize fluid handling, vendors have stepped up to innovate solutions to help them achieve better results.
The integration of single-use components also continues to be an effective way for manufacturers to limit contamination risks.
“As this trend continues to develop, pharmaceutical manufacturers are requesting single-use system manufacturers to provide assurance that their single-use products are in compliance with current good manufacturing practices and do not alter the drug products beyond established regulatory requirements,” explains Aaron Updegrove, marketing director of Bioprocess Solutions at Saint-Gobain.
But according to Updegrove, tubing products are still rarely certified to meet endotoxin, bioburden and particulate standards.
“In some cases, pharmaceutical manufacturers have taken their own risk mitigation measures to reduce potential contamination such as rinsing tubing products with water for injection. However, these strategies are costly and in some cases, infeasible,” Updegrove explains.
Updegrove says that Saint-Gobain Life Sciences’ ValPlus products provide pharma manufacturers with an enhanced level of tubing certification and confidence in the cleanliness of the tubing products they use in critical applications. This enhanced documentation is available for a variety of Saint-Gobain tubing brands including C-Flex and Sani-Tech, and provides certification to USP <788> for particulate, USP <85> for bacterial endotoxin, and ISO 11737 for bacterial and fungal bioburden.
“This higher level of quality assurance is an industry-leading effort to quantify and reduce risks associated with fluid path contamination,” Updegrove says.
Ultimately, vendors are showing that manufacturers can find plenty of pathways to reducing costs and improving efficiency in their tubing and fluid control systems.