At Stress Engineering Services, our focus is on providing solutions that reduce schedule, cost, and regulatory risk in all areas of drug development and manufacturing. Using advanced computational tools such as computational fluid dynamics (CFD), finite-element analysis (FEA) and custom-written fluid system simulations, we can improve your equipment and processes. This predictive analysis technology is complemented by our expertise in developing special-purpose tests used to diagnose problems, provide design data, and validate final designs.
In the drug development process—from laboratory, through pilot-scale, to full-scale production—it is vital that the technologies used will scale properly. To help ensure success in process development and technology-transfer, we offer expertise in predictive computer and physical modeling, scale-up/scale-down studies, unit operations development and optimization for a variety of systems.
A process validation confirms the intended manufacturing elements are installed properly and inevitable variability in inputs produces product within specification. We have the unique ability to leverage our extensive experience and knowledge of equipment and product failure mechanisms to ensure a thorough and robust validation. Our staff will work closely with you to create master validation plans to ensure efficient execution with predictable performance.
We provide expertise in developing new facilities, planning new lines, and upgrading existing plants. A major focus of this work is on environmental systems: clean rooms and air-handling systems, including airflow analysis, emissions, and particulate migration studies. We also provide explosion containment evaluations/upgrades and design/analysis of explosion venting systems.
Our manufacturing support services often involve troubleshooting, problem solving, and failure analysis work on processing and assembly equipment. We deliver expertise in equipment reliability and risk assessment, improving process capability and throughput improvements. In addition, we provide independent 3rd party manufacturing system audits, which are frequently used for vendor assessment or internal improvement activities.
Production failures are costly and time-consuming. We have the knowledge and experience to help you quickly understand why a failure occurred, the consequences of the failure, and how to restore production safely and reliably. We utilize our expertise in failure analysis, remaining life assessment, instrumentation, and metallurgical evaluation to deliver reliable solutions that help reduce production costs and downtime.
Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products. As technological advances enable the merging of these product types with historically different regulatory pathways to commercialization, the need to direct attention toward the safe and reliable development of these products has emerged.
At Stress Engineering Services, we have the tools, expertise, and reputation for designing reliability into devices, drugs and biologics as well as helping clients improve the reliability of existing products.
ISO 9001:2015 & ISO 13485:2016 Certified
ISTA Certified Laboratory
Licensed for Laboratory Testing and Research on Drug Products
If you would like more information on Stress Engineering Services, please call us at 281.955.2900, or complete the following form and one of our representatives contact you shortly. For a complete listing of contact information, visit our Locations page.