Collaborative Performance Validation

Collaborative Performance Validation – Safebridge Consultants, Inc. and Flow Sciences, Inc.

Employees of a pharmaceutical manufacturing facility were producing synthesized estrogen, a female reproductive hormone. Some male workers exhibited symptoms of exposure to female hormones. In response, four Syntax employees collaborated with four other pharmaceutical companies to develop standards to prevent and attenuate exposure to pharmaceutical substances with unknown health effects. The efforts of all parties involved became the predecessor to the control banding policies which are practiced by many pharmaceutical companies today. The business collaborative was also a prelude to the founding of Safebridge Consultants, Inc.  Flow Sciences, Inc. utilizes Safebridge’s Industrial Hygiene and Toxicological expertise for numerous purposes. A demonstrative example is the development of a Containment Performance Target (CPT) for substances with unknown health effects.

Containment Performance Target (CPT) – customer defined level of acceptance exposure to personnel from potentially harmful materials handled in the process

Flow Sciences uses the CPT as a reference metric when validating the performance of enclosure through in-house testing. The concentration results of air samples taken in locations surrounding the enclosure and in the breathing zone of the simulation operators are compared to the CPT, which leads to a determination on whether the tested enclosure will contain contaminants to a concentration below the CPT. For more information regarding Flow Sciences’ internal performance validation testing, please visit the Performance webpage.

During selected containment projects, Flow Sciences, Inc. contracts Safebridge personnel to perform a Site Acceptance Test (SAT). The SAT is similar to that of Flow Sciences’ in-house performance validation; however the SAT is conducted on-site under simulated conditions similar to those present during the real-world use of the enclosure. Controlled, prescribed tasks are performed by simulation operators in accordance with the customer’s standard operating procedures (SOPs). If worst-case scenario (or catastrophic condition) testing is advantageous to the customer, breathing zone and area air samples are collected and the laboratory results compared to the CPT and/or internal metrics at the customer’s discretion or prerogative.

Another Flow Sciences, Inc. and Safebridge Consultants, Inc. Collaboration.