Acoustical Products Made in USA.
Medical device manufacturing requires extremely precise assembly processes and strict contamination control. Workers assembling surgical instruments, implants, and diagnostic equipment must perform tasks that demand high levels of concentration. However, surrounding production equipment can generate manufacturing noise around 75 dB(A). Over time, this background sound can disrupt workflow and reduce worker focus.
In environments where sound levels exceed 70 dB(A), communication between technicians becomes more difficult. Workers may need to repeat instructions or move closer to hear each other clearly. These interruptions can slow production and affect quality assurance processes. Maintaining proper medical device manufacturing acoustics helps ensure efficiency and product accuracy.
Medical device facilities must comply with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 manufacturing standards. These regulations require strict environmental controls to ensure product quality and worker safety. While contamination control is the primary focus, maintaining a controlled acoustic workspace also helps support safe and accurate manufacturing procedures.
Santrix® Acoustic Modular Cleanrooms combine cleanroom contamination control with soundproof modular construction to create an ideal workspace for medical device assembly. Acoustic wall panels block external sound transmission while maintaining sterile airflow conditions. In environments where surrounding sound levels reach 75 dB(A), interior sound levels can often be reduced to 45–50 dB(A). This quieter environment improves concentration and supports regulatory compliance in medical manufacturing facilities.
