Business Decisions 2

Description of Company Environment

Medical Needs is a company located in Tennessee, with locations in Nashville and Memphis. This is a company that manufactures many different medical devices. They have been in business for over a year now. Production managers in the medical device industry have faced the need to determine the appropriate production environment for a given product for many years now. In making the determination, questions to consider include the question, does a cleanroom give extra advantages that would legitimize the expense of structure and looking after one? What are the guidelines encompassing cleanroom environments? What items or procedures manage the requirement for such an environment?

This manufacturer has established a controlled environment and appropriate specifications for temperature, cleaning, and contamination controls are in place. For example, filters should be replaced per schedule or as needed based on scheduled inspections. Any practices or factors from the following list that the manufacturer has deemed appropriate and elected to use should be specified and routinely performed or followed. Using a controlled environment rather than a cleanroom often equates to significant cost savings during initial construction and in planned, periodic maintenance. The primary reason for building a cleanroom is to account for future economic considerations.