Cleanroom and Organizational Direction Setting
Governing agencies and auditors today expect to review the design concept basis as part of the initial orientation and review of a regulated facility. This quality document should contain the information essential to understanding the overall development of a GMP manufacturing plant, and can also provide important user requirement information.
AES uses a standardized approach to integrating a manufacturing process into an AES modular cleanroom environment, using pre-engineered process stations, MAL’s, PAL’s and other similar templates. This approach drives a comprehensive, solidified and compliant design. For typically less than one percent of the project cost, the AES Compass program provides a business case executive summary, manufacturing and transition philosophies, basis of design information, a (FDA Type C) drawing package, a detailed estimate (5% accuracy), and a Level 1 schedule.