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.
AES Compass Program Output – FDA Type C Compliance Meeting Package
Sample Pages From Compass Package
Early planning with AES sets the stage for a successful project. Cleanroom facilities must be compliant not only to regulatory requirements, but also to strict environmental criteria that protect the products manufactured, and personnel working within the facility. AES Compass is a process of developing the initial concept for a project’s design by combining our facility expertise with our client’s processing expertise. This initial engagement delivers tremendous value through a robust conceptual design package that fully defines the project’s expectations. The net result is a package of deliverables that is both technical and commercial in nature – focusing not only on the compliant design of the facility, but also on its cost, schedule, and execution strategy.
By leveraging our experience from millions of square feet of successfully completed facilities, AES seamlessly develops a cleanroom facility that wraps around a client’s process. We utilize a standardized approach that leverages optimized strategies for material and personnel movement, integration of the latest in process technology, and confirming the host building infrastructure that is required to support the cleanroom facility.
The cost of this compliance planning effort is less than one percent of the total project cost, and the output is exceptional. 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 project estimate, and a Level 1 schedule.