Plans and permits
Is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”.
If you are a manufacturer of non-sterile medicinal products, you should define your own cleanroom/area standards using national and international standards. Usually manufacturers will define an airborne particulate concentration standard class such as ISO 14644-1 ISO 8 (at rest), outline gowning and a pressure cascade regime, defining a “clean corridor” design or a “dirty corridor” design.
What makes a clean room a “clean room”?
Cleanrooms and clean areas are defined in the GMP’s as having the following characteristics.
There are three things that keep a cleanroom “clean”:
1. The internal surfaces of the clean room and the equipment within them;
2. The control and quality of air through the clean room;
3. The way the clean room is operated (i.e. the number of staff).
Each of the three items above is equally important.
All our projects includes:
|Site plan.||Floor plan.||Soil Report.||Mechanical Plan|
|Utility Detail.||Exterior elevation.||Foundation plan.||Mechanical Schedule|
|Site Detail.||Interior elevation||Foundation detail.||Mechanical Detail|
|Storm drainage.||General notes.||Wall Section.||Electrical Plan|
|SWMP.||ADA.||Structural frame/Roof.||Lightning Plan|
|Structure general notes.||Construction Detail.||SWMD.||Plumbing Plan.|
|Plumbing Detail .|