What facilities are affected by USP 797:
USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.
For more in-depth knowledge on USP 797 regulations
Regulations for Clean Rooms:
Low & Medium Risk
Must have an ante area but does not need to be separated with a physical wall.
Physical Characteristics of Construction-
- Walls, floors, fixtures and ceilings should be smooth, impervious & free of cracks, crevices, and non-shedding.
- Surfaces should be resistant to damage from sanitizing agents.
- Junctures of ceilings to walls should be covered & caulked.
Gowning:
- Before entering the ante or buffer area personnel should remove outer lab coats, make-up, jewelry, & thoroughly scrub hands and arms to the elbow.
Leaving & Reentry:
- Upon leaving the clean room the coat should be carefully removed and hung outside the entry in the buffer area. Coats can only be used for one shift. All other coverings are to be discarded and new ones donned prior to reentry.
High Risk
All facilities except the ante area must be a separate room
Gowning:( All are necessary)
- Hair covers
- Shoe covers
- Lab coats
- Facemasks (for covering facial hair)
** Need a product to Sterilize your clean room?
Check out some of our Clean Room products!
