What are USP 797 guidelines?
What are USP 797 guidelines?
The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).
What does USP 797 provide?
It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.
How often should an IV room be cleaned?
On ISO-5 surfaces (including under the work surface) at least monthly. Document cleaning and disinfecting agents (and contact time as applicable).
What is the difference between USP 795 and USP 797?
Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.
Is USP 797 a law?
USP 797 is considered a standard of practice and as such can be adopted and enforced by the FDA, local state boards of pharmacy, and accreditation organizations.
How many risk levels are found in USP 797?
USP 797 assigns each CSP one of five potential contamination risk levels: immediate use, low, low with 12 hours or less beyond use date (BUD), medium, high. The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP.
Do you clean from dirtiest to cleanest?
Cleaning should always occur cleanest to dirtiest, with the restroom always cleaned last to reduce the likelihood of spreading contamination.
Which ISO Class is the cleanest?
ISO 1
ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room. The most common ISO clean room classes are ISO 7 and ISO 8.
What are essential supply items in the clean room?
Below is a list of the three most important cleanroom supplies you should always have on hand, and why they’re so important:
- Replacement Filters. Filters are what keep the air in a cleanroom clean.
- Gowning Materials.
- Cleanroom Cleaners.
Can you wear earrings in an IV room?
No jewelry can be worn inside cleanrooms, including rings, necklaces, earrings, and other piercings. Staff also cannot use nail polish, lip balm, or even lash extensions.
What is the 797 or 800?
The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.
