Everything You Need to Know About USP 797 Standards for Hospitals
The USP 797 standards for hospitals are a set of wide-set regulations, that is applicable to health care institutions, physicians practice facilities, pharmacies and other institutions in which compound sterile preparations are developed, stored and dispensed. The purpose of this particular regulation is to restore and maintain hygiene, prevent infections in patients and staff members who use these pharmaceutical products.
Facilities Impacted By USP 797
Facilities of the USP 797 standards for hospitals where products are compounded using ingredients or devices that are not sterile for preparing products that must be sterilized before using.
Facilities where sterile products are prepared as per the manufacturer’s labeling, and manipulations are performed while compounding the products, so as to decrease the potential for contamination of microbes in the end product.
Products may be diagnostics, biologic, nutrients, drugs, or radiopharmaceuticals that include, but not limited to, soaks and baths for live tissues and organs, inhalations, implants, injections, metered sprays, irrigation, otic and ophthalmic preparations among others.
Microbial Contamination Risk Levels
Low Risk Conditions- This risk level of USP 797 guidelines for hospitals includes compounding with manipulations that are aseptic, entirely with better air quality or ISO class 5, using only sterile products, ingredients, devices and compounds.
Medium Risk Conditions- Small doses of sterile products or multiple individual products are pooled or compounded to prepare a sterile compound product, which is administered to either one or multiple patients, on one or multiple occasions. The process of compounding includes complex aseptic manipulations, which is different from the single volume transfer. The process usually takes very long, to complete dissolution or homogeneous mixing.
In case of a medium risk preparation, that does not need to pass sterility tests, the storage period of the products should not exceed more than 30 hours, in case of room temperature, 7 days in a cold temperature and 25 days when kept in a solid frozen state, at -20 degrees C or less.
High Risk Conditions- Non-sterile ingredients that include manufactured products for administration, rather than using those that have been listed under the C in the introduction are incorporated before terminal sterilization. High risk preparations that are passed in the absence of a sterility test can be stored for a maximum time period of 24 hours at room temperature, 3 days at a controlled cold temperature and for 45 days at a solid, frozen state, which is -20 degrees C or less.
This is all the necessary information about the USP 797 guidelines for hospitals. It is very important for medical and pharmaceutical institutions to abide by this set of rules, to gain the trust and loyalty of patients, in the field of health care.
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