WebApr 7, 2024 · For occasional compounding of non-sterile hazardous products, a C-PEC used for sterile hazardous compounding (e.g., Class II BSC or CACI) may be used, … Webminimum professional standards for non-sterile compounding in order to safeguard the public health and welfare. 247 CMR 18.00 applies to pharmacies that hold a drug store license, non-resident drug store license, complex non-sterile compounding pharmacy license, and non-resident complex non-sterile compounding pharmacy license.
USP Chapter 797 Contec
WebSterile polyester knit wipers are used before production to clean the isolator and during production to clean spills, to wipe down gloves when wetted with sterile 70% isopropyl alcohol (IPA), or to clean work surfaces. All IPA solutions described here are assumed to be 70% IPA/30% water (v/v), where the “water” is either water for Websterile compounding practices. The use of technol-ogies, techniques, materials, and procedures other 〈797〉 PHARMACEUTICALthan those described in this chapter is not prohib-ited so long as they have been proven to be equiva-COMPOUNDING— lent or superior with statistical significance to STERILE PREPARATIONSthose described … forchies
Elaine Strauss, PharmD, MS, BCSCP - LinkedIn
WebJan 15, 2014 · Extract Purpose. The compounding of medications is a fundamental part of pharmacy practice. All compounding personnel, mainly pharmacists and pharmacy technicians, are responsible for compounding and dispensing sterile products and preparations of correct ingredient identity, purity (freedom from physical contaminants, … WebSterile swabs wetted with sterile water or a sterile neutralizing buffer may be used when sampling irregular surfaces and difficult-to-reach locations, such as crevices, corners, and spaces between surfaces. Some … WebThe displacement concept shall not be used for high-risk compounding. (c) The PEC must be placed out of the traffic flow in a manner to avoid conditions that could adversely affect its operation. (d) Cleaning materials must be nonshedding and dedicated for use only in the sterile compounding area. (e) Only the furniture, equipment, supplies ... elk county pa tax claim