How do you clean compounding equipment?
Cleaning and Sanitizing Agents Though isopropyl alcohol is widely used to clean ISO Class 5 compounding surfaces, 3% hydrogen peroxide and 2% sodium hypochlorite (bleach) solutions are also effective as sanitizing agents.
What are the three steps taken to comply with USP 797?
Designed to protect both patients and pharmacists, USP 797 requires attention to three main areas to ensure compliance: staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures.
What are the 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).
How often must ISO Class 5 compounding areas be cleaned?
every 30 minutes
According to USP <797>, ISO 5 PECs should be wiped down with 70% IPA before and after each use, and at least every 30 minutes when ongoing compounding activities are being performed.
Which part of a sterile compounding room should be cleaned and disinfected daily?
Daily cleaning includes cleaning and disinfecting of the PEC (which has already been discussed), easily cleanable work surfaces, and floors in the ISO Class 7 and ISO Class 8 areas as well as the segregated compounding areas. Start by cleaning from the cleanest area (buffer area) to the dirtiest area (ante area).
What is cleaning in compounding?
Cleaning is a mechanical process enhanced by germicidal detergents to remove dirt, debris, biofilm, and microbes, • Cleaning prepares a surface to be disinfected. Germicidal detergents should be used on all surfaces (PEC’s, furniture, bins, walls, ceilings, floors).
What is the difference between USP 795 and 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.
What is the main purpose of USP 797?
The purpose of USP Chapter <797> Pharmaceutical Compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused …
What does USP 797 cover?
USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.
Which ISO Class is the cleanest for sterile preparations?
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.
What is the difference between USP 797 and USP 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.
What should be used to clean the compounding area prior to compounding medications?
Cleaning with a germicidal detergent and water will remove visible solids or soiling before disinfecting. Disinfecting removes microbial contamination. It is critical that an ap- propriate germicidal detergent and water be used to clean all surfaces of the buffer and ante areas in addition to all of the PECs.
USP 797 Guidelines & Standards. The objective of the USP 797 Guidelines 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 is non sterile compounding?
Sterile compounding is usually most common in a hospital pharmacy, whereas non sterile compounding is used in hospital and retail pharmacies. Instead of preparing sterile medications, such as those delivered intravenously, non sterile preparations are prepared in the open without isolation from the outside.
What is compounded sterile product?
A CSP is a sterile drug product (including a radiopharmaceutical) that was prepared by compounding or underwent other handling or manipulation prior to administration. Interestingly, a CSP is not explicitly defined in USP.
What is sterile compounding pharmacy?
Sterile compounding: Pharmacy profession should take back control. It is time for the pharmacy profession to stand together and take back control of sterile compounding. We all know that sterile compounding is challenging. It is one of the highest risk areas of pharmacy practice, and yet it has little technology to support safe compounding.
