WHAT IS USP 797?
USP <797> was developed to establish best practices for the production of compounded sterile preparations (CSPs). As part of these regulations, pharmacies producing CSPs must periodically perform environmental testing to comply with USP <797> standards. USP 797 is an enforceable set of standards issued by the United States Pharmacopeia (USP), making it essential for pharmacies, hospitals, and other compounded sterile preparation sites to adhere to all regulations.
WHO DOES USP 797 APPLY TO?
Any and all personnel who prepare compounded sterile preparations (CSPs) or work within a compounding facility must adhere to these regulations to ensure a safe, sterile environment. Pharmacy technicians, pharmacists, physicians, and nurses who are involved in sterile compounding are required to conform to USP <797> requirements. Lab 797 works with clients across the country, including physicians’ offices, pharmacies, hospitals, and more.
HOW DO I COMPLY WITH ALL USP 797 STANDARDS?
In order to best address any and all concerns associated with USP <797>, companies are responsible for determining the risk level of compounding in their facility. These sterile compounding regulations dictate the expectations for sterility and require a high level of control to achieve the best results.
Once you determine the risk level of your facility, it is important to perform an analysis to provide the best means for success. After completing your analysis and plan, the last step includes developing an action plan to address any shortcomings and prepare for any foreseeable sterility problems later on.
WHEN MUST ENVIRONMENTAL AND PERSONNEL SAMPLING BE PERFORMED?
Environmental and personnel sampling must be performed:
- As part of the commissioning and certification of new facilities and equipment
- Following any servicing of facilities and equipment
- Every six months as part of recertification
- In response to identified problems with end products or staff techniques
- In response to issues with CSPs, observed compounding personnel work practices, or patient-related infections
WHAT TYPES OF SAMPLES WILL NEED TO BE TAKEN?
In order to ensure you are running an aseptic facility, USP <797> requires both air and surface samples. Impaction on a media plate is the preferred method for gathering your sample. If you work in an ISO-classified environment, regular testing of the surfaces will be needed to ensure a clean, safe environment. Your company may be asked to perform a media fill, which is the substitution of a sterile growth medium in place of a regular drug solution to check for contamination issues.
LAB 797 provides trustworthy sampling media for general-purpose testing as well as tests for yeasts and molds. Browse our shop to find the USP <797> media you need!
WHAT LOCATIONS SHOULD I SAMPLE IN MY CSP FACILITY?
Where you collect your samples will play a vital role in accurately determining the sterility of your facility. This process also depends on the level of your ISO environment, as each classification will yield different facility requirements. In general, high-risk areas such as doors and entryways should be checked regularly for contamination concerns. If a room relies on doors or pass-through boxes for access, those contamination zones require extra attention. Compounding facilities also rely on USP <797> testing procedures to check zones dealing with air backwash turbulence, which can disrupt the unidirectional flow of air.
Throughout the sampling process, you will need to record valuable data pertaining to your USP sample, including the time and date, sample location, volume of air collected (or surface inspected), activity in the compounding area, and so on.
WHAT ARE ACTION LEVELS?
Action levels are limits set in place by USP as guidelines for the maximum number of viable organisms allowable in a single sample. Once these levels are exceeded, a facility is required to take action to ensure corrections are made and processes are revised. ISO action levels are determined based on the number of colony-forming units (CFUs) of bacteria present. Any living bacteria or fungal cell sampled can be considered colony-forming.
The number of viable organisms recovered from environmental testing must be compared to action levels to determine what corrective actions must be completed. If the number of organisms recovered exceeds the action level for the corresponding sample type, corrective action must be taken.
CURRENT ACTION LEVELS – FROM USP <797>
WHAT IS REQUIRED IF ACTION LEVELS ARE EXCEEDED?
If your results come back with a high level of CFUs, immediate action will need to be taken to ensure the safest and healthiest results for your facility. Areas in need of action will require you to readdress your current compounding sterile preparations, including the production process, personnel training, cleaning procedures, and air infiltration system. An investigation will be the first step in determining how to correct any discrepancies.
Once the cause of your contamination has been identified, it’s time to implement new policies, procedures, and equipment to create an aseptic environment. This process can range in scope from equipment changes to comprehensive personnel training.
Trust LAB 797 Today!
Our company focuses on providing quality environmental monitoring supplies and services to ensure facilities are equipped to create the best results. LAB 797 is here to serve as your comprehensive resource for USP <797> testing, including bacterial identification, CFU counts, proper sample incubation, and more.
If you’re dealing with sterility concerns, time is of the essence. Be sure to browse our USP media, and feel free to contact us if you still have questions. We look forward to helping you!
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