Improved safety outcomes for patients who receive compounded sterile preparations (CSPs) can be traced to the issuance and implementation of the quality system described in U.S. Pharmacopeia Chapter <797>: Pharmaceutical Compounding – Sterile Preparations. The intent of USP 797 is to prevent patient harm and death through minimum practice and quality standards expected of any entity or individual involved in storage, handling, preparation and transportation of CSPs. By carefully adhering to USP 797 standards, pharmacies are reducing the risk of causing patient harm and keeping staff safe.
USP 797 standards cover three key areas – personnel, engineering/facility design and environmental controls. The chapter provides requirements for each area designed to ensure safe, sterile compounding.
One of the most critical USP 797 standards requires well-trained and routinely-monitored personnel. Repeated studies conclude that personnel represent the number one source of microbial contamination in a cleanroom.1 Given this fact, attention must be given to personnel garbing and aseptic technique and compliance with standard operating procedures (SOPs) to achieve and maintain USP 797 compliance.
Donning sterile gloves
Studies have shown significantly higher rates of positive media fills among operators who begin with non-sterile gloves, compared to those who utilize sterile gloves. To avoid this potential contamination source, use only sterile gloves. Another key factor that minimizes contamination is to sanitize gloved hands with sterile isopropyl alcohol routinely. 2
Properly garb - regardless of compounding risk level
Despite the level of risk in your compounding facility, proper garbing is essential. Personnel should always wear shoe covers, face masks, hair covers and gowns, regardless of the level of risk in the compounding environment. Those involved with high-risk compounding may take it a step further and require the use of hoods and sterile garb.
Train, monitor, and test
Compounding personnel can be the pharmacy’s best asset. Ongoing training and evaluations (glove fingertip sampling, aseptic media fills) are vital for evaluating the competency and skill of personnel and avoiding adverse patient outcomes.
The second key area of USP 797 compliance involves an adequately designed facility. Some essential requirements include:
Air quality and cleanliness can significantly impact microbial contamination, making this a high priority for facility design. A high-quality air ventilation design is critical, as well as installation and regular maintenance of high-efficiency particulate air (HEPA) filters for cleanroom applications.
Line of demarcation (LOD)
Design the facility so that there is a clear line of demarcation in the ante-area or segregated compounding area that separates the dirty area from the clean area. The LOD provides a visual job aid to assist compounding personnel to properly sequence the donning and doffing of their personal protective equipment (PPE).
A temperature of 20°C or cooler will allow for work comfort and limit microbial contamination produced by staff from excessive temperatures while garbed.
Easily cleanable surfaces will aid in effective cleaning procedures and prevent the accumulation of contaminants introduced by the personnel and components.
A robust environmental compliance management program provides objective data to track facility integrity, air quality, and microbial levels; it enables the pharmacy to adjust if shifts in environmental control occur, as seen through the recovery of elevated colony forming units (CFUs). Important environmental USP 797 standards include:
Microbial and particulate monitoring
The compounding pharmacy must perform semi-annual monitoring for viable microbial (bacterial, mold, fungus) contamination in the air, and particulates. Performing surface sampling monthly is recommended.
Environmental sampling plan
Only 66 percent of respondents in the 2019 USP Chapter <797> Compliance Survey reported planning to establish formal environmental monitoring. A robust environmental sampling plan includes the following: sample locations, collection method, sampling frequency, air sample volume (for viable air samples), time of day in relation to compounding and action levels. Having and using an EM plan will provide a consistent method of monitoring locations within the cleanroom suite (anteroom and buffer room).
1. Agalloco J, et al. Aseptic Processing: A Review of Current Industry Practice. Pharmaceutical Technology. 2004; 28(Oct 10): 128.
2. Trissel LA, Gentempo JA, Saenz LM, Woodard MY, Angeles CH. Effect of two work practice changes on the microbial contamination rates of pharmacy-compounded sterile preparations. Am J Health Syst Pharm. 2007 Apr 15;64(8):837-41.
3. The 2019 State of Pharmacy Compounding. Pharmacy Purchasing & Products. April 2019, Vol. 16 No. 4."