Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond

Contamination Risk and Prevention

Vondra Wesley

Rasmussen College

Author Note

This paper is being submitted on January 27, 2019, for Jessica Howard’s Sterile and Non-Sterile Compounding course.

Contamination Risk and Prevention

Pharmacy carries out an essential role in preparation and storage of compound sterile and non-sterile preparations. The functions of pharmacy in preparing aseptic compounds range from infection prevention and control activities, and sterile fluid preparation. Whether the formulation is completed by pharmacy staff, there are particular programs used in parental preparation of sterile compounds. Parenteral preparation should be done in entirely sterile conditions preventing harm and other risks such as death that the patient receiving the compound might suffer after receiving treatment. Generally, preparation of sterile parenteral products needs a lot of care in control of material, ingredients, and materials to ensure the purity and quality of the product. USP (797) is recommended as the appropriate and applicable guidance to apply in pharmacy to install quality training and suitable equipment.

There are several types of contamination of the sterile compound that might occur. They include physical or chemical contaminants unintentionally involved in the process. Also, including ingredients of inappropriate quality to the mixture prepared is another common sterile compound contaminant. More so, microbial contamination might occur in the process of developing the sterile compound. Lastly, an increase in bacterial endotoxins is a common contaminant in the development of sterile compound preparation (Fetter et al., 2017). These contaminants can lead to harm, minor infection as well as death. For example, parenteral nutrition bags which were contaminated caused the outbreak of Serratia marcescens bacteremia in 2011 (Fetter et al., 2017). The occurrence led to the death of 9 patients among the infected 19 at several Alabama hospitals. The sterile compound was compounded in California which later in 2012 led to the meningitis outbreak.

The USP (797) also known as the U.S. Pharmacopeia chapter (797) provides the improved safety outcomes of patients receiving sterile compound preparation. The main aim of USP 797 is to prevent and minimize possibilities of patients’ harm through quality standards and minimum practice applied in any individual or object regardless of the compounding risk level. This practice assists in eliminating the risk of Touch Contamination. Touch Contamination is the most common form of contamination and the easiest to prevent. Follow proper hand washing guidelines and gloving procedures. All supplies, utensils and packaging materials must be appropriately sterilized before being introduced into the DCA (Direct Compounding Area) to prevent this type of contamination. (Anderson & Ballington, 2014), (McCartney, 2012). USP 797 standard requires training, monitoring and evaluating competence and skills used in compound sterile preparations handling, storage, preparation as well as transportation (Cooper et al., 2017). The standards used by USP 797 covers three critical entities which include personnel, engineering design, and environmental controls. The guidelines help avoid contamination when compounding sterile preparations. Under Personnel, USP 797 requires that routine monitored and well-trained staff should perform the process. Proper personal hygiene should be maintained at all times. No staff member that is sick or in poor health is to be allowed to enter into the compounding area, neither participate in the compounding procedures. This is a very crucial barrier to enforce since water contamination from coughing and sneezing in the laminar flow hood can introduce moisture droplets into the air and contaminate the compounded product. It is also essential that only sterilized water be used since it is free of microorganisms.

The recommended practices include wearing sterile gloves; proper garbing such as wearing shoe covers, hair covers, face masks and gown of the personnel. Also, it is required that there should be a clear line of division in the segregated compounding area separating the clean and dirty areas. USP 797 compliance also requires a properly designed facility to avoid contamination in the process of sterile compound preparation. Under engineering or facility design, USP 797 compliance requires air ventilation of high-quality and installation and maintenance of high-efficiency HEPA air filters are to be used only. Cleanliness and air quality impact microbial contamination significantly making it an area of concern. Since Air contamination occurs through dust particles or moisture droplets in the air, working in the laminar flow hoods within the zone of turbulence help to prevent this type of contamination. Shadowing is a form of contamination that involves improper placement of products in the laminar flow hood or interruption of the air flow by your hands or another object. The zone of turbulence continually provides sterilized air flow into the Direct Compounding area and must be allowed to flow without any obstructions.

Environmental management enables the pharmacy to adjust in the case of unfavorable results (Cooper et al., 2017). USP 797 standards require environmental sampling plan including location sample, sampling frequency, air sample volume, time of the day concerning compounding, collection methods and action levels. Lastly, USP 797 compliance under environmental control requires monitoring of particulate and microbial contamination and is a requirement to be completed semi-annually. Particulate matter contamination occurs when there is a solid substance within the IV solution, including coring or precipitation. To prevent coring, proper techniques are in use when withdrawing from a vial. Particulate matter contamination is preventable if the compatibility is verified before mixing the compound. (Anderson & Ballington, 2014), (McCartney, 2012). However, USP (797) does not offer the necessary protection in the mass production of drugs which need GMP control. (Fetter et al., 2017).

As I conclude, environmental management, monitoring, and aseptic techniques are essential to track facility’s air quality, levels of microbial contaminants and prevention of pathogenic organisms from entering into the sterile environment or preparation procedures.

References

Cooper, J. F., Petry, N. A., & Director, B. C. N. P. (2017). USP Chapter< 797> Pharmaceutical compounding; sterile preparations potential impact on handling radiopharmaceuticals. University of New Mexico Continuing Education Program for Nuclear Pharmacists, 13, 19. Fetter, C. W., Boving, T., & Kreamer, D. (2017). Contaminant hydrogeology. Waveland Press. Anderson, R., & Ballington, D. (2014). Pharmacy Practice for Technicians [eBook] (5th ed.). St. Paul, MN: Paradigm Publishing. McCartney, L. (2012). Sterile Compounding and Aseptic Technique: Concepts, Training, and Assessment for Pharmacy Technicians [eBook]. St. Paul, MN: Paradigm Publishing.