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

Sterile Compounding Areas

Vondra Wesley

Rasmussen College

Author Note

This paper is being submitted on January 20, 2019, for Jessica Howard’s Sterile and Non-Sterile compounding course.

Sterile Compounding Areas

In the Pharmacy area, there should not be any unauthorized personnel. The compounding area is a very critical and important sterile environment where the best personal hygiene is encouraged. The compounding staff should remove all outerwear, no artificial nails or polish, no makeup or piercing or jewelry. Hair should be well groomed and appropriate for the profession. Any person or staff with a cold or illness are not allowed in the compounding area or allowed to compound under no circumstances to avoid the spread of contamination. The first aseptic practice is to have a sticky mat at the entrance of the Anteroom doorway. The sticky mat will allow for the Pharmacist or technician to clean their feet before entering the sub-sterile environment by removing any dirt or debris from footwear. ("13 Sterile Compounding", 2019) Upon entering the Anteroom, the proper procedure for preparation is a requirement. The first one is Garbing. Garbing is the practice of dressing appropriately in Personal Protective Equipment (PPE) to enter into a sterile environment without transporting or taking in any germs, contaminants or potential hazards that could pose a direct danger to medications, staff or patient care. Apply 70% isopropyl alcohol to both hands in washing motion. Put on booties front to back, apply alcohol to hands again. Apply hair net over entire head, ensuring no hair is uncovered. Tie the top first over the ears, then the bottom. Apply alcohol to hands again. Apply face mask, ensuring to completely cover nose, mouth and chin. Men are to put on beard mask if applicable. Apply goggles if required to avoid possible eye contamination or injury from splashing of liquids. Get a package of the aseptic soap and walk over to sink (Never use hands to control faucet, but use provided foot pedals for operation) squeeze the package twice to activate the soap, then open. Discard packaging. Always start with left hand, clean fingernails on both hands first with the enclosed pic to remove any dirt or debris, discard pic. Wet the sponge and scrub under each fingernail. Scrub thumbs on the outer side and all four surfaces. Clean the webbing between all fingers of both hands. Then scrub the palms of both hands (left then right), then scrub the back of both hands with the sponge. Then starting on the left, clean left forearm gradually in a circular motion up towards the elbow, then proceed to right arm ensuring that your scrubbing wrist to elbow (upward motion). The handwashing technique should last for two-four minutes. Dispose of sponge, but never touch the trash receptacle, use foot pad. Rinse left hand and forearm under water with fingertips pointing up circulating the rinse water up the forearm towards elbow, then repeat same steps for the right arm. Use aseptic, lint free paper towel to dry left hand and forearm, then repeat for the right arm. Dispose of paper towel. Open sterile gown and remove from package. Do not let it touch the floor. Insert one arm at a time and pull up to shoulder and repeat. Secure neck closure and wrap waist ties around and secure in the back. Sterilize hands again with alcohol and let dry. Open sterile glove package, place inner packet onto sterile surface. Put left glove on first, pull up arm and place over cuff of gown and repeat for right hand. Upon removal, remove gloves first, gown(roll-up), facemask, hairnet then shoe coverings and dispose properly. (2019) Now you may enter the Cleanroom. The Cleanroom is a regulated environment created to provide an aseptic environment for preparing and creating compounded medications and special formulations. The Cleanroom has a minimal level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. A Cleanroom is a secured space specifically designed where provisions are allowed to reduce contamination by particles and control other environmental factors such as temperature, humidity, and pressure. ("What is a Cleanroom? Cleanroom Classifications, Class 1, 10, 100, 1,000, 10,000, 100,000, ISO Standard 14644, Cleanroom Definition", 2019). Majority of the industries currently use cleanroom’s where small particles can adversely affect the manufacturing process. Sterile compounding is one of the highest risks of the Pharmacy practice. Dust and other low-level environmental pollutants, such as airborne microbes, aerosol particles, and chemical vapors require strenuous control. (2019) All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary. Cleanrooms maintain particulate-free air through the use of HEPA filters employing laminar or turbulent airflow principles. Laminar air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. The quality control guidelines and regulations protect healthcare personnel who receive, prepare, administer, transport, or otherwise come in contact with hazardous drugs from possible negative acute and chronic health effects of exposure to hazardous drugs and decrease the potential risks of the patients from obtaining contaminated medications. ("What is a Cleanroom? Cleanroom Classifications, Class 1, 10, 100, 1,000, 10,000, 100,000, ISO Standard 14644, Cleanroom Definition", 2019) Air entering a cleanroom from the outside must be filtered to exclude dust. The air inside a cleanroom receive constant recirculation through high-efficiency particulate air (HEPA) filters to control contaminants that are generated inside the room. Particle levels are tested using a particle counter, and microorganisms are detected and counted using environmental monitoring methods.  ("Contamination Control in Pharmaceutical Cleanrooms," 2019) In the Cleanroom is where the Pharmacist and Pharmacy Technicians prepare aseptic compound medications, dilutions, mixing and injections of various medical products. This practice is commonly used in hospitals and home healthcare settings for patients who are unable to swallow oral medications, whose digestive systems preclude the use of oral medications, or whose system necessitates a more rapid delivery of medication into the blood supply. Intravenous (IV), Intramuscular (IM), Subcutaneous (SQ) and Intrathecal (IT) are the major routes of medication administration prepared in compounding pharmacies. Total Parenteral Nutrition intravenous feedings (TPN) are also prepared in compounding settings. In the cleanroom mass quantities of vaccines can be prepared without risks of contamination if the proper procedures are used effectively with precautions. Some Physicians may request some topical ointments, creams, and gels that require compounding with highly potent medications that need mixing in a sterile environment. Daily cleaning of the entire compounding environment which includes the clean rooms and ante-rooms require disinfection on a regular basis. Including floors, hoods, and countertops. Make sure compounding staff uses the proper cleaning agents so that any microorganisms are eliminated. (Cathy Thompson, 2019) Why it is necessary that we have both an anteroom and a cleanroom? The reason we have the Anteroom is pretty self-explanatory. The Anteroom is pretty much the same as a surgical prep room. It is used as a prep and sterilization room by the immediate pharmacy staff to ensure that no virus, microorganisms or bacteria enter into the cleanroom where the process of compounding of the medication requested and to ensure staff doesn't take in any contaminants or germs that would render the whole process as contaminated and unusable. The Cleanroom is a sterile environment with its components to keep out air-borne germs and contaminants and should be cleaned and sanitized daily and after each use. Strict adherence to this practice is essential to the production of medication to maintain its integrity and to provide safety to the patients and the staff.

References

13 Sterile_Compounding. (2019). Retrieved from http://resources.emcp.com/EPC_Books/EPC_Sterile_Compounding/ (2019). [Image]. Retrieved from https://www.youtube.com/watch?v=QyiNoC5oYto What is a Cleanroom? Cleanroom Classifications, Class 1, 10, 100, 1,000, 10,000, 100,000, ISO Standard 14644, Cleanroom Definition. (2019). Retrieved from https://www.cleanairtechnology.com/cleanroom-classifications-class.php (2019). Retrieved from http://www.rld.state.nm.us/uploads/files/Personnel%20Metrics.pdf Contamination Control in Pharmaceutical Cleanrooms. (2019). Retrieved from https://www.rdmag.com/article/2018/03/contamination-control-pharmaceutical-cleanrooms Cathy Thompson, M. (2019). 7 USP 797 Clean Room Guidelines You Need to Know. Retrieved from http://blog.pharmacyonesource.com/7-usp-797-clean-room-guideline-you-need-to-know