Compounding personnel

Should be limited to those adequately trained and competency-tested for aseptic technique and to the minimal number required for the planned procedures. Since the human body is constantly shedding particles, many of which are viable microorganisms, major efforts must be made to reduce the ingress of these particles into the buffer area but, particularly, into the direct compounding area. This is accomplished by good personal hygiene, through washing/disinfecting hands, donning garb to confine the particles as much as possible and following good aseptic technique.

Training and evaluating compounding personnel

To achieve good sterile compounding practice, personnel must be adequately trained and the effectiveness of the training must be tested by written exams, observation by a trained observer, media fill testing and fingertip glove testing. Training is the most significant factor contributing the assurance of quality in sterile preparations, because personnel are recognized as the primary source of contaminants, both viable and nonviable shed in the clean room environment. Therefore compounding personnel must be taught to understand this natural phenomenon and how they can control particulate shedding while compounding. Pharmacists and technicians who compound sterile preparations must understand good compounding practice and practice excellent aseptic technique. Training should make clear that sterile preparations must have the highest level of quality and purity of all dosage forms Trainees should be instructed in the nature of contaminants and the means of achieving the required level of purity, maintaining stability during the required beyond use dating of the preparation, and evaluating the required characteristics

Pharmacists should be sufficiently familiar with the principles of sterilization to work swith technicians who perform autoclaving or hot-air sterilization of supplies or preparations. The validation of these processes for their bacterial effect is highly critical and requires considerable expertise. Pharmacists and technicians should know the specifications for facilities and devices in which they must perform. This includes the selection of equipment from external suppliers or working with in-house engineers to assure proper clean air flow into the ante and buffer areas. An understanding of some engineers principle is needed to achieve required environmental standards. The use of barriers to interrupt the ingress of contaminants into the direct compounding area must be understood. Trainees must have a basic understanding of microbiology Compounding personnel should understand the principles of environmental eavaluation

Aseptic Technique
Manipulations by compounding personnel are used in small-scale compounding sterile preparations in the buffer area for low and medium-risk preparations. Medium-risk preparations may require automated compounding devices for the addiction of smallvolume additive to TPN solutions Compounding personnel must set up such devices, connect fresh stock containers, fill the final preparation containers, and generally monitor the operation. High-risk preparations are particularly exposed to the environment and to compounding personnel

Garb and Behavior

Because of the inherent shedding of viable and nonviable particles from the body of compounding personnel, serious efforts must be made to control this shedding. Means used include garbing, designed to confine most particulate discharge within a garb; planning movements while using aseptic technique to minimize losing particles from the body; and removing human beings as far as possible from the direct compounding area. One of the advantages of using compounding aseptic isolators is the fact that the bodies of compounding personnel are physically separated from the direct compounding area.

 Before entering the buffer area, compounding personnel must remove outer garments, all cosmetics, and all hand, wrist, and other visible jewelry or piercings that can interfere with the effectiveness of personal protective equipment (PPE). The wearing of artificial nails is prohibited. natural nails must be kept neat and trimmed. Personnel done the following PPE in an order that proceeds from those activities considered the dirtiest to those considered the cleanest.

 Garbing activities considered the dirtiest include donning of dedicated shoes or shoe covers, head and facial hair covers and face masks/eye shields. Thereafter, a hand cleansing procedure must be performed by removing debris from under fingernails using a nail cleaner under running water followed by vigorous hand washing. Hands and forearms are washed to the elbows for at least 30 seconds with soap and water while in the ante area. Hands and forearms to the elbows should be completely be completely dried using a lint-free disposable towels or an electronic hand dryer. After completion of hand washing, a non shedding gown with sleeves that fit snugly around the wrists and enclosed at the neck is donned. Gowns designated for buffer area must be worn, and they should be disposable

 Once inside the buffer area and prior to donning sterile powder-free glove, antiseptic hand cleansing must be performed using a waterless alcohol-based surgical hand scrub with persistent activity following manufacturers recommendations. Hands are allowed to dry thoroughly before donning sterile gloves.

 Sterile gloves are the last item donned before compounding begins. Gloves become contaminated when they contact nonsterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70% IPA to all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Only use gloves that have been tested for compatibility with alcohol disinfection by the manufucturer

 Routine application of sterile 70% IPA must occur throughout the compounding process and whenever nonsterile surfaces are touched. Gloves on hands must also be routinely inspected for holes, puncture, or tears and replace immediately if such are detected. Compounding personnel must be trained and evaluated in the avoidance of touching critical sites.

 When compounding personnel exit the compounding personnel exit a compounding area during a work shift, the exterior gown may be removed and retained in the compounding area if not visibly soiled, to be re-donned during that same work shift only. Shoe covers, hair and facial hair covers, face masks/eye shields and gloves must be replaced with new ones before re entering the direct compounding area, and proper hand hygiene must be performed

Elements of good aseptic technique

Practice good personal hygiene; be organized and calm Be healthy, without eczema or other skin rashes, and free from allergies or other conditions causing sneezing or coughing Put on garb properly Replace garb or parts of garb that become contaminated while gowning or working. Disinfect all interior surfaces of the LAFW (except the HEPA filter face) with sterile 70% IPA Disinfect gloves frequently Replace gloves with new sterile ones if they become puncture or torn

 Move with slow, smooth, gentle motions Do not talk unnecessarily Do not disrupt HEPA-filtered laminar air flow within the direct compounding area. Do not interpose arms or any other nonsterile objects above a critical site in BSC or behind a critical site in horizontal laminar air flow Do not spray or splash disinfectants where the liquid might enter a preparation container or reach other preparation Do not introduce any packages into the buffer area unless they have been adequately disinfected or sterilized externally

 Minimize in and out movement at the LAFW BSC or compounding isolator Disinfect glove with sterile 70% IPA after handling any package if the outside had uncertain sterility or surfaces such as switches of mixing pumps Cooperate with other compounding personnel and mutually assist in maintaining proper aseptic technique Pass through doorways, plastic curtains, or other passageway slowly and carefully to minimize the generation of potentially contaminating air currents. Do not leave open vials, tanks, or other critical sites exposed to the environment during breaks or other delays in operation

 Inspect all supply items before using and the finished preparation after preparation of evidence of defects Remove used supply items and clean/disinfect work area as needed Prepare and apply appropriate labels and complete documents away from the direct compounding are of, preferably, pass preparation outside so that a second person can perform the paperwork Remove used garb carefully to avoid disturbing accumulated body contamination before exiting the gowning room Leave the HEPA filter blower operating at all times