Many people have questions regarding sterile compounding, much as they do about non-sterile compounding. The following information provides an overview of seven key principles related to this type of compounding. Individuals need this material when preparing for the section on sterile compounding on the NAPLEX.
The Gloved Fingertip Test
Candidates must be aware of the three levels of the gloved fingertip test when it comes to iv sterile compounding. Every person must be tested initially. Once this testing is complete, individuals performing high-risk compounding must undergo testing semi-annually. Men and women who carry out low and medium-risk compounding only complete gloved fingertip testing once a year. Many pharmacies now choose to use an iv compounding robot to reduce the risk of the operator being exposed to dangerous chemicals.
ISO Classification
Areas where sterile compounding will occur must come equipped with a PEC hood that has an ISO 5 rating. Furthermore, it must be fitted with a HEPA filter. The area itself is required to be a minimum of ISO 7 and is referred to as the Clean/IV room. The Ante Room leading into the IV Room is where a person washes their hands and dons the appropriate garb. Regulations require this room to be an ISO 8 at a minimum. However, if the Ante Room leads to a negative pressure room, guidelines say it must be ISO 7.
Garb Order
In addition to knowing which garb is required, men and women must know the order in which the garb is to be put on. Always start with the hair and face before putting on shoe covers. Wash the hands using soap and water before putting on the gown. Once the gown is on, clean the hands with alcohol-based hand sanitizer and put on gloves.
Recall Classification
Individuals must understand the recall classification when it comes to sterile IV compounding. A Class I recall is serious and involves death, and a Class II recall is temporary and involves reversible harm. With a Class III recall, there has been no harm. The FDA maintains a list of all compounding inspections, recalls, and other actions.
Additional Requirements
Chemotherapy drugs and other hazardous drugs must be compounded in class II aseptic containment isolators and biological safety cabinets. When testing for endotoxins, individuals must use the LAL or Limulus Amoebocyte Lysate test. Compounds unable to survive heat sterilization and those that are heat sensitive must pass through a 0.22-micron filter for sterilization purposes.
Sterile Beyond Use Dates
The beyond use date (BUD) provides information about the compounded preparation and when it can no longer be stored. This is determined by the date it was originally compounded. The BUD remains of great importance as it ensures a patient isn’t given a compound that has physically or chemically degraded. In addition, it protects them from microbial contamination and proliferation. Finally, the BUD helps retain the product’s integrity and its container. The type of compound determines how long it may be kept at room temperature, in the refrigerator, and in the freezer.
Monitoring
Individuals must be aware of monitoring parameters to ensure they aren’t breached. To ensure sterility, items must be monitored at different time periods. For example, the temperature requires daily monitoring while the air pressure and HEPA filter need to be checked every shift to every day. The air sampling and pharmacy environment, in contrast, must only be checked every six months.
Every person involved with sterile compounding must know these seven key principles. Furthermore, they must monitor the industry to be knowledge of any changes to the guidelines. Although this may appear overwhelming, it doesn’t need to be. Once you begin working in sterile compounding, most of these actions become second nature.
