Pharmaceutical compounding is a branch of pharmacy that continuous to play a crucial role in drug development. Pharmacists develop and test pharmaceutical formulations for new drugs, to ensure that active ingredients are effective and stable.
Physicians may prescribe individually compounded medications for patients with unusual health needs. Compounded preparations are especially common for patients requiring limited dosage strengths, patients with drug allergies, home healthcare, and anti-cancer treatment.
Risks Involving Cytotoxic Drug Preparation
Cytotoxic drugs sometimes known as antineoplastic, anti-cancer chemotherapy drugs include a wide range of chemical compounds because of their ability to kill tumor cells, they are extensively used to treat cancer, however, their actions are not specific to tumors cells and normal cells may also be damaged. As a result, they can produce significant side effects in patients or others exposed this together with the increasing use and complexity of chemotherapy has raised concerns about the risks to health care workers involved in preparing and administering cytotoxic drugs.
USP Guidelines and requirements
The United States Pharmacopeia and other related organizations have established enforceable guidelines for sterile drug preparation. USP Chapter 797 requires the use of engineering controls such as Isolators while conventional engineering controls such as Laminar Flow Clean Benches and Biological Safety cabinets may be used. USP 797 imposes stricter requirements on the environment in which this equipment must be cited.
Types of Isolators
Isolators protect compounded drug products from room contaminants. Some offer operator and environmental protection from handling hazardous drugs. Three different types of Isolators are offered by manufacturers. Each is designed for different applications.
Positive Pressure Isolators are suitable for work involving non-hazardous materials. The work zone and pass-thru works under positive pressure to the room. To maintain sterility in case of a breach in the barrier isolation system.
Negative Pressure Recirculating Isolators are suitable for work involving hazardous materials, anti-neoplastic or cytotoxic compounding applications such as chemotherapy. The work zone and pass-thru interchange are under negative pressure to the room. To maintain operator protection. In case of a breach in the barrier isolation system, they may be optionally vented.
Negative Pressure Total Exhaust Isolators are
for work involving hazardous materials that may volatilize. the work zone and pass-thru interchange are under negative pressure to the room. To maintain operator protection in case of a breach in the barrier isolation system, they must be externally vented.
Isolators protect the products and in some cases, the operator through the following:
1. Total physical separation between the product and the environment unlike in laminar flow clean benches of biological safety cabinets, the operator works in the front of the isolator. The intentional use of air pressure relationships positive or negative defines the direction of airflow in and out of the isolator. This experiment illustrates how a positive pressure isolator protects drug products from contamination even in case of a breach. Notice how no room air enters the arm ports even with the glove assembly being removed.
2. The use of directed airflow either unidirectional or turbulent maintains sterility in the work zone, unidirectional airflow also known as laminar airflow is the most effective. Isolators incorporating unidirectional airflow typically direct filtered air downward in a piston-like fashion. Therefore, rapidly purging the work zone of the contaminant. This experiment with a smoke source illustrates the efficacy of unidirectional airflow.
3. The use of high-efficiency filters to capture aerosols and particles. Isolators utilize either HEPA or ULPA filters. HEPA filters are 99.99% efficient at 0.3 microns while ULPA filters are 99.999% efficient at 0.1 to 0.3 microns. The supply air entering the isolator is always filtered.
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