UHSP Pharmacy Technician Training Module 8: Pharmaceutical Compounding and Sterile Techniques

Compounding

Compounding is the process where a pharmacist or technician creates a customized medication by combining individual ingredients based on a prescription from a healthcare provider. This process is often used to tailor medications to meet specific patient needs, such as adjusting the dosage or creating a different formulation for patients with allergies or sensitivities.

Active Pharmaceutical Ingredient (API)

The API is the primary ingredient in a medication that provides the therapeutic effect. It is the component responsible for treating the specific condition or symptoms for which the medication is prescribed. APIs can come in various forms, such as powders, liquids, or solids.

Excipient

Excipients are inactive ingredients in a medication that help deliver the API to the body, improve the stability of the medication, enhance taste and appearance, and aid in the manufacturing process. Excipients play a crucial role in ensuring the effectiveness and safety of the medication.

Base

The base of a compounded medication refers to the foundation or the primary vehicle in which the active ingredients and excipients are combined. Bases can take various forms, such as creams, ointments, lotions, gels, solutions, or suppositories, and they provide the structure and consistency for the compounded medication.

Diluent

A diluent is a substance used to decrease the concentration of the active ingredient in a medication preparation. Diluents are added to adjust the strength of the medication and ensure it is safe and effective for the patient. Common diluents include water, saline solution, or other inert substances.

Solvent

A solvent is a liquid used to dissolve the active ingredient in a compounded medication. Solvents are essential for creating liquid formulations and ensuring the proper distribution of the active ingredient within the medication. Examples of solvents include ethanol, propylene glycol, or vegetable oils.

Osmolarity

Osmolarity is a measure of the concentration of solute particles in a solution. It is a critical parameter in pharmaceutical compounding as it influences the stability, safety, and effectiveness of the medication. Osmolarity must be carefully controlled to prevent irritation or damage to the tissues upon administration.

Ratio Strength

Ratio strength refers to the proportion of the active ingredient relative to the total volume or weight of the compounded medication. Understanding the ratio strength is crucial for ensuring the correct dosage and potency of the medication, as it determines the concentration of the active ingredient in the final formulation.

Compounding Technician

A pharmacy technician trained in the compounding process who assists pharmacies in preparing compounded medications

Non-Sterile Compounding

Involves preparing medications that do not require sterile conditions, such as creams, ointments, capsules, and suspensions. These medications are typically administered topically, orally, or rectally.

Sterile Compounding

Refers to the preparation of medications that must be sterile to prevent microbial contamination, including injectables, eye drops, and intravenous solutions. Sterile compounding requires strict aseptic techniques and specialized equipment

Milling and Levigating

Milling involves reducing the particle size of solids to improve solubility or dispersibility. Levigating is the process of incorporating powders into liquids to form a smooth paste.

Molding and Casting

Involves shaping medications into specific dosage forms such as suppositories, troches, or lozenges using molds or casting techniques. 

Aseptic Technique

Aseptic technique is essential in sterile compounding to prevent microbial contamination. This involves creating and maintaining a sterile field and using sterile equipment and supplies.

Primary Engineering Control (PEC)

A device, such as a laminar airflow hood, used to maintain a sterile environment during compounding

ISO Class

The classification system used to define the level of cleanliness in a controlled environment, such as an ISO class 5 environment for sterile compounding.

Media-Fill Test

Conducting periodic tests to validate the aseptic technique and sterility of the compounding environment.

USP

The United States Pharmacopeia, an authoritative source of standards for pharmaceuticals and other healthcare products in the United States

Beyond-Use-Date

The date after which a compounded medication should not be used due to potential risks of contamination, stability issues, or effectiveness.

USP Chapter <795> (Non-Sterile Compounding)

USP Chapter <795> provides standards and guidelines for the compounding of non-sterile preparations, including oral solutions, ointments, and capsules. These standards are essential for ensuring the accuracy, stability, and safety of compounded medications.

USP Chapter <797> (Sterile Compounding)

USP Chapter <797> provides standards and guidelines for the compounding of sterile preparations to prevent microbial contamination and maintain sterility throughout the preparation process. These standards are crucial for ensuring patient safety, particularly for vulnerable populations such as immunocompromised patients.