Non-Sterile Compounding Fundamentals for Pharmacy Techs

Non-Sterile Compounding: What Every Pharmacy Technician Needs to Know

Non-sterile compounding is the preparation of medications that do not require a sterile environment. This includes creams, ointments, capsules, solutions, suspensions, and other dosage forms. Pharmacy technicians play a vital role in the compounding process, and understanding the fundamentals is essential for both daily practice and the PTCB exam.

What Is Non-Sterile Compounding?

Non-sterile compounding involves combining, mixing, or altering ingredients to create a customized medication for a specific patient. This practice is necessary when commercially available products do not meet a patient's needs. Common reasons for compounding include creating a medication in a different dosage form, removing an allergen or dye, preparing a pediatric-friendly liquid from a tablet, or combining multiple medications into a single preparation.

USP Chapter 795 Standards

USP (United States Pharmacopeia) Chapter 795 establishes the standards for non-sterile compounding in pharmacies. These guidelines cover personnel training, facility requirements, equipment maintenance, ingredient sourcing, quality assurance, and documentation. Key USP 795 requirements include:

• Proper training and competency assessment for all compounding personnel
• A dedicated compounding area that is clean and organized
• Appropriate equipment that is calibrated and maintained
• Use of ingredients from reliable, FDA-registered suppliers
• Master formulation records and compounding logs for every preparation
• Quality control procedures including visual inspection and weight verification

Essential Compounding Equipment

Non-sterile compounding requires specific equipment. Pharmacy technicians should be familiar with the following tools and their proper use:

An electronic balance or Class III torsion balance is used for weighing ingredients accurately. Electronic balances are preferred for their precision and ease of use. Weighing papers or boats prevent contamination and ensure accurate measurements.

A mortar and pestle is used for grinding, crushing, and mixing solid ingredients. Glass mortars are used for liquids and semi-solids, while porcelain (Wedgwood) mortars provide a rougher surface better suited for grinding hard materials.

An ointment slab (also called a compounding slab) provides a smooth, non-porous surface for mixing ointments and creams. Parchment paper may be used on the slab for easier cleanup. Spatulas are used for mixing and transferring ingredients on the slab.

Graduated cylinders and beakers are used for measuring liquids. Always read the meniscus at eye level for accurate volume measurements. Use the smallest graduated cylinder that will hold the required volume for maximum accuracy.

Common Compounding Techniques

Several techniques are fundamental to non-sterile compounding:

Geometric dilution is a method for evenly distributing a small amount of a potent ingredient throughout a larger quantity of base or diluent. Start by mixing the smallest quantity ingredient with an approximately equal amount of the diluent. Then add an equal volume of diluent to the mixture and mix again. Continue doubling until all ingredients are incorporated.

Trituration involves grinding a solid substance in a mortar to reduce particle size. This technique improves dissolution, ensures uniform mixing, and produces a smoother final product. Proper trituration technique uses a circular grinding motion with moderate pressure.

Levigation is the process of reducing particle size by incorporating a small amount of liquid (called a levigating agent) with the solid in a mortar. Mineral oil is a common levigating agent. This technique produces a smoother ointment or cream than trituration alone.

Spatulation involves mixing ingredients on an ointment slab using a spatula. This technique is appropriate for ingredients that are already fine powders and do not require further particle size reduction.

Documentation and Record Keeping

Proper documentation is a critical component of non-sterile compounding. Two types of records are required:

A Master Formulation Record contains the complete formula for each compound, including the name and strength of each ingredient, equipment needed, compounding procedures, quality control measures, and beyond-use dating. This record serves as the recipe that is followed each time the compound is prepared.

A Compounding Log (also called a Compounding Record) is created for each individual batch. It documents the specific lot numbers of ingredients used, actual quantities measured, the name of the compounder, the date of preparation, the assigned beyond-use date, and any quality control checks performed.

Quality Assurance in Non-Sterile Compounding

Quality assurance ensures that each compounded preparation meets appropriate standards. Key quality checks include verifying ingredient identity and purity, checking weights and measurements for accuracy, performing visual inspections for proper consistency and appearance, and conducting pH testing when applicable. Any preparation that does not meet quality standards must be rejected and discarded.

PTCB Exam Focus Areas

For the PTCB exam, focus on understanding USP 795 requirements, compounding calculations including percentage strength and dilution problems, proper use of compounding equipment, beyond-use dating guidelines, and documentation requirements. Practice problems involving geometric dilution and concentration calculations are especially common on the exam.