15 Introduction to Sterile Products

State Standard 15) Demonstrate the following skills surrounding compounding: a. Handling and disposal requirements (e.g., receptacles, waste streams) b. Documentation (e.g., batch preparation, compounding record)** c. Determination of product stability (e.g., beyond-use dating, signs of incompatibility)** d. Selection and use of equipment and supplies e. Sterile compounding processes** f. Non-sterile compounding processes 25) Demonstrate the following skills of prescription packaging requirements: a. Type of bags b. Syringes c. Glass d. PVC e. Child resistant f. Light resistant**

Objectives Students will be able to… Identify regulations and guidelines for aseptic technique. Identify sterile equipment used in preparations. Measure and mark dosages on a syringe

Figure 15-1 A technician dressed in sterile clothing.

Aseptic Technique Procedure performed under controlled conditions in a manner that minimizes the chance of contamination of the preparation. Environment Conditions such as the air where the compounding is being performed must be controlled.

Aseptic Technique Procedure performed under controlled conditions in a manner that minimizes the chance of contamination of the preparation. Equipment All objects that come in contact with the drug(s) must be sterile. Personnel Touch contamination is the most frequent cause of contamination.

Aseptic Technique Sterile Class 100 environment Free from bacteria and other microorganisms Class 100 environment Classification of airflow unit capable of producing an environment containing no more than 100 airborne particles of a size 0.5 micron or larger, per cubic foot of air

Regulations and Guidelines FDA Publishes good manufacturing practices (GMPs) Guidelines on manufacture of sterile products by aseptic processing Quality system regulations making standards consistent with quality system requirements

Regulations and Guidelines The Joint Commission Many general standards regarding pharmaceuticals and the facilities that manufacture, store, and deliver them Centers for Disease Control and Prevention (CDC) Guidelines to prevent spread of disease or infection Hospital environmental controls

Regulations and Guidelines USP 797 First enforceable national standards for sterile compounding Other agencies use USP 797 as universal guide. ASHP Guidelines QA with sterile products Three risk levels

Basic Equipment and Supplies Laminar flow hood— Reduces risk of airborne contamination during IV admixture preparation HEPA filter; used for preparing sterile products Console model sits on floor. Bench/countertop model sits on counter.

Basic Equipment and Supplies Vertical flow hood Laminar flow hood that blows air from the top to the workspace; not recommended for chemotherapy products. Biological safety cabinet: a vertical laminar flow hood used to provide protection for the worker, the work environment, and the drug.

Figure 15-2 A laminar flow hood.

Basic Equipment and Supplies Biological safety cabinet A vertical laminar flow hood recommended to provide protection for the worker, the work environment, and the drug

Figure 15-3 An example of a biological safety cabinet.

Basic Equipment and Supplies Needles Shaft Bevel cut at end to form point, hollow bore of shaft is the lumen Hub End to which syringe is attached Needle size designated by length and gauge

Basic Equipment and Supplies Syringes Barrel Plunger Prefilled

Figure 15-4 The parts of a needle.

Figure 15-5 The parts of a syringe.

Basic Equipment and Supplies IV bags Plastic bags used for diluting a solution Most common container for administering intravenous medications to patients Piggyback bags Minibags that hold 50 mL or 100 mL of solution and are used to administer drugs intermittently

Figure 15-6 The parts of an IV.

Routes of Administration Intravenous administration Intravenous—in the vein Fastest route to bloodstream No barriers (like skin or muscle) Drugs that are irritating by other routes can be given by IV injection IV push Administered over short time

Routes of Administration Intravenous administration Intravenous—in the vein IV infusion Larger volume at constant rate Risks Dosage errors, infection Intramuscular—in the muscle Subcutaneous—in the skin

Routes of Administration Other common methods of injection Intramuscular—in the muscle Subcutaneous—in the skin Used less frequently Intradermal—in the dermis of the skin Intrathecal—in the spine

Routes of Administration Most common injection routes Intravenous—in the vein Fastest route to bloodstream No barriers (like skin or muscle) Drugs that are irritating by other routes can be given by IV injection

Routes of Administration Most common injection routes Intravenous—in the vein IV push Administered over short time IV infusion Larger volume at constant rate Risks Dosage errors, infection

Activity Complete drug cards for the following… Amoxicillin + Clavulanate Terazosin Sumatriptan Complete the labeling a syringe activity. Follow all directions, use a color to “fill” your syringe.

Sterile Products

State Standard 15) Demonstrate the following skills surrounding compounding: a. Handling and disposal requirements (e.g., receptacles, waste streams) b. Documentation (e.g., batch preparation, compounding record)** c. Determination of product stability (e.g., beyond-use dating, signs of incompatibility)** d. Selection and use of equipment and supplies e. Sterile compounding processes** f. Non-sterile compounding processes 25) Demonstrate the following skills of prescription packaging requirements: a. Type of bags b. Syringes c. Glass d. PVC e. Child resistant f. Light resistant**

Objectives Students will be able to… Identify common sterile products produced in the pharmacy setting. Demonstrate sterile gloving for preparation of sterile products.

Sterile Products Sterile products, such as IV solutions and total parenteral nutrition (TPN), are medications compounded using aseptic technique. Sterility Freedom from bacteria and other microorganisms pH Degree of acidity of a solution

Sterile Products Tonicity State of normal tension of the tissues; keeps body tissues and parts in shape, alert and able to function properly

Sterile Products Tonicity Isotonic solution has same concentration as red blood cells. Isotonic IV solutions minimize patient discomfort and damage to red blood cells. 0.9% sodium chloride and 5% dextrose injections are both approximately isotonic.

Sterile Products Storage Avoid extreme hot and cold temperatures. Some drugs precipitate in cold temperatures. High temperatures accelerate drug decomposition.

Sterile Products Common products Sodium chloride injection Dextrose injection Ringer's injection

Sterile Products Compatibility Incompatibility can exist between two drugs or between drug and IV solution. Can lead to patient not receiving full therapeutic dose or an adverse reaction

Sterile Products Compatibility Some incompatibilities can be seen. Color change or hazy appearance; precipitate forming in solution; evolution of a gas that can be smelled Not all incompatibilities can be detected.

Sterile Products Compatibility Common causes of incompatibility pH incompatibility Light Dilution Chemical composition Time Solutions

Sterile Products Compatibility Common causes of incompatibility Temperature Buffer capacity Order of mixing Plastic Filters

Sterile Products Compatibility Minimizing incompatibility Use solutions promptly after preparation to ensure administration of the most stable product. Minimize the number of drugs added to a solution. Check incompatibility resources to verify which drugs have a very high or very low pH.

Sterile Products Total Parenteral Nutrition Parenteral nutrition solutions are complex admixtures used to provide nutritional support to patients who are unable to take in adequate nutrients through the gastrointestinal tract. Pump module Control module

Sterile Products Chemotherapy Cancer treated with chemotherapy or antineoplastics since 1940; in 1970s, hazards associated with handling antineoplastics were recognized. Health problems from acute exposure to cytotoxic agents Threshold of danger to professionals handling these substances is not established.

Sterile Products Chemotherapy OSHA, NIH, and American Society of Health System Pharmacists have issued guidelines regarding safe handling of these drugs.

Basic Procedures Basic procedures for proper aseptic technique include: Dressing/garbing up Proper hand washing Withdrawing from a vial Reconstituting a powder vial Removing fluid from an ampule

Basic Procedures View step by step procedures for proper aseptic technique https://www.youtube.com/watch?v=eQeuIK5cUJI

Activity Complete drug cards for the following… Raloxifene Mirtazepine Hydroxyzine Now that we have discussed sterile products, and looked at basic sterile procedure, we will practice putting on a sterile gown and sterile gloves. I will be observing you while you perform the procedure.

Summary Sterile products must be prepared using proper aseptic technique to ensure they remain free of bacteria, fungi, pyrogens, infections, and other microorganisms. Laminar flow hoods (including horizontal flow hoods and biological safety cabinets) that contain HEPA filters

Summary Sterile products commonly administered parenterally