Guidelines, Equipment and Supplies for Sterile Compounding Patty Ghazvini, PharmD. Assistant Professor of Pharmacy Practice Florida A&M University

Special requirements Sterility Particulate material Pyrogen-free Stability pH Osmotic pressure

NABP Model Rules for Sterile Pharmaceuticals Policy and procedure manuals for compounding, dispensing, and delivering sterile products should be established and periodically reviewed. These records should be part of a documented, ongoing quality assurance program. Pharmacists and supportive personnel should be trained and adhere to hygienic and aseptic techniques.

Rules Con’t Sufficient reference materials about sterile products should be available Drugs and supplies should be stored, labeled, and disposed of properly Sterile compounding should be done in an area separate from other activities

Equipment, Supplies, and Devices Laminar flow hoods (horizontal and vertical) - Used to control airborne contamination of sterile products during preparation. - Horizontal flow hood are most commonly used, with the more costly vertical flow hoods being reserved for agents that may produce an environmental hazard. HEPA filter – removes 99.97% of all particles 0.3 microns or larger.

Horizontal flow hood/Vertical flow hood

Laminar Flow hoods Downstream contamination – when any object comes between the HEPA filter and the sterile product, interrupting the parallel air flow. Cross-stream contamination – may occur due to rapid movements of the operator in the hood. Backward contamination – may be caused by turbulence created by objects being placed in the hood, or by coughing, sneezing, etc. by the operator.

Filtration/Filters Two types of filters: - Depth filters – seldom used; microorganisms are adsorbed to the filter material. - Screen filters – have a continuous uniform structure that consists of fixed size pores. Particles are larger than the pore openings cannot pass through the filter and are retained on the surface of filter. - Example: “membrane filter”

Membrane Filters Thin microporous sheets made from a variety of plastics. Must have a pore size of 0.22 microns or less Eliminate the risk of air embolism Hydrophilic filters are easily wetted and are used for aqueous solutions. Hydrophobic filters repel water but allow solvents such as alcohol to pass

Syringes Basic parts: barrel, plunger and tip Come in different sizes ranging from 1 to 60 ml. As a rule, always select a syringe whose capacity is the next size larger than the volume to be measured.

Syringes

Needles Three parts: - Hub - Shaft - Bevel

Large Volume Parenteral Solutions Bags or bottles containing larger volumes of intravenous solutions Packaged in containers holding 100ml or more Two types of containers: - Plastic bags - Glass bottles

Plastic Bags Advantages: - Do not break - Weigh less - Take up less storage space - Take up much less disposal space Disadvantages: - Some drugs adsorb to the plastic

Glass Bottles Advantage: - Administer drugs that are incompatible with plastic bags Disadvantage; - For solutions to flow out of a glass container, air must be able to enter the container to relieve the vacuum as the solution leaves and another administration set with a filtered airway must be used.

Small Volume Parenteral Solutions 100 ml or less Can be packaged as ampules and vials Ampules: Sealed glass containers with an elongated neck that must be broken off. Vials: Made of glass or plastic and are sealed with a rubber stopper

Ampules / Vials

Quality Control For each preparation of a sterile product or a batch of sterile products, there should be appropriate laboratory determination of conformity: - Purity - Accuracy - Sterility - Non-pyrogenicity Written policies and procedures should specify measurements and methods of testing.