Guidelines, Equipment and Supplies for Sterile Compounding

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

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

3. 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.

4. 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

5. 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.

6. Horizontal flow hood/Vertical flow hood

7. 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.

8. 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”

9. 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

10. 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.

11. Syringes

12. Needles • Three parts: - Hub - Shaft - Bevel

13. 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

14. 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

15. 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.

16. 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

17. Ampules / Vials

18. 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.