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Sterile Compounding Guidelines, Equipment & Supplies

Sterile Compounding Guidelines, Equipment & Supplies. Payam Parchamazad, PharmD Staff Pharmacist Capital Regional Medical Center. Why is aseptic preparation important?. Patients who are receiving intravenous therapy tend to be the most critical.

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Sterile Compounding Guidelines, Equipment & Supplies

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  1. Sterile CompoundingGuidelines, Equipment & Supplies Payam Parchamazad, PharmD Staff Pharmacist Capital Regional Medical Center

  2. Why is aseptic preparation important? • Patients who are receiving intravenous therapy tend to be the most critical. • The IV route is the most dangerous route of administration because it bypasses all of the body's natural barriers. • An improperly prepared  solution if administered can have very serious consequences.

  3. Sterile Compounding Services • Home care agencies • Infusion service agencies • Outpatient clinics • Community pharmacies • Hospitals

  4. What dosage forms are considered sterile formulations? • Intravenous • Intramuscular • Subcutaneous • Epidural

  5. What are the requirements for sterile formulations? • Sterility • Particulate Matter • Pyrogen-free • Stability • pH • Osmotic Pressure

  6. Sterility • Freedom from bacteria & other microorganisms. • Sterility is not a relative term a solution is either sterile or it is not sterile. • All formulations must be sterile

  7. Particulate Matter • Mobile, undissolved substances unintentionally present in parenteral products • Particles > 50 microns can be seen on visual inspection. • USP sets limits on the number and size of particulates that are permissible. • Potential sources • The product itself • Manufacturing • The packaging components • The administration sets and devices used to administer • The manipulations & environment of the product at time of administration.

  8. Pyrogen-free • Metabolic by-products of living organisms • If pyrogens are present that means that bacteria are or have been present. • May cause fever, chills, increased blood pressure, nausea. • Rarely fatal

  9. Stability • Hospital • Most products prepared hours before the medication is administered • Home Health/Outpatient • Products may be prepared days in advance of administration. • Stability of a particular product in a particular sterile formulation must be known

  10. pH • Physiological pH is about 7.4. • Sterile products should not vary immensely from a pH of 7.4 if at all possible. • Acidic or alkaline solutions may burn or cause damage to tissue upon administration.

  11. Syringes • Basic parts • Barrel, plunger, tip • Size ranges from less than 1 ml to 60 ml • As a rule, always select a syringe whose capacity is the next size larger than the volume to be measured.

  12. Needles • Three parts • Hub, Shaft, Bevel • Needle size • Gauge • Designates the size of the lumen. • Length • Measured from the junction of the hub and shaft to the tip of the needle • When choosing a needle consider • Viscosity: Use a smaller gauge ( i.e a larger needle) • Coring of rubber closure: Use a larger gauge (i.e a smaller needle)

  13. Large Volume Parenteral Solutions • Bags or bottles containing larger volumes of intravenous solutions. • Used for correcting fluid imbalances, nutrition and delivery of medication • Packaged in containers holding 100 mls 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 • Advantages • Administer the drugs that are incompatible with plastic bags • Disadvantages • For solutions to flow out of the glass container air must be able to enter the container to relieve the vacuum as the solution leaves • 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. • Must use a filter when drawing up the medication to because glass may be present • Vials • Made of glass or plastic and are sealed with a rubber stopper. • May be a liquid or a powder for reconstitution • May be a single or a multi-dose vial

  17. USP 797 Guidelines • Set the standards for sterile preparation of compounded sterile products. • Applies to pharmacies, health care institutions, physicians practices and any other healthcare facility which prepares sterile products. • Official minimum standard for sterile compounding and is enforceable by the Food and Drug Administration ( FDA ) , state boards of pharmacy, board of health and regulatory agencies like Joint Commission on Accreditation of Healthcare Organizations ( JCAHO )

  18. Questions • Dr. Payam Parchamazad • parchamp@gmail.com • CRMC

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