Parenterals: Compounding Sterile Formulations

1. Parenterals:Compounding Sterile Formulations Chapter 9 Pgs.250-283

2. What is/are Parenterals? • Most commonly refers to medicines administered through syringes and intravenous sets. • Can also include dialysis solutions and irrigation solutions.

3. Special requirements for how products are made, packaged, and administered. • Solutions MUST be sterile!!! • pH of IV solution should be about 7.4 • Free of all visible particulate material. • IV solutions should have an osmotic pressure similar to blood • Pyrogen-Free • Stable for its intended use

4. Why need to be sterile? • Rapid access to circulatory system and can cause harm if infection develops. • Must use aseptic techniques during compounding.

5. LVP Solutions (Large Volume) • Container holds 100 mL or more • Common uses: • Solutions s additives for electrolyte/ fluid correction • Nutrition • Administering medications • Common sizes: • 100, 250, 500, and 1000 mL

6. LVP cont. • Three types of containers: • Glass bottle with air vent tube, glass bottle without air vent tube, and plastic tube. • Container will have 2 ports on one end. • An administration port to connect to tubing. • Medication port so medicines can be added to LVP.

7. Discussion of CSP and USP <797> regulations on compounding noted on pages 254 and 255

8. Plastic Bags vs. Glass • Plastic Bags • Do not break • Weigh less • Require less space for storage and disposal • Not vented to outside air, so bag collapses as solution administered. • ***Some drugs/ solutions can not be used with plastic because they interact with the plastic.

9. Common LVP Solutions • NS: sodium chloride solution • D5W: dextrose 5% in water solution • Ringer’s: Ringer’s solution • LR: lactated ringer’s • Various combinations of different strengths of sodium chloride and dextrose solutions also available.

10. SVP Solutions • Packaged products that are either directly administered to a patient or added to another parenteral formulation. • When added to another parenteral it is referred to as an additive and the final mix is an admixture.

11. Types of SVPs • Ampule • Vial • Minibag • Prefilled syringe

12. Ampules • Elongated, sealed glass containers with a neck that must be snapped off. • Most are weakened around the base – will have a colored band. • Once ampule is opened becomes open-system container.

13. Vials • Has a rubber stopper through which a needle is inserted to withdraw or add to the contents. • Before withdrawing solution, an equal volume of air is usually drawn up in syringe and injected into the vial. • May be prepared for single or multidose use.

14. Minibags • Made of the same plastic materials as LVPs and same solutions. • Just smaller in size, contain only 50-100 mL.

15. Special Solutions • TPN • Dialysis Solutions • Irrigation Solutions

16. TPN (Total Parenteral Nutrition) Complex admixtures used to provide nutritional support unable to take in adequate nutrients through their digestive tract. • They are hypertonic solutions and generally 2,000 to 3,000 mL solutions. • Base solution is an amino acid and dextrose solution. • Fat emulsions can be added; resulting solution is referred to as a TNA ( total nutrient admixture).

17. Dialysis Solutions • Peritoneal Dialysis • These are hypertonic solutions; so water will not move into the circulatory system. The toxic substances will move into the dialysis solution. • Administered several times a day into abdominal cavity; remains in cavity 30-90 minutes and then drained. • Solutions supplied as 2,000 mL or larger

18. Irrigation Solutions • Not administered directly into veins but subject to same stringent controls. • Containers are larger than 1,000 mL and designed to empty rapidly. • Surgical solutions are usually NS or Sterile H2O; used to: bathe/ moisten body tissues, moisten dsgs, and/or wash instruments. • Urological solutions used to maintain tissue integrity and remove blood • Other common used solutions: Glycine 1.5% and Sorbitol 3% r/t being nonhemolytic. • Page 259

19. Administration Devices Administration Sets • Usually flexible plastic tubing • May have air vents, filters, or a flashball. Drip chambers and tubing length can vary in size. Controllers/ Pumps used to regulate flow rate, can program medications into “Smart” pumps. Volume Control Chambers plastic cylinder that holds a desired amount of fluid to be delivered. IV Catheters one to five inches of plastic, with a needle inside that is removed after insertion.

20. Positive Pressure Pumps • Cassette Pumps • Elastomeric Pumps • Syringe Pumps • Peristaltic Pumps Piggy backs Heparin Locks

21. Laminar Flow Hoods pg. 264 • Used to establish and maintain an ultraclean work area. • HEPA filter used in hood will remove 99% of particles larger than 0.3 microns. • According to USP <797> must maintain an ISO Class 5 environment when preparing sterile parenteral preparations.

22. Two types of flow hoods. • Horizontal flow hood • Air enters the work area in a horizontal direction. • Vertical flow hood • Air enters the work area in a vertical direction. • The air can enter the hood/ filter from the bottom, top, or back. Pg.265

23. Biological Safety Cabinets • Many different types • These take air into cabinet through work surface vents and recirculate it through a HEPA filter. • Protect both personnel and environment from contamination. • Use while working with cytotoxic and hazardous drugs.

24. Clean Rooms • Area where Laminar Flow Hoods and Safety Cabinets MUST be housed. • Isolated area away from the pharmacy’s main traffic. • Regulations from USP <797> have mandates for standard requirements. Must be an ISO Class 7 environment. • Preparing and cleaning instructions on pg. 267

25. Aseptic Techniques • Sum total of methods and manipulations required to minimize the contamination of sterile products. • Includes positioning of materials, clothing, sanitation procedures, and supply collection • Need to sterilize puncture surfaces; use a new alcohol wipe when wiping each surface. Avoid excess alcohol or lint that might be carried into the solution.

26. Pages 270-274 provide information on working with ampules and vials. • Opening, mixing, and transferring solutions.

27. Syringes and Needles • Multiple types of syringes available depending on need. • Vary in size; 1- 60 mL. • Needle sizes are indicated by length and gauge. • Length of the needle is in inches, from where the shaft meets the hub to the tip of the bevel. • The gauge is the size of the needle lumen; 27 (smallest)- 13 (largest).

28. Filters • Used to remove particulate materials or microorganisms from solutions. • Two main types: depth and membrane. • Depth: traps particles as solution moves through twisting channels. • Membrane: contains many small pores that retain particles larger than the pores. • Another, less common is a final filter. • Solution enters filter immediately before entering patient’s vein.

29. Quality Assurance and Infection Control information can be located on pages 278/ 279. • Parenteral incompatibilities on page 280 • Factors affecting incompatibility page 281 • Units of Measurement (concentration of a drug in a parenteral solution) page 282/ 283.