1. 15
Introduction to Sterile Products

2. 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**

3. 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

4. Figure 15-1 A technician dressed in sterile clothing.

5. 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.

6. 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.

7. 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

8. 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

9. 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

10. 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

11. 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.

12. 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.

13. Figure 15-2 A laminar flow hood.

14. 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

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

16. 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

17. Basic Equipment and Supplies
Syringes
Barrel
Plunger
Prefilled

18. Figure 15-4 The parts of a needle.

19. Figure 15-5 The parts of a syringe.

20. 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

21. Figure 15-6 The parts of an IV.

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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.

28. Sterile Products

29. 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**

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

31. 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

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

33. 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.

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

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

36. 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

37. 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.

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

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

40. 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.

41. 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

42. 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.

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

44. 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

45. Basic Procedures
View step by step procedures for proper aseptic technique

46. 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.

47. 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

48. Summary
Sterile products commonly administered parenterally