1. Theoretical Principles and Practical Skills of Aseptic Manipulations
Curriculum:
Pharmacy
Target Audience:
Pharmacists and Pharmacy Technicians
Authors:
Philip Trapskin, PharmD
Rebecca Reagan, RPh
Kimberley Hite, MS, PharmD
John Armitstead, MS, RPh, FASHP
Service Area:
Pharmacy Services
Phone:
Date Developed
Or Revised:
April, 2005

2. Barrier isolator technology
Menu
Definitions
Background
Laminar Air Flow Hoods
Barrier isolator technology
Aseptic Technique
Exit

3. Definitions Enteral Parenteral Aseptic Technique
Of or relating to the intestines
(e.g. by mouth, orally, per tube)
Parenteral
Introduced other than by way of the intestines
(e.g. intravenous, intramuscular, subcutaneous)
Aseptic Technique
The technique for manipulations of compounded sterile products and parenteral preparations that prevents contamination

4. Definitions (cont.)
Contamination – any effect or action that has a negative impact on a product's integrity making it unfit for use
Chemical composition pH
Sterility (e.g. microorganism contamination)
Pyrogenicity
Biological or therapeutic potency
Physical appearance
Particulate matter (e.g. dust, glass or precipitation)

5. Why do we give medications parenterally?
Background
Why do we give medications parenterally?
Patients who are not able to take medications by mouth
Need for rapid action of the medication as in emergency situations
Medication not available in a suitable dosage form to be given by mouth
Patients with difficulty absorbing medications

6. Sources of product contamination
Background (cont.)
Sources of product contamination
People (most common)
Touch contamination
Generation of particulates from shedding cells or hair
Supply air
Heating Ventilation and Air Conditioning (HVAC)
Infiltration
Particles from adjacent spaces (e.g. anteroom)
Internal generation
Walls, floors, ceilings, packaging, equipment

7. Importance of Aseptic Technique
Background (cont.)
Importance of Aseptic Technique
Parenteral administration bypasses the skin and gastrointestinal tract, the bodies natural barriers to infection
Giving a patient a contaminated product can cause serious adverse effects including DEATH
Parenteral medications account for >40% of all medications administered in institutional practice

8. Laminar Air Flow Hoods
The underlying principle of a laminar air flow hood is that a constant flow of HEPA filtered air at a rate of approximately 90 linear feet per minute physically sweeps the work area and prevents the entry of contaminated air
The hood workspace is used to prevent the contamination of compounded sterile products and parenteral preparations
The space between the HEPA filter and sterile product being prepared is referred to as the critical work surface
HEPA filter - High Efficiency Particulate Air filter removes 99.97% of all air particles 0.3mm or larger

9. Laminar Air Flow Hoods (cont.)
HEPA Filter in Frame

10. Laminar Air Flow Hoods (cont.)
Horizontal Flow (Laminar Flow Hood)
Air blows towards worker
Used for non-chemotherapy preparations
Vertical Flow (Biological Safety Cabinet or Chemotherapy Hood)
Air blows from top down to maintain sterility and protect the worker
Used to make chemotherapy

11. Laminar Air Flow Hoods (cont.)
Horizontal Laminar Air Flow Hood
Horizontal Laminar Air Flow Hood
Hepa Filter
Filtered Air
Room Air
Prefilter

12. Laminar Air Flow Hoods (cont.)
Vertical Laminar Flow Hood

13. Correct placement of items in a laminar flow hood

14. Incorrect placement of items in a laminar flow hood
Wrong!!

15. Laminar Air Flow Hoods (cont.)
All aseptic manipulations should be performed at least SIX inches within the hood to prevent the possibility of contamination from room air entering the hood.
6 inches
inside hood

16. Laminar Air Flow Hoods (cont.)
A laminar flow hood should be left operating continuously
If hood is turned off it must run for 30 minutes to reestablish laminar air flow and then be cleaned prior to use
Before use, all interior working surfaces of the laminar flow hood should be cleaned from back to front away from the HEPA filter
Back to Front
Away from HEPA filter

17. Laminar Air Flow Hoods (cont.)

18. Laminar Air Flow Hoods (cont.)

19. Laminar Air Flow Hoods (cont.)
At UKCMC the procedure for cleaning a hood should occur in the following order:
Obtain 4X4 gauze
Clean the hood with sterile water for irrigation (bar, sides, base)
Obtain new 4x4 gauze
Clean the hood with 70% isopropyl alcohol (bar, sides, base)
Hoods should be cleaned at the beginning of each shift and as needed throughout the shift

20. Laminar Air Flow Hoods (cont.)
The HEPA filter is located in the fragile mesh between thin metal strips at the back of the hood behind the HEPA filter screen
Nothing should be permitted to come in contact with the HEPA filter
NO cleaning solution
NO aspirate from syringes
NO glass from ampules
NO fluids, even if sterile
DO NOT touch HEPA filter

21. Laminar Air Flow Hoods (cont.)
Only products essential to product preparation should be placed in the laminar flow hood to minimize the potential for contamination
No Paper, Pens, Calculators or Labels in the Hood

22. Laminar Air Flow Hoods (cont.)
Eating, drinking, and smoking is always prohibited
Talking or coughing should be directed away from the hood to minimize air flow turbulence
A mask covering mouth and nose must be worn while working in the hood
The use of a laminar flow hood alone without the observance of aseptic technique, cannot insure product sterility

23. Barrier Isolator Technology

24. Barrier Isolator Technology (cont.)
Closed system: workers manipulate compounding through gloved ports
Personnel are the primary source of contamination of compounded preparations
Barrier Isolator removes personnel from environment where parenteral products are prepared
Good aseptic technique is still required
Barrier isolators are exempted from placement restrictions of materials within the workspace

25. Barrier Isolator Technology (cont.)
Barrier Isolator Workstations consist of:
Physical Structure
Internal Environment
Transfer and Interaction Technology
Monitoring Systems

26. Barrier Isolator Technology (cont.)
Physical Structure
Hard shell or soft shell
Hard shell (plastic, Plexiglas, stainless steel)
Soft shell (soft plastic film)
Internal Environment
Less airflow required to achieve ISO 5 (Class 100) conditions
Entering and exiting air is to be HEPA filtered
Isolators for cytotoxic preparations should capture vapor
Positive pressure maintained for non-chemotherapy products
Negative pressure is maintained for chemotherapy products

27. Barrier Isolator Technology (cont.)
Transfer and interaction technology
Transfer
Rapid transfer ports
Air-lock
Laminar-airflow interfaces
Interaction
Glove ports (most common)
Half-suits
Monitoring Systems
Gauges to monitor positive pressure environment
Surface sampling for contamination

28. Aseptic Technique
Aseptic technique is the technique for manipulations of compounded sterile products and parenteral preparations that prevents contamination
Aseptic technique requires specific manipulations for:
Syringes
Needles
Vials
Ampules
Removal of packaging
Assembling of sterile products
Hand placement

29. Aseptic Technique - Syringes
NEVER TOUCH
Tip or Plunger

30. Aseptic Technique - Syringes
1.5ml measured

31. Aseptic Technique - Syringes
Syringes are available in sizes ranging from 0.5 to 60 milliliters (ml)
Graduation marks on syringes represent different increments depending on size of syringe
DO NOT use syringes whose gradations are greater than twice the volume being measured
To maintain sterility, neither the syringe tip or plunger should be touched

32. Aseptic Technique - Needles
Hub
Where the needle attaches to the syringe tip and allows the fluid in the syringe barrel
Bevel
The tip of needle is slanted to a point and the slanted part of the needle is the bevel. The bevel allows for smooth insertions through stoppers and ports with minimal coring

33. Aseptic Technique - Needles
Coring
The development of a core or hole in the rubber of a vial
To prevent coring insert needle as shown
Insert the bevel tip first, then pressing downward and toward the bevel so the bevel tip and heel enter at the same point

34. Aseptic Technique - Needles
Needle size is determined by two numbers
Gauge
Length
The larger the gauge number the finer the diameter of the needle’s bore
27 gauge needle finer than 13 gauge needle
Common needle sizes at UK include
16G 1&1/2 inch
18G 1&1/2 inch
20G 1 inch
Needle length is measured in inches
Never touch any part of the needle
Open needle package within hood to maintain sterility

35. Aseptic Technique - Needles and Syringes
It is important that when using needles and syringes in product preparation that they not be removed from the hood workspace
Needles and syringes must be properly disposed in a sharps container located near the hood to prevent injury to others
Never dispose of needles or syringes in regular trash

36. Aseptic Technique - Vials and Ampules

37. Aseptic Technique - Vials and Ampules
To prevent contamination
Swab rubber closure with 70% alcohol using firm strokes in the SAME direction
To prevent core formation
Insert needle to penetrate the rubber closure at same point with both tip and heel of bevel
To prevent vacuum formation
Inject an equal amount of air for the volume of fluid to be removed
Reconstituting drug powder
Remove an equal amount of air for the volume of diluent added

38. Aseptic Technique - Vials and Ampules

39. Aseptic Technique - Vials and Ampules
To break ampule
Clean ampule neck with alcohol swab
Leave swab in place
Grasp ampule neck with thumb and index finger
Use quick, firm, snapping motion away from body towards side wall of hood
DO NOT BREAK TOWARD HEPA FILTER

40. Aseptic Technique - Vials and Ampules
To withdraw medication from ampule
Tilt ampule
Place needle bevel in corner space near opening
Pull back syringe plunger
Do NOT use a filter needle to remove ampule contents
To avoid glass contamination of ampule solution
Use 5 micron filter needle to filter glass as solution is pushed out of the syringe
A filter needle can only be used in one direction, otherwise glass particles originally filtered are reintroduced
For UK consistency always use the filter needle as the second needle

41. Aseptic Technique - Vials and Ampules1 2 3 4

42. Aseptic Technique - Removing Packaging
Any sterile component or supply (e.g., syringes, needles, and ampules) should only be opened and/or removed from their packaging within the laminar-flow workspace.
When opening the wrapper on a needle, it should be peeled open.
Tearing paper introduces paper particles into the hood which could lead to product contamination.

43. Aseptic Technique - Assembling
Great care must be exercised to prevent any touch contamination of critical edges or component surfaces.
The syringe tip and plunger and all parts of the needle are critical surfaces.

44. Aseptic Technique - Hand Placement
It is important that hand placement during any aseptic manipulation is such that laminar airflow is not interrupted around any of the critical sterile fluid pathways.
Great care should be taken to avoid contact with the syringe plunger, especially during multiple manipulations using the same syringe. Since the plunger enters the barrel of the syringe during repeated uses, contamination can be accidentally introduced into the barrel.

45. If in doubt, throw it out Summary
Aseptic technique is the manipulation of sterile products to prevent contamination
Giving a patient a contaminated product can cause serious adverse effects including DEATH
Discard any potentially contaminated product and inform the pharmacist that product was discarded
If in doubt, throw it out

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