This document provides information about aseptic techniques for intravenous (IV) preparation: 1) Aseptic technique involves procedures to keep sterile products contamination-free. IV is the most common parenteral route of drug administration today. 2) Risks of IV therapy include infection, air embolism, bleeding, allergic reactions, incompatibilities, extravasation, particulate contamination, and phlebitis. 3) Sterile areas and laminar flow hoods are used to maintain sterile conditions during IV preparation, with strict protocols for equipment placement, personnel movement, and cleaning.

1. Pharmaceutics III
PHCT 431
Lab 4
Aseptic Techniques
IV Preparation
Dr. Sameh Rabea

2. Aseptic Technique
• Aseptic technique:
is the term used for all procedures and techniques
to keep a sterile product from becoming
contaminated.

3. Parenteral drug administration
• Basic IV therapy:
• IV route of administration is the most common route that
parenteral dose are administered today.
• Other parenteral dosage forms:
• - IM
• -SC
• -ID
• -Epidural
• IV fluid is in a large-volume parenteral (LVP), usually >
100 ml.

4. • Hang on an IV pole approximately 36 inches
higher than the patients bed.
• The LVP is usually a simple solution of dilute
dextrose, sod. Chloride or both.
• Solution is infused continually to keep blood
from clotting in the catheter and plugging the
line.

5. Risks of IV Therapy
• 1- Infection (Human touch is the common source)
• 2- Air embolus (low incidence due to use of air-in-alarm)
• 3- Bleeding
• 4- Allergic reactions
• 5- Incompatibilities (precipitated, inactivated or
adherence to the container)
• 6- Extravasation
• 7- particulate matters (Hair, lint or cotton fibers,
undissolved drugs, rubber stoppers).
• 8- Pyrogen
• 9- Phlebitis.

6. Aseptic Preparation of Parenteral Products
• Aseptic Technique:
• Programs designed to ensure the aseptic preparation of
sterile products.
• The main elements these programs focus on are:
• 1- The development and maintenance of good aseptic
tec. In the personnel
• 2- The development and maintenance of a sterile
compounding are complete with sterilized equipment
and supplies.
• 3- development and maintenance of the skills needed to
properly use a laminar flow hood (LAH).
• N.B. The proper use of a LAH and strict aseptic tec. Are the most
important factors in preventing the contamination of sterile products.

7. Sterile Compounding Area
• A Sterile compounding area should be cleaned daily and
segregated from normal pharmacy operations, patient
specimens, nonessential equipment.
• E.g. cardboard into clean area should be avoided
• Traffic flow should be minimized
• Floors should be disinfected periodically
• Trash should be removed frequentelly.

8. Sterile Compounding Area
• Sterile products should be prepared in a Class 100
environment, which contains no more than 100 particles
per cf that are 0.5 micron or larger in size.
• LAH are frequently used to achieve a Class 100
environment.

9. LAH
• Two common types:
• 1- Horizontal LAH- Sweeps filtered air from the back of
hood to the front.
• 2- Vertical LAH- HEPA filtered air emerges from top and
passes through the work area.
• This type used for: anticancer and dangerous biologicals
so its called ( Biological Safety Cabinets) BSCs.
• The critical principle of using LAHs is that nothing
interrupts the flow of air between the HEPA filter and the
sterile object. The space between HEPA filter and the
sterile object is known as the critical area.

10. LAH
• To maintain sterility, nothing should pass behind a sterile
object in a horizontal LAH or above sterile object in a
vertical LAH.
• Materials placed within LAH disturb the patterned flow of
air blowing from the HEPA filter. This ( zone of
Turbulence) created behind an object allowing
contaminated room air into the aseptic working area.
• Its advisable to work with objects at least 6 inches from
the sides and front edge of the hood without blocking air
vents, so that unobstructed airflow is maintained
between the HEPA filter and sterile objects.

11. Types of LAFH
• 1- Horizontal Flow LAFH:
• Where air blows towards worker
• Used for non-chemotherapy preparations
Hepa Filter
Filtered Air
Room Air

12. • 2-Vertical Flow LAFH:
• Air blows from top down to maintain sterility and
protect the worker
• Used to make chemotherapy and biologicals.

13. Correct placement of items in a laminar
flow hood

14. Wrong placement of items in a laminar flow
hood

15. Important Precautions During Procedure
• 1- All aseptic techniques should be performed at least 6
inches within the hood to prevent the possibility of
contamination from room air entering the hood.
• 2- A laminar flow hood should be left operating
continuously.
• 3- If hood is turned off it must run for 30 minutes to
reestablish laminar air flow and then be cleaned prior to
use.
• 4- Before use, all interior working surfaces of the laminar
flow hood should be cleaned from back to front away
from the HEPA filter.
• 5- Nothing ( cleaning solution, syringes aspirates, glass
from ampoules and fluids) should be permitted to come
in contact with the HEPA filter.

16. • 6- Only products essential to product preparation should
be placed in the laminar flow hood to minimize the
potential for contamination ( no pens, papers or
calculators).
• 7- Avoid eating, drinking, and smoking.
• 8-Talking or coughing should be directed away from
hood.
• 9- A mask must be worn while working in the hood
• 10- Quality control (QC) and quality assurance (QA)
should be implemented.

17. LAH Cleaning

19. USP 797- New Standards
• The primary structure of the new USP standards is
based on 3 risk levels classified according to the
potential for:
• 1- Microbial Contamination
• 2- Physical Contamination
• 3- Chemical Contamination.
• There are specific standards for each risk level.
• Standards regarding personnel training, environmental
QC, verification of compounding accuracy, packaging
and transport, adverse event repot, and storage.

20. Environmental QC
• Work bench area: where compounding is completed
• Buffer area= clean room: area immediately surrounding
the work bench. Should not contain drains or sinks.
• Ante area: Space beyond the buffer area where hand
sanitizing and gowning occurs.
• Include hands free facets and air dryers or low=shedding
towels.
• Supplies are unpacked and disinfected for storage in the
ante room

22. Applications of Aseptic Technique:
• Aseptic technique requires specific manipulations for:
• Syringes
• Needles
• Vials
• Ampoules
• Removal of packaging
• Assembling of sterile products
• Hand placement

23. Aseptic Technique- Syringes and Needles
1- Don’t use syringes whose gradations are greater than
twice the volume being measured.
2- To maintain sterility, neither the syringe tip or plunger
should be touched.
3- Insert the bevel tip first, then pressing downward and
toward the bevel so the bevel tip and heel enter at the
same point.
4- Never touch any part of the needle
5- Open needle package within hood to maintain sterility

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

26. Aseptic Technique- Vials
• 1- Swab rubber closure with 70% alcohol using firm
strokes in the same direction in order to prevent
contamination.
• 2- Insert needle to penetrate the rubber closure at same
point with both tip and heel of bevel to prevent core
formation.
• 3- Inject an equal amount of air for the volume of fluid to
be removed to prevent vacuum formation.
• 4- Remove an equal amount of air for the volume of
diluent added.

28. Aseptic Technique- Ampoules
• 1- Clean ampule neck with alcohol swab
• 2- Leave swab in place
• 3- Grasp ampule neck with thumb and index finger
• 4- Use quick, firm, snapping motion away from body
towards side wall of hood
• 5- Don’t break toward the HEPA filter.
• 6- To withdraw medication from ampoule
• Tilt ampoule
• Place needle bevel in corner space near opening
• Pull back syringe plunger

30. Aseptic Technique- Ampoules
• 7- To avoid glass contamination of ampoule 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.

31. Aseptic Technique - Removing Packaging
• 1- 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.
• 2- When opening the wrapper on a needle, it should be
peeled open.
• 3- Tearing paper introduces paper particles into the hood
which could lead to product contamination.

32. Aseptic Technique - Assembling
• 1- Great care must be exercised to prevent any touch contamination
of critical edges or component surfaces.
• 2- The syringe tip and plunger and all parts of the needle are critical
surfaces.
Aseptic Technique - Hand Placement
• 1- 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.
• 2- 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.

34. Practical
Session