ASEPTIC DISPENSING:

TPN, I/V Admixtures, Cytotoxic Dispensing, Semi-sterile

Dispensing (Eye drops, Ear drops) and Hyperalimentation

1
 Aseptic Dispensing
Preparation and supply of sterile medical
products, which requires manipulation
before administration.
Preparation is carried out by trained
pharmacist under controlled environment
before being dispensed in a form ready for
use without further manipulation.

2
3
 Aseptic Technique
 Aseptic technique is programs designed to ensure the aseptic
preparation of sterile products.
The main elements these programs focus on are:
 The development and maintenance of good aseptic technique
in the personnel who prepare and administer sterile products.
 Development and maintenance of a sterile compounding are
complete with sterilized equipment and supplies.
 Development and maintenance of the skills needed to
properly use a laminar airflow hood (LAH).
 Aseptic technique is a means of manipulating sterile products
without contaminating them.
 Proper use of a LAH and strict aseptic technique are the most
important factors in preventing the contamination of sterile
products.
4
 Sterile Compounding Area
 Sterile parenteral solutions must be free of living
microorganisms and relatively free of particles and pyrogens.
 A sterile compounding area should be cleaned daily and
segregated from normal pharmacy operations, patient
specimens, non-essential equipment, and other materials that
produce particles. Examples:
 Cardboard into the clean environment should be avoided.
 Traffic flow should be minimized.
 Floors should be disinfected periodically.
 Trash should be removed frequently and regularly.
 Sterile products should be prepared in a Class 100
environment, which contains no more than 100 particles per
cubic foot that are 0.5 micron or larger in size.
 LAHs are frequently used to achieve a Class 100 environment.
5
 Laminar Airflow Hoods (LAH)
 Underlying principle of LAHs is that twice-filtered layers of
aseptic air continuously sweep the work area inside the
hood to prevent the entry of contaminated room air.
Two common types:
Horizontal LAH – sweeps filtered air from the back of the
hood to the front.
1. use an electrical blower to draw contaminated room air
through a pre-filter.
2. The pre-filter only removes gross contaminants and needs
to be cleaned or replaced on a regular basis.
3. The high efficiency particulate air or (HEPA) filter removes
99.9% of particles that are 0.3 micron or larger.

6
7
1- Air is pulled from the top/back of the unit
2-A fan module pushes the air through HEPA filter and into the enclosure
3- Back plenum allows air to be recirculated, reducing the percentage of dirty
air passing through the filter. Extends the life of the filter
4- Filtered air exits the enclosure back into the room

8
9
Vertical LAH – HEPA filtered air emerges from the top and
passes downward through the work area.
 used for antineoplastic (anticancer) drugs.
 the risk of exposure to airborne drug particulates is
minimized.
 the type of vertical LAH used for the preparation of
antineoplastic contains airflow within the hood and are
referred to as 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 the HEPA filter and the sterile object is
known as the critical area.

10
 To maintain sterility, nothing should pass behind a sterile
object in a horizontal flow hood or above a sterile object in
a vertical flow hood.
 Materials placed within the laminar flow hood disturb the
patterned flow of air blowing from the HEPA filter.
 This “zone of turbulence” created behind an object could
potentially extend outside the hood pulling or allowing
contaminated room air into the aseptic working area.
 It is advisable to work with objects at least six 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
The following are general principles for operating LAHs
properly:
 A LAH should be positioned away from excess traffic,
doors, air vents, or anything that could produce air currents.
 If turned off, it should be allowed to run for minutes before
use.
 Before use, all interior working surfaces of the laminar flow
hood should be cleaned with 70% alcohol or other
appropriated disinfecting agent and a clean, lint-free cloth.
 Cleaning should be performed from the HEPA filter toward
the front of the LAH (in a horizontal LAH) so that
contaminants are moved out of the hood.

12
 Nothing should be permitted to come in contact with
the HEPA filter. Ampules should not be opened
directly toward the filter.
 Do not put paper, pens, labels, or trays into the hood.
 Jewelry should not be worn on the hands or wrists
when working in the LAH since it may introduce
bacteria or particles into the clean work area.
 Actions such as talking and coughing should be
directed away from the LAH working area, and any
unnecessary motion within the hood should be
avoided to minimize the turbulence of air flow.

13
Smoking, eating or drinking are prohibited in
the aseptic environment.
All aseptic manipulations should be
performed at least six inches within the hood
to prevent the possibility of potential
contamination
LAHs should be tested by qualified personnel
every six months, whenever the hood is
moved, or if filter damage is suspected.

14
 Personal Attire
 The first component of good aseptic technique is
proper personal attire.
 Clean garments, which are relatively particulate free,
should be worn when preparing sterile products.
 Many facilities provide clean scrub suits or gowns
for this purpose.
 Hair covers and shoe covers help reduce particulate
or bacterial contamination, and some experts claim
that the use of surgical masks and gloves is
warranted as well.

15
USP 797 – New Standards
 The primary structure of the new USP standards is
based on 3 risk levels classified according to the
potential for:
Microbial contamination
 (microorganisms and endotoxins)
Physical contamination
 (particulate contaminants: from cotton garments,
cardboard cartons, pencils, paper towels, chewing gum
and electronic equipment)
Chemical contamination
 (solid or liquid matter from precipitates)

16
 REQUIRES KNOWLEDGE of RISK LEVEL for
COMPOUNDING STERILE PRODUCTS
Low Risk:
 ISO Class 5 or better air quality using only sterile
ingredients, transferring drugs from the
manufacturer’s original packaging (e.g., vials or
ampules), and no more than 3 products and entries
into one container to compound sterile products.
 Beyond Use Dating for Low Risk compounds prior to
administration cannot exceed the following unless
sterility testing is performed:
 48 hours room temperature
 14 days cold temperature
 45 days solid frozen at –25 to -10 C
17
18
 Medium Risk:
 Multiple individual or small doses of sterile products are
compounded to prepare a sterile product that will be
administered either to multiple patients or to one patient on
multiple occasions (i.e. prepare a batch), or mixing takes a long
duration and the compounded sterile products do not contain a
broad spectrum bacteriostatic substance and are administered
over several days.
 Beyond Use Dating for Medium Risk compounds prior to
administration can not exceed the following unless sterility
testing is performed:
 30 hours room temperature
 9 days cold temperature
 45 days solid frozen at –25 to -10 C

19
 High Risk:
Using non-sterile ingredients that will be
terminally sterilized.
Beyond Use Dating for High Risk
compounds prior to administration can not
exceed the following unless sterility testing
is performed:
24 hours room temperature
3 days cold temperature
45 days solid frozen at –25 to -10 C

20
 Personnel Training
 Training prior to beginning to prepare products Perform
didactic review, written testing and the following suggested
training, competency and process validation methods:
1. Cleansing and garbing competency
2. Aseptic work practice assessment with glove fingertip
sampling
3. Aseptic manipulation competency with media fill test
procedures
4. Surface cleaning and disinfection sampling assessment
5. Cleaning and disinfecting competency evaluation
6. Suggested standard operating procedures (SOPs) defined
in the standards

21
 Clean rooms
Hoods are located in rooms with smooth walls
& floors without cracks, non-shedding, and
resistant to sanitizing chemicals.
Positive pressure exists between buffer and
ante area and ante area and the general
environment that is measured and documented
each work shift (at least daily). At least 30 air
changes per hour.
No cardboard boxes to minimize air particles.

22
Gowning and Personal Protective Equipment (PPE)

Artificial nails are prohibited

Staff with sunburn, rashes, conjunctivitis, and upper respiratory infections
cannot prepare sterile compounds
Remove lab coat, make-up, hand and wrist jewelry and visible piercings that
may interfere with PPE
Apply shoe covers
Apply head and facial hair covers
Apply face mask
Wash hands and forearms for 30 seconds and dry with hand dryer or non-
shedding towels
Put on non-shedding gown closed at neck and snug at wrists
Enter buffer area and use waterless alcohol-based surgical hand scrub. Allow
to dry
Put on sterile powder-free gloves
Disinfect sterile gloves with Sterile 70% Isopropyl Alcohol after touching non-
sterile surfaces during compounding

23
I/V admixtures
Sterile product produced when one or more
drugs are added to the IV solutions/fluids.
Additive – drug added to IV solution
IV fluids
Large volume parenteral to be administered
by intravenous infusion.
Group of sterile products referred to as
large- volume parenteral
Prepared with Water for Injection, USP

24
Used in:
Correction of disturbances in electrolyte balance
Correction of disturbances in body fluids (fluid
replacement)
Vehicles for other drug substances
Examples
Dextrose 5%, 10% Injection
NaCl Injection (0.9%, 0.45%)
Dextrose and NaCl Injection

25
Perpetration and dispensing of I/V
additive solutions
1.Receipt of physician order
Pharmacist work from physician’s order sheet.
2. Prepare the label
Label provide information:
▪ Patient identification with location.
▪ Physician’s name
▪ Drugs with quantities
▪ Date of compounding
▪ Expiry date
▪ Pharmacist name
3. If necessary – prepare additional label.
Positioned in upside down – to facilitate when container is hung from pole on
patient’s bed.
4. Preparation of IV solution – always in LFH.
Using sterile needles, syringes etc.

26
5. Once drug is added – new seal crimped
on container.
Seal color should be different – warn that
drug has been added.
6. Before supplying – final inspection by
pharmacist.
Like label, clarity of solution and
calculations of preparation

27
TPN or hyperalimentation
IV administration of sufficient nutrients above usual basal requirements
to achieve;
 Tissue synthesis
 Positive nitrogen balance & Anabolism
 Used for specific patients – unable in enteral feeding
TPN – part of total patient care
Simple procedures for its preparation but require appropriate facilities
& equipment’s such as LFH – provide controlled environmental
conditions.
Pharmacist – should know about:
Preparation methods
Stability & compatibility
Facilities
Equipments required for this program.

28
Stability & compatibility
 TPN – consists of various ingredients. i.e., complex
pharmaceutical system
 Possibility of interactions & incompatibility between entities
present, so increase risk of its toxicity to patients.
 Pharmacist – thorough understanding of stability & compatibility
issues, should consult available literature before preparing TPN.
Facility & environment
 TPN – require aseptic environment, so LFH are used.
Personnel & training
 Trained personnel – should carry out aseptic preparation of TPN,
should know about patient requirements & product use.
Documentation
 Work sheet – should be designed for TPN dispensing &
maintained.
 Work sheet contain information about materials, patient name,
label details
29
Manufacturing procedures
 Should be developed jointly by production & quality control staff.
 On receiving request for TPN, feasibility & stability is checked within
normal clinical limits of requested combinations.
 Information is then transferred to dispensing work sheet.
 Materials – placed well within LFH.
 Organized in manner which will facilitate systematic steps and cause
minimum disruption of air flow.
 TPN bag – inspected for integrity of all ports, leaks and particulate
materials
 TPN – should meet criteria for limit test of particulate material.
Labeling
Label should contain:
Patient name/number, Ward, Product constituents, Batch no., Expiry
date
and storage conditions.
Storage
TPN – stored at 2-8 °C. to protect it from microbiological & chemical
degradation. 30
Packaging
Quality of packaging systems – should comply
QC standards to maintain product temp. during
transfer.
Insulated polystyrene containers – most useful.
Dispensing
TPNs – dispensed according to above mentioned
procedure.
In addition – pharmacist in ward should check
that TPN is administered correctly.

31
Cytotoxic Dispensing
 Cytotoxic drugs – can kill cells, so used in treatment
of cancer & to destroy tumour & neoplastic cells.
 Most cytotoxic injectable – available in powdered
form require reconstitution.
 Pharmacist – can provide cytotoxic reconstitution
service because of knowledge in pharmaceutics,
pharmacology, pharmaceutical chemistry &
pharmacokinetics.
 Knowledge necessary for understanding
pharmacological action of cytotoxic drug & their
stability in solution.

32
AREA OF SKILLS NEEDED FOR
PHARMACIST
Safe handling
 Cytotoxic agents – non-selective so far & can destroy some
healthy tissue as well.
 So, precautions necessary for personnel handling them.
Exposure to cytotoxic agents may cause:
 Irritation of mucus membranes, eyes, skin
 Light-headedness, nausea
 Allergic reactions
 Risk of malignancy, teratogenesis, leukaemia, infertility
So, if proper precautions & procedures are followed then
possible direct exposure, inhalation of aerosolized drugs or
ingestion – can be eliminated.

33
Preparation areas
LAF cytotoxic cabinet used for preparation provides;
 Product protection
 Worker protection
 Cytotoxic cabinet – reserved only for cytotoxic drugs.
 Ventilation of area – should be adequate but doors &
windows – closed to prevent draughts.
Working area – non-porous.
 can be easily cleaned.
 Equipments & drugs – arranged in orderly manner.
 To avoid accidents.
 Neutralizing solutions – close to hands.
 To neutralize effects of spills.
 Horizontal LAF – never be used.
34
Techniques & precautions
 Prior to dispensing – product reconstituted but
maintaining sterility of product & ensuring maximum
protection to operator.
 Eating, smoking, drinking – prohibited in work area.
 Suitable protective clothing & gloves – protect skin.
 Latex gloves used commonly.
 Surgical face masks – to prevent inhalation.
 Goggles – protect eyes, eyes should be washed after
use.
 Reconstitution – carried out on solid surface to clean
easily.
 Broad edge tray – suitable when LFH surface is
perforated.
35