COURSETITLE

Supervise small scale compounding of Aseptic pharmaceutical

.
products

Introduction to aseptic preparation

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 Course Content
oPreparing Production Process For Sterile Products
oSterile Preparations And Procedures Of Compounding
oPreparation Of Cytotoxic Products
o Materials Used In Sterile Production
oOrientation On Manufacturing Of Sterile Products
oQuality control

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 Definition of terms
oAnteroom: An area providing space for hand washing, garbing, and
product decontamination.
oAseptic “Free of or using methods to keep free of Pathological Micro-
organisms”. synonym : sterile
oAseptic Processing: As products are aseptically produced individual
components are sterilised separately and brought together in the final
form in a sterile environment.
oBatch : Preparing a number of non-patient specific doses, with the
same characteristics and quality, with the intention to use based on
future patient need.
oBeyond-Use Date (BUD) :The date beyond which the product cannot
be used and must be discarded.

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oCompounded sterile preparation : A sterile preparation that is
created by combining, diluting, pooling, or otherwise
altering a drug product or bulk drug substance .
oHEPA : High Efficiency Particulate Air filters, capable of
removing 99.97% of all particles 0.3 and higher
oReconstitution : The process of dissolving or dispersing a
medicinal product in, or diluting or mixing it with some
other substance resulting in sterile solution or suspension as
a vehicle for administration

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Objective of aseptic processing
Sterile preparations are considered to be a high risk
category, for example due to:
o The increased potential for microbiological contamination;
o The higher levels of microbial contaminants in
uncontrolled environments
oThe increased risk of systemic infection;
o The increased risk of medication errors when preparing
injections without responsible person supervision.
•The preparation should take place in well-controlled
environments using well established, quality assurance
driven procedures. This considerably reduces the risk linked
to these products

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The objective of aseptic processing is to maintain the sterility
of a product.
The operating conditions should be used to prevent microbial
contamination

Dosage form selection

Sterile pharmaceutical products
oSterile products are dosage forms of therapeutic agents that are
free of viable microorganisms.
Principally sterile products include:
◦ Parenterals
◦ Ophthalmic preparations
◦ Dosage forms designed for surgical use
◦ Irrigating preparations
◦ Topical preparations or application to large open wound

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Seven Basic Characteristics of Sterile Product Dosage
Forms
1. Safety (freedom from adverse toxicological concerns)
2. Sterility (freedom from microbiological contamination)
3.Nonpyrogenic (freedom from pyrogenic—endotoxin—
contamination).
oPyrogens are fever-producing entities originating from a
variety of sources primarily ,microbial
4. Particle-free (freedom from visible particle
contamination)
5. Stability (chemical, physical, microbiological)
6. Compatibility (formulation, package, other diluents)
7. Tonicity (isotonic with biological fluids)

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Master label
oEthiopia's FDA ( FDA) defined ‘label’ as any material
which is printed or affixed to a packing material which
provides the necessary information about a food or
medicine, and includes an insert.
o Labeling includes any legend, word, or mark attached to,
included in, belonging to, or accompanying any drug
including:
1) the immediate container label;
2) cartons, wrappers, and similar items;
3) information materials, such as instructional brochures and
package inserts

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oSample labelling information shall contain, legally required
information like, generic name and quantity or concentration of each
active ingredient, preparation BUD, storage conditions and

prescription or control number (batch number)

oThe following information must be identified by labelling:
(a) the name of the drug product;
(b) a list of the active ingredients
(c) the batch number assigned by the manufacturer;
(d) the expiry date in an uncoded form;
(e) any special storage conditions or handling precautions that
may be necessary;
(f ) directions for use, and warnings and precautions that may be
necessary

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 1.Preparing Production Process For Sterile Products

It is essential to ensure that proper aseptic technique be

used for the preparation of safe and effective sterile
pharmaceutical compounding.
oThe compounding of sterile preparations requires high-quality standards
to ensure preparation quality and safety.
oThe production of sterile preparations should be carried out in clean
areas. Clean areas should be maintained to an appropriate standard of
cleanliness and supplied with air that has passed through filters of the
required efficiency
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 …cont
. o
Regardless of where aseptic processing (compounding)
is practiced—in an institutional setting, a home
infusion pharmacy, or a pharmaceutical
manufacturing facility the principles are the same;
only the practices differ.

o Practices will differ because of the nature of the

product being produced, the size of the batch, the
length of the projected shelf life, and the extent of the
regulatory requirements involved

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 oPharmacy technicians who are trained to deal with
. pharmaceutical compounding must understand basic
microbiology, and principles of asepsis.
oThey must also be familiar with clean rooms and clean
air environments.
oThe technician needs to understand the goal of
laminar-airflow hoods and follow the policy and
regulation of working in clean rooms to reduce the
risk of bacterial contamination

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 Pharmacy Laboratory Clean room

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 1.2. Sterile pharmaceutical products
Sterile products are dosage forms of therapeutic agents that
are free of possible microorganisms.

Principally sterile products include;

 Parenterals (large volume or small volume)

 Ophthalmic preparations

 Dosage forms designed for surgical use

 Irrigating preparations

 Topical preparations or application to large open wound

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 Sterile pharmaceutical products

Parenteral products

oAre unique among other dosage forms of drugs because they are injected

through the skin or mucous membranes in to internal body

compartments.

oAll components and processes involved in the preparation of these products

must be selected and designed to eliminate, as much as possible,

contamination of all types, whether of physical, chemical, or

microbiological
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 Preparations for the eye
o Though not introduced in to internal body cavities, are placed
in contacts with tissues that are very sensitive to contamination.
oTherefore, similar standards are required for ophthalmic
preparations.
Irrigating solutions
oAre also required to meet the same standards as parenteral
solutions.
oDuring an irrigation procedure substantial amounts of these
solutions can enter the blood stream directly through open blood
vessels of wounds or abraded mucus membranes.
oSterile products are most frequently solutions or suspensions, but
may even be solid pellets for tissue implantation.

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 

Types of microorganisms

oMicroorganisms, minute life forms that are invisible to the

naked eye, are a natural part of the world in which we live.

oDifferent types of microorganisms, including bacteria,

viruses, fungi, and protozoa to contaminate pharmaceutical
preparations during compounding

oThe microorganisms that are most important to guard against

in the clean room when dealing with aseptic techniques are
bacteria and viruses.

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 1.3. GMP Requirements for Sterile Processing
1.3.1. Minimizing risk of contamination
Principles of Asepsis
The safety of the patient depends on strict adherence by
pharmacy technicians to sterile technique.
Technicians must also be constantly aware of the sterile technique
of other personnel within the clean room.

Adherence to the principles of asepsis reflects the pharmacy

technician’s compounding conscience and ability to assist in
preventing contaminations.

This will result in a lower risk of harm to patients.

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preparing compounding with aseptic techniques in a clean room

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Identifying dosage forms that must be prepared with aseptic
techniques in a clean room environment

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 Medical Asepsis
1. Asepsis:- is the absence of disease-producing microorganisms.
It can be achieved by medical aseptic technique and surgical
aseptic technique.
A) Medical asepsis is the use of practices such as hand washing,
general cleaning, and disinfecting contaminated surfaces.
These measures are aimed at destroying pathologic organisms
after they leave the body.
These techniques are used to decrease the risk for transmission
of contaminants to others.
Medical aseptic technique is sometimes called clean technique.

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 Medical Asepsis…….
Microbes may be reduced by using medical aseptic technique, which includes:
 Regular hand washing
 Using non sterile gloves (especially when in contact with blood,
body fluids, mucous membranes, or non-intact skin).
 Proper cleaning and disinfecting of equipment

A list of commonly used antiseptics and disinfectants agents, and

their areas of application, is shown in Table

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 Medical Asepsis

Hand hygiene

•Hand hygiene is the most important health procedure that can be performed to
prevent the spread of microbes of all types.
It requires washing the hands by vigorous rubbing of all surfaces of the hands
while lathered with an appropriate antimicrobial soap followed by rinsing under
running, warm water.
Cold water does not provide enough lather from the soap and hot water may
damage the skin.
While washing, always keep the fingertips pointed downward, never lean against
the sink, and never touch the inside of the sink

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 Medical Asepsis…..
The friction created by rubbing the hands together during washing
mechanically removes microbes from the hands, and along with
proper soap and running water, is the most significant way to
prevent nosocomial infections (those that can be acquired by
caring for patients in health care facilities).
Likewise, proper hand hygiene is the single most important
control measure to break the chain of infection.

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Procedure: Hand washing
Objective: To use proper technique during hand hygiene
procedures to reduce the spread of infection.
.
Equipment Needed: sink, running water, antimicrobial liquid
soap, a nail brush (or orange stick), Paper towels within a
dispenser, water-based antimicrobial lotion, and a properly
labeled biohazard waste container.
Step 1: Remove all jewelry.
Step 2: Turn on the water valves with a paper towel if they are
not foot-operated.
Step 3: Make sure that the water is warm.
Step 4: Wet your hands.
Step 5: Apply soap and lather with a circular motion and friction,
holding the fingertips downward
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Step 7: If this is the first time of the day you are washing
your hands, use a nail brush (or orange stick) to clean under
every fingernail.
.
Step 8: Rinse well while holding the hands with the fingertips
still pointed downward
Step 9: Repeat the scrubbing procedure a second time, for 1
to 2 minutes.
Step 10: Rinse again.
Step 11: Dry hands with paper towels, avoiding touching the
paper towel dispenser
Step 12: Turn off the water valves with a paper towel if they
are not foot-operated
Step 13: Place used towels in the biohazard waste container.
Step 14: Apply the water-based antibacterial hand lotion to
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 Medical Asepsis

Cleaning and Disinfection

Cleaning is the physical removal of soil, debris, blood, and body
fluids from instruments, furniture, and other items. Cleaning is
necessary before disinfection because organic debris decreases the
effectiveness of disinfectants.
Disinfection is destruction of pathogenic microorganisms by direct
exposure to chemical or physical agents. This process is done by
using specific detergents that are selected according to the type of
instrument to be cleaned.
Instructions must always be followed for correct dilution,
temperature, and use.

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 Medical Asepsis….
Aseptic Techniques
The primary method through which microbes are kept to an absolute
minimum in the clean room for sterile compounding is aseptic technique.
This involves creating a sterile field for each procedure.
For sterile compounding in any pharmacy setting, a laminar-airflow hood may
be used.

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 Medical Asepsis……
Pharmacy technicians must regularly follow the procedures of aseptic
technique, which include:
 The removal of all jewelry
 Not wearing artificial nails because of possible microbial growth around and
under them.
 Tying long hair back away from the face
Washing hands after entering the work area and before entering a laminar-airflow
hood.

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 GMP Requirements for Sterile
Processing
2.Autoclaves
Autoclaves are basically pressure cookers that are used to achieve sterilization.
They use steam under pressure to obtain temperatures of approximately 250
to 254 °F.
Items are exposed to this heat and at least 15 pounds of pressure for specific
amounts of time, assuring the killing of all microorganisms and their spores.
Pharmacy technicians must be familiar with the proper operating procedures
for autoclaves in the laboratory.
Water is poured into the reservoir and the autoclave’s door is closed and
secured.

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.

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 Autoclave

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 .Autoclaves …..
When the autoclave is turned on, the water heats until vapor is produced.
This enters the middle steam chamber.
This pushes the air in the steam chamber out to increase the pressure,
causing the steam to enter the inner sterilizing chamber where the surgical
instruments to be sterilized have been placed.

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 Autoclaves….
The inner chamber pressure then increases, with temperatures
reaching their intended peak.
The steam reaches all surfaces of each item and sterilizes them.
Unwrapped items are usually sterilized for 20 minutes.
Loosely wrapped items are usually sterilized for 30 minutes, with
40 minutes being used for tightly packed items.
The pharmacy technician must follow proper operating
procedure for the autoclave to be effective in sterilizing items.

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1.3.3. Production in Clean rooms

Clean rooms are specialized work areas (separate rooms) where air quality,
humidity, and temperature are highly regulated. This helps to reduce the risk
of cross-contamination. Clean room air is filtered repeatedly to remove
impurities such as dust particles and particulates. The laminar- airflow hood
is located inside the clean room.

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 Production in Clean rooms…
Clean rooms are usually single-door, positive-pressure rooms designed to
keep particulates from flowing into the room when the door is in use.
Wooden items should never be placed in clean rooms because they contain
free-floating particles.
Positive pressure keeps unfiltered or dirty air from entering.
This in turn, allows the purified clean room air to offer a reduced risk that
contaminants will be introduced into sterile products.

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 Production in Clean rooms
The ceilings, floors, walls, fixtures, counters, cabinets, and shelves located
inside clean rooms must all be resistant to sanitizing cleaners.
Floors should be made of continuous material with no cracks or breaks, and
must be strong and chemically impervious.
There should not be any sinks or floor drains in the clean room.

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.
.

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Production in Clean rooms
The clean room contains the following major equipment:
Sterilization devices.
Laminar-airflow hoods.
Automated compounding devices
Environmental monitoring devices (air particulate counters)
Clean room dress.
Cleaning materials: Detergent, Wipers, Sanitizing solutions.

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Production in Clean rooms
Personal computers, keyboards, monitors, and printers are not allowed
inside clean rooms.
Most of the furniture and equipment found in clean rooms is made of stainless
steel, which can be easily cleaned with 70% isopropyl alcohol.
Alcohol swabs, needles, and syringes must be kept to a minimum inside
clean rooms in order to maintain an aseptic environment.

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 Clean Air Environments
Sterile products are regularly prepared in clean room environments.
A clean room should not allow more than 3,500 airborne particles (of no
larger than 0.5 microns each) per square meter of air.
The United States pharmacopoeia classifies “clean” or “critical” room
environments as “Class 100” or “Grade A.”
In these environments, the air is rapidly cycled through.

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 Laminar-Airflow Hoods
Laminar-airflow hoods are designed for the handling of materials whenever
sterile working environments are required.
These devices use circulating filtered air in parallel flow planes to reduce
the risk of bacterial contamination or exposure to chemical pollutants.
If operating properly, laminar-airflow hoods are very effective for providing a
clean working area.

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.
.

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 Clean Air Environments…
Room air may be highly contaminated by normal human actions such as
sneezing, which produces up to 200,000 aerosol droplets that can attach to
dust particles and remain in the air for weeks.
Laminar-airflow hoods are commonly used in pharmacies, surgery areas,
laboratories, and food preparation rooms.

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 STERILE PREPARATIONS AND
PROCEDURES OF
COMPOUNDING
2.1. Introduction
2.2. Preparation of Parenteral Products
2.2.1. Role of the Technician
2.2.2. Compounding Records
2.2.3. Policies and Procedures for Sterile Product Preparation
2.2.4. Procedures for Handling and Preparing Parenteral Products
2.2.5. Visual Inspection of the Parenteral Product
2.3. Preparation of IV Admixtures
2.4. Transport and delivery of final compounded sterile preparations
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 Objectives
Upon completion of this chapter, you should be able to:
Identify the circumstances that require compounding of the sterile products
Identify materials used in aseptic production (therapeutic agents and additives)
Identify containers and packaging in sterile manufacturing
Describe environmental monitoring and product sampling methods for QC
Explain methods of quality control of finished products
Perform compounding of sterile pharmaceuticals by applying principles of cGMP

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 Chapter two
STERILE PREPARATIONS AND PROCEDURES OF COMPOUNDING

2.1 Introduction
Sterile products are injected directly into body tissue through the skin and
veins.
Therefore, parenteral administration bypasses the skin and gastrointestinal
tract, which are the body’s natural barriers to infection.
Sterile products must be produced in a sterile environment to reduce the risk of
infection that administration of these products imposes.
Sterile preparations must be kept pure and free from biological, chemical,
and physical contaminants.
The pharmaceutical industry strives to maintain good manufacturing
practices of parenteral dosage forms as a result.
Likewise, pharmacists and technicians must practice good aseptic technique
when working with these products.

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Parenteral preparations are given when a medication is rendered
inactive in the gastrointestinal tract or when a patient is unable
A. Parenteral Preparations

to take medication by mouth (due to vomiting or

unconsciousness).
Fluids, electrolytes, and nutrients are often administered
parenterally.
Eg. Ringer lactate (KCL), Normal saline (NaCl),and Dextrose
(Glucose).

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…cont
Parenteral products must have the following unique qualities:
 They must be sterile.
 They must be free from contamination by endo toxins
 They must be free from visible particles, which includes reconstituted
sterile powders.
 They should be isotonic
They must be chemically, physically, and microbiologically stable
 They must be compatible with IV delivery systems, diluents, and other drug
products to be co-administered.

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 …cont
For administration, injections may be classified in these six
categories:
a) Solutions ready for injection.
b) Dry and soluble products ready for combination with a solvent just
prior to use.
c) Suspensions ready for injection.
d) Dry, insoluble products ready for combination with a vehicle just prior
to use.
e) Emulsions
f) Liquid concentrates ready to be diluted prior to administration.

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…cont
Disadvantages of parenteral administration, include the following:
Asepsis required at administration.
Risk of tissue toxicity from local irritation.
Pain.
Difficulty in correcting errors.

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 B. Non Injectable Products
 There are certain non injectable products that must be sterile for use.
These include irrigations and ophthalmic products.
IRRIGATIONS
The most common sterile irrigations include gentamicin irrigation solution and
surgical antibiotic solution (SAS).
These agents, which include sterile water (saline), are used during surgery to
irrigate open surgical sites.
While not truly aseptic in nature, they must be compounded in a sterile environment
using sterile IV bottles or bags.
The labels of these types of irrigations state that they are to be used for
irrigation only, and they are never to be used intravenously.

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…cont
Ophthalmic

Ophthalmic are sterile preparations intended for direct administration into the
conjunctiva of the eye.
Ophthalmic drops contain filtered elements that are safe to use.
Ophthalmic are compounded in laminar-airflow hoods in aseptic conditions,
then autoclaved for sterilization.
They are then cultured to assure that they contain no contaminants.
The process for compounding Ophthalmic properly takes from 1 to 2
weeks.

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 …cont

Intravenous Products
Intravenous products are injected into the veins.
They must be completely sterile.
Intravenous products may be small-volume parenterals (SVPs) or large-volume
parenterals (LVPs).
Small-volume parenterals (SVPs) are usually 100 mL or less and are primarily
used as vehicles for delivering medications.
They are generally contained in ampoules, vials, prefilled syringes, or in
piggyback (a second intravenous solution, usually of smaller volume than a
primary IV) IVs.
Medications given with piggybacks usually contain 50 to 100 mL and are typically
infused over a period of 30 to 60 minutes.

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…cont
Large-Volume Parenteral
Large-volume parenterals (LVPs) are different from small-volume infusions
because they can deliver large quantities of fluids, electrolytes, total parenteral
nutrition solutions, or chemotherapy.
Popular large-volume parenterals include 0.9% sodium chloride, 5%
dextrose in water (DW), lactated Ringer’s, 5% dextrose, and 0.9% sodium
chloride.
Other premixed solutions may contain magnesium, lidocaine,
aminophylline, nitroglycerin, dopamine, and potassium.
When large-volume parenterals require compounding in the pharmacy, it is
important that the pharmacist ensures the stability, compatibility, and safety
of the mixture.
The pharmacist should also verify any high doses of drugs or electrolytes with
the physician who orders the compounded large- volume parenteral.

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2.2. Preparation of Parenteral Products
Parenteral products must be prepared with strict controls to avoid
contamination.
Parenteral products can be contaminated by contact with health care
personnel, supply air, particle infiltration, and contaminants on
equipment.
Giving a patient a contaminated product can cause serious adverse effects,
including death.
Parenteral medications account for more than 40 percent of all medications
administered in institutional practice.

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2.2.1Role of the Technician

The role of the pharmacy technician in handling sterile preparations and

the procedures of compounding are varied.
These activities include:
 In-depth knowledge of sterile compounding.
 Excellent aseptic technique.
 Skill and knowledge of pharmaceutical calculations.
 Familiarity with parenteral devices and equipment.
 Labeling of sterile products.
 Completing of compounding records.

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…cont
Performing quality control activities in the compounding area.
 Cleaning and disinfection the compounding area.
 Completing cleaning logs.
 Ordering, receiving, and stocking IV medications and compounding
supplies.
 Picking, assembling, and packaging of the appropriate equipment and
supplies, and arranging for their delivery.  Excellent computer skills.
Knowledge of the legislation and regulations pertaining to sterile
compounding.

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2.2.2 Compounding Records

A compounding record is also known as a mixing report. It may be a

computerized or paper record.
Compounding records are used to document the activities that are undertaken
during compounding.
They are stored along with patient charts.
A compounding record includes the following information: Expiration dates
of the substances used, Lot numbers, stability Information about the
final mixture, and Specific compounding instructions for the mixture

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2.2.3. Policies and Procedures for Sterile Product
Preparation
Before compounding sterile products, health care personnel should read their
facility’s policies and procedures, and verify by signature that they have done
so.
The following topics should be covered by the policies and procedures manual
concerning sterile product preparation:
 Job description – education level; certification; registration; length of
experience; type of experience; ability to lift various weights; ability to push
carts; ability to do rapid, repetitive, and accurate manipulations; work shifts;
environment; garb; ability to compound pharmaceutical products that are free
of contaminants.
 Job orientation – roles of employees; garb; facilities; equipment; area
specific techniques; reference materials.

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…cont
Training and education – aseptic technique and quality control; chemical,
pharmaceutical, and clinical properties of drugs; good manufacturing practices;
equipment operation; product handling.
 Competency evaluation – methods of observation and/or testing; intervals
between evaluations; aseptic technique; handling new equipment; written math
skills tests.
 Acquisition – ingredient selection; bulk drug substance dating procedures;
repackaging guidelines; identification of ingredients by testing; purchasing
equipment, containers, and closure.

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Cont.…
Storage – temperature monitoring of refrigerators and freezers, light,
ventilation, and humidity; stock rotation and inspection; locations of
quarantined products.
 Handling – removal of outer packaging in anterooms; handling of pouched
supplies; decontamination of ampoules and vials; disposal of used items,
hazardous wastes, and sharps; inspection of sterile ingredients and containers
prior to compounding; handling expired drugs and supplies; handling product
recalls.
 Facilities – cleaning procedures; traffic control; safety.
 Equipment – location; use; cleaning; cart entry past demarcation line in the
anteroom; laminar-airflow hoods; traffi c.

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Check and log temperature twice a day

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 …cont

Personal conduct and garb – eating; drinking; smoking; wearing makeup and
jewelry; hand washing and drying; dealing with infectious conditions; garb
policies and procedures.
 Other important areas – product integrity, aseptic technique, work sheets,
batch preparation records, sterilization methods, environmental monitoring,
process validation, expiration dating, labeling, end-product valuation,
maintaining quality of compounded products, patient monitoring, housekeeping,
quality assurance, and documentation records.

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2.2.4. Procedures for Handling and Preparing Parenteral
Products
Pharmacy technicians must follow the policies and procedures of the pharmacy
concerning sterile compounding.
The goal is to handle and prepare parenteral preparations in a manner that is as
free from biological, chemical, and physical contaminants as possible.
This requires proper aseptic technique because parenteral preparations are often
unstable and highly potent—their characteristics must be preserved without
contaminating them. Important properties of parenteral preparations that must
be considered include compatibility, osmolality (concentration of particles
or substances), osmolarity (concentration of diffused, active particles), pH,
stability, and tonicity (tone or tension of a substance).

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2.2.5. Visual Inspection of the Parenteral Product
It is important to visually inspect parenteral products to check for cloudiness,
color changes, or other conditions that can demonstrate the product may
be contaminated, defective, or otherwise unusable.
.

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Procedure: Visually Inspecting a Parenteral Solution before Use
Objective: To properly determine that a parenteral solution is in
.
acceptable condition to use and is not
contaminated or damaged in any way.
Equipment
. Needed: parenteral product
Step 1: Inspect the parenteral solution container for any damage and
proper seal.
Step 2: Read the label.
Step 3: Verify that it is the correct medication required for use
Step 4: Verify that it is not expired.
Step 5: Turn the container upside down. Using good lighting,
inspect the container for any clouding,
hazing, or particles in the solution
Step 6: If there is no visible contamination and the container is
properly sealed, it may be used.
Step 7: If there is any visible contamination or the container is not
properly sealed, it should be
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2.3. Preparation of IV Admixtures
Intravenous admixtures consist of several sterile products added into an IV
fluid for administration.
They must be mixed using aseptic technique. This may be accomplished by
mixing them inside a laminar-airflow hood. Each sterile product should be
added into the IV fluid with a fresh disposable syringe.
Some IV admixtures, such as antibiotics, may be frozen after mixing due to
the limited stability they may have after being mixed—as long as they are
not intended for immediate use. Others do not have to be frozen, but must be
used within a short period of time after being mixed

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Procedure: Adding a Medication to an IV Bag
Objective: To demonstrate the proper technique used to add a medication to an existing IV bag.
Equipment Needed: primary IV, drug additive, alcohol swab, needle and syringe, label

.
Step 1: Review the medication order.
Step 2: Check for any drug allergies.
Step 3: Make sure that the drug to be added to the IV bag is compatible with the existing IV
solution. .
Step 4: Wash your hands.
Step 5: Clean the IV bag’s injection port with an alcohol swab.
Step 6: Insert the needle of the syringe containing the drug to be added into the IV bag’s
injection port.
Step 7: Inject the drug into the bag.
Step 8: Withdraw the needle from the port.
Step 9: Rotate the IV bag gently (this will mix the solution).
Step 10: Inspect the solution for any separation of the ingredients (you can only use the mixed
solution if there is no separation)
Step 11: Note the date, time, drug name, and dosage of the additive on the medication label.
Step 12: Place this label on the IV bag so that it can be easily read after the bag is hung.
Step 13: The mixed solution is now ready to be administered to the patient.

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2.4. Transport and delivery of final compounded sterile preparations
Policies and procedures must be developed and implemented for the transport
of compounded sterile preparations and their delivery to patient care units,
patients and dispensing pharmacists.
A policy for return of expired or unused compounded sterile preparations from
the patient’s home or the patient care unit in a health care facility must also be
developed.
The transport and delivery procedures must identify the delivery person and
the times when the min/max thermometer must be checked during
transport.
The steps to be followed in the event of non-maintenance of target storage
temperature during transport must be indicated in the procedure.

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…cont

The transport and delivery procedures must include any precautions to be

taken by the delivery person, especially during delivery (e.g., personal delivery
of the compounded sterile preparation, rather than delegation to another
person) and during return of medications, waste, and sharp or pointed items.

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