Federal TVET

Pharmacy level -III

Learning Guide:09
Learning Guide Code: HLT PHS3 LO1- LG 09

Unit of competence: Assist in preparing

extemporaneous preparations
Title: Assist in preparing extemporaneous
preparations
LG Code : HLT PHS3 M03 LO1- LG 09
TTLM Code : HLT PHS3 TTLM 0919

LO1: Prepare for production process

September 29,Adama,Etthiopia

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Instruction sheet Learning Guide#9

Objective:
This learning Guide is developed to provide you the necessary information regarding the
Following coverage contents and Topics
 Compounding
 Industrial manufacturing
 Compounding versus industrial manufacturing
 The national standard for establishing compounding lab
 Preparing compounding sheet
 Assigning lot number and beyond-use/discard-after/ dates
This Learning guide will also assist you to attain the learning outcome stated in the cover page.
Specifically, upon completion of this Learning Guide, you will be able to:
 Follow correct dress code, safety and personal hygiene procedures
 Maintain preparation areas according to FMHACA Guidelines for the Preparation of Pharmaceuticals
 Clean work area and equipment correctly
 Maintain inventory levels of raw materials and disposable equipment
 Obtain and clarify the confirmed and formulated manufacturing order/master batch sheet from
pharmacist
 Prepare production work sheet from formulated manufacturing order/master batch sheet
 Interpret manufacture work sheet and assign appropriate product batch number
 Check and set up manufacturing/compounding machinery
 Prepare production work sheet from master batch sheet /formulated manufacturing order
Learning-intructions
1. Read the contents of this Learning Guide
2. Read the information written in the ―Information Sheet #1 and # 2‖.
3. If you earned a satisfactory evaluation on self-check proceed to next learning Guide. However, if
your rating is unsatisfactory, see your teacher for further instructions.
4. Accomplish the ―Self-check #1 on page 30
5. Read the ―Operation Sheet‖ and try to understand the procedures discussed.
6. Practice the steps or procedures as illustrated in the operation sheet. Go to your teacher if you need
clarification or you want answers to your questions or you need assistance in understanding a
particular step or procedure
7. Do the ―LAP test‖ in page 32
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 Informati Learning Prepare for production process
on sheet Guide#9
#1 Topics Compounding/manufacturing

1.1.Compounding is the preparation, mixing, assembling, packaging or labeling of a drug in

response to a prescription written by a licensed practitioner.
Extemporaneous compounding is defined as the timely preparation of a drug product
according to a physician‘s prescription, a drug formula, or a recipe in which calculated
amounts of ingredients are made into a homogenous (uniform) mixture.
1.2.Distinguishing Compounding from Manufacturing
Compounding
Compounding is the act of preparing, mixing, assembling, packaging, and/or labeling a drug
or device as the result of a practitioner‘s prescription drug order or initiative based on the
practitioner–patient–pharmacy professional relationship in the course of professional
practice, or for the purpose of, or incident to, research, teaching, or chemical analysis and not
for sale or dispensing but, manufacturing is the production, preparation, propagation,
conversion, and/or processing of a drug or device, either directly or indirectly, through
extraction from substances of natural origin or independently through means of chemical or
biological synthesis.
Compounding also includes the preparation of drugs or devices in anticipation of
prescription drug orders, on the basis of routine, regularly observed prescribing patterns.
Importance of Extemporaneous compounding
Most dosage forms of medications are already pre-packaged by the manufacturer and thus the
Pharmacy professional redistributes medications and involve in the clinical aspect of
Pharmaceutical Care. In addition to this, Extemporaneous compounding is done when
certain medical needs of individual patients cannot be met by the use of an approved
commercial drug product.
Reasons for Extemporaneous Compounding include;
A. Unavailable dosages, strengths and routes of commercial products
B. Dilution of adult doses of medications to Pediatric/Geriatric strengths
C. Conversion of solid dosage forms to solutions or suspensions
D. Combination of topical dermatological products not available by the manufacturer
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E. Inactive ingredients of commercial products which may cause allergic reactions in
individuals
1.3.The compounding process
During the compounding process, the compounder adheres to strict procedures to ensure the
safety of the patient for whom the extemporaneous formulation is intended.
The measures indicated below are designed to ensure that the compounding process is
undertaken in a logical and safe manner for both the intended recipient of the medication and
the compounder. Because of the diversity of the types and number of preparations that can be
formulated extemporaneously, compounder experience and expertise are significant factors
in the production of safe and effective extemporaneous formulations.
Standards for extemporaneous compounding
The products produced in the pharmacy must be suitable for use, accurately prepared, and
prepared in such a way as to ensure the products meet the required standard for quality
assurance. So although this is small-scale production, the same careful attention to detail is
required as would be found in a manufacturing unit. The following measures must be taken
into consideration when preparing a product extemporaneously.
A. Personal hygiene and protective equipment
Personal hygiene is extremely important. This is because medications are being prepared for
patients who may already be ill. A clean white coat should be worn to protect the
compounder from the product and, conversely, the product from contamination from the
compounder. During the compounding process, safety glasses should always be worn and,
depending on the nature of the ingredients to be incorporated into the preparation, additional
safety equipment (e.g. facemasks, gloves) may also be required.
It is the responsibility of the individual compounder to assess the risk posed by any
pharmaceutical ingredient and to ensure that the correct safety equipment is in use. Similarly,
long hair should be tied back and hands washed, ensuring any open cuts are covered.

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(For further reference see pharmacy grooming standard and dress code in Box 1
below).
Box 1: Pharmacy Grooming Standards & Dress Code
Professional appearance and attire helps convey an image of confidence and competence to
the public. Pharmacy Grooming Standards
Hair: Must be clean, conservatively colored, styled and neatly combed so that it will not
hinder vision, work performance or cause a safety hazard. Contact of hair with hands must be
avoided.
Male: The length of the hair must not extend past the top of the shirt collar.
Female: Long hair must be pulled back off of the face.
Hands and fingernails: Are to be kept neat, clean and well-groomed at all times. For
females, the length of the fingernails shall not inhibit job functions; clear, neutral or
conservative color polish may be worn, if desired.
Male facial hair: Must be clean‐shaven at all times. Sideburns shall be neatly trimmed and
shall not extend more than 1/2‖ below the earlobe. Mustaches are permitted, provided they
are neatly groomed, shaped and do not extend past the corners of the mouth. Beards, goatees
and handlebar mustaches, etc., are not permitted.
Jewelry: If worn, it should be simple and businesslike.
Male: Neck chains should be worn inside the shirt so as not to cause a safety Hazard. No
earrings or visible piercings.
Female: Necklaces should be worn inside the shirt and earrings should be kept small. No
visible piercings other than earrings.
General appearance:
Adequate personal hygiene must be maintained. Precautions need to be taken to prevent
unpleasant breath or body odor. Objectionable habits (i.e., running hands through the hair,
biting nails, hands in mouth, coughing or sneezing without a tissue) are to be avoided.
Employees should have no fashion extremes in dress or grooming (i.e., tattoos, hair
color/style, and body ornamentation visible in public view). Visible tattoos are not acceptable
and must be covered by a company approved garment.
Badge: an employee name badge must be worn on the upper left side of the uniform at all
times.
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Pharmacy Dress Code
Smock: A short or long sleeved, crisp, white, laundered pharmacist smock with a front
zipper or buttons will be provided and will be worn unless otherwise authorized by Regional
Pharmacy Manager Dirty or wrinkled smocks are prohibited. Sleeve length of smock will
match the sleeve length of shirt, blouse, or dress.
All clothing:
• Clothing must be clean, pressed, properly fitted and in good condition. All dress code
deviations from Classic White or Blue shirt professional attire and tie will be accompanied
by a crisp, white, laundered pharmacist smock.
• Conservative holiday accent attire is permitted such as holiday theme ties and/or
shirt/blouse pins.
Male:
A white or solid colored professional, button front, collared dress shirt must be worn. A solid
white T‐ shirt may be worn underneath the professional collared dress shirt. No decals or
writing are permitted on the T‐shirt. A white cardigan or sweater may be worn under the
smock. No sweatshirts or jackets are allowed.
Female:
A white or colored professional, button front, collared dress shirt or a dress with long or short
sleeves are acceptable. If the shirt has buttons, it must be buttoned to assure a professional
appearance.
Avoid overly bright, potentially distracting colors. Must be accompanied by a crisp, white,
laundered pharmacist smock.
Shoes: Must be polished at all times. Polished, dark leather shoes must be worn. Athletic
shoes made of all polished leather (no fabric) are acceptable. Rubber heels should be worn
for safety.
No canvas shoes, saddle shoes, boating shoes, open toe/backless shoes, or sandals are
allowed.

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Procedure: Hand washing
Objective: To use proper technique during hand hygiene procedures to reduce the read 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 faucets with a paper towel if they are not foot-operated.
Step 3: Make sure that the water is lukewarm.
Step 4: Wet your hands.
Step 5: Apply soap and lather with a circular motion and friction, holding the fingertips
downward
Step 6: Make sure to rub well between the fingers
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 faucets 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 prevent chapping or drying of the
skin.

B. Clean work area and equipment

The cleanliness of the work area and equipment used during the compounding procedure is
of vital importance. The risk of contaminating the final product with either dirt or
microorganisms from the surroundings, or from ingredients from a previous preparation, can
be considerable if attention is not paid to the cleanliness of the work area and equipment.
Before starting to compound a product, the work area and equipment should be cleaned with
a suitable solution which must be allowed to dry fully. Detailed procedures and cleaning

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methods are presented below.

Procedure of Cleaning and Disinfecting

Objective: To properly clean and disinfect work areas and equipment to prevent the spread
of infection.Equipment Needed: disinfectant, cloth.
Step 1: Thoroughly rinse and/or clean items before a disinfectant is used. The foundation of
manual cleaning is friction, which loosens the organic materials and allows their removal
during the rinsing process.
Step 2: When cleaning stainless steel instruments, use a back-and-forth motion to follow the
grain of the instrument, rather than a circular motion, which can scratch the surface of the
item
Step 3: To avoid spotting on the instruments, dry the items immediately after rinsing

C. Appropriate work area

In addition to the cleanliness of the work area, consideration needs to be given to the work
area itself to ensure that it is suitable for its intended purpose. Both lighting and ventilation
need to be adequate. Some pharmaceutical ingredients are highly volatile and if the
ventilation within the work area is inadequate this could cause problems for the
compounding staff. For additional information, see premises standards below.
D. Label preparation
The label for any pharmaceutical product must be prepared before starting the compounding
procedure. This will enable the product to be labeled as soon as it has been compounded and
packaged, eliminating the possibility that an unlabeled product will be left on the bench. It
also reduces the possibility of the product being mislabeled and given to the wrong patient.
Reasons for having labels include;
• To give the patient clear and complete instructions on how to use the preparations.To indicate
the storage condition necessary to ensure full potency through the period of treatment.
• To uniquely identify the contents of the container
• To increase patients‘ compliance by giving clear and concise information about the preparation
• To provide information about some cautions /warnings about the preparations

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Requirements for labels
There are both legal and professional requirements, which must be complained between labeling
a dispensed medicine.
It is the pharmacist responsibility to ensure that these requirements are satisfies and that all
labeling is accurate. The regulation indicates the standard details which must appear on label.
Requirements for labeling compounded medicines
All labels must be type written or computer generated.
The details, which must appear on the label of a dispensed medicine, are:
• The name and address of the pharmacy
• The patient‘s name
• Name of the preparation
• Quantity of the preparation
• Formula of the preparation (for unofficial preparations only)
• The strength of the preparation
• Use of the preparation
• Instructions for the patient
• The date of compounding
• Beyond used date (shelf life)
• Storage conditions
• Additional label
 Precautions
 Advise
 For further details on the preparation of a suitable label, please read the table below

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 Table1: Special labeling instructions for particular type of dispensed dosage form
Sr. No. Name of preparation Labeling instructions
1 Aerosol inhalation Pressurized containers keep away from heat source.
Shake before use. Do not exceed the prescribed
dose follow the instructions

2 Applications For external use only

3 Capsules Swallow with a draught of water
4 Creams For external use only, Store in a cool place
5 Dusting powders -For external use only
-Not to be applied on open wound or to raw or
weeping surface.

6 Ear drops For external use only

7 Emulsions Shake the bottle before use
8 Enemas -For rectal use only
-Shake well before use
-Warm to body temperature before use.
9 Eye drops To be used in 30 days after first opening
10 Eye lotions To be used with 24 hrs after first opening
11 Gargles and mouth washes Not to be swallowed in large amounts
12 Granules To be dissolved or dispersed in water before
taking
13 Inhalation Not to be taken
Shake the bottle before use
14 Nasal drops For nasal use only
15 Ointments For external use only
16 Paints For external use only
17 Pessaries -for vaginal use only
-store in cool place
18 Pastes For external use only

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19 Solutions For external use only
20 Suppositories -For rectal use only
-Store in a cool place
21 Tablets: for soluble or Dissolve or dispensed in water before taking
dispersible tablets

Stability and Beyond-use Dating (BUD)

Compounding professionals should avoid ingredients and conditions that could result in
excessive physical deterioration or chemical decomposition of drug preparations, especially
when compounding.
 The beyond-use date is the date after which a compounded preparation is not to be used
and is determined from the date the preparation is compounded. Because compounded
preparations are intended for administration immediately or following short-term storage,
their beyond-use dates is assigned based on criteria different from those applied to
assigning expiration dates to manufactured drug products.
 Compounders should consult and apply drug-specific and general stability documentation
and literature when available, and should consider the nature of the drug and its
degradation mechanism, the container in which it is packaged, the expected storage
conditions, and the intended duration of therapy when assigning a beyond-use date.
 At all steps in the compounding, dispensing, and storage process, the compounder should
observe the compounded drug preparation for signs of instability. However, excessive chemical
degradation and other drug concentration loss due to reactions may be invisible more often than
they are visible.
 In the absence of stability information that is applicable to a specific drug and
preparation, the following maximum beyond-use dates are recommended for non-sterile
compounded drug preparations that are packaged in tight, light-resistant containers and
stored at controlled room temperature unless otherwise indicated.

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BUD For Non-aqueous Liquids and Solid Formulations:
• Where the compounded drug Product is the source of Active ingredient— the beyond-use
date is not later than 25% of the time remaining until the product‘s expiration date or 6 months,
whichever is earlier.
• Where a United States Pharmacopoeia(USP) or British Pharmacopoeia (BP) Substance is the
Source of Active Ingredient— the beyond-use date is not later than 6 months. For Water-
Containing Formulations (prepared from ingredients in solid form):
• The beyond-use date is not later than 14days for liquid preparations when stored at cold
temperatures between 2°C and 8°C (36°F and 46°F).
For All Other Formulations:
• The beyond-use date is not later than the intended duration of therapy or 30 days, whichever is
earlier. These beyond-use date limits may be exceeded when there is supporting valid scientific
stability information that is directly applicable to the specific preparation (i.e., the same drug
concentration range, pH, recipients, vehicle, water content

E. Weighing and measuring procedure

During weighing and measuring, unless strict guidelines are followed, it can be very easy to
mix up different pharmaceutical ingredients as many ingredients resemble each other. It is
preferable to incorporate a weighed or measured ingredient into a product as soon as possible
to prevent any accidental switching. If this is not possible, when weighing or measuring more
than one ingredient, place each on a piece of labeled paper as soon as it has been weighed or
measured. This will avoid any accidental cross-over of ingredients.
F. Premises standards
The premises where an extemporaneous product is being prepared needs to be of an
appropriate standard.
• Premises‘ decoration should be of a good basic standard.
• The floor should be covered but in such a manner as to be easily cleaned, surfaces
should be smooth.
• Sinks should be clean and have a supply of hot and cold water.

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 • There should be a functioning, clean refrigerator.
• There should be a supply of mains (potable) water.
Premises Standards for the establishment and practice of pharmaceutical compounding in
Ethiopia are given below.
Premises Standards for the establishment and practice of pharmaceutical compounding
in Ethiopia (September 2002)
• A pharmaceutical compounding laboratory shall have adequate number of rooms suitable
for the purpose of pharmaceutical compounding.
• A pharmaceutical compounding laboratory shall have rooms of minimum sizes as indicated
below:

• The walls, floor ceilings, and floor of a compounding laboratory shall be smooth, have no
cracks or holes.
• The walls, floor and ceilings shall be painted and/or made of washable material.
• The compounding room shall have adequate light and ventilation (ventilator, etc.)
• The compounding room should be protected from direct sunlight.
• The window(s) of the compounding room shall be high enough and sealed.

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 Compounding lab

Premise standards in pharmacy working area

G. Equipment requirements
A dispensary should have sufficient equipment available in order to be able to operate

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effectively. Equipment commonly required for extemporaneous compounding are described
below under sub title “Equipments used in pharmaceutical compounding”.
H. Avoidance of contamination
To avoid contamination of any extemporaneously prepared product, compounders should
adhere to the following guidelines:
• Ensure all equipment is clean and dry prior to use.
• Keep the dispensing area clear of unnecessary items.
• Do not leave lids off stock bottles: always replace immediately after use.
• Do not return material to stock containers once removed.
• Do not leave weighed and measured items unlabeled on the work surface.
• Do not allow raw materials or the final product to come in contact with the hands (if
necessary wear gloves).
I. Suitable record keeping
Suitable record keeping is a vital part of good extemporaneous preparation. Poor record
keeping can lead to dispensing errors which could result in the patient receiving a product
other than that intende by the prescriber. Therefore, the completion of the record will be
another safety check for the patient and is an essential part of any standard operating
procedure for extemporaneous dispensing. A suggested layout for a dispensing record sheet
is given in Figure 1-1 below.
1.4.Compound record
• Name, strength, and dosage form of the compounded preparation (CP)
• Master Formulation Record reference for the CP, when used
• Date and time of preparation of the CP
• Assigned internal identification number (e.g., prescription or lot number)
• Signature or initials of individuals involved in each step (e.g., technician or pharmacist)
• Name, vendor or manufacturer, lot number, and expiration date of each ingredient and
container-closure system
• Weight or measurement of each ingredient
• Documentation of the calculations, made to determine and verify quantities and/or
concentrations of components, if appropriate
• Documentation of quality control procedures in accordance with the SOP (e.g., filter
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integrity, pH, and visual inspection)
• Any deviations from the Master Formulation Record, if used, and any problems or errors
experienced during the compounding of the CP
• Total quantity compounded
• Assigned Beyond Use Date
• Duplicate container label if prepared in a batch
A master formulation record is recommended when performing batch or high risk
compounding.The following is a Best Practice recommendation on the elements of a master
formulation record.
1.5.Master formulation record
• Name, strength, and dosage form of the CP
• Physical description of the final preparation
• Identities and amounts of all ingredients and appropriate container-closure systems
• Complete instructions for preparing the CP, including equipment, supplies, and a
description
of the compounding steps
• BUD and storage requirements
• Quality control procedures (e.g., pH, filter integrity, and visual inspection)
• Sterilization method, if applicable (e.g., filter, steam, or dry heat)
• Any other information needed to describe the operation and ensure its repeatability (e.g.,
adjusting pH and tonicity and temperature)
In addition to recording the compounding process for extemporaneously dispensed items,
other records (e.g. fridge temperatures) should be routinely recorded.
Refrigerators used in pharmacies must be capable of storing medicines between 2°C and 8°C
and must be equipped with a maximum/minimum thermometer.
This should be checked each day the premises are open and the maximum/minimum
temperatures recorded to ensure that the equipment is operating correctly and that patient
safety is not compromised. Extemporaneous record sheets should be kept for a minimum of
two years, although ideally five years would be advisable. All records and reports should be
readily available in the pharmacy for authorized inspection during the retention period.
The proper recording of information is so vital to ensuring consistent preparation of a

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formulation that an entire chapter is devoted to the subject, discussing each type of record in
detail.
Figure 1-1: Compounding Process Recoding Form (Compounding sheet)
Name of the dispensary/health institution __________________________Date
_______________
Batch number/control number_____________________________ Batch
quantity______________

J. Storing or transporting the compounded product

After drugs have been compounded and repackaged, they must be properly stored.
Appropriate storage requires environmental, security, and safety considerations. Certain
medications require storage that includes freezing, refrigeration, light-protection, or room-
temperature conditions. Certain toxic chemicals should be kept inside cabinets and kept low
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to the ground; they should never be stored out in the open. The proper storage of every
substance in the pharmacy is the responsibility of all pharmacy employees.
K. Patient Counseling
Compounded prescriptions offer an excellent opportunity for patient counseling. The
compounder can explain that the particular prescription has been prepared especially for the
patient and can describe steps that are required before its administration.This occasion can
also be used to discuss other routine subjects with the patient. In general, the common
procedures in compounding of extemporaneous preparations are listed below
In summary, the steps to be followed before, during, and after compounding can be grouped
into five categories: preparatory, compounding, final check, sign-off, and cleanup steps.
These are summarized in the sidebar below.
Preparatory
• Judging the suitability of the prescription in terms of its safety and intended use and the
dose for the patient.
• Performing the calculations to determine the quantities of the ingredients needed.
• Selecting the proper equipment and making sure it is clean.
• Donning the proper attire and washing hands.
• Cleaning the compounding area and the equipment, if necessary.
• Assembling all the necessary materials and ingredients to compound and package the
prescription.
Compounding
• Compounding the prescription according to the formulary record or the prescription, using
techniques of the art and science of pharmacy.
Final Check
• Checking, as indicated, the weight variation, adequacy of mixing, clarity, odor, color,
consistency, and pH.
• Entering the information in the compounding log.
• Labeling the prescription.
Sign-Off
• Signing and dating the prescription, affirming that all of the indicated procedures were
carried out to ensure uniformity, identity, strength, quantity, and purity.
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Cleanup
• Cleaning and storing all equipment.
• Cleaning the compounding area.
Equipments used in pharmaceutical compounding
A wide variety of equipment is used in extemporaneous dispensing, depending on the
product type to be prepared.
Mortars and pestles
Mortars and pestles are used to:
• Mix powders
• Reduce the particle size of powders
• Grind crystals into powder form and liquids
• Make emulsions.
It should be noted that the mortar is the bowl and the pestle is the pounding/shearing/grinding
implement, so compounders mix in a mortar with a pestle. In pharmacy two main types of
mortar and pestle are used:
Glass –The surfaces of a glass mortar and its pestle are very smooth, making them less
suitable for size reduction of powders, although they are efficient when grinding crystals into
powder form. Glass mortars are particularly useful when dissolving small amounts of
medicament or when incorporating substances such as potassium permanganate or dyes that
are absorbed by and stain porcelain mortars.

Porcelain – Generally much larger than their glass counterparts, these lend themselves to
larger scale production. They are ideal for the size reduction of powders for mixing powders
with other powders, for mixing powders with liquids, and for the preparation of emulsions

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 Mortar and pestle

Figure 1-2: Porcelain and glass mortars and pestles

Tiles and spatula

Ointment tile or slab is the term used to describe the piece of equipment used to prepare ointments by means
of trituration or levigation. Tiles are usually made of glazed porcelain or glass and should be large enough
for the quantity of ointment to be prepared. Spatula is equipments used to pick solid or semi solid
ingredients, and also used for levigation of ointment bases with other ingredients on tiles.

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Figure 1-3: Ointment tile and spatulas
Stirring rods
Stirring rods are used to agitate liquids to speed up the process of dissolution of solids.
These are normally between 20 and 30mm in length and made of glass. Care must be taken not to stir too
vigorously as this may cause the stirring rod to break

Figure 1-4: Glass Rods

Suppository moulds
Traditionally, suppository moulds come in a range of sizes: 1 g, 2 g, 4 g and 8 g. These weights are nominal
and imply calibration with Theobroma Oil BP. For accurate calibration a mould would need to be filled with
base alone, the individual suppositories formed weighed, and the mean weight taken as the true capacity.
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Suppositories and pessaries are made using the same moulds when no weight is specified a 1g mould is used
for suppositories and the larger 4 g and 8 g moulds are used for pessaries
(see Figure 1-5 below)

Figure 1-5 Metal and plastic suppository moulds

Water baths
A water bath is laboratory equipment made from a container filled with heated water. It is used to melt or
heat reagents as required.
The item to be melted or heated is placed in an evaporating basin over a water bath containing hot water and
allowed to melt or get heated.
All water baths have a digital or an analogue interface to allow users to set a desired temperature

Figure 1-6: Water bath

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Weighing balances
Balance is one of important equipment used to weigh the required amount of pharmaceutical
ingredients in pharmaceutical extemporaneous preparation. Balances are differentiated each other by the
following parameters.
1. Sensitivity: Is the smallest weight that makes a perceptible change in the pointer which
indicates equilibrium.
2. Sensitivity Requirement (SR): Is the weight necessary to move the pointer of the balance one division on
the index plate against which equilibrium is observed.
3. Capacity: The maximum weight, which a balance can weigh.

Figure 1-7: Triple beam balance/Manual balance

Digital/Electrical balance

Figure 1-7: Triple beam balance and digital balance

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Watch glasses
Watch glass is used as a surface to evaporate a liquid, to hold solids while being weighed, for heating a small
amount of substance and as a cover for a beaker.

Figurer.1-8 Watch glasses

Measuring apparatus
Measuring apparatus are glass or plastic equipments used to measure different volumes of liquid ingredients.

There are several types of measures. Some of them are the following.
 Cylindrical graduates Beakers
 Conical graduates
 Graduated pipettes
 Bottles Burette
 Dropper

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Figure 1-9: Cylindrical and conical graduates

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Figure.1-10 Graduated pipette

Figure 1-11 beakers and dropper

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Box 2: How to use a pipette
1. Select a pipette that is suitable for the required volume to be measured and graduated
suitably, i.e. the one that has a maximum volume nearest to the volume to be measured.
2. Check whether the pipette is a ‗drainage‘ type or ‗blow out‘ variety.
3. Check that the pipette is clean and dry.
4. Attach a bulb or teat over the mouth of the pipette (never use mouth suction).
5. Pour some of the solution to be measured into a small clean, dry beaker (never pipette from
a stock bottle).
6. Insert the tip of the pipette into the liquid and suck up a sufficient amount of the liquid so
that it is well over the required volume.
7. Adjust the meniscus as required to measure the appropriate volume.
8. Remove any excess droplets of fluid on the outside of the pipette by wiping with a non-
shed disposable towel.
9. Transfer the volume required to the final container of the product.

Figure 1-12: Burettes with its holder

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Figure 1-13: Medicine bottles

Role of Pharmacy Technicians in Compounding

The pharmacy technician‘s role in compounding is always changing and expanding. Most commonly,
pharmacy technicians are involved in assisting compounding of extemporaneous preparations (sterile or non-
sterile)
 Pharmacy technicians may involve by assisting in the following areas of practice
• The securing of all prescribed medications or devices from inventory.
• Measuring finished dosage forms (known as ―quality sufficient‖ or ―q.s.‖)
• Collecting ingredients for preparations.
• Determining amounts of ingredients to be compounded.
• Compounding sterile preparations using appropriate aseptic technique, equipment, and
devices.
• Compounding cytotoxic or other hazardous preparations.
• Disposing of hazardous or non-hazardous waste materials.
• Packaging of finished preparations.
Generating accurate and complete labels and affixing them appropriately.
• Storing all medications correctly prior to dispensing.

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 Information Learning Guide#9 Prepare for production process
sheet #2 Topics Manufacturing

2.1.Manufacturing
Manufacturing is the production, preparation, propagation, conversion, and/or processing of a drug or
device, either directly or indirectly, through extraction from substances of natural origin or
independently through means of chemical or biological synthesis; the term includes any packaging or
repackaging of the substance(s) or labeling or relabeling of its container and the promotion and
marketing of such drugs or devices.
Manufacturing also includes the preparation and promotion of commercially available products from
bulk compounds for resale by pharmacies, practitioners, or other persons.

self-check #1 Written Test

1. The preparation, mixing, assembling, packaging, and labeling of a drug is referred to as:
A. Dispensing
B. Compounding
C. Sorting
D. Selecting
2. Why extemporaneous compounding is required
A. If the dosages are unavailable
B. When dilution is required
C. When dosage form conversion is necessary
D. All of the above

3. One of the following steps in compounding process is concerned with getting the appropriate amounts of
ingredients for compounding?
A. Personal hygiene
B. Label preparation
C. Weighing and measuring
D. Record keeping

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4. The date after which a compounded production is not to be used is called
A. Expiry date
B. Preparation date
C. Beyond use date
D. Dispensing date
5. Which of the following professional people are responsible to select the most appropriate chemicals to use
for compounding?
A. Physicians
B. Pharmacists
C. Pharmacy technicians
D. All of the above
6. Which of the following equipment is used to pick up prescription weights?
A. Pestles
B. Counter balances
C. Forceps
D. Compounding slabs
7. Simple liquid measuring equipment that usually used are:
A. Burette
B. Droppers
C. Funnels
D. Graduates
8. Which one is the role of pharmacy technicians in compounding?
A. Collecting ingredients for preparations
B. Packaging of finished preparation
C. Storing and transporting finished preparations
D. All of the abov
Note: -satisfactory point above 4 points
-Unsatisfactory point below 4 point

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 Answer Sheet;
1.________ 5._________
2.________ 6._________
3.________ 7._________
4.________ 8._________

Score:________________

Rate:_________________

Name:_________________ DATE:__________________________

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 operation sheet #1 Compounding procedure

Purpose:
 To identify and undersanding of compounding steps
General Procedures for Compounding
1. Receive, validate and interpret the prescription as per the Standard Operating Procedures (SOP) for
dispensing
2. Ensure that the compounding area, equipments and containers are ready for the process and don‘t
compromise the quality of the final product
3. Calculate the quantity of each ingredient accurately
4. Weigh and measure the ingredients necessary for compounding of the product as per the procedures
for weighing and measuring, respectively
5. Compound the preparation following the appropriate procedure
6. Transfer to the final container, if it is not prepared in the final container, and make up to volume, if
necessary
7. Close the container and shake well as appropriate
8. Assign beyond-use date for the preparation
9. Prepare and attach a proper label on the product container
10. Clean all the equipments used for the compounding process and return to their original place
11. Clean the working table
12. Record the compounding process on the Compounding Sheet
13. Dispense the product to the patient with proper counseling
14. Record the prescription on the Compounding Prescription Registration Book

LAP Test #1 Practical Demonstration

Name:__________________ Date:_____________________
Started Time:______________ Finished Time:________________
Instructions: You Expected to perform the following activity within 1 hour

Task 1: Perform compounding procedure??

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Reference:
1. Jahangir Moini, Laboratory Procedures for Pharmacy Technicians. (2010), 1st ed.Delamar.
2. National Association of Pharmacy Regulatory Authorities,Guidance Document for Pharmacy
Compounding of Non-sterile Preparations.(2018) 1st edition
3. John F Marriot et.al pharmaceutical compounding and dispensing. (2010), 2nd ed. The
pharmaceutical press.
4. Loyd V. et.al Ansel‘s pharmaceutical dosage forms and drug delivery systems (2011), 9th
ed.Lippincott Williams and Wilkins.
5. Ministry of Health Malaysia ,GOOD COMPOUNDING PRACTICE.( 01August 2018) 1st Edition
6. Allen LV Jr, The Art, Science, and Technology of Pharmaceutical Compounding. 1998, American
Pharmaceutical Association
7. Ethiopian Hospital Services Transformation Guidelines volume 1, September 2016

Prepared By
Educational LEVE
No Name Region College Email Phaone Number
Background L
1 deebisaaseenaa12@gmail.co
Debisa Taressa Pharmacy B oromia Nagelle HSC m 0921798728
2 Tamene Galchu Pharmacy B oromia Nagelle HSC maatigelchu@gmail.com 0930675055
3
Ebrahim Dawud Pharmacy A Somali Jigjiga HSC ebraadaa@yahoo.com 0910480186
4 Alemseged Workneh Pharmacy A Harari Harar HSC yealemwerk@gmail.com 0913739792
5
Habtamu Tarekegn Pharmacy B BGRS Pawi HSC htarekegn25@.gmail.com 0917504094

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