MAKERERE UNIVERSITY

COLLEGE OF HEALTH SCIENCES

SCHOOL OF PHARMACY

INDUSTRIAL PHARMACY
COURSE CODE: PHS3207

STANDARD OPERATING PROCEDURE FOR A

SUPPOSITORY MOULD
By BRENDA AKAMPULIRA 20/U/3041/PS
 MAKERERE UNIVERSITY, KAMPALA UGANDA
DEPARTMENT OF PHARMACY
STANDARD OPERATING PROCEDURE
SOP NO. 1 PAGE NO. 1 OF 2 DATE 30.07.2023
ISSUED
REVISION 1 SUPERCEDES NONE DATE OF 30.07.2025
NO. EXPIRY

DEPARTMENT: PRODUCTION UNIT

1. PURPOSE:
Suppository mold instruction manual
2. SCOPE:
These procedures provide guidelines on operation, cleaning, maintenance and
troubleshooting of the suppository mold.
3. DEFINITIONS:
Suppository mold: This is a device used in suppository production. They have
an ergonomic shape that puts into factor the patient’s comfort while
administering the medication to the required areas.
Suppository: This is a dosage form used to deliver medications by insertion into
the body cavities where it dissolves or melts to exert local or systemic effects.
Standard operating procedure: This is a set of systematic instructions for
completing a task.
4. ABBREVIATIONS:
 SOP: Standard Operating Procedure.
5. MATERIAL AND EQUIPMENT:
Aluminum metal molds come in a variety of cavity sizes and with a variety of
number of cavities per mold. Common sizes vary from 1 g to 2.5 g, and
common number of cavities range from 6 cavities up to 100 cavities. The two
halves of the mold are held together with either nuts or some molds have 1
centered screw.
Aluminum molds usually require lubrication before use. One way is to use a
vegetable oil spray. Other lubricants include light mineral oil when water-
soluble bases are being used and glycerin or propylene glycol when oleaginous
Author AKAMPULIRA Checked STEVEN Authorized MASEREKA
BRENDA by EGWALU by ALEX
Signature; Signature; Signature;
Date 14.07.2023 Date 24.07.2023 Date 26.07.2023
 MAKERERE UNIVERSITY, KAMPALA UGANDA
DEPARTMENT OF PHARMACY
STANDARD OPERATING PROCEDURE
SOP NO. 1 PAGE NO. 1 OF 2 DATE 30.07.2023
ISSUED
REVISION 1 SUPERCEDES NONE DATE OF 30.07.2025
NO. EXPIRY

bases are being used. For whatever lubricant is used, only a light coating is
needed. If too much lubricant is used, the excess will pool in the tip of the
suppository cavity. Any excess lubricant should be wiped off with an absorbent
tissue.
6. PROCEDURE:
6.1 OPERATING INSTRUCTIONS
1. Lubrication of the mould cavities.
Cocoa butter and glycerol-gelatine bases require lubrication of molds.
This prevents the stacking of bases to the wall of the mold cavity. It is
also useful in the easy removal of suppositories from the molds. The
lubricants form a film between the wall of the mold cavity and the
base of suppositories so, they prevent adhering of bases to the molds.

Using a gauze pad apply lubricant to cavities on the inner side of both
plates. Mould is lubricated using a pad of gauze or muslin or with a
small fairly stiff brush. Cotton wool is not used because some fibres
adhere to the mould. Excess lubricant can be removed by inverting the
mold on a clean white tile.

2. Place Front Plate onto locating pins of Rear Plate of the mold.

Author AKAMPULIRA Checked STEVEN Authorized MASEREKA

BRENDA by EGWALU by ALEX
Signature; Signature; Signature;
Date 14.07.2023 Date 24.07.2023 Date 26.07.2023
 MAKERERE UNIVERSITY, KAMPALA UGANDA
DEPARTMENT OF PHARMACY
STANDARD OPERATING PROCEDURE
SOP NO. 1 PAGE NO. 1 OF 2 DATE 30.07.2023
ISSUED
REVISION 1 SUPERCEDES NONE DATE OF 30.07.2025
NO. EXPIRY

3. First, lightly tighten all locking knobs, and then fully tighten all knobs
to prevent leakage during filling.

4. Suppository Mold is ready for filling

5. Melt required quantity of suppository base in hot water bath or on hot

plate. Add active ingredients. Avoid overheating. For example, cocoa
butter & glycerinated gelatin base should not be heated above 35º C
and 90 - 95º C, respectively.

6. Pour melted mixture into mold cavities. Fill cavities until there is a
slight overflow onto the top surface of the mold. This allows for
shrinkage after solidifying.
When filling a suppository mold, start pouring the molten mixture at
one end and pour continuously without stopping. Do not go to the
next cavity until the previous cavity is filled and a slight excess has
been poured to overfill the cavity.
Author AKAMPULIRA Checked STEVEN Authorized MASEREKA
BRENDA by EGWALU by ALEX
Signature; Signature; Signature;
Date 14.07.2023 Date 24.07.2023 Date 26.07.2023
 MAKERERE UNIVERSITY, KAMPALA UGANDA
DEPARTMENT OF PHARMACY
STANDARD OPERATING PROCEDURE
SOP NO. 1 PAGE NO. 1 OF 2 DATE 30.07.2023
ISSUED
REVISION 1 SUPERCEDES NONE DATE OF 30.07.2025
NO. EXPIRY

7. Allow suppository mixture to cool at room temperature for 30 minutes

and check whether suppositories have solidified.
To test if suppositories have solidified, touch the suppository or the
overflow material with your finger or plastic scraper. It should be
firm, not soft. If the suppository base does not solidify at room
temperature, refrigerate mold for 30 minutes. Do not place in freezer.
Use plastic scraper to scrape excess material off surface of mold or by
trimming the top of the mold with a warm stainless steel spatula.

8. Opening the suppository Mold.

An efficient way to separate the mold is to remove the wing nuts or
loosen the centered screw and place the mold so that the posts rest on
the tabletop. Then apply a downward pressure only on the bottom half
of the mold.
Never try to separate mold plates with knife, spatula, or other
instrument as damage may occur. Damage to mold plates may result
in leakage during subsequent use.
6.2 CLEANING INSTRUCTIONS
Cleaning is recommended when changing formula or at the end of each
production batch.

Author AKAMPULIRA Checked STEVEN Authorized MASEREKA

BRENDA by EGWALU by ALEX
Signature; Signature; Signature;
Date 14.07.2023 Date 24.07.2023 Date 26.07.2023
 MAKERERE UNIVERSITY, KAMPALA UGANDA
DEPARTMENT OF PHARMACY
STANDARD OPERATING PROCEDURE
SOP NO. 1 PAGE NO. 1 OF 2 DATE 30.07.2023
ISSUED
REVISION 1 SUPERCEDES NONE DATE OF 30.07.2025
NO. EXPIRY

1. HAND WASHING INSTRUCTIONS

i) Dismantle parts and soak in warm water with detergent for 5-10
minutes.
ii) Clean using nylon brush, sponge or wash cloth.
iii) Wipe with dry cloth or paper towel. Always dry parts fully
before using mold.
iv) To speed drying, use a cool or hot air dryer.
2. PRECAUTIONS DURING WASHING
 Do not use acidic cleaning solutions.
 Do not clean with abrasive cloth, gritty materials, or steel wool.
Use only plastic brushes or nylon pads.
 Do not apply excess force when cleaning parts.
 Do not use a knife, spatula, or other similar instrument for
cleaning Damage to inside surface of mold plates may result in
leakage during subsequent use.

6.3MAINTENANCE REQUIREMENTS FOR MOLDS

i) It is recommended that cleaning be done for all parts of the mold
after completion of each batch.
ii) Routine calibration of the mold. This is necessary because the size
of the suppositories remains the same from a particular mold but
their weight varies because the density of the different types of
bases and the medicaments used are different.
 The first step is to prepare molded suppositories from base
material alone.
 The suppositories are combined and the average weight is
recorded.
 To determine the volume of the mold, the suppositories are
melted in a calibrated beaker, and the volume of the melt is
determined.
Author AKAMPULIRA Checked STEVEN Authorized MASEREKA
BRENDA by EGWALU by ALEX
Signature; Signature; Signature;
Date 14.07.2023 Date 24.07.2023 Date 26.07.2023
 MAKERERE UNIVERSITY, KAMPALA UGANDA
DEPARTMENT OF PHARMACY
STANDARD OPERATING PROCEDURE
SOP NO. 1 PAGE NO. 1 OF 2 DATE 30.07.2023
ISSUED
REVISION 1 SUPERCEDES NONE DATE OF 30.07.2025
NO. EXPIRY

6.4TROUBLESHOOTING.
Observation Possible Cause Remedies
1 Excessive Locking knobs are Tighten locking knobs until 2
leakage of not fully tightened. plates of mold are pressed firmly
ingredients together.
outside the Inside surface or Replace the Suppository Mold.
mold edges of suppository
mold are damaged.
2 Suppository Incomplete Lubricate entire surface of mold
sticks to lubrication to mold. inner cavities.
mold Lubricant used may Use another lubricant. Be sure
not be appropriate. the lubricant does not react with
the suppository ingredients.
3 Suppository Cooling time is too Cool suppositories for longer
not formed short. time or place in refrigerator.
While melting the Check the characteristics of
suppository base and suppository base and other
other ingredients, ingredients. Do not heat above
temperature was recommended temperature.
raised above the
recommended limit.
Incompatibility of Check ingredients for
suppository base and compatibility. Change
other ingredients. ingredients or formula as
necessary.
4 Mold Plates Locating pins of Rear Straighten the pins if bent or
do not fit Plate may be bent or replace the suppository mold.
together missing.
properly

Author AKAMPULIRA Checked STEVEN Authorized MASEREKA

BRENDA by EGWALU by ALEX
Signature; Signature; Signature;
Date 14.07.2023 Date 24.07.2023 Date 26.07.2023