Introduction to Sterile Pharmaceutical Preparations
Session 1: Introduction to Sterile Pharmaceutical Preparations
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 Minutes Presentation Introduction, Learning Tasks
2 10 Minutes Presentation Definition of Sterile Pharmaceutical Products
25 Minutes Presentation Classification Categories of Sterile
3
Brainstorming Pharmaceutical Products
4 35 Minutes Presentation Qualities of Sterile Pharmaceutical Products
35 Minutes Presentation General Methods of Sterilizing Pharmaceutical
5
Buzzing Products
6 05 Minutes Presentation Key Points
7 05 Minutes Presentation Evaluation
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SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Definition of Sterile Pharmaceutical Products (10 minutes)
microorganisms, these are pharmaceutical products from which viable micro-organisms must be
totally absent.
microbial and particulate contamination at all stages of manufacture and wherever possible also
includes a terminal sterilization process.
STEP 3: Categories of Sterile Pharmaceutical Products (25 minutes)
Activity: Brainstorming (10 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
o Parenterally administered products e.g. injections, irrigations, ophthalmology products etc.
o Pharmaceutical products that come into direct contact with broken skin/mucous membrane or
internal organs e.g. certain instruments, sutures, surgical dressings etc.
Handout 1.1 Categories of Sterile Pharmaceutical products & medical devices
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STEP 4: Qualities of Sterile Pharmaceutical Products (35 minutes)
Activity: Buzzing (10 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
therefore will be of low microbial content (bio burden) prior to sterilization.
o Should be sterile
o Free from particulate contaminants
o Free from pyrogen
o Should be physically and chemically stable
o Should have the same pH as the blood; (isohydric means the same concentration of H+
o Same Osmotic pressure as blood plasma (isotonic)
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STEP 5: Role of Aseptic Technique in Assuring Quality in Pharmaceutical
Production (40 minutes)
Activity: Brainstorming (5minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
chances of microbial contamination in order to obtain the sterile products.
production;
o To minimize and reduce the risks of contamination
o To disinfect working area, equipment and ingredients in order to attain sterility
o To prevent access of viable micro-organisms and particulate contamination during preparation
and testing of pharmaceutical products
STEP 6: Key Points (5 minutes)
particulate contaminants, free from pyrogen, been physically and chemically stable, should have
the same pH as the blood and same Osmotic pressure as blood plasma (isotonic)
microbial and particulate contamination at all stages of manufacture and wherever possible also
includes a terminal sterilization process.
STEP 7: Evaluation (5 minutes)
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References
Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania
Pharmaceutical Handbook (2nd ed.). Dar es salaam.
A. J. Winfield, J. A. R., I. Smith. (2009). Pharmaceutical Practice (4th ed.) British
Britain, R. P. S. o. G. (1994). The Pharmaceutical Codex (12 ed.). London: London Pharmaceutical
Press.
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Handout 1.1. Categories of Sterile Pharmaceutical products & medical devices
SN Types/Categories Examples
1. Injections • Intravenous infusions
2. Non-injectable sterile fluids • Non-injectable water, (Sterile water for
irrigation)
3. Ophthalmic preparations • Eye drops
4. Intravenous additives • Potassium chloride
These are sterile drugs or additives
regularly added to infusions
immediately before administration.
5. Surgical dressings • Paraffin gauze dressing
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Hormones.
Defn: Implants are small, sterile
cylinders of drug, inserted beneath
the skin or into muscle tissue to
provide slow absorption and
prolonged action therapy.
7. Absorbable haemostats • Oxidized cellulose
Defn: consist of a soft pad of solid
material packed around and over the
wound that can be left in situ and
absorbed by body tissues over a
period of time, usually up to 6 weeks
and to act as a matrix for complete
blood clotting.
8. Surgical ligatures and sutures Sterilized surgical catgut
Defn: These are strands of material This consists of absorbable strands of collagen
used to tie off blood or other vessels derived from mammalian tissue, particularly the
(ligature) and to stitch wounds intestines of sheep.
(suture) in surgery.
Non–absorbable Sutures and ligatures; e.g.
linen, nylon, silk and polypropylene
9. Instruments and equipment Instruments that may be required in a sterile condition
includes syringes (glass or plastic disposable), needles,
giving sets, metal surgical instruments (e.g.
scalpels, scissors, forceps), rubber gloves, catheters,
etc
Equipment such as pressure transducers,
pacemakers, kidney dialysis equipment, incubators,
Respirator parts, medical devices and endoscopes.
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