Prevention and Control of Contamination in Pharmaceutical
Session 40: Prevention and Control of Contamination in Pharmaceutical
Settings
Total Session Time: 120 minutes + 2 hours Assignment
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Pharmaceutical Settings
Resources Needed
SESSION OVERVIEW
|Step |Time |Activity/ |Content |
| | |Method | |
|1 |05 minutes |Presentation |Introduction, Learning Tasks |
|2 |20 minutes |Presentation |Sources of Contamination in |
| | |Brainstorm |Pharmaceutical Settings |
|3 |20 minutes |Presentation |Consequences of Contamination on |
| | |Buzzing |Pharmaceutical Products |
|4 |50 minutes |Presentation |Measures for Preventing and |
| | |Small group |Controlling Contamination in |
| | |discussion |Pharmaceutical Settings |
|5 |05 minutes |Presentation |Key Points |
|6 |10 minutes |Presentation |Evaluation |
|7 |10 minutes |Presentation |Assignment |
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: Sources of Contamination in Pharmaceutical Settings (20 minutes)
|Activity: Brainstorming (10 minutes) |
| |
|Ask students to brainstorm on the following question: |
| |
|What are sources of contamination in pharmaceutical setting? |
| |
|ALLOW few students to respond |
| |
|WRITE their responses on the flip chart/ board |
| |
|CLARIFY and SUMMARISE by using the content below |
Microbiological contamination
Refers to non- intended or accidental introduction of infectious material
like bacteria, yeast, mould, fungi, virus, prions, protozoa or their toxins
and by-products
Sources of contamination in pharmaceutical settings
In manufacture/ compounding
scale in the hospital pharmacy, the microbiological quality of the
finished product will be determined by:
o Formulation components used
o Environment in which they are manufactured
o Manufacturing process itself.
not inspected at the end of manufacture or compounding. The following are
sources of contamination:
o Raw materials: particularly water and ingredients
o Processing equipment
o Cleaning equipment: Premises/environment
o Staff
o Packaging
In use
with the supply of a well- preserved product of high microbiological
standard in a suitable pack and that the subsequent use, or abuse, of
the product is of little concern to them.
continued use or if subjected in a contaminated state, particularly in
hospitals where it could result in the spread of cross – infection.
o During normal usage, patients may contaminate their medicine with
their own microbial flora; subsequent use of such products may or may
not result in self – infection.
o Topical products are considered to be most at risk, as the product
will probably be applied by hand, thus introducing contaminants from
the resident skin flora of staphylococci,
o Micrococcus species and diphtheroids but also perhaps transient
contaminants, such as pseudomonas or coliforms, which would normally
be removed with effective hand- washing.
o A further potential source of contamination in hospitals is the
nursing staff responsible for medicament administration.
o Small numbers of airborne contaminants may settle in products left
open to the atmosphere.
o Patients and nursing staff may use a range of applicators (pads,
sponges, brushes and spatulas) during medicament administration,
particularly for topical products
o If reused, these easily become contaminated and may be responsible for
perpetuating contamination between fresh stocks of product, as has
indeed been shown in studies of cosmetic products.
STEP 3: Consequences of Contamination on Pharmaceutical Products (20
minutes)
|Activity: Buzzing (5 minutes) |
| |
|ASK students to pair up and buzz on the following question for 2 |
|minutes |
| |
|What are the consequences of contamination on pharmaceutical products? |
| |
|ALLOW few pairs to respond and let other pairs to add on points not |
|mentioned |
| |
|WRITE their response on the flip chart/board |
| |
|CLARIFY and SUMMARIZE by using the content below |
o Cross-contamination of medicines contributes to most of the
nosocomial infections occurring in hospitals
o It also accounts for most of the postsurgical infections and deaths
occurring in hospitals.
o Cross-contaminated medicines weaken the relationship between patients
and healthcare givers.
o This occurs mostly in the event of drug resistance and treatment
failure, but also infections due to contaminated medicines make
patients lose trust in their health care givers.
o This occurs by microorganisms chemically decomposing the active
ingredient or the excipients. This may lead to:
o Contaminated products have financial implications in terms of:
STEP 4: Measures for Preventing and Controlling Contamination in
Pharmaceutical Settings (50 minutes)
|Activity: Small Group Discussion (10 minutes) |
| |
|DIVIDE students into small manageable groups |
| |
|ASK students to discuss on the following question |
|What are the measures for preventing and controlling contamination in |
|pharmaceutical settings? |
| |
|ALLOW students to discuss for 10 minutes |
| |
|ALLOW few groups to present and the rest to add points not mentioned |
| |
|CLARIFY and SUMMARIZE by using the contents below |
origin, must be of a high microbiological standard.
usually by distillation, reverse osmosis or deionization
preventive maintenance and should be properly cleaned after use to
prevent cross – contamination between batches
be thoroughly cleaned and properly maintained.
o These are responsible for distributing organisms around the pharmacy
area.
o For example mops, buckets, cleaning cloths and scrubbing machines if
stored wet they provide a convenient niche for microbial growth.
filtered air, for which the environmental requirements vary according
to the type of product being made.
can normally be found in wet sites, such as drains, sinks and taps.
o This may be minimized by observing good manufacturing practices (GMP),
by installing heating traps in sink U – bends, thus destroying one of
the main reservoirs of contaminants
brushes, spatulas and spoons) during medicament administration,
particularly for topical and oral products.
o Hand – washing between attending to patients may be overlooked and
o Contaminants may subsequently be transferred to medicaments during
administration
o Emphasize use of non – touch techniques for medicament administration
health but also a sound knowledge of the importance of personal and
production hygiene.
coats, caps, gloves and masks in controlling contamination
contamination during its shelf- life and is itself free from
contamination.
packaging pharmaceuticals, as they are heavily contaminated.
o These have now been replaced by non -biodegradable plastic materials.
o Re-use of packaging materials should be discouraged.
o Effective control method includes the supply of products in individual
patient’s packs.
STEP 5: Key Points (5 minutes)
manufacturing/compounding and use
products spoilage and financial loss
contamination in pharmaceutical settings in order to minimize the risks
of contamination.
STEP 6: Evaluation (10 minutes)
pharmaceutical settings?
STEP 7: Assignment (10 minutes)
|Activity: Take Home Assignment (10 minutes) |
| |
|DIVIDE students in groups or individuals |
| |
|ASK the students to work on the following Assignment |
|Visit a hospital pharmacy department, basing on its design/set up; |
|write a presentation on factors responsible for contamination of |
|pharmaceutical products and give suggestions on what should be done to |
|avoid the consequences of contamination. |
| |
|ALLOCATE time for students to do the assignments and submit |
| |
|REFER students to recommended references |
References
Denyer, P. D, Hodges, N. Gorman, S. P. & Gilmore, B. F. (2011). Hugo &
Russell’sPharmaceutical Microbiology. (8thed.). West Sussex:Blackwell
Publishing Ltd,
Gabriel J (2008). Infusion therapy: Prevention and management of
complications. Nurs Stand.; 22(32): 41-48
Senya, S., Mwasha, C.Y.S, Muyinga, A.M, Amir, R.I, & Mauga, E.A.S.K, (2011)
Tanzania Pharmaceutical Handbook. (2nded.). Dar es Salaam: ARU Printing
Unit
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