Requirements for Preparation of Sterile
Session 3: Requirements for Preparation of Sterile
Pharmaceutical Products
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Explain premise requirements for sterile production.
Explain personnel requirements for sterile production.
Explain raw materials requirements for sterile production.
Explain documentation requirements for sterile production.
Explain equipment requirements for sterile production.
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 Minutes Presentation Introduction, Learning Tasks
30 Minutes Presentation
2
Buzzing Premise Requirements for Sterile Production.
30 Minutes Presentation
3
Brainstorming Personnel Requirements for Sterile Production.
15 Minutes Presentation
4 Raw Materials Requirements for Sterile Production.
Buzzing
15Minutes Presentation
5 Documentation Requirements for Sterile Production.
Brainstorming
15 Minutes Presentation Equipment Requirements for Sterile Production.
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Brainstorming
7 05 Minutes Presentation Key Points
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8 05 Minutes Presentation Evaluation
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: Premise Requirements for Sterile Production (30 minutes)
preparation.
product.
minimise the risks of particulate, microbial and pyrogens contamination.
microbial contamination, so as to reduce the introduction, generation, and retention of
contaminants during preparation.
o The facilities for the manufacture of sterile products should be designed for near to perfect
level of cleanliness.
o The maximum degree of cleanliness must be achieved in the aseptic filling rooms.
o The surrounding areas should provide a buffer area in which standards of cleanliness are only
slightly lower than the aseptic rooms.
o The prevention of contamination must be the primary objective in the design of these
facilities.
o Well-maintained premise is a good indicator that production of infusions is done in clean
environment that reduces risks of contamination to the product.
o All equipment and surrounding work area must be cleaned thoroughly at the end of the
working day.
o After thorough cleaning, all surfaces should be disinfected, at least in the aseptic area.
o An effective liquid disinfectant should be sprayed or wiped on all surface.
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o Irradiation from UV lamps properly located will further reduce the viable microorganisms on
surfaces and in the air.
o The facility should be designed in such a way that it provides a continuous flow of production
activities.
o A change area has to be available before entering the facilities to allow change of street
clothes into the appropriate production garments and gear.
o There should then be a continuous process from supply storage to compounding of product,
filling, sealing, sterilisation, labelling/packaging and finally to storage of the finished product.
STEP 3: Personnel Requirements for Sterile Production (30 minutes)
Activity: Brainstorming (5 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
pharmaceutical technology, microbiology and hygiene.
product. e.g. Aware of the sources of contamination.
procedures.
o These include removing outside street clothing, scrubbing the hands and arms thoroughly
with disinfectant soap, and wearing of prescribed uniforms.
o Uniforms usually consist of sterile overalls, hats, facemasks and shoe covers. Sterile rubber
gloves also may be required.
o Uniforms are worn to control emission of particulate matter, which is continually shedding
from body surfaces.
o Aware of the hazards, which can be caused by using products of poor standards.
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o Behaviour like smoking, eating, drinking, chewing, attending phone calls, in- and out-
movements and any other activity that influence the product quality while in production
processes are restricted
STEP 4: Raw Materials Requirements for Sterile Production (15 minutes)
o Should be of suitable quality and obtained from a licensed or reliable source.
o „In house‟ check of quality may be made on starting materials.
o Materials should be fully identifiable and carry a clear batch identification and expiry date.
o Appropriate storage conditions should be maintained and out-of-date stock safely disposed
o Should be pyrogens free
STEP 5: Documentation Requirements for Sterile Production (15 minutes)
following details:
o The name of the product.
o A written master formula & the working formula of the batch being prepared.
o The method of preparation
o The names, quantities and identification of each starting material
(Supplier, batch number and date received)
o The date of manufacture.
o The appropriate container and closure.
o The required storage conditions.
o A copy of the label.
STEP 6: Equipment Requirements for Sterile Production.(15 minutes)
Activity: Buzzing (5 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
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o Should be of appropriate design,
o Suitable, well maintained and adequate for the work to be undertaken.
o All equipment must be maintained in accurate working order
o Checked for cleanliness prior to each use.
o Should be simple to use.
o Should be durable
o Spare parts should be available
o Service free
o Cheap
o Should be stainless
STEP 7: Key Points (5 minutes)
taken during its preparation; each step in the production process is a possible source of
contamination to the manufactured product.
obtained from a licensed or reliable source, „In house‟ check of quality may be made on starting
materials.
details like the name of the product, a written master formula & The working formula of the batch
being prepared and the method of preparation the names, quantities and identification of each
starting material (supplier, batch number and date received)
STEP 8: Evaluation (5 minutes)
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References
Nally, J.D., ed. (2007). Good Manufacturing Practices for Pharmaceuticals (6th ed.). CRC Press.
p. 424. ISBN 9781420020939. New York
FDA Guidelines (2004) "Guidance for Industry Sterile Drug Products by Aseptic Processing,
Current Good Manufacturing Practices,"
A. J. Winfield, J. A. R., I. Smith. (2009). Pharmaceutical Practice (4th ed.). British
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:
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