Sterilization Classification
Contents
• Sterile products
• Sterilization processes
Intended
learning objectives
At the end of this lecture, the student will be able to:
• Enumerate the different types of sterile pharmaceutical
• Explain the factors affecting sterilization process
• Classify the different methods of sterilization
Sterile
Pharmaceutical Products
1. Injections
– Intravenous infusions
– Intravenous additives
– Total parenteral nutrition
– Small volume injections
– Small volume oily injections
– Freeze-dried products
2. Non-injectable sterile fluids
– Non-injectable water
– Urological (bladder) irrigation solutions
– Peritoneal dialysis and haemodialysis solutions
– Inhaler solutions
3. Ophthalmic preparations
– Eye-drops
– Eye lotions
– Eye ointments
– Contact lens solutions
• Wetting solutions
• Cleaning solutions
• Soaking solutions
4. Dressings
5. Implants
6. Absorbable haemostats
– Oxidized cellulose
– Absorbable gelatin foam
– Human fibrin foam
– Calcium alginate
7. Surgical ligatures and sutures
– Sterilized surgical catgut
– Non-absorbable types
8. Instruments and equipment
Sterilization
processes
Sterilization processes that involves
The application of a biocidal agent or physical microbial removal process to a
product or preparation with the object of killing or removing all
microorganisms
• These processes may involve:
Elevated
temperature
Reactive gas
Irradiation
Filtration
through a microorganism-proof filter
• The success
of the process
depends upon a
suitable choice of treatment conditions, e.g. temperature and
duration of exposure
Summary
• Sterile pharmaceutical products – Injections, ophthalmics,
dressings, sutures, ligatures, containers and closures for sterile
preparations, Syringes…
• Selection of sterilization technique depends on maximum
acceptable risk of failing to achieve sterility and maximum level of product
damage that is acceptable
• Sterilization methods: Physical, chemical and mechanical
• D-value is ‘the time taken at a fixed temperature or the
radiation dose required reduce a microbial population by 90% or one decimal
• Z-value represents the increase in temperature needed to
reduce the D-value of an organism by 90%
• The F value for a process is the number of minutes
required to kill a known population of microorganisms in a given food under
specified conditions.
