Sterilization Classification - Pharmaceutical Microbiology Third Semester PDF Notes

 Sterilization Classification


• 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


     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


• 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.

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