STERILIZATION.pptx

8/10/2019 STERILIZATION.pptx

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STERILIZATION

Definition:Killing or removing all forms of microbial life

(including endospores) in a material or an

object.


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TerminologiesDisinfection: Killing of most microorganisms on a

substance (Inanimate Objects)

Antisepsis: Reduction or Inhibition of microbes found onLIVING TISSUE

Bacteriostatic Agent: Agent that inhibits the growth of

bacteria, but does not necessarily kill them.Suffix stasis: To stop or steady.

Germicide: Agent that kills certain microorganisms.

Bactericide: Agent that kills bacteria. Most do not kill

endospores.Viricide: Agent that inactivates viruses.

Fungicide: Agent that kills fungi.

Sporicide: Agent that kills bacterial endospores or fungalspores.


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Microbial Control Methods

Five sterilization processes are described in the U.S.P:1. By Steam

2. By Dry heat

3. By Filtration4. By Gas

5. By Ionizing Radiation

All are commonly used for parenteral products,

except gas and ionizing radiation, which are

widely used for devices and surgical materials.


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---sterilization--

For sterilization purposes, microorganisms

can be categorized into three general

categories:

a) Easy to kill with either dry or moist heat

b) Susceptible to moist heat, but resistant to dry

heat (e.g. Bacillus subtilis)

c) Resistant to moist heat, but susceptible to

dry heat (e.g. Clostridium sporogenes)


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EVALUATION OF PARENTERAL

PREPARATIONS

The finished parenteral products are subjectedto the following tests, in order to maintain

quality control:

A) Sterility test

B) Clarity test

C) Leakage test

D) Pyrogen test

E) Assay


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A) Sterility test

It is done by detecting the presence of viableforms of bacteria, fungi and yeast in

parenteral products. The test for Sterility

must be carried out under strict aseptic

conditions in order to avoid accidental

contamination of the product during test.

All glass-wares required for the test must be

Sterile.


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---Sterility test---

The test for Sterility may be carried out either by:

a) membrane filtration method

b) Direct inoculation method

Sterility testing attempts to reveal the presenceor absence of viable micro-organisms in a

sample number of containers taken from batch

of product. Based on results obtained from

testing the sample a decision is made as to the

sterility of the batch.


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Major factors of importance in sterility

testing:

o The environment in which the test is conducted

o The quality of the culture conditions provided

o

The test methodo The sample size

o The sampling procedure


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Environmental conditions:

a. Environmental conditions avoid accidental

contamination of the product during the test.

b. The test is carried out under aseptic conditions

regular microbiological monitoring should be

carried out.

Culture conditions: Appropriate conditions for

the growth of any surviving organismshould be provided by the culture media

selection.


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Factors affecting growth of bacteria:

Nutrition

Moisture

Air

Temperature

pH

Light

Osmotic pressure

Growth inhibitors


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Culture media for sterility testing:

Culture media for sterility testing capable ofinitiating and maintaining the vigorous growth

of a small number of organisms

Sterile Types of media:1. Fluid thioglycollate medium,

2. Soya-bean casein digest medium


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1. Fluid thioglycollate medium:

specific role of some ingredients primarily

intended for the culture of anaerobic

bacteria.

incubation of the media: 14 days at 30 -35C


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2. Soya-bean casein digest medium :

Soya-bean casein digest medium primarily

intended for the culture of both fungi and

aerobic bacteria specific role of some

ingredients.

Incubation of the media: 14 days at 20 -25C


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Membrane filtration method

In this method, the test sample of parenteral

preparation are transferred (aseptically) into

sterile nutrient media, suitable pH and

incubated for suitable period of time at

optimum temperature.

Evaluated in the presence of turbidity.


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Membrane filtration Appropriate for:

(advantage)

filterable aqueous preparations

alcoholic preparations

oily preparations

Preparations miscible with or soluble in

aqueous or oily (solvents with no antimicrobial

effect) solutions to be examined must be

introduced and filtered under aseptic conditions. All steps of this procedure are performed

aseptically in a Class 100 Laminar Flow Hood


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Selection of filters for membrane

filtration:

pore size of 0.45 mm effectiveness

established in the retention of micro-

organisms

appropriate composition the size of filter

discs is about 50 mm in diameter


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The procedure of membrane filtration:

Sterilization of filtration system andmembrane filtration of examined solutionunder aseptic conditions (suitable volume,dissolution of solid particles with suitable

solvents, dilution if necessary). The membrane is removed, aseptically

transferred to container of appropriateculture medium passing the culture mediathrough closed system to the membrane,incubation in situ in the filtration apparatus(sartorius, millipore).


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Direct inoculation of the culture

medium:

suitable quantity of the preparation to be

examined is transferred directly into the

appropriate culture medium volume of the

product is not more than 10% of the volume

of the medium suitable method for aqueous

solutions, oily liquids, ointments an creams


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CLARITY TEST

It is performed to ensure that the parenterals are

free from visible foreign particles. Each parenteralpreparation in its final container is subjected

individually to a visual inspection to exclude the

possibility of foreign particles. The un -labeled containers are held by the neck

against strongly illuminated black (for dark

particles) & white screen (for light color particles).

The contents of the container are slowly inverted &

rotated, then examined.


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--Clarity Test--

It may be dangerous when the particle size

is larger than R.B.C. & may block the blood

vessel. This type of products is immediatelyrejected from the batch.

The limit test for particulate matter is

prescribed in I.P. 1996 (A- 125)


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---Clarity test---

Applicable for: 100 ml or more volume

containers of single dose LV given by IV

infusion.

Not applicable for: Multi-dose injections

Single dose SVP injectable solutions

constituted from sterile solids.

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