🔴DEFINITION:


PURIFIED WATER:

“Water which is prepared by the distillation or deionization of potable water or by the process of reverse osmosis.”

🔴DEFINITION

PARENTRAL:

“The definition of a parenteral is medicine or liquid that is is introduced into the body through a route other than the gastrointestinal (GI) tract.”

🔴DEFINITION

OPHTHALMIC:

“Ophthalmic means relating to or concerned with the medical care of people's eyes.”

🔴DEFINITION

PARATONIC SOLUTION:

“The solutions having different osmotic pressure is called as paratonic solutions.”

Sterility Test Methods

-The USP specifies two basic methods for performing sterility tests:
1. The direct transfer or direct inoculation method.
2. The membrane filtration method.


Direct Transfer Method
-The direct transfer (DT) method is the more traditional sterility test method. Basically, the DT method involves three steps:

1. Aseptically opening each sample container from a recently sterilized batch of product.

2. Using a sterile syringe and needle to withdraw the required volume of sample for both media from the container.

3. Injecting one-half of the required volume sample into a test tube containing the required volume of FTM and the other half volume of sample into a second test tube containing the required volume of TSB.


Membrane Filtration Method:
-The membrane filtration (MF) sterility test became official in the 18th edition of the USP in 1970.
-It has since become the more popular and widely used method over the DT method.
-The successful employment of this technique requires more skill and knowledge than that required for the DT method.
-Five basic steps are involved in the use of the MF sterility test method:

1. The filter unit (Figure 1.5) must be properly assembled and sterilized prior to use.

2. The contents of the prescribed number of units are transferred to the filter assembly under strict aseptic conditions.

3. The contents are filtered with the aid of a vacuum or pressure differential system.

4. The membrane is removed aseptically and cut in half.

5. One-half of the membrane is placed in a suitable volume (usually 100 ml) of FTM and the other membrane half is placed in equal volume of TSB.

-The membrane used usually is a 0.450.22 micrometer porosity filter with a diameter of 47 mm and can accommodate a flow rate of 55 to 75 ml of water per minute at a pressure of 70 cm of mercury.

Sterility Testing of Different Sterile Products
-The USP describes the sterility test procedures to be followed for all types of sterile products excluding human biologics, human antibiotics, and veterinary biologics, to which Federal regulations apply.

-Test procedures for the direct transfer to test media are given for the following six types of products:

1. Liquids.

2. Ointments and oils insoluble in isopropyl myristate.

3. Solids.

4. Purified cotton, gauze, surgical dressings, sutures, and related articles.

5. Sterilized devices.

6. Sterile empty or prefilled syringes.


Test procedures for using the MF technique are specified for the following five types of products:

1. Liquids miscible with aqueous vehicles

2. Liquids immiscible with aqueous
vehicles, less than 100 ml per container

3. Filterable solids

4. Ointments and oils soluble in isopropyl myristate

5. Devices

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🔴 DEFINITION

Aerosol =

It is a disperse system that functions on the power of a compressed or liquefied gas to expel the contents from the container.

🔴 DEFINITION

Propellant =

It is the component of the aerosol system which develop pressure within the container and expel the product.