VALIDATION OF STERILIZATION OF STERILE AREA UNIFORM

1. PURPOSE

1.1 To establish the system for Validation of Sterilization of uniform.

2. SCOPE

2.1 It is applicable for Injectables Department.

3. RESPONSIBILITY

3.1 Quality Control Manager

3.2 Microbiologist

3.3 Production Officer (concerned)

4. PROCEDURE

1. VALIDATION BY AUTOCLAVE TAPE

Autoclave tape is affixed to the uniform wrapped in butter paper and Effectiveness of its sterilization is determined by the change in color of the tape.

2. VALIDATION BY BIOLOGICAL INDICATOR:

Prepare the media as directed on the label.

1. Fluid Thioglycollate Medium ( For Bacteria )

2. Tryptic Soy Broth ( For Fungi )

Sterilize in an autoclave and incubate at required temperatures for at least 24 hours.

Inoculate the Fluid Thioglycollate Medium with Staphylococcus aureus and Tryptic Soy Broth, with Candida Albicans.

Keep one portion of each of the un-inoculated media un-opened ( Medium Control.)

Keep one portion of each of the inoculated media un-opened. ( Culture Control.)

Place the Rest of the Inoculated tubes along with the uniforms in the Autoclave chamber.

After completion of the process incubate the media at their respective temperature.

Fluid Thioglycollate Medium ( For Bacteria ) at 30 – 35º C

Tryptic Soy Broth ( For Fungi ) at 20 – 25º C

Incubate the samples and controls for 14 days and observe.

INTERPRETATION OF RESULTS:

Media Control: Must NOT show any growth to ensure the sterilization of media.

Culture Control: Must show the growth to ensure the growth promoting activity of the media.

Test Samples: NO GROWTH VALIDATES THE PROCESS OF UNIFORM STERILIZATION.

5. Frequency / Year

Validation of uniform Sterilization should be conducted Once in a Year.