procedure for the sanitization of equipments located in Microbiology Laboratory.

1.0            OBJECTIVE:

1.1                   To lay down a procedure for the sanitization of equipments located in Microbiology Laboratory.

2.0            SCOPE:

2.1                   This procedure is applicable to all the equipments located in Microbiology Laboratory of    Pharma Private Limite

3.0            RESPONSIBILITY:

3.1                 Lab Assistant: Responsible for sanitization of the equipment.

3.2                 Microbiologist: Responsible for review the sanitization.

3.3                 QC Head: Responsible for implementing the Procedure.

3.4                 QA Head: Overall compliance.

4.0            PROCEDURE:

4.1                 Sanitization of Incubators (QC, QC & QC)

4.1.1             Disconnect the electric connections of incubator.

4.1.2             Remove all the agar media plates, broth flasks and culture tubes.

4.1.3             Wipe all the areas with a lint free cloth soaked in any of 5 % Dettol, 5 % Savlon, 1% Bacillocid special or 1% Hospal –OT solution and then with a dry lint free cloth to remove the wetness.

4.1.4             Allow the racks to dry and replace the media plates, broth flasks and culture tubes into incubator.

4.2                 Sanitization of Refrigerator (QC)

4.2.1             Disconnect the electric connections of refrigerator.

4.2.2             Remove all the cultures, media and solutions or reagents if any.

4.2.3             Wipe all the areas with a lint free cloth soaked in any of 5% Dettol, 5% Savlon, 1% Bacillocid special or 1% Hospal –OT solution and then with a dry lint free cloth to remove the wetness.

4.2.4             Allow the interiors to dry before running and replace the contents.

4.3                 Sanitization of Hot Air Oven (QC)

4.3.1             Disconnect the electric connections of hot air oven.

4.3.2             Transfer all the glassware to a cleaned tray.

4.3.3             Wipe all the areas with a lint free cloth soaked in any of 5% Dettol, 5% Savlon, 1% Bacillocid or 1 % Hospal -OT special solution and then with a dry lint free cloth to remove the wetness.

4.3.4             Allow the racks to dry and replace the glassware into oven.

4.4                 Sanitization of Pass boxes (QC, QC, and QC)

4.4.1             Disconnect the electric connections of Pass boxes.

4.4.2             Sanitize the pass boxes with a lint free cloth soaked in any of 5% Dettol, 5%           Savlon, 1% Bacillocid special or 1% Hospal -OT solution and then with a dry lint free cloth to remove the wetness.

4.5                 Sanitization of Laminar Air Flow chambers (QC and Q)

4.5.1             Disconnect the electric connections of LAF.

4.5.2             Wipe the upper, lower and middle surfaces of the Laminar Air Flow chamber with a lint free cloth soaked in any of 5% Dettol, 5% Savlon, 1% Bacillocid special or 1% Hospal–OT solution and then with a dry lint free cloth to remove the wetness.

4.6                 Sanitization of Colony Counter (QC)

4.6.1             Disconnect the electric connections of colony counter.

4.6.2             Wipe the colony counter with a lint free cloth soaked in any of 5% Dettol, 5% Savlon, 1% Bacillocid special or 1% Hospal –OT solution and then with a dry lint free cloth to remove the wetness.

4.6.3             Allow the instrument to dry.

4.7                 Frequency: Monthly once.

4.8                 Sanitization details of all equipments shall be entered in Annexure – I.

4.9                 Preparation details of solutions used for sanitization:

4.9.1             5 % Dettol solution:

4.9.1.1       Mix Dettol and water in the ratio of 5: 95.

4.9.2             5 % Savlon solution:

4.9.2.1       Mix Savlon and water in the ratio of 5: 95.

4.9.3             1% Bacillocid special or 1% Hospal -OT:

4.9.3.1       Mix Bacillocid special or Hospal ­– OT and water in the ratio of 1:99.

4.9.4             Record the preparation details of disinfectant solutions in Annexure-II of current                 version of SOP No.: QC/MB/xxx (Cleaning Procedure for Microbiology Laboratory).

5.0            ABBREVIATIONS:

QA: Quality Assurance	QC: Quality Control
SOP: Standard Operating Procedure	%: Percentage
v/v: Volume/Volume	WHO: World Health Organization

7.0            REFERENCES:

WHO good practices for pharmaceutical microbiology laboratories WHO Technical     Report Series, No. 961.