Cleaning and Operation Procedure of Octagonal Blender.

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Cleaning and Operation Procedure of Octagonal Blender.

1.0         Purpose

 1.1       To define a standard cleaning and operation procedure of Octagonal Blender.


2.0         Scope

2.1   This procedure is applicable for Octagonal Blender of Tablet Manufacturing area at “NAME” Pharmaceuticals Ltd.

 

3.0      Responsibility

3.1.       Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains logbook.

3.2.       Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.

3.3        Production and Quality Assurance Officer shall ensure that the procedure is implemented properly.


 

4.0      Abbreviations and Definitions

4.1        BMR     : Batch Manufacturing Record

 

5.0       Materials and Equipment

 

5.1        Polybag

5.2        Tap water

5.3        Purified water

5.4        Hand brush / Nylon brush

5.5        Clean lint free cloth

5.6        Detergent Solution / Cleaning agent: 0.4% (w/v) Sodium Lauryl Sulphate solution; 4 gm  Sodium lauryl Sulphate is dissolved in 1.0 liter of portable / tap water to prepare detergent   solution.

5.7        70 % Isopropyl Alcohol.

 

 

6.0      Precaution / Health and Safety Considerations

6.1        Check the electric connection before operation.

6.2        Cover the control panel, air control box and adjacent machine switch board with the poly bag.

6.3        Ensure  the butterfly valve are close in position during operation.

 

7.0       Procedure 

7.1            Cleaning

 

7.1.1        After completion the operation, Switch OFF the machine and main switch.

7.1.2        Open the lid cover and remove the dust/ powder of the previous product from the inner and outer surface of the octagonal blender.

7.1.3        Pour potable water into the blender (1/3 of its volume) and closed the lid cover.

7.1.4        Turn on power switch and run the blender for 5 minutes.

7.1.5        Place a tub just below the butterfly valve to collect washing water.

7.1.6        Open the butterfly valve to collect water into the tub.

7.1.7        Rub the inner part, inner and outer surface of octagonal blender with Sodium Lauryl Sulphate 0.4% solution (if require).

7.1.8        Wash the Octagonal blender and lid cover with Sodium Lauryl Sulphate 0.4% solution then wash with portable / tap water to remove cleaning agent.

7.1.9        Finally rinse with purified water.

7.1.10      Wipe the surface of the octagonal blender with dry clean lint free cloth to remove the water.

7.1.11      Dry the octagonal blender compressed air to remove water deposited on the different junction.

7.1.12      Wipe the octagonal blender of the container and sieve with lint free cloth soaked in 70% IPA (Isopropyl Alcohol) thus surface water evaporates quickly.

7.1.13      Machine operator / worker will request Production Officer and QA Officer for checking visual inspection. 

7.1.14      At first Production Officer will check the machine and its surroundings, then QA Officer will check the machine and its surroundings. If it found satisfactory result, then he / she will issue “Cleaned” label.

7.1.15      Record in Machine Logbook (Annexure-I) and affix the label of “Cleaned” in the machine.

7.1.16      After cleaning the machine if it remains without operation for next 72 hour, will undergo Re-cleaning operation.

 

7.2            Operation

 

7.2.1        Production person shall ensure the cleanliness of the machine.

7.2.2        Before starting the operation production person get the line clearance from QA person and affix the status label with Product Name, batch details to equipment.

7.2.3        Check the butterfly valve are close in position

7.2.4        Place the material into octagonal blender and close the lid cover.

7.2.5        Close the safety guard.

7.2.6        At first “ON” the main switch board.

7.2.7        Fix parameter according to BMR.

7.2.8        Press start button.

7.2.9        After complete of operation press stop button and discharge material.

7.2.10      Affix “To be Cleaned” label & fill the “Machine Logbook”.

 

 

8.0      Reference Document

8.1        In-house

 

9.0       Annexure           

9.1        Annexure- I   : Format of Machine Logbook

  

10.0    Revision History 

Revision No.

Brief reason for the revision

   Effective Date

   Remarks

01

New

 

 

02

 

 

 

                                                                                                                                          

11.0     Training 

11.1      Head of Production or his nominee give the training of operator and worker.

 



 

Cleaning and Operation Procedure of Octagonal Blender.

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