Cleaning of Tablet Compression Machine

 

1.0           Purpose

1.1            To define a standard cleaning procedure of Tablet Compression Machine.

 

2.0           Scope

2.1         This Sop is applicable for cleaning of Tablet Compression Machine 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 log book.

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

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

 

4.0           Abbreviations and Definitions

4.1            Not Appreciable

 

5.0           Materials and Equipment

5.1            Clean lint free cloth

5.2            Tap water / portable water

5.3            Purified water

5.4            Plastic Brush

5.5            Liquid Paraffin

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.

5.8            Punch Holder

5.9            Die / Punch Tray Box

 

6.0           Precaution / Health and Safety Considerations

6.1            Use mask during sweeping of chemicals / Powder.

6.2            Handle Die, punches and other removable parts carefully in order to avoid damage.

7.0           Procedure

7.1           Dismantling

7.1.1       Dismantle hopper, auto feeder cable, feed frame assembly, filter and machine cover.

7.1.2       Remove residual powder from the turret and machine body by vacuum suction device.

7.1.3       Remove upper punch guide then lift out all the upper punches.

7.1.4       Remove cam and then remove lower punch by loosening the anti-turning screw.

7.1.5       Unlock the die locking screws by die driving rod and remove dies.

 

7.2           Removable Parts cleaning

7.2.1        Remove adhered dust and sticky materials from hopper, feed frame assembly, die locking screws, anti-turning screws, S.S scoop, auto loading pipe, canvas filter, dust cup and machine cover by a clean and dry cotton cloth.

7.2.2        Wash the hopper. feed frame assembly, die locking screws , anti-turning screws , S.S scoop, auto loading pipe, canvas filter, dust cup and machine cover with portable water thoroughly by hose pipe.

7.2.3        Rub the hopper. feed frame assembly, die locking screws , anti-turning screws , S.S scoop, auto loading pipe, canvas filter, dust cup and machine cover with lint free duster soaked in 0.4%  Sodium Lauryl Sulphate solution (4 gm/liter).

7.2.4        Wash the hopper. feed frame assembly, die locking screws , anti-turning screws , S.S scoop, auto loading pipe, canvas filter, dust cup and machine cover with portable water until no residue of previous product remain. Finally rinse with purified water.

7.2.5        Wipe the surface of the hopper. feed frame assembly, die locking screws , anti-turning screws , S.S scoop, auto loading pipe, canvas filter, dust cup and machine cover with dry clean lint free duster to remove the water.

7.2.6         Wipe the die locking screw, anti-turning screws, and dust cup by lint free duster. Wipe the above parts again with cotton cloth dampened with 70% IPA (Isopropyl Alcohol) .

7.2.7        Cleaned storage of die and punches. 

   

7.3           Machine Cleaning

7.3.1      Remove adhered dust by vacuum suction device on turret, safety glass and SS cabinet followed by wiping with dry cotton cloth.

7.3.2      Clean the die punch hole and different junction of machine with plastic brush soaked in 0.4% SLS solution. (  4 gm SLS in 1 liter purified water)

7.3.3      Clean the die punch hole and different junction of machine with cotton cloth soaked in purified water so that no residue of previous product remains.

7.3.4      Finally clean the die punch hole of different machine junctions and body of machine (safety glass and outer surface of cabinet) with cotton cloth dampened with 70 % IPA.

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

7.3.6      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.

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

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

 

7.4           Cleaning & Storage of Die and Punch

7.4.1      Clean the dies and punch as per respective SOP and store the die and punches on Punch Cabinet.   

  

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

  

11.0        Training

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