Cleaning And Assembly Of Tube Filling Machine

Cleaning And Assembly Of Tube Filling Machine

 

1.0 Objective
To lay down guidelines of procedure for cleaning and assembly procedure for tube filling machine (double head).
2.0 Scope
This Standard Operating Procedure is applicable to cleaning and assembly procedure for tube

filling machine (double head) at abc company
3.0 Responsibility
3.1 Production Executive
3.2 Operator
3.3 Head-Quality Assurance
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
PE : Production External
QA : Quality Assurance
SLS : Sodium Lauryl Sulphate
5.0 Procedure
5.1 Preparation of 2.5% SLS solution.
5.1.1 Take 0.250 kg SLS dissolved in 10 liter of raw water.
5.1.2 Remove the hopper along with the valve housing. Remove the nozzle and the release pin.

Remove the cups holding the empty / filled tubes. Clean the jaws of first fold, second fold and embossing

assemblies with lint free wet cloth / sponge. Clean with 2.50% SLS solution in raw water and then again with raw water.
5.1.3 The hopper, valve housing, nozzle, release pin and cup holders are washed with raw water. Then these

are washed with raw water at least twice than they are then dried with lint free cloth. Over all clean the outside of

the machine with hot water and then rinse twice with raw water.
5.1.4 Dry the exterior surface of the machine with lint free wet cloth. Ensure that no cream / gel / ointment

sticks to the machine parts and the machine parts are not greasy in nature. If so, then again clean them with raw water.
5.1.5 Sanitize all parts / surfaces coming in contact with the product to rinse with raw water and

with the help of 70 % Isopropyl Alcohol.
5.1.6 Reassemble the valve housing, Nozzle and hopper. Place the cups back into belt and fix the outlet

can suitably. Kindly ensure that tube lifting system both at filling stage and ejection stage matches

with the cup holders.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Production Department
8.0 History

Revision Number Details For Change
Reason for Revision
00 New SOP NA

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

Cleaning And Assembly Of Tube Filling Machine

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