Operation and cleaning of Automatic Four Head ROPP Cap Sealing Machine

 

Operation and cleaning of Automatic Four Head ROPP Cap Sealing Machine

 

1.0 OBJECTIVE :
1.1 To lay down a procedure for Operation and cleaning of Automatic Four Head R.O.P.P. Cap Sealing
Machine.

2.0. SCOPE :
2.1 This procedure is applicable to Operation and cleaning of Automatic Four Head R.O. P. P. Cap Sealing Machine in production liquid department at

3.0. RESPONSIBILITY :
3.1 Officer /Executive production or designee.

4.0. ACCOUNTABILITY :
4.1 Production Head .
5.0. PROCEDURE :
5.1 For Operation
5.1.1 Visually check and ensure the cleaning Automatic Four Head R.O.P.P. Cap Sealing Machine as per
respective SOP .
5.1.2 Remove the CLEANING status label and affix the STATUS label on Automatic Four
Head R.O. P.P. Cap Sealing Machine
5.1.3 Switch on the main power supply
5.1.4 Ensure that the line clearance from IPQA is obtained prior to start the product
5.1.5 Set the height of M/C according to the height of bottle
5.1.6 Set the speed of conveyor belt which is suitable for filled bottles.
5.1.7 Ensure that the sealing , threading & bridge quality is to satisfactory by visually & by performing
the Leak test.

5.1.8 If sealing is proper, proceed the activity by talking the approval from production and IPQA person .

5.1.9 Record the process activity in relevant log book .
5.2 For Cleaning :
5.2.1 Switch of the electric supply .
5.2.2 Remove the STATUS label of previous batch from Automatic Four Head R.O. P.P. Cap Sealing Machine.
5.2.3 Clean the Automatic Four Head R .O. P. P. Cap Sealing M/C and conveyor belt with purified water.

5.2.4 then dry it by using compressed air.
5.2.5 Final clean the liquid filling M/ C with 70 % IPA by using lint free cloth .
5.2.6 Visually check the cleaning of Automatic Four Head R .O. P. P. Cap Sealing M/C .
5.2.7 Record the cleaning activity in relevant log book .

6.0. ABBREVIATION :

Sr. No. Abbreviation used Full form of abbreviation used
1- SOP Standard Operating Procedure
2- M/C Machine
3- IPA Iso Propyl Alcohol
4- R.O.P.P. Round opaque pilfer proof
   8- IPQA In Process Quality Assurance

7.0. ATTACHMENTS (ANNEXURES) :
NA

8.0. REFERENCE :

Sr. No. Reference Title
1. IHS

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

procedure for cleaning of Multimill

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