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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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