cleaning and operation of sugar syrup manufacturing vessel
1.0 OBJECTIVE
1.1 To describe the cleaning & operation of sugar syrup manufacturing vessel.
2.0 SCOPE
2.1 This procedure is applicable for sugar syrup manufacturing vessel present in the production liquid department.
3.0 RESPONSIBILITY
3.1 Operator – To perform the procedure.
3.2 Officer production- To ensure that the operation is being performed in compliance with the
SOP.
3.3 IPQA person – To ensure in-process checks, and counter check that the
Compliance is in line with SOP.
4.0 ACCOUNTABILITY
4.1 Department Head
5.0 PROCEDURE
5.1 Cleaning: Type A procedure (Batch to Batch Cleaning)
5.1.1 Ensure all the material is removed from the equipment.
5.1.2 Remove the product status label and affix ‘To be cleaned’ status label as per sop over the equipment.
5.1.3 Type A cleaning applicable for batch to batch cleaning of same strength, color, and flavor and continuous seven batches.
5.1.4 Type A cleaning applicable for shift end cleaning and continue five batches.
5.1.5 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.1.6 Apply potable water with pressure on the inner and outer surface of the vessels to remove the adhered material and open the outlet valve with connection to drain through PVC pipe.
5.1.7 Open the lid and fill the vessel with approx. 300 lit of potable water through pipe.
5.1.8 Above potable water circulated through high pressure pump & spray valve for 5 minutes.
5.1.9 Open the outlet valve of the vessel and let the water drain through it.
5.1.10 Repeat the process twice, finally rinse with 40-50 lit of purified water.
5.1.11 Cleaning operation should be supervised by Production officer & necessary records should be maintained.
5.2 Cleaning: Type B procedure
5.2.1 Ensure all the material is removed from the equipment.
5.2.2 Remove the product status label and affix ‘To be cleaned’ status label as per sop over the equipment.
5.2.3 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves.
5.2.4 After continue five batches, Type B cleaning should be performed.
5.2.5 Open the lid & approx. 300 lit of potable water in the vessel through pipe.
5.2.6 Above potable water circulated through high pressure pump & spray valve for 15 minutes.
5.2.7 Open the outlet valve of the vessel and let the water drain through it. Repeat the process twice.
5.2.8 Take 100 liters hot purified water (80 to 85oc) circulated through high pressure pump & spray valve for 10 minutes for sanitization of vessel.
5.2.9 Open the outlet valve of the vessel and let the water drain through it.
5.2.10 Inform IPQA officer to the sample of rinse water to QC for wash water analysis.
5.2.11 After getting the approval of QC, affix “Cleaned Label” as per sop take the fresh batch manufacturing as and when required.
5.2.12 Cleaning operation should be supervised by Production officer & necessary records should be maintained.
5.2.13 Type B Cleaning Valid For 72 Hours.
5.2.14 Type B cleaning should be performing after maintenance of any contact parts.
5.3 OPERATION
5.3.1 Ensure the surrounding areas are cleaned before starting operation.
5.3.2 Switch ON the main.
5.3.3 Open the lid of the vessel and Add required quantity of purified water in to the vessel
5.3.4 Switch ON the electric main and start the stirrer
5.3.5 Open the inlet of the steam valve and open outlet of the steam valve.
5.3.6 Keep the steam valve open till the temperature of the vessel reaches 90°C. Once the temperature attained.
5.3.7 Put the required quantity of sucrose in to the vessel and continue stirring.
5.3.8 Check the steam valve (outlet & inlet) & temperature.
5.3.9 Let the temperature rise according to BMR and maintain this temperature about 5 minutes.
5.3.10 Take 20-liter sugar syrup from bottom of the vessels and transfer it into inlet of the vessels. Perform this process twice.
5.3.11 Take sugar syrup from bottom of the vessel check clarity.
5.3.12 Switch OFF the steam valve & stirring continued
5.3.13 Open the outlet of the jacket & circulate raw water from Cooling tower Line so as to bring temperature down to 40-50°C with the help of cooling tower.
5.3.14 Sugar Syrup is transferred in to manufacturing tank through transfer pump.
6.0 TRAINING
6.1 Trainer: Production Head.
6.2 Trainee: Production, Quality Assurance and Operator person.
6.3 Period: One Hour or as per required.
7.0 DISTRIBUTION
7.1 One set of Master copy and one set of Controlled copy submit the QA department.
8.0 ENCLOSURES
8.1 NIL
9.0 ABBREVIATIONS
9.1 IPQA : In-process Quality assurance
9.2 BMR : Batch manufacturing record.
9.3 SOP : Standard operating Procedure.
9.4 QC : Quality Control
9.5 QA : Quality assurance
10.0 DOCUMENT CHANGE HISTORY
| Revision | Reason for revision | Effective Date
|
| 00 | NEW SOP |
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
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area