sop for Cleaning and operation of spray gun and assemble
1.0 OBJECTIVE
1.1 To describe the procedure for the cleaning and operation of spray gun and assemble.
2.0 SCOPE
2.1 This procedure is applicable to the spray gun present in the production department.
3.0 RESPONSIBILITY
3.1 Operator – To perform the procedure.
3.2 Executive production- To ensure that the operation is being performed in compliance with the
SOP and BMR.
3.3 IPQA person – To ensure line clearance, in-process checks, and to counter check that the
Compliance is in line with SOP and BMR.
4.0 ACCOUNTABILITY
4.1 Department Head
5.0 PROCEDURE
5.1 Cleaning: Follow Cleaning Type A & Type B procedure as per respective sop no
5.1.1 Ensure all material is removed from the spray gun.
5.1.2 Remove the equipment status label as per sop and affix ‘To be cleaned’ status label as per sop over the equipment.
5.1.3 Check and ensure the cleanliness and availability of accessories used for cleaning Nylon brush, Nylon scrubber, Lint free cloth, Gloves, Clean polythene bag.
5.1.4 Remove the powder adhered to the inner and outer surface of the equipment using nylon brush and S.S dust hand.
5.1.5 Dismantle the moveable parts (gun & parts) and transfer to washing area.
5.1.6 Remove the adhered powder from dismantled parts using S.S dust hand, and collect the waste material in poly bag and destroy.
5.1.7 Clean the dismantled parts and S.S container using potable water and moping of 0.5% SLS solution.
5.1.8 Scrub the dismantle parts and S.S container using nylon brush and wash using of potable water.
5.1.9 Wash with potable water to remove the traces of SLS solution.
5.1.10 Clean the inner parts of the guns and Remove the spray guns nozzles and clean using IPA.
5.1.11 Finally rinse the dismantled parts using 20 liters of purified water.
5.1.12 Inform to IPQA, to collect rinsed/swab water sample for analysis.
5.1.13 Allow them to dry.
5.1.14 Transfer all the cleaned dismantled parts to cleaned equipment area.
5.1.15 Remove the TO BE CLEANED status label, verification of cleanliness of equipment, affix CLEANED status label as per on the equipment.
5.1.16 Record the cleaning details in the equipment log as per SOP no
5.5 Operation
5.5.1 Replace “CLEANED” label with “equipment status label” as per sop no
5.5.2 First of all, assemble all the parts.
5.5.3 Take color dedicated pipe assemble.
5.5.4 Secondly fit the air pipe. Set air pressure as per product requirement
5.5.5 Fit the Gun in S.S Stand. Set the distance of Spray gun as per product requirement.
5.5.6 Fill the solution in spray Gun tube attach with the peristaltic pump and set the rate of flow according to BPR.
5.5.7 Check the air pressure. Check the Spray rate as per Master Formula Record adjusts the control spreader as per product requirement.
5.5.8 All activity to be recorded as per sop no
5.6 Shutdown
5.6.1 Switch OFF the machine.
5.6.2 Switch OFF the main.
6.0 TRAINING
6.1 Trainer:- Department 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 ENCLOSURE
8.1 NIL
9.0 ABBREVIATIONS
9.1 SOP : Standard operating Procedure
9.2 IPQA : In-process Quality assurances
9.3 BMR : Batch Manufacturing record
9.4 kg/cm : kilogram/centimeter
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