The objective of this (Standard Operating Procedure) SOP For Preventive Maintenance of combi Ampoule/vial is to describe the steps for performing preventive maintenance on the Combi Ampoule/Vial Filling and Sealing Machine to ensure its optimal performance, reliability, and longevity.
SOP For Preventive Maintenance of combi Ampoule/vial Filling and Sealing Machine:
OBJECTIVE:
This SOP is describing the Preventive Maintenance procedure of combi Ampoule/vial Filling and Sealing Machine.
SCOPE:
This SOP is applicable for Preventive Maintenance of combi Ampoule/vial Filling and Sealing Machine.
RESPONSIBILITY:
Technician/ Operator shall be responsible for proper execution of preventive maintenance as per SOP.
Engineering – Head shall be responsible for reviewing the SOP and for ensuring proper execution of preventive maintenance.
ACCOUNTABILITY:
Engineering – Head shall be accountable for proper implementation of the SOP.
DEFINITIONS:
Preventive Maintenance: The preventive maintenance describes all scheduled work done on a routine, predefined basis to maintain facilities, equipment, utilities and devices in good status in order to ensure reliable performance.
PROCEDURE:
Preventive maintenance shall be executed as per the SOP No.: SOP/EN/XXXYYY– Execution of Preventive Maintenance.
Ensure that the spare parts are available at the time of preventive maintenance.
Preventive Maintenance – Mechanical
Checking of fasteners
Check that all the fasteners / mounting bolts of filling, and sealing machine are properly tightened. There should not be any loose bolts.
If found loose, tighten the bolts and nuts by using suitable spanners.
Checking shall be done monthly.
Checking of pneumatic tubes and fittings
Physically check the pneumatic tubes and connectors for any damaged/leakage. There should not be any damage/leakage in the tubes and connectors.
If any damage/leak is observed, replace the tube/connector.
Checking shall be done monthly.
Checking of waste gas ducting / exhaust gas piping
Check the tightness of end connections if required tightens the same.
Check and clean the duct for any kind of obstruction or plugging.
Checking shall be done yearly.
Checking of the gas piping
Check and clean the gas line filters for compressed air and nitrogen.
Check the end connection of oxygen and LPG gas.
Check the hose connection of gas piping for any leakages; if required replaces the same.
Check the performance of pressure regulator.
Check for the gas backflow preventer installed between gas connection point and the burner.
Clean the torch flames; dirty mixing nozzles and pressure nozzles leads to irregular torch flames and make it difficult to adjust.
Check the torch nozzles orifice for wear.
Check the position of pointing tongs ensures that it must not be within the range of torch limits.
The checking shall be done monthly.
Checking of Valve pumps for filling
Check the valve filling pumps for any damaged. If found damaged /worn out, replace the same.
Checking shall be done six monthly.
Checking of belts
Check the timing belts of the filling machine and all the conveyor belts of the filling,
Physically check the wear and tear of conveyor belts, if required rectify or replace the conveyor belts.
Stoppering and capping line. If found damaged / worn out, replace the same.
Checking shall be done monthly.
Checking and lubrication of bearings, chains, gears and sprockets.
Check sprockets, gears, chain and cams for any damage. If found damaged, replace the same.
Lubricate bearings, cams, gears, chain and sprocket with the help of grease gun.
Checking shall be done monthly.
Recommended Oil and grease for the lubrication as follows.
Sr.No.
Lubricants
Type
Grade
Interval
Application
1
Grease
Mineral Oil
NLGI 0,1,2
1000 Hours
Bearing, Bushing, slides rollers, and cam followers
2
Oil
Mineral Oil
SAE 80W – 90, SAE 85W-140
300 Hrs
Gears, bearings and chains
Checking of Valves
Check the valves for smoothly movements, if the operating handle of valve is found jammed or stuck, then open the valve and carry out the maintenance as follows.
Switch off the supply system.
Close the nearby upside and down side valves.
Open the end connections and dismantle the valve.
If gasket found damaged (cut, leached, deform, shape and size change) change the same.
After physically checking of valve, refit in to the system and check for leakage and valve operation if found satisfactorily then it is okay otherwise replace the valve.
Check frequency shall be quarterly.
Checking of Cutting assembly
Check the clippers physically.
Check the condition of clipper springs.
Checking shall be done monthly.
Checking of Cams
Check the cams for radial play.
Check the cam bushes and connecting shafts.
Checking shall be done monthly.
Checking of clutches
Check the proper functioning of clutches.
Check the electrical wiring and connections of clutches.
Checking of clutches shall be done monthly.
Cleaning of Utility inline Filters cartridge
Check the reading of differential pressure gauges; if it filters get choked and not giving uniform flow; then the cleaning of cartridge filter is necessary.
To clean the cartridge filter follows the following procedure.
Close the inlet and outlet valves of filter.
Open the drain plug, and drain out the hold water form filter housing; through close drain piping.
Loose the body flange of cartridge filter housing.
Remove the cartridge filter; check the condition of filter; if it is found damaged; then replace the same or sterilized the cartridge filter and check for the integrity testing as per “Procedure for Cleaning and Operation of Filter Integrity Test Instrument” SOP No.: SOP/PR/XXXYYY
Frequency of checking and replacement of filter cartridge shall be as needed.
Checking of Filter housing
Physical verify the filter housing for any damaged, shape change, dents; surface roughness and end connections. If found, then rectify or replace the same.
Check frequency shall be half yearly.
Checking of printer
Check the printer for paper alignment and printer cartridge ribbon.
Check frequency shall be half yearly.
Preventive Maintenance – Electrical
Checking of terminals and wiring
Ensure that the main electrical supply to the machine is switched OFF.
Visually check all the power and control wiring and terminals in the electrical panel and for control elements mounted on the machine for any loose connection and damage.
Check and ensure by using the screwdriver that all the wires are properly tightened at the distribution terminals inside the electrical panel and on the terminals of all the control elements.
Checking shall be done six monthly.
Checking motor
Check the insulation resistance of motor winding with the help of megger.
Check the phase continuity and winding continuity of motor with the help of tong tester.
Physically check the motor terminal box and terminal connections.
Check the voltage drawn by motor with the help of multimeter
Check the current drawn by motor with the help of tong tester.
Physically check the direction of rotation; it should be as per recommended direction.
Checking shall be done after every six month.
Checking of PLC
Check the PLC for blinking of LED.
Check the display.
Check the wiring contacts, if required tight the same.
Checking of PLC shall be done after every six month
Checking of contactors
Switch OFF the Electrical supply to the Machine.
Remove all the power and control wires from the contactor terminals
Remove the dust from the control panel with help of air blower.
Remove the contactor from the panel and visually check all the contacts for the signs of pitting and deposit of carbon on the contacts.
Clean the contacts, terminals and all the moving parts of the contactor by spraying contactor cleaner, replace the contacts if found damaged / welded.
Put back the contactor in the panel and re-terminate all the power and control wires properly to their original locations.
Check the earthing of the panel body.
A good earthing shall show less than 2 Volts between the Neutral Wire of the Incoming Power supply and Panel Body.
Checking of contactors shall be done six monthly.
Check the stock of recommended spare part list as follows;
List of recommended Spare part list; checking frequency shall be after every six month.
SOP For Preventive Maintenance of combi Ampoule/vialspares:
Sr. No.
Description
Part No.
Quantity (Nos.)
1
TOP PLATE
2
CONVEYOR DRIVE
3
SPROCKET
4
BUSH.
5
SHAFT
6
SPRING ANCHOR
7
BALL BEARING
8
WASHER
9
SPRING
10
WORM DRIVE SHAFT
11
BEARING HOUSING (MAIN )
12
WASHER
13
INDEX CAM
14
LEVER
15
LEVER STUD
16
LINEAR BEARING.
17
COLLAR
18
LOCK NUT
19
FILLING NEEDLES
20
WASHER
21
WASHER
22
CLAMP
23
LEVER STUD
24
WASHER
25
BUSH HOUSING
26
DRIVE SLEEVE
27
WASHER
28
SHAFT
29
SIDE CLAMP
30
BUSH.
36
STUD
31
CLIPPER HEAD
32
SPRING ANCHOR
33
CLIPPER SPRING
34
CLUTCH WIRE (BIG)
35
CLUTCH WIRE (SMALL)
36
NYLON BOLT
37
LOCK NUT
38
BUSH
39
STUD FEMALE
40
STUD MALE
41
TIE BAR
42
LOCK NUT
43
HANDLE
44
WASHER
45
LEVER BOLT
46
WASHER
47
GATE SPRING
48
SPROCKET
49
WASHER
50
LINK PIN
51
ROLLER CAP
52
GUIED BUSH
SOP For Preventive Maintenance of combi Ampoule/vial:
Checking for safety alarms
Check the system for following alarms; frequency shall be after every six month
Sr. No.
Alarms and Conditions
Alarm Message
Control Action
1.
LOW BUNG ON TRACK The machine stops because of low bung on the feed chute track
audio alarm is activated .OIT (operator interface terminal) Display the following alarm message. (LOW BUNG ON TRACK)
The machine stops. Reset the fault by pressing the RESET button after ensuring required Amount of bung on track.
2
TORQUE OVERLIMIT The infeed turret stops when the sensor is not in correct position
Audio alarm is activated .OIT (operator interface terminal) Display the following alarm message .
The machine stops. Place sensor in position. Reset the fault by pressing the reset button
3
EMERGENCY STOP Emergency push button is pressed.
Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (EMERGENCY STOP)
The machine stops. Release the emergency push button. Reset the fault by pressing the RESET button.
4
MOTOR OVERLOAD The main motor stops so the conveyor As well as the turntable motor and powder dosing motor stops.
Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message. (MOTOR OVERLOAD )
The machine stops. Reset the fault by pressing the RESET button after the motor load is set.
5
LOWCAP ON TRACK The machine stops .because of low cap on the feed chute track
Audio alarm is activated. OIT (operator Interface Terminal) displays the following alarm message.
The machine stops. Reset the fault by pressing the RESET button after ensuring required amount of cap on track.
6
LAF OFF LAF system stops working.
Audio alarm is activated. OIT (operator interface Terminal) displays the following alarm message (LAF OFF
The machine stops. Reset the fault by pressing the RESET button.
7
VIBRATOR OVERLOAD The vibrator stops working due to tripping of overload relay.
Audio alarm is activated. OIT (operator interface Terminal) should be energized and display the following alarm message. (VIBRATOR OVERLOAD)
The machine stops. Reset the fault by pressing the RESET button. after the load is set
Record the Preventive Maintenance details as per the Format No.: SOP/EN/XXXYYY “Preventive Maintenance Checklist & Record for Combi Ampoule/vial filling and Sealing Machine”.
Whenever any modifications and major works are carried out to the equipment, the same shall be mentioned in the equipment history card as per the respective SOP.
Connect the equipment main power supply and start the equipment.
Ensure that the equipment is running smoothly, without any abnormality.
If any abnormality is observed in the above, same will be attended in co-ordination with User department Head.
ABBREVIATIONS:
CRF No. : Change Request Form number
QA : Quality Assurance
MMI : Man Machine Interface
PLC : Programmable Logical Controller
LED : Light Emitting Diode
LAF : Laminar Air Flow
REFERENCES:
Operational & Maintenance Manual of combi Ampoule/vial filling and sealing machine
DISTRIBUTION LIST:
SOP shall be distributed to following departments Quality Assurance, Engineering as per user request.
ANNEXURES:
Preventive maintenance checklist and record for : SOP/EN/XXXYYY
Combi Ampoule/vial filling and Sealing Machine
PREVENTIVE MAINTENANCE CHECKLIST & RECORD FOR COMBI AMPOULE/VIAL FILLING AND SEALING MACHINE
Equipment Name
Location
Equipment ID
Frequency
Things to be done:
Check List
Remarks
Monthly Check List
Checking of the gas piping for leakages.
Check the performance of pressure regulator.
Check the orifice nozzle for wear.
Check the position of pointing tongs ensures that it must not be within the range of torch flame.
Checking of fasteners,
Checking of pneumatic tubing and fittings.
Checking of conveyor belts.
Checking of vacuum cups.
Checking of lubrication of bearings, chains gears and sprockets.
Checking of CAMs
Checking of Clutches
Checking of cutting assembly
Quarterly Check List
Check the valves.
Half Yearly Check List
Checking of printer.
Checking of filter housing.
Checking of terminals and wiring.
Checking of motor.
Check the stock of recommended spare parts.
Checking of safety alarms.
Yearly check List
Checking of waste gas ducting for leakage and any obstruction or plugging.
