Preventive Maintenance Operation and Management System[SOP]

Leave a Comment / By /

Preventive Maintenance: This SOP [Preventive Maintenance] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP. 1.0 Purpose: The purpose of this SOP is to describe the measures involved in conducting and managing preventive maintenance activities of the machines/equipment of […]


Preventive Maintenance: This SOP [Preventive Maintenance] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.

Preventive Maintenance

1.0 Purpose: The purpose of this SOP is to describe the measures involved in conducting and managing preventive maintenance activities of the machines/equipment of XX Pharmaceuticals Limited.

2.0 Scope: This procedure applies to all machines/equipment of Production, Product Development [PD] and sampling area of every Blocks of XX Pharmaceuticals Ltd.

3.0 Abbreviation/Definitions

SOP: Standard Operating Procedure.

PM: The Preventive maintenance can be defined as to the routine maintenance which prevent the unwanted failure of any machine and keep the machine in working condition. The successful maintenance program prevent any type unwanted failure of running machine. To execute the successful maintenance program a schedule must be prepare and maintain the same.

4.0 Responsibilities:

The roles and responsibilities are described below:

4.1 Equipment Numbering and Database Maintaining

Validation Personnel [Engineering Department]

To maintain the Equipment Numbering System of the Equipment Database based on Excel Tracker.

To make the preventive maintenance proposal in accordance with the production planning.

To arrange the equipment list for Preventive Maintenance help of Maintenance engineer, comprising the maintenance intervals listed in respective section.

4.2 Setting up Preventive Maintenance for New Equipment

Head of Engineering/Designee

To ensure that all critical equipment’s are identified and are entered in the Equipment database.

To approve new Preventive Maintenance Planning and take initiative to if required changes to existing Preventive Maintenance Planning based on-

Equipment consumption.

Trending of maintenance antiquity (existing alike equipment).

Safety and legal necessities.

Discussion with the User, Technician and Engineering Executive

Merchant’s manuals and references

Engineering Executive

Inform the relevant departmental Head about the new routines and to ask appropriate time for Preventive maintenance prior to making PM Plan.

To update a list of spare parts based on the manufacturer’s references and to refer the list to the Planning and Procurement department [PPD] with a request to place order if required.

To support for arranging the PM schedule.

To check and ensure that the logbook is filled up by the technicians.

4.3 Preventive Maintenance Routine and Schedule

Maintenance Technician

To switch off the power and keep out the switch where the performing of maintenance activities does not involve any electrical connection and to retain the equipment entire time in lockout mode.

Before initiating the work, check the accurate equipment label has been attached to the equipment and it imitates to the equipment number based on the PM record datasheet.

To fill up the “PM record datasheet” upon accomplishment of activities.

Engineering Executive

To check and ensure that the “Preventive maintenance record datasheet” is filled up completely and to sign it upon completion of work.

To check that PM work is complete and to inform the area manager that the machine is ready for action.

4.4 Managing & Preserve Equipment Maintenance History File

Head of Engineering/Designee

To ensure that the PM planning table is kept up-to-date. If required, to refresh the schedule on a monthly basis or sooner.

To monitor the activities of the Engineering Executive performing the PM work and to provide technical support and assistance with documentation requirements. Also to ensure that PM work for particular equipment is completed within 30 days of scheduled PM date.

Validation Department [Engineering]

To uphold and preserve the equipment maintenance history files, maintenance instructions and associated documents at Engineering Department.

Head of Engineering/Designee

To confirm that the equipment maintenance history files are secured at Engineering Department.

4.5 Trend Analysis and Follow up Action

Head of Engineering/Designee

To check and review the history files of equipments maintenance annually and to find out the time of occurrence of major failures and to identify the repeated component of failures or other events.

5.0 Revision Details:

Sl. No. / Version No./ Effective Date/ Change History-will be se entitled in separate column.

6. Annexures:

List of Annex has been mentioned at the bottom of this document

7. Procedure:

Note: All maintenance work must be accomplished carefully in accordance with the necessities of the Plant Safety Declaration and the safety notices from place to place in the plant. Definite attention must be paid in the following:

a) Equipment must be electrically inaccessible and locked out where possible.

b) Personal Protective Equipment [PPE] and clothing suitable to the assign job must be worn.

7.1 All serious equipments must be acknowledged and PM processes must be set up with defined interludes and must be incorporate in the PM schedule.

7.2 PM plan is organized prior to performing the activities. For the production equipment this plan is prepared based upon the settlement with the Head of Plant Operations.

7.3 The lists of equipment/machine for preventive maintenance are to be provided in a separate Annexure. If any equipment/machine needs to be added or deducted from the list, Head of Quality Assurance/Designee will do it by hand writing it with signature with date without reviewing the entire SOP. The list will be restructured during next revision of this SOP.

7.4 There is a checklist included in the respective section for every equipment/machine which are undergone PM. The maintenance logbook of every equipment/machine will be store in the respective room and the technicians or engineering persons who are involved in doing the maintenance work will be liable to fill up the logbook upon close of the task. The forms will be store in the room of the respective machine in the shop floor.

7.5 “Under Maintenance”[Annexure-III]:  status label must be attached on the machine by the engineering personnel during preventive maintenance activities.

7.6 “Shifting in Progress for Maintenance”[Annexure-IV] status label must be placed by the engineering personnel on the machine at the time of shifting for maintenance activities.

7.7 Status label of “Preventive Maintenance” [Annexure-V] must be affixed by the engineering personnel on the machine after completion of preventive maintenance.

7.8 Photocopy of all approved forms to be used where easily applicable. Computer Generated form with exact format can be used with mentioning the following note at footer:

“This is a computer generated report and the format is as per the original approved form”

7.9 PM schedule [Annexure-I] must followed accordingly. The monthly preventive maintenance scheduling table should be circulated to the relevant department at the starting of every month and engineering department must keep a copy of the PM schedule.

7.10 Preventive maintenance schedule/plan may be changed if any requalification is carried out due to major modification or breakdown.

7.11 PM records/history[Annexure-II] must be reviewed to facilitate, evaluate and improving the performance of the PM programme and the performance of the Equipment/Machine.

7.12 Frequency/Interval of preventive maintenance schedule/Plan of a machine/equipment can be revised based on the frequency/interval and nature of breakdown happened in the past as per trending/trend analysis of the specific machine.

7.13 When the preventive maintenance of an equipment/machine is completed, successful trial will be run and the respective engineer will hand over/transfer/deliver the machine to the relevant departmental head/designee.

7.14 Maintenance activities of a number of equipment’s/machines:

The maintenance activities of various equipment’s/machines of XX Pharmaceuticals Ltd. are described here:

Fluid Bed Dryer:

Maintenance Interval: Monthly

Maintenance Task:

  1. Check the blower housing and drain for the possible condensate
  2. Check smooth operation of the blower
  3. Clean locking bolt using grease
  4. Check the Heat Exchanger
  5. Inspect All Screw Connection In-Process Piping System

Maintenance Interval: 6 Monthly

Maintenance Task:

  1. Check all O-Ring and adjustment if it is necessary
  2. Check the filter elements aimed at contamination
  3. Exchange filter elements, if there is any perceptible damage

Maintenance Interval: Yearly

Maintenance Task:

  1. Check the blower motor mount screws for tightness
  2. Check pneumatic inflatable gasket
  3. Check the all silicon gasket seals

Coating Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the pneumatic system
  2. Check and clean the pre filter
  3. Check the spray gun & air connection
  4. Check the pan motor, gear box drive belt
  5. Check the pan bearing & gear box bearing
  6. Check the door seal, pan bearing, hinges, and tightness
  7. Check the blower motor, blower housing & heat exchanger
  8. Check the solution mixing pneumatic motor and grease the bearings
  9. Check the flow switch, water solenoid valve, bar limit switch & hose retighten

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the spray pump
  2. Check the Electrical Wire Connection
  3. Check the main gear box & gear oil level
  4. Grease the bearing and if it is damaged then replace the same

Yearly

  1. Check the gear oil level and add oil if it is necessary
  2. Check the door seals, pan bearing, coupler hinges and joints
  3. Check the blower motor and heat exchanger unit motor hose

Blister Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the Heater
  2. Check the Cam Bearing
  3. Check the Gear Oil Level
  4. Check the Electrical Connection
  5. Check the Pneumatic Connection

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the Blade
  2. Check the Spring Tension
  3. Check the electrical connections
  4. Check the Roller Bearing & Bearing Pin

Maintenance Interval: Yearly

Maintenance Task

  1. Check the Air filter
  2. Check the Lubricated spring set
  3. Check the Gear oil and change if it is necessary
  4. Check the Oil spring set, if damage than change the same

Autoclave:

Maintenance Interval: 03 Monthly

Maintenance Task

  1. Check the door seal.
  2. Check the gasket of all TC clamp connections.
  3. Check for any lime build up in the vacuum pump discharge pipe.

Maintenance Interval: 06 Monthly

Maintenance Task

  1. Check the strainers fitted with the machines
  2. Check the pneumatic valve & solenoid valve seal and gasket
  3. Check the operational status of the non return valve fitted on sterilizer

Maintenance Interval: Yearly

Maintenance Task

  1. Check the all electrical connections
  2. Check the emergency button is working properly
  3. Visually check the condition of the mechanical chain
  4. Check the pneumatic cylinder opening/closing the door
  5. Visual check for any water leakage from the vacuum pump body

Encapsulation Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the Gear Oil Level
  2. Check the Vacuum Oil Level
  3. Check the Bearing Condition
  4. Check the Electrical components
  5. Check the Main Motor Connections
  6. Check the Powder Sensor Sensitivity

Maintenance Interval: Half Yearly

Maintenance Task

  1. Refill Vacuum Oil if necessary
  2. Check Gear Oil and change if necessary

Bottle Washing Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the filters
  2. Check the gear box
  3. Check the float switch
  4. Check the pneumatic line
  5. Clean the electrical panel board
  6. Check the nozzle and clean it if necessary

Maintenance Interval: 3 Monthly

Maintenance Task

  1. Check the Gear oil level
  2. Check the bearing condition
  3. Check the main motor connection
  4. Check the electrical all components

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the Gear oil and change the same if required.

Conveyer Belt:

Maintenance Interval: Weekly

Maintenance Task

  1. Check the main motor
  2. Check the roller bearing
  3. Check the gear box with oil
  4. Check the roller adjustment belt
  5. Check the chain, clean and grease

Maintenance Interval: Monthly

Maintenance Task

  1. Check the Gear oil level.
  2. Check the electrical all component.

Maintenance Interval: Yearly

Maintenance Task

1. Check and change gear oil if it is required.

De-duster Machine:

Maintenance Interval: Weekly

Maintenance Task

  1. Check the main motor
  2. Check the roller bearing
  3. Check the gear box with oil
  4. Check the roller adjustment belt
  5. Check chain and clean and grease

Maintenance Interval: Monthly

Maintenance Task

  1. Clean the Electrical panel board.
  2. Check the gear oil and change, if it is needed.

Blending Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check all safety interlock and mechanisms.
  2. Check the machine for irregular noise or vibration.
  3. Check compressed air filter and clean/change if required.
  4. Check Pneumatic System (Air Condition Filter and Regulator)

Maintenance Interval: Yearly

Maintenance Task

  1. Check the double cone tool
  2. Clean the electrical cabinet sensibly
  3. Check the Gear Oil Level If need then replace
  4. Check for any unfamiliar noise or shaking from the machine

Two Head Liquid Filling Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the roller bearing
  2. Check the gear box with oil
  3. Check the piston and the disks
  4. Check the main motor with v-belts
  5. Check and grease all movable parts

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the overall cleaning
  2. Check the electrical all component
  3. Check the pistons and disks for any damage

Manufacturing Vessel:

Maintenance Interval: Monthly

Maintenance Task

  1. Check gear box with oil
  2. Check main motor with V-belt
  3. Check roller bearing of the pump
  4. Check and grease all movable parts
  5. Check the transfer pump of the vessel

Maintenance Interval: half Yearly

Maintenance Task

  1. Check the overall cleaning
  2. Check the electrical all component
  3. Check the mechanical seal of the pump

Tablet Compression Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the V-belt
  2. Check the main shaft
  3. Check the warm gear
  4. Check the pressure roller
  5. Check the electrical cabinet
  6. Check the pressure adjust knob

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the filling depth
  2. Check the Gear oil level
  3. Check the hydraulic oil level
  4. Check the electrical connection
  5. Check the powder level sensor

Maintenance Interval: Yearly

Maintenance Task

  1. Check the Gear oil viscosity
  2. Check the electrical component
  3. Check the Hydraulic oil if need replace it

Cap Sealing Machine:

Maintenance Interval: 6 Montly

Maintenance Task

  1. Check the gear oil level
  2. Check the cap sealing holder
  3. Check the motor piston with grease
  4. Check the pressure adjustment knob
  5. Check the bearing with gear premium

Maintenance Interval: Yearly

Maintenance Task

  1. Check the pneumatic motor
  2. Check the electrical cabinet
  3. Check the pressure adjustment knob
  4. Check the motor with bearing piston grease
  5. Check the gear oil level if need change the same

Stability Chamber:

Maintenance Interval: Monthly

Maintenance Task

  1. Clean the PT100 Sensor
  2. Check the door pipe connection
  3. Check the chamber door closing
  4. Check the operations of safety thermostat
  5. Check the condenser fan, if found loose then tighten it
  6. Check the proper earthling connection to the stability chamber

Maintenance Interval: Half Yearly

Maintenance Task

  1. Check the evaporation tray
  2. Clean the condenser by blower air through
  3. Check the water immersion heater and reservoir tank
  4. Check the side port hole is properly fitted with rubber cork

7.14.16 Rapid Mixer Granulator of Product Development:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the pneumatic component
  2. Check the electrical wire connection
  3. Check any unusable noise or vibration
  4. Check all safety interlock and mechanism

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the electrical wire connection
  2. Check the oil level and viscosity of oil manually

Rapid Mixer Granulator of Product department:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the main motor with gear
  2. Check the chopper motor bearing
  3. Check the impeller and motor bearing condition

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the Electrical Wire Connection
  2. Check the V-Belt & Motor Condition
  3. Check the Mechanical Seal or Bearing
  4. Check the Main Gear Box Gear Oil Level

Maintenance Interval: Yearly

Maintenance Task

  1. Check the discharge valve’s motor condition.
  2. Check the gear oil level if it is needed then replace the same.

Sampling Booth:

Maintenance Interval: fortnightly

Maintenance Task

  1. Clean the pre filter (G4).
  2. Check the motor condition.
  3. Check the machine’s all nuts and bolts.

Maintenance Interval: Monthly

Maintenance Task

  1. Clean blower motor.
  2. Check electrical constituents & motor.
  3. Check for any unfamiliar noise or vibration.

Dispensing Booth:

Maintenance Interval: Forthightly

Maintenance Task

  1. Clean pre filter (G4).
  2. Check the motor condition.
  3. Check the machine’s all nuts and bolts.

Maintenance Interval: Monthly

Maintenance Task

  1. Clean the blower motor.
  2. Check electrical components and motor.
  3. Check for any unfamiliar noise or vibration.

Solution Mixing Tank:

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check the baffle plate
  2. Check the pneumatic motor
  3. Check the pressure adjustment knob
  4. Check the pneumatic motor piston grease

Maintenance Interval: Yearly

Maintenance Task

  1. Check the baffle plate
  2. Check the pneumatic motor
  3. Check the Pressure Adjustment knob
  4. Check the pneumatic motor piston grease

Vacuum Pump

Maintenance Interval: Fortnightly

Maintenance Task

  1. Clean the filter
  2. Clean the O ring
  3. Check the nut bolt
  4. Check the motor condition

Maintenance Interval: Yearly

Maintenance Task

1. Clean the blower motor

2. Check the electrical all component and motor

Vibratory Shifter:

Maintenance Interval: Monthly

  1. Maintenance Task
  2. Check housing flange
  3. Check the motor body
  4. Check the motor flange
  5. Check electrical Components

Maintenance Interval: 6 Monthly

Maintenance Task

1. Check the motor electrical connection

2. Check the motor bearing house with bearing

Powder filling machine:

Maintenance Interval: 6 Monthly

Maintenance Task

  1. Check airline
  2. Check gear box
  3. Check all grease point
  4. Check all pulley and Belt
  5. Check vibration and abnormal noise
  6. Check all screws on driving units, tighten it if necessary

Maintenance Interval: Yearly

Maintenance Task

  1. Check the earthing
  2. Check the switches
  3. Check voltage and frequency

Sticker Labeling Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the pneumatic system
  2. Lubricate the motor bearing as needed
  3. Check all screws on driving units & tighten it if required

Maintenance Interval: Yearly

Maintenance Task

  1. Check the earthing
  2. Check the inverter connection
  3. Check the voltage & frequency
  4. Check the electrical control unit

Automatic Dehumidifier:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the fan.
  2. Check for somewhat leakage
  3. Check the cooling coil
  4. Check the gas pressure of the compressor
  5. Remove the condenser water from container
  6. Check the screw on driving units & tighten it if needed

Maintenance Interval: Yearly

Maintenance Task

  1. Check the electrical switches
  2. Check the electrical connections

Tablet De-duster:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the main motor
  2. Check the gear oil level
  3. Check the roller bearing
  4. Check the gear box with oil
  5. Check the roller adjustment belt
  6. Check the electrical all component
  7. Check the chains and clean & grease

Maintenance Interval: Yearly

Maintenance Task

  1. Check the electrical panel board & overall cleaning
  2. Check the viscosity of gear oil & change it if necessary

Inkjet Printer:

Maintenance Task

Maintenance Interval: Monthly

  1. Check the vacuum pump
  2. Check the ink spray needle
  3. Check the electrical cabinet
  4. Check the solvent or ink status
  5. Check the pressure adjust knob
  6. Check the main ink head of printer

Inkjet Printer:

Maintenance Task

Maintenance Interval: Monthly

  1. Check the main head
  2. Check the vacuum filter
  3. Check the ink expire date
  4. Check the electrical connection
  5. Check the ink or solvent level sensor

Vial Washing Machine:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the Nozzle
  2. Check the Gear Box
  3. Check the Float Switch
  4. Check the Pneumatic Line
  5. Check the Electrical Panel Board
  6. Check the Pneumatic Line, Connector & Filter

Maintenance Interval: 3 Monthly

Maintenance Task

  1. Check the Gear Oil Level
  2. Check the Hot Water Line
  3. Check the Bearing Condition
  4. Check the Main Motor Connection
  5. Check the Electrical All Component
  6. Check the Powder Sensor Sensitivity
  7. Check the Turret and Moving Parts Clean and Grease

Maintenance Interval: 3 Monthly

Maintenance Task

  1. Change the Gear Oil
  2. Refill the Vacuum Oil
  3. Clean the Overall Machine

Multi Mill:

Maintenance Interval: Monthly

Maintenance Task

  1. Check the pulley
  2. Check the hopper will blades
  3. Check screws on driving units, tighten it if required

Maintenance Interval: Yearly

Maintenance Task

  1. Check the earthing
  2. Check the inverter connection
  3. Check electrical switches
  4. Check the electrical control unit
  5. Check the voltage and frequency

List of  Annexures:

Annexure-I:   Schedule for Preventive Maintenance of Equipment

Annexure-II:  Record Data Sheet for Preventive Maintenance

Annexure-III: Status label “Under Maintenance”

Annexure-IV: Status label “Shifting in Progress for Maintenance”

Annexure-V: Status label of “Preventive Maintenance”


Related Posts

Leave a Comment

Your email address will not be published. Required fields are marked *

error: Content is protected by www.pharmaguideline.co.uk !!