PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT

OBJECTIVE; To define the procedure for preventive maintenance of production equipment.

SCOPE: This procedure is applicable for preventive maintenance of production equipment.

RESPONSIBILITY: This procedure is applicable for preventive maintenance of production equipment.

RESPONSIBILITY: Mechanical Engineer

ACCOUNTABILITY: Engineer Head

ATTACHMENTS:

Attachment I – Preventive maintenance schedule

Attachment IІ – Preventive maintenance logbook

Attachment III – Executed works logbook

Compressed air validation in Pharmaceutical Industries

PROCEDURE:

The maintenance is carried out regularly for the assurance of continued work of the equipment and the operations safety.

Preventive maintenance is carried out mostly on weekends or any other day as long as it doesn’t affect the Production.

Preventive maintenance is performed as per approved schedule (Attachment – I)

GENERAL CONDITIONS

The maintenance should be performed by the staff of Engineering department. If there is no possibility to assure the appropriate maintenance of some specific equipment, outsourced organizations, which specialize in the specific equipment, must be involved.

The record for maintenance performance should be indicated in the equipment logbook and in the Preventive maintenance equipment logbook (Attachment – II). Work done shall be recorded in Executed works logbook (Attachment-III).

MAINTENANCE WORK TYPES 

Daily maintenance includes checking of the uniformity of equipment units and gaskets, protection devices, presence of guard fence, the uniformity of electrical wires and plugs, air flue, steam pipelines and water pipelines. The check is performed only for the equipment that is specified in the production department request, by operator before the start of activity. If any non-conformities are found, operator should not switch on the equipment till the nonconformities are corrected.  Then the activity entry in the Equipment Log Book shall be made, which confirms that the daily maintenance has been performed.

Monthly maintenance includes the  following activities:

– Checking of technical conditions of wearing nods and detail with minimum of disassembling and assembling works;

– Replacement of details that cannot function till the next scheduled maintenance;

– Maintenance of lubrication, cooling, heating system;

– Checking of the status of the drive, fasteners, gear unit, chain and other types of gears, bearings, gland seals,safety and protection device;

– Checking of the inter repair maintenance quality;

– Clarification of the scope and timing of the next scheduled maintenance.

– Monthly maintenance is conducted without interference in production process (during technical breaks, between shifts and not in a working time). It shall be conducted by engineering and technical department employees according to the confirmed preventive maintenance schedules.

Quarterly maintenance includes the following activities:

– Partial disassembling of machine, disassembling of the most worn and the dirtiest nods into component parts, washing and cleaning them, inspection and cleaning of other nods;

– Checking of openings between stringer beads and liners, replacement of worn liners, regulation or replacement of worn bearings, replacement of worn gear wheels, trimming of rough edges on gear wheels’ teeth, trimming of tearings, scratches and dints on sliding surfaces;

– Replacement of worn details that cannot last till the next scheduled maintenance;

– Maintenance and washing of lubrication, cooling, heating system, changing of old lubricant;

– Discovering of the details that need to be replaced during the next average or general maintenance.

– Quarterly maintenance is performed by engineering and technical department employees according to the confirmed preventive maintenance schedules.

Yearly maintenance includes the following activities:

– Checking of all details of machines with partial disassembly;

– Repair of separate nods with replacement of the details, the wear of which exceeds acceptable limit as per  manufacturing specifications or norms;

– Checking and replacing worn ropes, chains, belts, etc.;

– Cleaning all bearings, scheduled replacement of ball, roller bearings and sleeve bearings;

– Checking and washing reduction gears;

– Trimming of damaged surfaces, dints and rough edges;

– Checking and replacing worn gaskets, seals and fasteners;

– Repair or replacement of worn-out valves;

– Painting of machine parts, if necessary;

– Checking of mounting assemblies and mechanisms, regulation and testing of the unit idle and under production  load.

– Yearly maintenance is performed by engineering and technical department employees according to the confirmed preventive maintenance schedules.

General maintenance needs to be done depending on equipment manufacturer recommendations and it includes:

– Complete disassembling of all machine nods in details;

– Replacement of all worn nods and details or their restoration bringing to the sizes that are established by manufacturing specifications;

– Thorough inspection, alignment and balancing of nods and equipment details;

– Trueing of the bedplate and frame of the machine together with sole, base stand and  supporting structure  repair, if necessary;

– Inspection, cleaning and repair of air flues, ductings with installed valves and piping;

– Debugging and regulation or replacement of  all automatic control and handling equipment;

– Maintenance of protective devices, insulation and lining as per new equipment specifications;

– Painting of separate parts or the whole machine, if necessary;

– Comprehensive inspection, regulation and testing idly and under production load.

– Equipment modernization can be done during general maintenance. It is carried out for performance characteristics improvement, technical improvement or for production technological problems solution.

Take all safety precautions before preventive maintenance work.

REFERENCES:None

Distribution list  – Engineering Department & Production Department

Revision of History / История изменений:

Version Number Effective Date Reason for Changes
00   New SOP

Preventive maintenance logbook 

Equipment name
Equipment location
Equipment number
     ____year  . Preventive maintenance date The signature of preventive maintenance actual doer The signature of the person who checked preventive maintenance
January    
February    
March    
April    
May    
June    
July  
August  
September  
October  
November  
December

Preventive maintenance schedule

Eq.

Name

Equipment number Installation location Month___________year
January February March April May June July Aug. Sept. Oct. Nov. Dec.

Executed works logbook

Month ________________________________        Date ______________________ 

Sr. No. List of executed works Remarks

Done by (Date)   ______________________                   Checked by (Date) ______________________

Indian Pharmacopoeia

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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