- Objective:To lay down a procedure for Preventive Maintenance of Purified Water System (Generation and Distribution).
- Scope:This Standard Operating Procedure is applicable for formulation plant of pharmaceutical company.
- The Concerned Technician shall follow the procedure for Preventive Maintenance as per this SOP.
- The Officer/Executive-Engineering shall be responsible for implementation of this procedure as per this SOP.
- Accountability:Head-Engineering and QA shall be accountable for the compliance of this SOP.
- Abbreviations and Definitions:
- UV- Ultra Violet
- FRC -Filter Regulator and Connector
- RO – Reverse Osmosis
- LPH – Liter Per Hour
- TC – Tri Coupling
- Monthly Schedule
- Switch “OFF” the main power supply through MCC and hang the Preventive Maintenance Display Board on the electrical control panel.
- Check all pressure switches for proper functioning.
- Check and note the reading of hour meters of all UV lamps and change the UV lamp between 7200 hours to 7500 hours.
- Clean all S. S. visible part of purified water system by coline and cloth properly.
- Checked, all pressure gauges for proper functioning, if not working, replace with same range calibrated gauge.
- Clean all panels by vacuum cleaner and duster.
- Check all TC joints for leakages, if leakage found change its silicon gasket.
- Checked dosing pump, cleaned its suction & discharge pipe with air & water pressure.
- Check all indicators change if fused.
- Check all electrical connections, MCB, push button & switches for proper functioning. Rectify if required
- Check three way valves for smooth functioning, lubricate if required.
- Check all diaphragm valves for proper functioning change, if faulty.
- Clean the Prefilter and air vent filter if required. Change the Prefilter if pressure gauge (PI001) shows measure pressure drop upto 2 bar.
- Check all pumps for any leakages and smooth operation, rectify if found any abnormality.
- Check the all motors for the loose connection and smooth operation and apply grease on the bearing and change the bearing if necessary.
- Record all the observations in Preventive Maintenance Checklist (Annexure -I).
- Yearly Schedule
- Check all pneumatic valve for proper functioning change if found faulty.
- Change the Prefilter and Vent filter with a new filter after every 2 years.
- Change MCF filter after every two years or as and when required.
- Record all the observations in Preventive Maintenance Checklist (Annexure-1).
- Forms and Annexure:
- Preventive Maintenance Logbook – Annexure -I
- Master Copy – Documentation Cell
- Controlled Copies : Engineering, Quality Assurance, Production,Warehouse, Quality Control, Administration and House keeping
Reason for Revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 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