- Objective:To lay down an Operating Procedure for Purified Water Distribution System.
- Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company(Make- Neela Metal,Capacity- 2.5m3/hr) .
- The Concerned Technician shall follow the Operating Procedure as per this SOP.
- The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP.
- Accountability: Head-Engineering andQA shall be accountable for the compliance of the procedure as per this SOP.
- Abbreviations and Definitions:
- NMT: Not More Than
- NLT: Not Less Than
- MMI: Main Machine Interface
- MCB: Miniature Circuit Breaker
- PLC: Programmable Logic Control
- Turn “ON” the main power supply to the panel by means of starter switch at side of control panel.
- Turn “ON” the MCB inside the control panel for powering the PLC and MMI.
- Press the ‘ENTER’ button on the MMI to start the system. Make sure the utilities (i.e. compressed air and steam) are available to the system at required pressure and temperature respectively.
- Make sure all the pump suction and discharge valves are kept open.
- Make sure the MCB for the pumps are turned “ON” inside the control panel
- Put the system in ‘AUTO’ mode with the help of selector switch (AUTO/ OFF/ MANUAL) on the panel door.
- Record all the observations of Purified Water System in the Log Sheet. As per operation parameter conductivity should be less than 1.3 Micro siemens and TOC should be less than 500 ppb.
- Forms and Annexure:
- Logbook of Purified Water Distribution System: Annexure-I
- Master Copy: Documentation Cell
- Controlled Copies: Engineering, Production, Quality Assurance,Warehouse, Quality Control, Administration and Housekeeping.
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