Objective : To take the photographs of pipe weld joints made by fusion of base material without the addition of filler and recorded in the attached compact disc and should meeting the required specifications mentioned below. Uniformity in weld joint. Should have proper penetration. Should not have any foreign object or pit holes. Scope :this … Read more
Orbital Welding Procedure for purified water system Objective : To get more consistent root weld beads and weld overrun, pinholes should be absent. Scope :This SOP is applicable for Orbital Welding of purified water system Procedure : Ensure the welder is qualified before starting of welding. Clamp the welding head at position of welding joint. Centre … Read more
Hot Water Sanitization Procedure of Purified Water Distribution Loop Objective : To ensure that the Purified Water Distribution Loop along with the tank is sanitized at 85 degree Centigrade to reduce the microbial count. Scope : Procedure : Fill the Purified Water Storage Tank till the Half Level. Ensure Suction & Discharge valve of pump … Read more
Dead Leg Verification Procedure for Purified water storage & Distribution System Objective : To Check that the dead-leg in Sampling lines/ Instrument Connection are not greater than 1.5 times pipe diameters in length. Scope :Dead Leg Verification for Purified water storage & Distribution System Procedure : Collect the As Built Isometric Drawing of the PW … Read more
Protocol for perfomance qualification of water for injection generation, storage and distribution system Objective: To establish the methodology for the Performance Qualification of WFI Generation, Storage and Distribution system , which produces pyrogen free, water for injection, used as a Sterile products manufacturing facility. Purpose and Scope The purpose of this Protocol is to establish … Read more
CLEANING AND SANATIZATION (PASSIVATION) REPORT SYSTEM: PURIFIED WATER GENERATION SYSTEM Objective: The system needs cleaning and sanitization before start of the plant and loading of RO membrane to remove any microbial load or any bio film present in the existing interconnecting piping and the RO Housing and Pumps. Procedure : The sanitization has to be … Read more
CHEMICAL CLEANING Reverse RO System and EDI System RO CLEANING – CITRIC ACID Preparation of Cleaning solution: Prepare a solution of 2% (By weight) of Citric acid (C6H8O7). This is useful in removing of inorganic scales and organic based colloidal material. Recommended quantity is 7.7 kg Citric acid (100 % powder) which is to be … Read more
Cleaning & Passivation Procedure Purified water System Fill the Storage Tank upto the Half Level & Start the recirculation pump & circulate water for 25-30 minutes Then drain the water from the Tank & piping ( Via User Points, & Sampling Points.) Prepare cleaning chemical by diluting Sodium Hydroxide ( NaOH) ( of 100% Purity) … Read more
RESPONSIBILITY :Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. OBJECTIVE :To lay down policy for calibration of Instruments/Equipment’s wherever applicable. Heads of the concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products shall be calibrated. There shall be an SOP … Read more
Objective:To lay down a procedure for Calibration of equipments and instruments from external authorized Agencies / Supplier. Scope:This procedure shall be applicable for calibration of equipment / instrument of all the departments. Responsibility Head of Engineering: (i) For maintaining records (ii) For the selection of authorized calibration agency / Supplier (Annexure-6) Heads of Production, Engineering, … Read more