Engineering

CLEANING OF AIR HANDLING UNIT (AHU) FILTERS

OBJECTIVE To lay down a procedure for Cleaning of Air Handling Unit (AHU) filters  20 Micron, 10 Micron , 5 Micron  SCOPE This SOP is applicable to cleaning of Air Handling Unit (AHU) filters 20 Micron , 10 Micron, 5 Micron . RESPONSIBILITY  Technical Supervisor / Engineer ACCOUNTABILITY  Manager  PROCEDURE …

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Performance Qualification Protocol. Bung washer

OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the BUNG WASHING MACHINE. To verify the Rubber stopper washing process is capable of consistently and reliably removing Particulate matter contaminants, such as dust, lint, fibres etc., Bacterial Endotoxins, from the …

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Performance Qualification Protocol. Vial washing machine

OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the VERTICAL ROTARY VIAL WASHING MACHINE. To verify the vial washing process is capable of consistently and reliably producing appropriate washing of different types of vials at different speeds encountered in …

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Hydro Testing Procedure for Purified Water Distribution Loop and Purified Water Storage Tank

Hydro Testing Procedure for Purified Water Distribution Loop Objective : To ensure that the Purified Water Distribution Piping is Leakage proof from TC joints & Orbital Weld joints. Scope :Applicable for Hydro Testing of Purified Water Distribution Loop Procedure : Fill the Purified Water Distribution piping loop completely with Purified …

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Passivation and Cleaning Procedure Purified Water Distribution Loop

Objective : To ensure that the Purified Water Distribution System is Chemically cleaned. Scope :Applicable for Passivation and Cleaning of Purified Water Distribution Loop Procedure : Fill the Purified Water Storage Tank till the Half Level.  Ensure Suction & Discharge valve of pump are open and all user points & sampling …

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Slope Verification Procedure for Purified Water Distribution System

Slope Verification Procedure for Purified Water Distribution System Objective : To ensure that the distribution lines are sloped towards the point of use and slope of the lines is approximately 1mm in 100 mm. Scope :Applicable for Slope Verification of Purified Water Distribution System Procedure Collect the As Built Isometric Drawing …

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Boroscopy Examination Procedure for Purified water system

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 …

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Orbital Welding Procedure for purified water system

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 …

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Hot Water Sanitization Procedure of Purified Water Distribution Loop

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 …

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Dead Leg for Purified Water Storage & Distribution System

Dead Leg for Purified Water Storage & Distribution System A dead leg within a water distribution system denotes a segment of piping that is no longer actively utilized. It has the potential to foster microbial contamination, thereby posing a risk to the overall quality of the water. Dead legs may …

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Protocol for perfomance qualification of water for injection generation, storage and distribution system

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 …

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Cleaning and Sanitization procedure of RO and EDI System of Purified water System

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 : …

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CHEMICAL CLEANING Reverse RO System and EDI System

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 % …

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Cleaning & Passivation Procedure Purified water System

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 ( …

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Procedure for calibration of Instruments/ Equipments

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. …

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Calibration of Equipment and Instruments from External Authorized Agencies / Suppliers.

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 …

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Procedure for Building Maintenance

Objective:To lay down a procedure for building Maintenance. Scope:This Standard Operating Procedure is applicable for the formulation plant. Responsibility Head-Engineering /Designee shall be responsible for implementation of the procedure as per this SOP. Head-Concerned Department / Area In charge shall be responsible for compliance of the procedure as per this …

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SOP ON MAINTENANCE OF AIR HANDLING UNIT

OBJECTIVE : To lay down a procedure for Maintenance of Air Handling Unit. SCOPE: This SOP is applicable to Air Handling Unit at Formulations II Service floor. RESPONSIBILITY: Technical Supervisor / Engineer . ACCOUNTABILITY: Head of Department and Head QA.  PROCEDURE:  Daily Maintenance : Check and ensure that the difference between inlet and outlet temperature …

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Engineering Question & Answer

Engineering Question & Answer 1.Question:What is the good engineering practice (GEP) Answer:  good engineering practice (GEP) means to established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions.   2.Question: How can defined the validation ? Answer:  The documented act of proving that any procedure, process, equipment, material, …

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