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Pharma Editor, Author At - Page 10 Of 12

Author: Pharma Editor

CHILLED WATER

Posted on By Pharma Editor

CHILLED WATER Chilled water systems have become a pioneering solution, transforming how we cool our buildings and industrial areas. Going beyond conventional air conditioning techniques, It presents a sustainable and economical option. we delve into the fundamentals of chilled water technology, its wide-ranging applications, and the environmental and financial advantages that accompany its implementation. Chilled…

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Engineering

AIR COMPRESSORS

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AIR COMPRESSOR OBJECTIVE: To lay down a procedure for the Maintenance of the Air compressor SCOPE: This SOP applies to Air compressors. RESPONSIBILITY: Technical Supervisor / Engineer        ACCOUNTABILITY: Sr.Executive / Manager                     PROCEDURE Daily Maintenance Check and ensure the oil level is as per the mark given on the view glass. Clean the outer surface of…

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Engineering

BOREWELL PUMP

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BOREWELL PUMP Borewell pumps stand as silent workhorses, drawing water from the depths below. These essential devices have transformed the way we access and utilize groundwater, playing a pivotal role in sustaining life and supporting various economic activities. Borewell Pumps: Functionality: Borewell pumps are specialized devices designed to extract water from underground sources, typically drilled…

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Engineering

AIR HANDLING UNIT

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Maintenance of Air Handling Unit OBJECTIVE: To lay down a procedure for the Maintenance of the Air Handling Unit SCOPE: This SOP applies to the Air Handling Unit. RESPONSIBILITY: Technical Supervisor / Engineer        ACCOUNTABILITY: Sr.Executive / Manager                     PROCEDURE :  Daily Maintenance Check and ensure that the difference between the inlet and outlet temperature of chilled…

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Engineering

CLEANING OF AIR HANDLING UNIT (AHU) FILTERS

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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  Precautions  Stop the Air Handling…

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Engineering

Performance Qualification Protocol. Bung washer

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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 spiked rubber stoppers, and to…

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Engineering

Performance Qualification Protocol. Vial washing machine

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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 the routine production operations. The…

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Engineering

Performance Qualification Protocol Vial sealing machine

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Vial sealing machine Vial sealing machine is installed in vial sealing room. The main action of vial sealing machine vials are accumulated on the turntable at the infeed of the machine and are carried towards the machine by a slats conveyor. A worm separates the vials are transfers them onto infeed star wheel. Vials and…

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Validation & Qualification

Performance Qualification Protocol for Vial Filling Machine

Posted on By Pharma Editor

Vial Filling Machine Automatic single Head Injectable Powder Filling Machine is a compact versatile machine. The Machine is precision built on sturdy welded frame of S.S. 304 completely enclosed in stainless steel sheet. This machine can be used to fill sterile powder in vials received from the Sterilizing tunnel. Then vial will be transferred to…

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Validation & Qualification

Sop for operation of BOPP taping machine

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Objective: To lay down a procedure for operation of BOPP taping machine. Scope This SOP is applicable for operation of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPQA : In-process Quality Assurance Procedure Pre-Start UP Check the status of…

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Production

SOP on operation of packing conveyer belt

Posted on By Pharma Editor

Objective To lay down the procedure for the operation of packing conveyer belt. Scope:  The SOP is applicable for the operation of packing conveyer belt installed in the packing hall of sterile injectables facility.  Responsibility Officers and above-Production Accountability Production Head Abbreviations MCB : Miniature Circuit breaker Procedure Ensure that the packing conveyer belt is…

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Production

SOP for operation of inkjet printing machine

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Objective: To lay down a procedure for operation of Ink jet printing machine. Scope This SOP is applicable for operation of Ink jet printing machine (make:Image). Responsibility Officers or above – Production.  Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. LCD : Liquid Crystal Display Procedure Start-up Ensure the cleanliness of area and machine….

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Production

SOP for operation of carton coding machine

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Objective:To lay down a procedure for operation of carton coding machine. Scope: This SOP is applicable for operation of carton coding machine. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. No.: Number Date : Manufacturing Date Date : Expiry Date MRP : Maximum Retail Price BPR : Batch…

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Production

SOP For Decartoning of primary and secondary packing materials.

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Transfer the required quantity of seals from warehouse to decartoning room on the receipt of the packing material requisition slip. Decartoning of Seal Decartoning of Rubber Stopper Transfer the required quantity of stopper from warehouse to decartoning room on the receipt of the packing material requisition slip. The production officer shall verify the Quantity, Analytical…

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Production, Uncategorized

Performance Qualification Protocol. H.P.H.V. Steam Sterilizer

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Steam Sterilizer H.P.H.V. Steam sterilizer is installed in vial washing room. Purpose Of The Equipment Purpose of this H.P.H.V. Steam sterilizer is for sterilization and drying of the garments, rubber stopper holding canisters, filling machine parts, filtration accessories and previously washed and siliconized rubber stoppers. Basic Mode Of Operation The main action of H.P.H.V. Steam…

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Validation & Qualification

Preparation of Validation and Qualification Protocols

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Preparation of Validation and Qualification Protocols Objective To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may affect the quality of products…

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Quality Assurance

Operational qualification for pure steam generator

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Operational qualification for pure steam generator To establish documentary evidence to demonstrate the Pure Steam Generator  system is qualified for correct operation as per guidelines outlined in this protocol & operational manual. SCOPE OF THIS DOCUMENT This protocol is applicable to pure steam generator. Functional testing (including safety tests) of the equipment with printouts for…

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Validation & Qualification

Template for Performance Qualification Protocol

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Performance Qualification Protocol OBJECTIVE To describe the Performance Qualification procedure to be used during qualification of NAME OF THE EQUIPMENT system in order to: Ensure the system reproducible over an appropriate time period as per user requirement specifications Ensure that the system is showing consistency in producing Product of pre-established specifications. SCOPE This procedure applies…

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Validation & Qualification

Mapping of the Environmental condition

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Mapping of the Environmental condition Objective The objective of this validation study is to provide a document evidence of Temperature and Relative Humidity distribution in Ware House area against predetermined acceptance criteria. Scope The validation study of the Temperature and Relative Humidity distribution in Ware House area shall be carried out for one year on…

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Validation & Qualification

Protocol for Shipping validation

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Shipping validation Objective The objective of this study is to establish a procedure to records temperature data to ensure that transportation conditions have not adversely affected a products, when transported as per regular Shipment practice. Scope The Shipping (Transportation) validation study shall be carried out for four times covering four seasons viz., Winter, Spring, Summer…

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Validation & Qualification