OBJECTIVE To lay down a procedure for Maintenance of Compressed Air Distribution SCOPE This SOP is applicable to Compressed Air Distribution. RESPONSIBILITY Technical Supervisor / Engineer ACCOUNTABILITY Sr.Executive / Manager PROCEDURE Daily Maintenance Clean the filter bowl externally with dry Cora cloth Ensure no waste material should be lie on …
Read More »RAW MATERIAL COLD STORAGE
RAW MATERIAL COLD STORAGE Raw materials must be stored in controlled temperature environments to guarantee their durability and uphold the quality and safety of the final products. This blog explores the importance of cold storage for raw materials, the advantages it offers, and the essential factors that businesses should consider …
Read More »CHILLED WATER
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 …
Read More »Process Validation: General Principles and Practices (January 2011)
Process Validation The concept of the product lifecycle connects the development of the product and the manufacturing process, the qualification of the commercial manufacturing process, and the maintenance of the process to ensure control during routine production. This guidance promotes scientific principles to support process improvement and innovation. This guidance …
Read More »Sanitization of Purified Water Generation and Distribution System
Purified Water Purified water is more than just a thirst-quenching beverage; it’s a cornerstone of health and well-being. In this blog, we explore the significance of purified water, the various purification methods, and why its consumption is essential for a healthy lifestyle. Purification Methods: Purified water undergoes processes that eliminate …
Read More »AIR COMPRESSORS
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. …
Read More »BOREWELL PUMP
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 …
Read More »AIR HANDLING UNIT
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 …
Read More »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 …
Read More »Cleaning Validation Protocol
Cleaning Validation Protocol CONTENTS S. No. Topic Page No. 1.0 Protocol Preparation and Approval Sheet 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Validation Team 6.0 Abbreviations and Definitions 7.0 Cleaning Validation Approach 7.1 Selection of Products 7.2 Selection of Equipments 7.3 Type Cleaning after every five consecutive batches of the …
Read More »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 …
Read More »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 …
Read More »Performance Qualification Protocol Vial sealing machine
Performance Qualification Protocol Vial sealing machine OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial sealing Machine. To demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and suitable for …
Read More »Performance Qualification Protocol for Vial Filling Machine
Performance Qualification Protocol for Vial Filling Machine OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial Filling Machine. To Demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and fill …
Read More »Sop for operation of BOPP taping machine
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 …
Read More »SOP on operation of packing conveyer belt
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 …
Read More »SOP for operation of inkjet printing machine
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 …
Read More »SOP for operation of carton coding machine
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 …
Read More »SOP For Decartoning of primary and secondary packing materials.
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 …
Read More »Performance Qualification Protocol. P.H.V. Steam Sterilizer
Performance Qualification Protocol. P.H.V. Steam Sterilizer OBJECTIVE The objective of this Validation Protocol is to obtain a high degree of assurance that the steam sterilization process is capable of sterilizing the specified loads using High Pressure and High Vacuum Steam Sterilizer (Bung Processor). To establish a documented evidence that the …
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