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 when implementing or enhancing their…
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…
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 applies to various categories of…
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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 impurities and contaminants, ensuring it…
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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…
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…
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…
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…
STABILITY STUDY MANAGEMENT To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Document describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms). The purpose of stability studies is to obtain an evidence on how…
Cleaning Validation The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level, which is below predetermined levels. Due to complexity of manufacturing and packing of multiple products using same equipment…
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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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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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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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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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…
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…
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….
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…
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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