Micro SOPs

SOP for Monitoring and Recording Critical Environmental Parameters of Different classes

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1.0 Purpose: To describe the procedure for monitoring and recording critical environmental parameters of different classes at the production facility. 2.0 Aim: This Standard Operating Procedure is applicable for monitoring and Recording Critical Environmental Parameters such as temperature, relative humidity, pressure differential, and non-viable particle count of a different class (class A, B, C, and … Read more

SOP for Microbiological Testing of In-Process Packing Material (Bioburden Test)

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Standard operating procedure for Microbiological Testing of In-Process Packing Material, SOP for Bioburden Test. I.0 Purpose: This SOP outlines the steps for conducting Microbiological Testing of In-Process Packing Material. 2.0 Scope: This SOP is applicable for the Microbiological Testing of In-Process Packing Material. 3.0 Responsibilities: All Quality Control personnel are responsible for adhering to and … Read more

SOP for Operating and Validating Anaerobic Systems

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Standard Operating Procedure for Operating and Validating Anaerobic Systems in Pharmaceutical Microbiology Laboratory. 1.0 Purpose: This document outlines the step-by-step procedure for operating and Validating Anaerobic Systems. 2.0 Scope: This SOP pertains to the operation and validation of the Anaerobic System Mark III (Hi-Media) within the Microbiology Department. 3.0 Responsibilities: Microbiologist: Responsible for implementation of … Read more

SOP for Operating and Validating a Biosafety Cabinet

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Standard Operating Procedure for Operating and Validating a Biosafety Cabinet 1.0 Objective: The purpose of this procedure is to outline how to use and verify the functionality of a Biosafety Cabinet. 2.0 Scope: This procedure covers the usage and internal validation of a Biosafety Cabinet. 3.0 Responsibilities: Microbiologist: Responsible for using, validating, and maintaining the … Read more

SOP for Operating and Cleaning a Vortex Mixer in Microbiology

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SOP for Operating and Cleaning a Vortex Mixer in Microbiology

Standard Operating Procedure for Operating and Cleaning a Vortex Mixer in the Microbiology Department. I.0 Purpose: The purpose of this SOP is to provide guidelines for the proper operation and cleaning of the Vortex mixer. 2.0 Scope: This procedure applies to the Microbiology section of the Quality Control Department. 3.0 Responsibilities: 3.1 Quality Control Department … Read more

SOP on Operation and Calibration of the Antibiotic Zone Reader

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SOP on Operation and Calibration of the Antibiotic Zone Reader

The Antibiotic Zone Reader quickly and accurately helps figure out how strong antibiotics are by measuring the size of the zone where bacteria can’t grow in a Petri dish. 1.0 Objective: The objective of this Standard Operating Procedure is to provide a written procedure for the operation and calibration of the Antibiotic Zone Reader. 2.0 … Read more

SOP for Operation and Calibration of Heating Block

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Standard Operating Procedure (SOP) for Operation and Calibration of Heating Block 1.0 Objective: The objective of this Standard Operating Procedure is to lay down the procedure for operating and calibrating the Heating Block. 2.0 Scope: This SOP covers the operation and calibration of the Heating Block in the microbiology Lab. 3.0 Responsibility: Microbiologist: Responsible for … Read more

SOP for Operation and Validation of Laminar Air Flow Hood

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SOP for Operation and Validation of Laminar Air Flow Hood

Standard Operating Procedure Operation and Validation of Laminar Air Flow Hood 1.0 Objective: To provide a written procedure for the operation and validation of Laminar Air Flow Hood. 2.0 Scope: This SOP covers the operation and validation (in-house) of Laminar Air Flow Hood. 3.0 Responsibility: Microbiologist: To perform or implementation of this SOPQA Officer/QAM: For … Read more

SOP on Procedure for Operating a Centrifuge Machine

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Centrifuge Machine

Standard Operating Procedure for Operating a Centrifuge Machine, This Standard Opеrating Procеdurе (SOP) provides еssеntial procedure and operation of the Centrigue machine. 1.0 Objective: The primary aim of this guideline is to establish the step-by-step process for effectively using the Centrifuge Machine. 2.0 Scope: This Standard Operating Procedure (SOP) outlines the procedure for the proper … Read more

SOP for Operation and Calibration of Colony Counter

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SOP for Operation and Calibration of Colony Counter

SOP for Colony Counter is an essential step towards maintaining the Functioning and integrity of instruments used in the Pharmaceutical microbiology section. 1.0 Objective: To establish a written procedure for the operation and calibration of the Colony Counter. 2.0 Scope: This SOP covers the process of operating and calibrating the Colony Counter. 3.0 Responsibility: Microbiologist: … Read more

Sop on Non-conforming Results in Total Microbial Count in Water Samples

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1.0 OBJECTIVE: 1.1 To lay down the procedure for the Corrective and Prevention Action for non-conforming resultsin total microbial count in water samples 2.0 SCOPE: 2.1 This procedure is applicable to the utility department and all the production department 3.0 RESPONSIBILITY 3.1 Microbiologist3.2 Head – Microbiology3.3 Head – Production Block3.4 Head Engineering and Utility 4.0 … Read more

SOP for Storage and Preparation of Media and Culture

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1.0 Objective: Media is the main source of growth of the microbial. To detect the microbes in the test samples we can follow some guidelines for the preparation of the Media. 2.0 Scope: This procedure is applicable to Microbiology Department. 3.0 Responsibility:The microbiology officer is responsible to implements this SOP.Head Department is responsible for overall … Read more

SOP on Microbiological Monitoring of Compressed Air

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1.0 Objective: To lay down a procedure for microbiological monitoring of compressed air used in manufacturing areas.2.0 Scope: This SOP shall be applicable for a total viable aerobic count of compressed air of “O” Zone and Class 10,000 (liquid manufacturing) area at Manufacturing area. 3.0 Responsibility:Execution: Tr. Executive and above –QC DepartmentChecking: Asst. Manager and … Read more

Procedure for Growth Promotion Test in Microbiology

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1.0 OBJECTIVE: To lay down the procedure for the Growth Promotion Test in Microbiology Laboratory. 2.0 SCOPE: This SOP applies to carry out the procedure of Growth promotion test in the Microbiology Laboratory. 3.0 RESPONSIBILITY: 3.1 Executive – to Provide training to new joiners. 3.2 Microbiologist3.2.1. To perform activity and preparation of SOP.3.2.2. Keep data as GDP. … Read more

Procedure For Operation Of Refrigerator

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Procedure For Operation Of Refrigerator

Read about the Standard Operating Procedure for a Refrigerator, including its objectives, scope, responsibilities, accountabilities, operations, annexes, and abbreviations. 1.0 OBJECTIVE: To lay down a procedure for the Operation of Refrigerator. 2.0 SCOPE: This procedure is applicable to the Operation of the Refrigerator in the microbiology lab. 3.0 RESPONSIBILITY: Microbiologist for implementation of this SOP Head/ … Read more