93 microbiology SOPs, generated on your letterhead

Environmental Monitoring by Settle Plate Method

To describe the stepwise procedure for environment monitoring by settle plate count method.

Environmental Monitoring by Active Air Sampling

To describe the stepwise procedure for environment monitoring by microbial air sampling method.

Surface Monitoring by Swab Sampling and Analysis

To describe stepwise procedure for swab sample analysis.

Cleaning and Fogging of the Microbiology Laboratory

To describe the stepwise procedure for cleaning and fogging of microbiology laboratory.

Operation of Fogger Machine

To describe stepwise procedure for operation of fogger machine.

Preparation of Disinfectant, Sanitisation and Cleaning Solutions

To describe stepwise procedure for preparation of disinfectant, sanitization and cleaning solution.

Preparation and Use of 70% v/v IPA

To describe stepwise procedure for preparation and usage of 70% v/v IPA.

Handling of Microbial Data Deviations (EM, Purified Water and TOC)

To describe the stepwise procedure of microbial data deviation for microbial results of purified water and environment monitoring as well as for Total Organic Carbon test data deviation of Purified water.

Trend Evaluation of Environmental Monitoring and Water Results

To lay down the procedure for evaluation of the results of Environment monitoring and water analysis by graphical trending.

Personnel Monitoring in the Sterility Testing Area

To provide standard procedure for personnel monitoring in sterility test area of microbiology testing laboratory, Bag line-1 filling area and aseptic process area.

Environmental Monitoring Programme for Clean Rooms

To provide uniform stepwise procedure for environmental monitoring of clean rooms.

Non-viable Particle Monitoring in Clean Rooms

To provide step wise procedure for offline non-viable particle monitoring in cleanrooms facility.

Microbial Monitoring of Compressed Air, Nitrogen and Other Gases

To describe the stepwise procedure for microbial monitoring of compressed air, nitrogen gas and carbon dioxide gas.

Investigation of Environmental Monitoring Excursions

To provide standard procedure for carrying out investigation and to plan corrective actions if the microbial monitoring results of environment, personnel and surfaces exceed the specification limits.

Monitoring of Temperature, Relative Humidity and Differential Pressure

To provide standard procedure for monitoring of room temperature, relative humidity and differential pressure in microbiology laboratory.

Environmental Monitoring of Warehouse Areas

To provide standard procedure for operation for environmental monitoring in Ware house area.

Operation and Monitoring of Online Microbial Air Sampler

To provide standard procedure for operation and Monitoring of online Microbial Air Sampler.

Operation and Calibration of Microbial Air Sampler

To provide standard procedure for operation and calibration of microbial air sampler, Make: {{make}}, Model: {{model}}.

Operation of Compressed Air Sampler

To provide standard procedure for operation of Compressed Air Sampler, Make: {{make}}, Model: {{model}}.

Disinfectant Efficacy Validation

To lay down the procedure for demonstrating that disinfectants and sporicides, at their in-use concentrations and contact times, are effective against relevant micro-organisms on representative surfaces.

Environmental Monitoring Performance Qualification of Cleanrooms

To lay down the procedure for the environmental monitoring performance qualification (EMPQ) of new or modified cleanrooms before routine use.

Handling of Microbial Data Deviations (EM, Purified Water and TOC)

To describe the stepwise procedure of microbial data deviation for microbial results of purified water and environment monitoring as well as for Total Organic Carbon test data deviation of Purified water.

Trend Evaluation of Environmental Monitoring and Water Results

To lay down the procedure for evaluation of the results of Environment monitoring and water analysis by graphical trending.

Sampling and Microbiological Testing of Water

To describe sampling and microbial testing procedure of water

Microbial Limit Test

To describe stepwise procedure for Microbial limit test.

Coliform Test in Microbial Limit Testing

To describe stepwise procedure for Coliform test in Microbial Limit Test analysis of the product sample.

Growth Promotion, Inhibitory and Indicative Properties of Media

To describe stepwise procedure for growth promotion, inhibition and indicative test of media.

Receipt, Preparation, Sterilisation and Storage of Culture Media

This standard operating procedure is prepared to define uniform and stepwise procedure for Receiving, Preparation, Sterilization and Storage of microbiological media, diluting fluids and test solutions used for microbiological testing and environmental monitoring.

Handling of the Media Store Room

To describe the procedure for Handling of Media Store Room.

Handling of Microbial Cultures

To describe stepwise procedure for handling of Microbial culture.

Receipt, Storage and Use of Ready-to-Use Lyophilised Cultures

To lay down the procedure for Receipt, Storage and Use of Ready to use - Lyophilized culture (Bioball).

Isolation and Identification of In-house Isolates

To describe stepwise procedure for isolation and identification of in-house isolates.

Gram Staining

To describe stepwise procedure to perform gram staining.

Bioburden Test of Bulk Solutions for Parenteral Products

To describe the stepwise procedure for bioburden test of bulk solution for parenteral preparation in Microbiology laboratory.

Antimicrobial Preservative Efficacy Test

To provide standard procedure for antimicrobial preservative efficacy testing.

Identification of Micro-organisms by Automated Biochemical System

To provide standard procedure for Identification of microorganism using Vitek 2 Compact (Make: {{make}}).

Operation of Fogger Machine

To describe stepwise procedure for operation of fogger machine.

Operation and Cleaning of Microscope

To describe stepwise procedure for operation and cleaning of microscope.

Operation and Calibration of Zone Reader

To describe stepwise procedure for operation and calibration of zone reader.

Operation and Verification of Colony Counter

To describe stepwise procedure for the operation and verification of colony counter.

Operation and Cleaning of Vertical Autoclave (Process Controller)

To describe stepwise procedure for operation and cleaning of vertical autoclave.

Operation and Cleaning of Vertical Autoclave (with Printer and Sensors)

To describe stepwise procedure for Operation and Cleaning of vertical autoclave.

Operation and Cleaning of Double Door Autoclave

To describe stepwise procedure for Operation and Cleaning of Double door autoclave.

Operation, Calibration and Cleaning of Incubators (PLC/HMI)

To describe stepwise procedure for operation, calibration and cleaning of Bacteriological Incubator and BOD incubators with total PLC control and touch screen HMI.

Operation, Calibration and Cleaning of Cooling Cabinet (PLC/HMI)

To describe stepwise procedure for operation, calibration and cleaning of cooling cabinet with total PLC control and touch screen HMI.

Operation and Cleaning of Microbiological Safety Cabinet

To describe the stepwise procedure for operation and cleaning of microbiological safety cabinet.

Operation and Calibration of Micropipette

To describe stepwise procedure for operation and calibration of micropipette

Operation and Cleaning of Dynamic Pass Box

To describe stepwise procedure for operation and cleaning of dynamic pass box

Operation of Electric Loop Sterilizer

To describe stepwise procedure for operation of Hi loop electric sterilizer.

Operation of Cyclomixer

To describe stepwise procedure for operation of cyclo mixture.

Operation of Infrared Thermometer (IR Gun)

To describe stepwise procedure for operation of Infrared Thermometer (IR) Gun.

Operation, Calibration, Verification and Cleaning of Top Loading Balance

To provide a method for Operation, Calibration, Verification and Cleaning of Top Loading balance in order to prevent error while weighing and to ensure accurate weighing of materials which will ultimately control the potency and quality of finished product.

Operation of Hot Plate with Magnetic Stirrer

To provide a written procedure for operation of Hot plate with Magnetic stirrer.

Operation and Cleaning of Deep Freezer

To describe stepwise procedure for operation and cleaning of deep freezer.

Operation and Calibration of pH Meter

To provide written procedure for Operation and Calibration of pH meter (Make: {{make}}, Model: {{model}}).

Operation of Sterility Test Pump (Closed Canister System)

To describe the stepwise procedure for operation of steritest symbio pump, Make: {{make}}

Operation of Membrane Filtration Pump for Microbial Testing

To describe the procedure for operation of Milliflex Oasis pump for microbial testing in microbiology laboratory.

Operation of Leak Test Apparatus

To describe the stepwise procedure for operation of Leak Test Apparatus. (Make: {{make}}).

Operation and Cleaning of Depyrogenation Oven

To describe the stepwise procedure for Operation and Cleaning of Depyrogenation Oven; Make: {{make}}

Operation and Verification of Visual Inspection Booth

To provide standard procedure for the operation and verification of visual inspection booth.

Operation of Capsule Filtration System

To provide standard procedure for operation of capsule filtration system, Make: {{make}}

Operation and Monitoring of Online Microbial Air Sampler

To provide standard procedure for operation and Monitoring of online Microbial Air Sampler.

Identification of Micro-organisms by Automated Biochemical System

To provide standard procedure for Identification of microorganism using Vitek 2 Compact (Make: {{make}}).

Operation of Vortex Mixer

To describe the procedure for Operation of vortex mixer in Microbiology laboratory.

Operation and Cleaning of Refrigerator

To describe the stepwise procedure for Operation and cleaning of Refrigerator, Make: {{make}}

Operation of Hot Air Oven

To describe the stepwise procedure for Operation of Hot air oven, Make: {{make}}

Operation of Decontamination Autoclave

To provide standard procedure for the Operation of decontamination autoclave in Microbiology laboratory.

Operation and Cleaning of Temperature Controlled Chambers (Walk-in Incubator, Cooling Chamber)

To describe the stepwise procedure for operation, and cleaning of temperature controlled chamber (Walk in incubator, Bacteriological incubator, Cooling chamber, Deep freezer).

Operation and Calibration of Microbial Air Sampler

To provide standard procedure for operation and calibration of microbial air sampler, Make: {{make}}, Model: {{model}}.

Operation of Unidirectional Airflow (UAF) Unit

To describe the stepwise procedure for operation of unidirectional air flow (UAF), Make: {{make}}.

Operation and Calibration of Stopwatch

To describe the procedure for operation and calibration of stopwatch.

Operation and Cleaning of Water Bath

To provide stepwise procedure for the operation and cleaning of Water Bath; Make: {{make}}.

Operation of Dry Block Heater

To describe the stepwise procedure for operation of Multiblock heater, Make: {{make}}

Operation of Compressed Air Sampler

To provide standard procedure for operation of Compressed Air Sampler, Make: {{make}}, Model: {{model}}.

Operation of Anaerobic Culture Jar

To provide standard procedure for operation of anaerobic culture jar being used for generation of anaerobic environment for growth and cultivation of anaerobic microorganisms.

Entry and Exit Procedure for the Microbiology Laboratory

To describe the entry and exit procedure for microbiology laboratory.

Good Microbiology Laboratory Practices

To describe stepwise procedure for good microbiology laboratory practices.

Disposal of Media and Biohazard Waste

To describe the stepwise procedure for disposal of media and biohazard waste.

Handling of Microbial Culture and Media Spillage

To describe stepwise procedure for handling of microbial culture spillage and media spillage.

Preparation, Control and Issuance of Protocols and Reports

To provide written procedure for preparation, control and issuance of protocol or report for Microbiology laboratory of Quality control department.

Analyst and Reviewer Qualification for Microbiological Testing

To describe stepwise procedure for Analyst and Reviewer Qualification for Microbiological Testing by validating his analytical skills and to confirm the reproducibility and reliability of analytical results.

Handling of Biological Indicators and Determination of BI Strength

To describe stepwise procedure for handling of biological indicator and to determine the biological indicator strength.

Handling of Cleanroom Garments

To provide standard procedure to describe the steps to be followed during handling of clean room garments.

Operation and Cleaning of Garment Cabinet and Mobile Cart

To provide standard procedure for operation and cleaning of mobile cart and garment cabinet in microbiology laboratory.

Material Movement in the Microbiology Laboratory

To describe the stepwise procedure for material movement in microbiology laboratory.

Handling of Out of Specification Results in Microbiology

To describe a process for handling out of specification results that may occur during microbiological analysis such as sterility testing, bacterial endotoxin test, microbiological test(Bioburden & Specified microorganisms), etc. in microbiology laboratory pertaining to raw materials samples, in-process samples, and finished product samples.

Monitoring of Temperature, Relative Humidity and Differential Pressure

To provide standard procedure for monitoring of room temperature, relative humidity and differential pressure in microbiology laboratory.

Receipt, Handling and Disposal of Samples in the Microbiology Laboratory

To provide a procedure for handling of samples in microbiology laboratory for analysis.

Cleaning, Sterilisation and Storage of Glassware

To provide standard procedure to describe the procedure for the cleaning, sterilization and storage of laboratory wares for ensuring the cleanliness of laboratory wares.

Numbering of Validation Protocols and Reports, and Calibration Schedule

To lay down a procedure for microbiological method validation and miscellaneous study protocol and report numbering and calibration schedule maintenance procedure at microbiology laboratory.

Sterility Test by Membrane Filtration and Direct Inoculation

To describe the stepwise procedure for sterility testing in microbiology laboratory.

Bacterial Endotoxin Test by Gel Clot Method

To provide standard procedure for bacterial endotoxin test by Gel clot method.

Bioburden Test of Bulk Solutions for Parenteral Products

To describe the stepwise procedure for bioburden test of bulk solution for parenteral preparation in Microbiology laboratory.

Container Closure Integrity Test by Microbial Ingress

To describe the stepwise procedure for container closure integrity test (CCIT) by microbial ingress in microbiology laboratory.

Personnel Monitoring in the Sterility Testing Area

To provide standard procedure for personnel monitoring in sterility test area of microbiology testing laboratory, Bag line-1 filling area and aseptic process area.

Operation of Sterility Test Pump (Closed Canister System)

To describe the stepwise procedure for operation of steritest symbio pump, Make: {{make}}

Operation of Membrane Filtration Pump for Microbial Testing

To describe the procedure for operation of Milliflex Oasis pump for microbial testing in microbiology laboratory.

Operation of Leak Test Apparatus

To describe the stepwise procedure for operation of Leak Test Apparatus. (Make: {{make}}).

Operation and Cleaning of Depyrogenation Oven

To describe the stepwise procedure for Operation and Cleaning of Depyrogenation Oven; Make: {{make}}

Operation and Verification of Visual Inspection Booth

To provide standard procedure for the operation and verification of visual inspection booth.

Operation of Capsule Filtration System

To provide standard procedure for operation of capsule filtration system, Make: {{make}}

Handling of Cleanroom Garments

To provide standard procedure to describe the steps to be followed during handling of clean room garments.

Operation and Cleaning of Garment Cabinet and Mobile Cart

To provide standard procedure for operation and cleaning of mobile cart and garment cabinet in microbiology laboratory.

Material Movement in the Microbiology Laboratory

To describe the stepwise procedure for material movement in microbiology laboratory.

Handling of Out of Specification Results in Microbiology

To describe a process for handling out of specification results that may occur during microbiological analysis such as sterility testing, bacterial endotoxin test, microbiological test(Bioburden & Specified microorganisms), etc. in microbiology laboratory pertaining to raw materials samples, in-process samples, and finished product samples.

Environmental Monitoring Programme for Clean Rooms

To provide uniform stepwise procedure for environmental monitoring of clean rooms.

Non-viable Particle Monitoring in Clean Rooms

To provide step wise procedure for offline non-viable particle monitoring in cleanrooms facility.

Microbial Monitoring of Compressed Air, Nitrogen and Other Gases

To describe the stepwise procedure for microbial monitoring of compressed air, nitrogen gas and carbon dioxide gas.

Aseptic Process Simulation (Media Fill)

To lay down the procedure for planning, performing, incubating, inspecting and evaluating aseptic process simulations (media fills).

Handling of Microbial Data Deviations (EM, Purified Water and TOC)

To describe the stepwise procedure of microbial data deviation for microbial results of purified water and environment monitoring as well as for Total Organic Carbon test data deviation of Purified water.

Trend Evaluation of Environmental Monitoring and Water Results

To lay down the procedure for evaluation of the results of Environment monitoring and water analysis by graphical trending.

Preparation, Control and Issuance of Protocols and Reports

To provide written procedure for preparation, control and issuance of protocol or report for Microbiology laboratory of Quality control department.

Analyst and Reviewer Qualification for Microbiological Testing

To describe stepwise procedure for Analyst and Reviewer Qualification for Microbiological Testing by validating his analytical skills and to confirm the reproducibility and reliability of analytical results.

Handling of Out of Specification Results in Microbiology

To describe a process for handling out of specification results that may occur during microbiological analysis such as sterility testing, bacterial endotoxin test, microbiological test(Bioburden & Specified microorganisms), etc. in microbiology laboratory pertaining to raw materials samples, in-process samples, and finished product samples.

Investigation of Environmental Monitoring Excursions

To provide standard procedure for carrying out investigation and to plan corrective actions if the microbial monitoring results of environment, personnel and surfaces exceed the specification limits.

Preparation, Review and Maintenance of the Contamination Control Strategy

To describe how the site-wide contamination control strategy (CCS) for micro-organisms, bacterial endotoxins and particles is prepared, reviewed and kept current.

Aseptic Process Simulation (Media Fill)

To lay down the procedure for planning, performing, incubating, inspecting and evaluating aseptic process simulations (media fills).

Disinfectant Efficacy Validation

To lay down the procedure for demonstrating that disinfectants and sporicides, at their in-use concentrations and contact times, are effective against relevant micro-organisms on representative surfaces.

Validation and Verification of Microbiological Test Methods

To describe how compendial microbiological methods are verified and how non-compendial or alternative methods are validated before routine use.

Data Integrity Controls in the Microbiology Laboratory

To define controls that keep microbiological data attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.

Environmental Monitoring Performance Qualification of Cleanrooms

To lay down the procedure for the environmental monitoring performance qualification (EMPQ) of new or modified cleanrooms before routine use.

Risk Assessment of Objectionable Micro-organisms in Non-sterile Products

To define how micro-organisms recovered from non-sterile products, raw materials and water are assessed to decide whether they are objectionable.

Readiness and Conduct During Regulatory Inspections (Microbiology)

To describe how the microbiology laboratory prepares for, and conducts itself during, regulatory and customer inspections.

Review and Implementation of Pharmacopoeial and Regulatory Updates

To ensure that changes in pharmacopoeias, regulatory guidance and industry standards relevant to microbiology are identified, assessed and implemented in time.

Microbial Identification and Maintenance of the Organism Library

To lay down the procedure for identification of micro-organisms and maintenance of the site organism library.