sop for liquid particle counter

sop for liquid particle counter

 

1.0 OBJECTIVE
This SOP describes the procedure for the Operation and Calibration of Liquid Particle Counter

2.0 PURPOSE
It is the policy Analytical Division that a written procedure shall be followed for Operation and Calibration of Liquid Particle Counter

3.0 SCOPE
This procedure is applicable to Liquid Particle Counter  in Microbiology Laboratory (Analytical Division).

40 RESPONSIBILITY
Officer Microbiologist
Executive Microbiologist

5.0 PROCEDURE
5.1 OPERATION
5.1.1. Switch on the Mains of the Computer System and CPU.
5.1.2. Switch on the instrument (Liquid Particle counter).
5.1.3. As soon as the instrument gets Switched on, it automatically rinse the Isopropyl Alcohol Solution (70%v/v) previously filled from the sampling burette to discard container.
5.1.4. Double click on the Software icon of the System named as “USP”.
5.1.5. The Software of instrument is opened with main menu.
5.1.6. First of all Blank (Purified HPLC Grade Purified water) is Analysed to check the system.
5.1.7. Add the Required Details of the Blank/Sample in the respective required field as Sample name, Batch No., Code No., Comments if any, Set Up (select method if any prepared), Standard (select IP/BP/USP/EP etc. as per the test request), Test type (Select the sample type e.g. in case of Blank elect Environmental test, for large volume containers samples select: Large Volume, for Eye drops select Ophthalmic solution test, for very small sample solution volume select: Pool Small Volume, for intermediate volume of sample container/volume select Small Volume option.
5.1.8. Under number of container, if Blank has to be analyzed, on selecting the Test type: Environment Test, no. of container is remained 1, where as in case of samples no. of containers can be selected based on respective number of containers.
5.1.9. In Container Volume, type the container volume accordingly in between the amount given automatically by the instrument a per the selected Test type.
5.1.10. In next Enter the Pre run Volume enter the desired Volume used for Pre run, may remain 0.
5.1.11. Under the Number of Run option, in case of Blank 5 runs are set and in case of Sample 4 runs are set.
5.1.12. Under next option ‘Discard First Run’, can be selected or not, if selected, the instrument discards the first sample volume and then count starts.
5.1.13. In next option Sample Volume select the volume of sample to be taken by sampling syringe.
5.1.14. In Next option Dilution factor, add the dilution factor if any other wise enter 1. (Note: e.g. in a liquid if 2 ml of the sample is further diluted to 30 ml then the dilution factor shall be written as 15).
5.1.15. Now after filling & selecting all the parameters, Place the container containing Blank/Sample under the nebulizer tube.
5.1.16. Click on Start option.
5.1.17. The instrument starts taking sample as per the procedure for respective times.
5.1.18. As soon as the replicates are done the system shows the replicates as SUM (X-Y), e.g. for total 5 runs after completion of First run the system shows SUM (1-5).
5.1.19. On Completion of the Run, system shows the result as “The Sample Meets the Requirement’ with green background. If the particle count exceeds the limit, the massage is shown as “The Sample Does not Meet the Requirement’ as green background.
5.1.20. The process can be stopped in between by pressing the Cancel option.
5.1.21. To take the prints, click on the Print option. Log record is maintained as per SOP
5.2 CLEANING
5.2.1 Clean the outer Surface with Clean Cloth.
5.2.2 Rinse the Sampling Burette with IPA solution (70 %v/v) after completion of work.

5.3 PRECAUTION:

5.3.1 Do not use the system for sample until the not Blank passed.
5.3.2 Do not hold the Nebulizer tube with hands to prevent the contamination.

6.0 CALIBRATION: Every year from External Calibration service provider.

7.0 ATTACHMENTS: Nil

 

8.0 ABBREVIATIONS & DEFINITION

SOP Standard Operating Procedure
S. No. Serial Number
QA Quality Assurance
AD Analytical Division

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STP for sterility testing of sterile gloves

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Growth Promotion Test In Microbiology Laboratory

Operation of B.O.D in Microbiology Laboratory

Operation of Horizontal Laminar Air Flow in the microbiology laboratory

Operation and cleaning of Pass Box.

Operation and cleaning of air sampler

Cleaning and Sterilization of Glassware

Analysis of water for microbial load in microbiology lab

Operation and temperature monitoring of Refrigerator

Fumigation of Microbiology Laboratory.

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sop for Environmental monitoring of all the Classified area

sop for Handling and Sub culturing of Microbial cultures

sop for Media Growth Promotion Test and various Microbiological test

sop for BOD incubator operation and cleaning

sop sampling of water for microbiological analysis

sop for Disinfectant Efficacy Test

sop for for cleaning and operation of vortex mixture

sop for Temperature & Relative Humidity Monitoring

sop for Operation and Calibration of Heating Block

sop for Sterility Testing of Microbiology

sop for Disposal of Culture Media

sop for Drain point of Microbiology

sop for entry & exit procedure In Microbial limit test and Biosafety

sop for Gram Staining of Bacteria in Microbiology Laboratory

sop for Monitoring of Compressed Air/gases for microbiological analysis

sop for BET (Bacterial Endotoxin) test in Microbiology

sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

sop for Bioburden test of Packing materials in Microbiology Laboratory

sop for microbiological assay of erythromycin antibiotic

sop for liquid particle counter

sop for operation and calibration of digital zone reader

sop for monitoring of ultraviolet efficiency LAF and pass box

microbiological assay of cyanocobalamin or vitamin B12

gowning procedure for microbiological testing area

swab testing of various surfaces for bioburden determination

sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

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sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

Sop for UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water

PROCEDURE FOR FUMIGATION

sop for depyrogenation of apparatus

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sop for fertility test growth promotion test of media

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sop for monitoring by active air sampler

sop for swab sampling and testing for clean rooms in production area

sop for monitoring in microbiology laboratory

sop for Fumigation of aseptic area and microbiology lab

sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware

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