Operation Calibration and Maintenance of Micropipette
1.0. OBJECTIVE :
1.1 To lay down a procedure for the Operation, Calibration and Maintenance of Micropipette having capacity of
20µl to 200µl .
2.0. SCOPE :
2.1 This procedure is applicable for the Operation, Calibration and Maintenance of Micropipette of Microbiology
Laboratory of the Quality control department
3.0. RESPONSIBILITY :
3.1 Sr.Officer / Officer – Quality Control
3.1.1 For the operation and maintenance of Micropipette as per this SOP.
3.2 Manager /Asst. Manager/Designee – Quality Control
3.2.1. To ensure that the operation and maintenance of Micropipette is done as per this SOP.
3.2.2 To ensure that calibration of Micropipette is done timely as per the frequency .
3.2.3 To ensure the compliance of SOP.
4.0. ACCOUNTABILITY :
4.1 Head – Quality Control Department
4.1.1 Head of the department is accountable to ensure the compliance of SOP for all aspects .
5.0. PROCEDURE :
5.1 OPERATION :
5.1.1 Clean the Micropipette by clean, dry cotton cloth before use .
5.1.2 Now take the one depyrogenated individually packed tip .
5.1.3 Place the tip firmly onto the end of the Micropipette .
5.1.4 Now adjust the required volume by the help of rotating knob ,provided on the top end of the Micropipette .
5.1.5 To increase the volume rotate the knob clock wise and to decrease the volume rotate the knob anti clock wise .
5.2 CALIBRATION :
5.2.1 Take 2 ml dried vials . Place one such vial on the pan of analytical balance (0.1 mg
Readability).
5.2.2 Place the tip firmly onto the end of the Micropipette .
5.2.3 Set the volume of pipette 20µl as per the below table no.5.2.6.1 of this SOP .
5.2.4 Pipette distilled water brought to 25° C ± 1° C into vial ,ensure that before pouring the distilled water in vial tare it properly , and weigh. Record the results in Annex – I. Likewise, repeat this using three more vials Record the results in the respective annex .
5.2.5 Divide the weight of water delivered by 0.99602 to obtain actual volume in ml. Take the
average of four readings .
5.2.6 Repeat the above said procedure also for the rest volumes i.e. 60µl , 100µl, 140µl and 200µl .
5.2.5 In case if the results obtained during calibration are not falling in acceptance criteria , inform to Head-QC , Head-QA ,Engineering department and or the respective service provider (as applicable) .
5.2.6. ACCEPTANCE CRITERIA :
Pipette ID.No. | |
Capacity | 20-200µl |
Set volume | Limit |
20µl | 19.8 – 20.2 µl |
60µl | 59.4 – 60.6 µl |
100µl | 99 – 101 µl |
140µl | 138.6 – 141.4 µl |
200µl | 198 – 202 µl |
5.2.7 Frequency : Half Yearly .
5.2.7.1 Tolerance window : 10 days .
5.4 MAINTENANCE :-
5.5.1 Record the nature of problem as soon as the problem is noticed during usage of the equipment .
5.5.2 Intimation to maintenance department shall be given according to the breakdown memo as per
SOP no
5.5.3 Whenever the respective equipment is out of order or is malfunctioning ,put the tag as per the format mentioned below :
5.3 PRECAUTION :
5.3.1 If the handle and/or piston has been changed the pipette must be recalibrated. If the O-ring and/or tip cone has
been changed it is recommended to check the calibration .
UNDER MAINTENANCE |
NAME : |
I D NO : |
LOCATION : |
DATE : |
SIGN (USER) : |
SIGN (E&M) : |
6.0. ABBREVIATION :
Sr. No. | Abbreviation used | Full form of abbreviation used |
1.0 | QC | Quality Control |
2.0 | Ltd. | Limited |
3.0 | SOP | Standard Operating procedure |
4.0 | ml. | Millie Liter |
5.0 | ° C | Degree Celsius |
6.0 | µl | Micro Liter |
7.0 | ID.No. | Identity Number |
8.0 | QA | Quality Control |
9.0 | DGM | Deputy General Manager |
Sr. No. | Abbreviation used | Full form of abbreviation used |
10.0 | Sr. | Senior |
7.0. ATTACHMENTS (ANNEXES) :
7.1. Annexure – I : Calibration of Micropipette .
8.0. REFERENCE :
Sr. No. | Reference Title | Author Name | Edition |
— | —- | —– | —- |
Annexure – I
Calibration of Micropipette
Set volume | Actual wt. of WFI at 25° C | Actual volume
wt. / 0.997 g/ml (at 25° C) |
Average volume | Acceptance Criteria |
20ml | 19.8 – 20.2 µl | |||
60ml | 59.4 – 60.6 µl | |||
100ml | 99-101 µl | |||
140ml | 138.6-141.4 µl | |||
200ml | 198-202 µl | |||
Frequency : Every six month
sop for calibration and validation of micro autoclave
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cleaning and operation of discard autoclave
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sop for Biological assay of lactic acid bacillus
sop for preparation of culture inoculum
STP for sterility testing of sterile gloves
sop for Operation and calibration of active air sampler
sop for transfer of material for testing and sampling in sterile area
entry & exit procedure in microbiology laboratory
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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.
Entry & Exit procedure In Sterility Area
SOP for Microbial analysis of Raw Material Finished Products
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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
Sop for Operation of Airborne Particle Counter
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 microbiological testing of water
sop for depyrogenation of apparatus
sop for fertility test growth promotion test of media
sop for Operation and cleaning of moist heat sterilizer
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
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