1.0 PURPOSE:
2.0 SCOPE:
This SOP is applicable for labeling, incubation and observation of microbial media filled Petri plate / glassware that are used in microbiological analysis at (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Microbiologist/Analyst: Responsible for execution of the procedure specified in this SOP.
4.2 Head Quality Control/QA: Responsible for ensuring the compliance of the SOP.
5.0 PROCEDURE:
5.1 General Instructions:
5.1.1 In-house prepared sterile petri plates should be labeled with name of the media (abbreviated), load number, prepared on and use before date. This information should be written on media side of the Petri plate.
5.1.2 Sterile liquid media in flasks / sterile solid media in flasks-bottles-tubes should have label showing media name, volume of medium, load number, prepared date, use before date and sign.
5.1.3 For ready to use plates from outside supplier, pre incubation plates before use as per the requirement of the test / respective Media preparation method sheet and store the plates as per supplier’s instructions. Just before using the plates, label the plates with the name of the media, batch number / lot number, use before date and sign if the details are not present on the plates.
5.1.4 Individual incubators or the individual shelf in an incubator should be appropriately labeled indicating whether the incubator or the individual trays are meant for pre incubation of media, storage of media.
5.2 Labeling and incubation of solid Media filled petri plates/ test tubes:
5.2.1 Label the prepared/ready to use plates for environment monitoring or any other analysis using a fine tip marker with the location, date, sign or details that are common for a set of plates can be written on the paper tape used to secure the plates.
5.2.2 Label the prepared/ready to use plates/test tubes used for water analysis and bio burden with the name of the sample, A.R.No. / Batch No., date of analysis and sign.
5.2.3 If the pour plate technique is used for analysis, label the plates with, name of sample, A.R.Number / Batch No. date of analysis and sign.
5.2.4 After the plates have solidified, invert the plates (except in case of antibiotic assays and where ever specified) and stack about 1-8 petri plate one above the other and place the stacks evenly in the incubator. The plates may be kept together by using paper tape.
5.2.5 The test tubes must be arranged neatly in a test tube stand and then placed in the incubator.
5.2.6 Record the time of start of incubation in the relevant columns in the work sheet designated for the analysis being carried out.
5.2.7 Refer the work Sheet for time at which the plates are to be read. Take out the plates from the incubator within four hours from the time noted on work sheet. After the completion of the period of incubation, remove the stack of petri plates carefully so as not to open the petri plates
5.2.8 Record the time of completion of incubation on the work sheet.
5.2.9 Take all the plates to the colony counter.
5.2.10 Arrange the plates for reading.
5.2.11 Take the respective work sheet.
5.2.12 Count the colonies as per Colony counter.
5.2.13 Record the number of colonies immediately, on the column provided in the work sheet after every plate counted.
5.3 Labeling and incubation of liquid media filled conical flasks / bottles/ canisters/ test tubes:
5.3.1 Label the liquid media filled conical flasks / bottles / canisters / test tubes using a marking pen with the name of the sample, A R number / Batch number, date of incubation and signature prior to analysis. Alternately label provided (quality control status), label for glassware in use, can be used.
5.3.2 Record the time of start of incubation in the relevant columns in the work Sheet designated for the analysis being carried out.
5.3.3 Refer the work sheet for the completion of the period of incubation. Take out the flask/ bottle / canisters/ from the incubator within four hours (if appropriate) from the time noted on work sheet. For e.g. if the flask has to be taken out from the incubator at 12:00 hours, then the flask can be read up to 16:00 hours on the same day.
5.3.4 Record the time of the completion of incubation and the results in the relevant columns of the work sheet.
5.3.5 Carry out any further analytical steps as required.
5.4 Prolonged incubation in case of holidays/weekly off:
5.4.1 If the observation date falls on a non-working day or late night incubation, the reason for additional incubation should be mentioned on the work sheet.
5.4.2 In case any microbiologist remains absent or is on leave, the Head/designee should allocate another microbiologist, to take the results and carry out the continuation to avoid prolonged incubation.
5.5 Recording of incidences:
5.5.1 Plate / flask / tube damaged or opened during handling:
5.5.1.1 If any plate or stack or flask or tube falls on the ground or work bench, immediately make a cross mark on the plate by marking pen and discard the plate.
5.5.1.2 Make note of the same on the work Sheet, if it is in case of sample plate.
5.5.1.3 Inform department Head/ QC Head for further necessary action
5.5.1.4 Invalidate the result if the plate falls before or during incubation.
5.6 Power shut down of AHU and LAF during analysis:
5.6.1 Any opened media container should be marked with a cross.
5.6.2 Make the note of the same in the work sheet if it is a sample plate.
5.6.3 Inform QC Head and department Head and invalidate the result.
6.0 ABBREVIATIONS:
QA :Quality assurance
A.R.No : Analytical Reference Number
SOP : Standard Operating procedure
No. : Number
QC : Quality control
AHU : Air Handling unit
LAF : Laminar Air Flow