To lay down procedure for Microbial Analysis of Personal Monitoring.
2.0 SCOPE
This SOP is applicable for microbial analysis of personal monitoring in QC department.
3.0 RESPONSIBILITY
3.1 Jr. Microbiologist and above shall be responsible for the preparation of this SOP.
3.2 Sr. Microbiologist shall be responsible for the checking of this SOP.
3.3 Manager QA shall be responsible for the approval of this SOP.
3.4 HOD shall be responsible for the authorization of this SOP.
4.0 ACCOUNTABILITY
Sr. Microbiologist QC
5.0 PROCEDURE
Microbiological Personnel monitoring is carried out as per following methods:
5.1 Finger Dab Method.
5.2 Gown swabbing at different places by two methods.
5.2.1 Surface Swab method
5.2.2 Contact Plate Method
5.1 Finger Dab Method
5.1.1 Prepare SCDA medium as per SOP for preparation & sterilization of media.
5.1.2 Aseptically pour approximately 15-20 ml of sterile molten cooled (40°C) SCDA agar into sterile 90 mm petri plates.
5.1.3 Allow to solidify the plates under LAF, after solidification label all the plates with name of media preparation batch No. and date of preparation.
5.1.4 Invert and incubate the plates for pre incubation to check the plates for any contamination, if there is any contamination discards the plates as per SOP for disposal of microbial waste by Autoclaving.
5.1.5 Label all the plates with date of sampling, Personnel and hand name (right/left) and Shift with the help of marker pen.
5.1.6 Call operator or personnel to be monitored, open the plate and tell personnel to place his/her right hand fingers with gloves gently on the surface of SCDA plate. Use fresh plate for left hand finger and follow the same procedure
5.1.7 Close the plate and immediately, disinfect the fingers with sterile 70% IPA solution and ask Operator to go to change room and replace with fresh sterile gloves and gown.
5.1.8 Prepare a positive control plate by streaking any pure culture of E.coli /Salmonella / S. aureus / P. aeruginosa, on the surface of SCDA plate. For negative control, incubate the plate as it is without streaking.
5.1.9 Invert and incubate all the plates at 20 to25°C for 72 hrs and 30 to 35°C for 48 hrs.
5.1.10 After incubation, count the number of cfu formed on the plates with the help of colony counter.
5.2.1 By Surface Swab method
5.2.1.1 Prepare normal saline solution by weighing accurately 0.9 gm of Sodium chloride AR/LR grade
and dissolve in PW / WFI. Finally make up volume to 100 ml with purified water.
5.2.1.2 Take cotton Swab wet in normal saline solution to the tube of swab and Similarly prepare the
required number of swab and place in a 1000 or 3000 ml beaker
5.2.1.3 Sterilize normal saline solution and prepared swab by Autoclaving at 121°C and 15 psi pressure
for 20 minutes.
5.2.1.4 After Autoclaving swab to microbiology lab and allow to cool at room temperature
5.2.1.5 Transfer the swab to aseptic area in a SS container and disinfect with sterile 70% IPA solution.
5.2.1.6 Open the container, remove the swab from tube and rub on the surface to cover approx 25
cm2 area, uniformly and horizontally in one.
5.2.1.7 Close the tubes and label with person name, location name, date. Carry out the same procedure
for all locations and analyze the samples without store a long period.
5.2.1.8 Transfer the swab aseptically for MLT in microbiology lab through pass box and place all the
sample swabs under LAF.
5.2.1.9 Unscrew the PP tubes and remove the swab stick by gently squeezing to remove excess liquid
and then aseptically transfer the content of PP tubes into a sterile petri plates.
5.2.1.10 Label the Petri plate and aseptically add 20-25 ml of sterile, cooled (40 to 450C), SCDA agar
medium.
5.2.1.11 Simultaneously prepare positive control, by streaking bacterial culture suspension (Salmonella
or S.aureus or P.aeruginosa) into a preincubated SCDA medium petri plate.
5.2.1.12 Invert and incubate all the plates at 20 to 25°C for 72 hrs and 30 to 35°C for 48 hrs.
5.2.1.13 After incubation, count the number of cfu formed on the plates with the help of colony counter
and record the results cfu per 25 cm2
5.2.2 By contact plate
5.2.2.1 Prepare the Contact media plates and pre incubate the prepared plate as per media preparation
SOP to check the contamination.
5.2.2.2 Transfer the plates to aseptic area in a SS container and disinfect with sterile 70% IPA solution.
5.2.2.3 Aseptically open the Contact media plates & gently touch plates for surface sampling at selected
places on the gown.
5.2.2.4 Label the contact SCDA medium plate with person name, date and location.
5.2.2.5 Close the plate & keep it in an inverted position.
5.2.2.6 Clean the area of Gown by using disinfectant from where the sample is taken.
5.2.2.7 Remove the sampled gown to send for washing and autoclaving at provided change room. Wear
another Gown before carrying out the work.
5.2.2.8 Invert and incubate all the plates at 20 to 25°C for 72 hrs and 30 to 35°C for 48 hrs and record
the observations.
6.0 REFERENCES
N.A
7.0 ANNEXURE
N.A
8.0 ABBREVIATIONS :
SOP : Standards Operating Procedure
QC : Quality Control
HOD : Head of the Department
QA : Quality Assurance
QCD : Quality Control Department
QAD : Quality Assurance Department
N.A : Not Applicable
MLT : Microbial Limit Test
LAF : Laminar Air Flow
SCDA : Soyabean Casein Digest Agar
SDA : Sabouraud Dextrose Agar
SCDM : Soyabean Casein Digest Medium
Hrs : Hours
AR : Analytical Reagent
LR : Laboratory Reagent
E.coli : Escherichia coli
P. aeruginosa : Pseudomonas aeruginosa
S. aureus : Staphylococcus aureus
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