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SOP for Microbial Monitoring of Drainage in Solid Dosage Manufacturing Area


Standard operating procedure of sampling (before sanitization and after sanitization) and testing of drain water, in solid dosage manufacturing area.

1.0  OBJECTIVE

       To lay down the procedure of sampling (before sanitization and after sanitization) and testing of drain water, in solid dosage manufacturing area.

2.0  SCOPE

       This procedure is applicable to all critical drains of Solid Dosage manufacturing area.

3.0  RESPONSIBILITY

3.1  Doing      :  Technical Assistant/Executive.
3.2  Checking :  Executive/ Manager

4.0  ACCOUNTABILITY 

 Head of the Department

5.0  PROCEDURE

5.1  Sampling Procedure

5.1.1  Collect approx 20 ml of drain sample (Before and after sanitization) in sterile container from   
           the drainage using sterile pipette.
5.1.2  Use sucking bulb and Pipette for collection of sample.

5.2  Testing Procedure for TOTAL VIABLE COUNT

5.2.1  Take 1 ml sample and dilute to 10 ml with sterile Soyalecithin medium. ( dilution )
5.2.2  Take 1 ml from dilution & further dilute to 10 ml with sterile Soya lecithin medium
          (1:100 dilution). Similarly prepare 1:1000 dilution.
5.2.3  Finally take 1 ml sample solution from 1: 100 dilution or 1:1000 dilution with the help of sterile micro pipette in to sterile Petri dish aseptically for Bacteria & fungi count.
5.2.4  Perform the test in duplicate.
5.2.5  Pour approximately 20 ml of Soyabean Casein digest agar for bacteria and Sabouraud dextrose  agar for fungi, previously melted and cool to 45°C in to two different plates and mix well by    tilting or rotating. Allow solidifying.
5.2.6  Write down the location No. and date on each plate.  
5.2.7  Incubate the SCD agar plate at 30°-35°C  for bacteria and Sabouraud dextrose agar plate at 20°-25°C for fungi. for 5 days
5.2.8  After incubation period, examine the plate for growth . (No. of colonies)
5.2.9  Calculate the average colonies of two plates in terms of cfu/ml.
5.2.10  Count the No. of colonies as per following calculation and   record in Annexure –I
5.3  Calculation
5.3.1  1 : 100  à  If the plate show N No. of cfu, the No. of cfu/ml  = N x 100 
          1 : 1000 à  If the plate show N No. of cfu, the No. of cfu/ml  = N x 1000 
5.4  Testing procedure of for Microbial Limit Test (E.coli & Salmonella)
5.4.1  Take 10ml of sample and add in sterile Soyalecithin Medium and proceed as per
          Method No.: ____________
5.4.2  Record the results in Annexure - II        
Frequency: Once in a month.

6.0  ABBREVIATIONS:

       SOP - Standard Operating Procedure


                                                                    ANNEXURE -I
                                MICROBIAL MONITORING OF DRAINAGE IN SOLID DOSAGE AREA

                                                                                                               S.O.P NO.: ______________


Name of Sample :   Drain Water

Location: __________________________________

Report No

Drain ID No


: _______________
: _______________

Method:  Plate Method


Medium Used : S.C.D Agar, Lot No.:______________
                          S.D Agar,    Lot No.:______________
Diluents: Soya lecithin medium, Lot No. :__________

Incubation Condition

SCD Agar: At 30-35°C for 5 days
S.D. Agar: At 20-25°C for 5 days


Date of Testing
Sample
Dilution
Dilution
Factor
(F)
cfu/plate (P)
Cfu/ml
F X P
Mean cfu/ml

Bacteria
Fungi
Bacteria
Fungi
Bacteria
Fungi

Before Sanitiz-ation


















After Sanitiz-ation




















Before Sanitization:

Bacteria: ______________ cfu/ml              

Fungi    : ______________ cfu/ml


E.coli         : ______________ 
Salmonella : ______________


After Sanitization:

Bacteria: ______________ cfu/ml              

Fungi    : ______________ cfu/ml


E.coli         : ______________ 
Salmonella : ______________


Acceptance Criteria for After Sanitization : NMT 1000 cfu/ml for Bacteria
                                                                            NMT 100 cfu/ml for Fungi
                                                                            E.coli and Salmonella Should be Absent
Conclusion:


Analyst :                                   Date of Completion :                                   Checked By :
Date:                                                                                                              Date




ANNEXURE -II
                                MICROBIAL MONITORING OF DRAINAGE IN SOLID DOSAGE AREA
                                                       
                                                                                           S.O.P NO.: ______________________      


Name of Sample :   Drain Water

Location: ______________________________

Report No

Drain ID No

Method No.
: _______________
: _______________

TEST FOR E.coli (a) 1st day date:______________ 10 ml of sample + 100ml Sterile Soyabean Casein Digest Medium, Lot No.:_____________________ Incubate for 24 hours.
(b) 2nd day date:_______________ 1ml of above suspension (a) + 10ml of MacConkey’s Broth, Lot No: ___________________Incubate for 48 hours.

OBSERVATION:  Date:__________________ Acid & Gas Production:  Yes  /  No          
                 
(c) 4th  day date:______________ 0.1ml of the above suspension(b) inoculate in Peptone water,                                Lot No.__________________ and MacConkey’s Broth, Lot No: ________________Incubate for 24 hours.

OBSERVATION:  Date:_________________
                                (1) MacConkey’s Broth:   Acid & Gas Production                      Yes  /  No
                   (2)  INDOL Test           :    Positive                                         Yes  /  No                                                        
Conclusion: E.coli is   Absent  /  Present                                                                         Positive Control:
TEST FOR Salmonellae Spec.

(a)     1st day date:_______________10 ml of sample + 100ml Sterile Soyabean Casein Digest Medium, Lot No.:_______________________ Incubate for 24 hours.

(b)     2nd day date:_____________1ml of the above suspension (a) + 10ml of Selenite Cystine Broth,
       Lot No._________________ or Tetrathionate Bile Brilliant Green Broth, Lot No.________________         Incubate for 48 hours.

(c)     4th  day date:________________ Streak 1 loop full of the above suspension(b) on to the

       Bismuth Sulphite Agar Plate       Lot No.____________________  Incubate for 24 hours.
       Brilliant Green Agar Plate,          Lot No.__________________ _   Incubate for 24 hours.
                         Deoxycholate Citrate Agar Plate, Lot No.____________________  Incubate for 24 hours.
                 
                    OBSERVATION:  Date:________________
                          1. Bismuth Sulphite Agar:        : Black or Green colony :  Yes  /  No
                          2. Brilliant Green Agar             : Small, Transparent, Pinkish or white colonies : Yes /  No
                          3. Deoxycholate Citrate Agar   : Colorless, Opaque with or without black centered :Yes / No
                    
             (d)  5th day date :___________________Streak & stab 1 loop full on TSI, Lot No._________ and inoculate in           
                   Urea broth, Lot No.:_____________ with typical colonies present on above medium plates. Incubate for 24 hours.
          
             OBSERVATION:   Date:__________________
                1.Slant –alkaline (Red), butt- acidic (yellow) + Gas (with or without blacking) :   Yes /  No
                2.Red colour observed in Urea Broth  :   Yes  /  No                
Conclusion: Salmonella Spec. is   Absent  /  Present                                                      
Positive Control:


Analyst                                 Date of Completion                                     Checked By             
Date                                                                                                        Date
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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