FP 201112123122121

MICROBIAL LIMIT TEST
(MLT)
REPORT No:
PRODUCT: BATCH/GRN No.:
SAMPLE SOURCE: Q.C. No.:
SAMPLE QUANTITY:
TESTING DATE: REPORTING DATE:
SUMMARY OF RESULTS
TEST LIMITS RESUL
Total Aerobic Microbial Count (TAMC) Not more than 1,000 CFU per g of Tab.
Total Combined Yeast/Mold Count

Not more than 100 CFU per g of Tab.
(TYMC)
Bile-tolerant Gram-
Should be absent.
negative Bacteria
Pseudomonas aeruginosa Must be absent
Staphylococcus aureus Must be absent
Escherichia coli Must be absent
Salmonella Species Must be absent
Clostridia Species Must be absent
Candida albicans Must be absent
CFU = Colony Forming Unit.
REMARKS: Sample complies the acceptance criteria, (P box shows the product's status).
Yes No

(MLT)
REPORT No:
DAY - 1:
1. Growth Promotion Test and Negative Controls of First Day Media Used:
Media Lot No. Growth Promotion Test No. Incubation Tem
Tryptic Soy Agar 30 - 35 C for

Tryptic Soy Broth 30 - 35 C for
Sabouraud Dextrose Agar 20 - 25 C for
Sabouraud Dextrose Broth 20 - 25 C for
Reinforced Clostridial Medium 30 - 35 C for
Enterobacteria Enrichment Broth-Mossel 30 - 35 C for

Test Performed By/On:
Microbiologist
DAY - 2:
2. Physical Check of Media: (P box shows test and media status)
Media Observation of Growth Positive Control Negative C
Tryptic Soy Broth Yes No Yes No No Yes
Enterobacteria Enrichment Broth-Mossel Yes No Yes No No Yes
3. Growth Promotion Test and Negative Controls of Second Day Media Used:
Cetrimide Agar 30 - 35 C for

MacKonkey Broth 42 - 44 C for
Mannitol Salt Agar 30 - 35 C for
Violet Red Bile Agar 30 - 35 C for
Rappaport Vassiliadis Salmonella Broth 30 - 35 C for

Microbiologist
DAY - 3:
4. Physical Check of Media: (P box shows test and media stauts)
MacKonkey Broth Yes No Yes No No Yes

Violet Red Bile Agar Yes No Yes No No Yes
Reinforced Clostridial Medium Yes No Yes No No Yes
Rappaport Vassiliadis Salmonella Enrichment
Yes No Yes No No Yes
Broth
5. Physical Check of Media for growth and Record: Examine the plates for growth and record if present
on specified media plates for specified microorganisms.
Specimen Plates
Media Dilution Absent / Present Negative C
#1 #2
Clostridia Species:
Reinforced Clostridial Medium 1 : 10 No Yes

(MLT)
REPORT No:
Bile-Tolerant Gram-Negative Bacteria:
Violet Red Bile Agar 1 : 10 No Yes
Escherichia coli:
MacKonkey Broth 1 : 10 No Yes
Salmonella Speices:
Rappaport Vassiliadis
1 : 10 No Yes
Salmonella Broth
6. Growth Promotion Test and Negative Controls of Three Day Media Used:
Columbia Agar 30 - 35 C for
MacKonkey Agar 30 - 35 C for
Sabouraud Dextrose Agar 30 - 35 C for
Xylose, Lysine, Deoxycholate Agar 30 - 35 C for

Microbiologist
DAY - 4:
Tryptic Soy Agar Yes No No Yes

Sabouraud Dextrose Broth Yes No Yes No No Yes
Specimen Plates Average

Media Dilution CFU/g or mL Negative C
#1 #2 Count
Total Aerobic Microbial Count (TAMC):
Tryptic Soy Agar 1 : 10 CFU No Yes
Clear / Turbid
Enrichment for Candida albicans:
Sabouraud Dextrose Broth 1 : 10 No Yes
Test Observed By/On:
Microbiologist
DAY - 5:
Cetrimide Agar Yes No Yes No No Yes

Mannitol Salt Agar Yes No Yes No No Yes
Xylose, Lysine, Deoxycholate Agar Yes No Yes No No Yes
Sabouraud Dextrose Agar Yes No Yes No No Yes
9. Physical Check of Media for growth and Record: Examine the plates for growth and record if present
on specified media plates for specified microorganisms.
Specimen Plates
Media Dilution Absent / Present Negative C
#1 #2
Pseudomonoas aeruginosa:
Cetrimide Agar 1 : 10 No Yes

(MLT)
REPORT No:
Staphylococcus aureus:
Mannitol Salt Agar 1 : 10 No Yes
Escherichia coli:
MacKonkey Agar 1 : 10 No Yes
Salmonella:
Xylose, Lysine, Deoxycholate
1 : 10 No Yes
Agar
Clostridia:
Columbia Agar 1 : 10 No Yes
Microbiologist
DAY - 6:
10. Physical Check of Media for growth and Record:
#1 #2 Count
Candida albicans:
Sabouraud Dextrose Agar 1 : 10 No Yes
11. Physical Check of Media for growth and Record: (P box shows test and medium status)
Sabouraud Dextrose Agar Yes No Yes No No Yes

#1 #2 Count
Total Combined Yeast / Mold Count (TYMC):
Sabouraud Dextrose Agar 1 : 10 CFU No Yes
Microbiologist
12. Acceptance Criteria:
Examine the plates for growth, count the number of colonies, and express the average of two plates in
terms of Colony Forming Unit per g (CFU/g) or per mL (CFU/mL).
If no growth / microbial colonies recover from the specimen's duplicate plates, express the result(s) as,
"Less Than 10 CFU/g or mL of Specimen (<10 CFU/g or mL).
Product complies with the test if no growth observed / detected on the surface of specified culture media.
If growth observed / detected on any specified medium, the product test must be repeated. After retesting,
if again observed / detected any sign of growth then reject the batch at non-compliance of the test.
13. Negative Controls:
To verify testing conditions, a negative control is performed using the chosen diluent in place of the test
preparation. There must be no growth of microorganisms observed / detected. A negative control is also
performed when testing the products as described under the Testing of Products.
If product sample shows no growth but negative control shows any growth then retest the product sample.
If product sample shows growth but negative control also shows any growth then again retest the sample.
A failed negative control requires an investigation.
14. Reference:
United States Pharmacopeia (USP - 39), Chapters: <61> & <62>.
British Pharmacopeia (BP - 2016), Chapters <2.6.12> & <2.6.13>.
RY OF RESULTS
RESULTS
No
Incubation Temp. & Time
30 - 35 C for 72 Hours
20 - 25 C for 120 Hours
Negative Control
No Yes
No Yes
42 - 44 C for 24-48 Hrs
Negative Control
No Yes
No Yes
No Yes
No Yes
Negative Control
No Yes
No Yes
No Yes
No Yes
Negative Control
No Yes
No Yes
Negative Control
No Yes
No Yes
Negative Control
No Yes
No Yes
No Yes
No Yes
Negative Control
No Yes
No Yes
No Yes
No Yes
No Yes
Negative Control
No Yes
Negative Control
No Yes
Negative Control
No Yes

FP 201112123122121

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MICROBIAL LIMIT TEST

PRODUCT: BATCH/GRN No.:

SAMPLE SOURCE: Q.C. No.:

TESTING DATE: REPORTING DATE:

Total Combined Yeast/Mold Count

Pseudomonas aeruginosa Must be absent

Staphylococcus aureus Must be absent

Escherichia coli Must be absent

Salmonella Species Must be absent

Clostridia Species Must be absent

Candida albicans Must be absent

CFU = Colony Forming Unit.

MICROBIAL LIMIT TEST

Tryptic Soy Agar 30 - 35 C for

Enterobacteria Enrichment Broth-Mossel 30 - 35 C for

Tryptic Soy Broth Yes No Yes No No Yes

Enterobacteria Enrichment Broth-Mossel Yes No Yes No No Yes

Cetrimide Agar 30 - 35 C for

Rappaport Vassiliadis Salmonella Broth 30 - 35 C for

MacKonkey Broth Yes No Yes No No Yes

MICROBIAL LIMIT TEST

Media Lot No. Growth Promotion Test No. Incubation Tem

Columbia Agar 30 - 35 C for

MacKonkey Agar 30 - 35 C for

Sabouraud Dextrose Agar 30 - 35 C for

Xylose, Lysine, Deoxycholate Agar 30 - 35 C for

Tryptic Soy Agar Yes No No Yes

Specimen Plates Average

Cetrimide Agar Yes No Yes No No Yes

MICROBIAL LIMIT TEST

Sabouraud Dextrose Agar Yes No Yes No No Yes

Incubation Temp. & Time

Incubation Temp. & Time

Incubation Temp. & Time

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