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REPORT FOR MLT (MICROBIAL LIMIT TEST) VALIDATION

NAME OF PRODUCT Protocol No. MBD/MVP/001
Effective Date 10/07/2015
SUCRALFATE ORAL SUSPENSION 1g / 5ml
Page 1 of 19

REPORT FOR MLT

(MICROBIAL LIMIT TEST)
VALIDATION OF
SUCRALFATE ORAL SUSPENSION
1g / 5ml
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REPORT FOR MLT (MICROBIAL LIMIT TEST) VALIDATION

NAME OF PRODUCT Protocol No. MBD/MVP/001
Effective Date 10/07/2015
SUCRALFATE ORAL SUSPENSION 1g / 5ml
Page 2 of 19
1.0 PRODUCT DETAILS:
Name of the Product.
Batch No. Specification No.

Added Preservative In activator Use

Sample Quantity Name of the method

Test Performed Date
2.0 MEDIA DETAILS:
Media
Name of Media Used Abbreviated Media Reference No. Valid Up to
Code
Soyabean casein digest medium SCDM
Soyabean casein digest agar SCDA
Sabouraud dextrose agar SDA
MacConkey broth MCB
MacConkey agar MCA
Rappaport Vassiliadis salmonella enrichment RVSEB
broth
Xylose lysine deoxycholate agar XLDA
Cetrimide Agar CA
Mannitol Salt agar MSA

3.0 CHALLENGE STRAINS USED:

Inoculum
NCIM or MTCC Culture Reference No. / Valid
Name of the Strains Concentration
No. Batch No. Up to.
(CFU/0.1mL)
Pseudomonas aeruginosa

Staphylococcus aureus

Escherichia coli

Salmonella species

Aspergillus brasiliensis

Candida albicans
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NAME OF PRODUCT Protocol No. MBD/MVP/001
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SUCRALFATE ORAL SUSPENSION 1g / 5ml
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4.0 SAMPLE PREPARATION DETAILS:
4.1 Preparation: ____________________________________________________________________
_______________________________________________________________________________.
4.2 Heat Treatment: given / not given _________for ________minutes. (Time from
________to________)
4.3 pH Checked: Done / not done pH adjustment: Done / not required.
pH of the sample: _____________ .

5.0 MICROBIAL ENUMERATION TESTS (TAMC &TYMC):

5.1 Product Positive Control (PPC):
Inoculum Details Volume
Incubation
Name of the of Number of Media
Conc. Volume temperature
organism sample plate taken Used
& Incubator Id:
CFU’s/0.1ml added plated
Salmonella

Escherichia coli SCDA

(TAMC)
P. aeruginosa

S. aureus

A. brasiliensis SDA
(TYMC)
C. albicans

5.2 Inoculum Control (IC):

Inoculum Details Incubation

Name of the Number of Media
Conc. CFU’s’ Volume added temperature
organism plates taken Used
/0.1 ml to plate & Incubator Id:

Salmonella
SCDA
Escherichia coli (TAMC)
P. aeruginosa
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S. aureus
SDA
A. brasiliensis
(TYMC)
C. albicans

5.3 Test Specimen and Negative Control:

Volume of Number of Incubation temperature

Name of the Sample Media Used
sample plated plates taken & Incubator Id:
Test specimen
Test Negative Control SCDA
Media Negative Control

Test specimen

Test Negative Control SDA

Media Negative Control

Analyzed By (Sign/date): Checked By (Sign/date):

5.4 TAMC (Total Aerobic Microbial Count) Observations (IC & PPC):
Product Positive Control
Name of the Incubated Inoculum Control (CFU’s)
(CFU’s)
organism
From To Plate 1 Plate 2 Avg Plate 1 Plate 2 Avg
Salmonella

Escherichia coli

P. aeruginosa

S. aureus

Observed By (Sign/date): Checked By (Sign/date):

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SUCRALFATE ORAL SUSPENSION 1g / 5ml
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5.5 TYMC (Total yeast and mould Count) Observation (IC & PPC):

Product Positive Control

Name of the Incubated Inoculum Control (CFU’s)
(CFU’s)
organism From To Plate 1 Plate 2 Average Plate 1 Plate 2 Average

A. brasiliensis

C. albicans

Observed By (Sign/date): Checked By (Sign/date):

5.6Test Specimen and Negative Control Observations:

Incubated Observations
Name of the Sample Media Used
From To Plate 1 Plate 2 Average
Test Specimen
Test Negative
Control SCDA
Media Negative
Control
Test Specimen
Test Negative
Control SDA
Media Negative
Control

Observed By (Sign/date): Checked By (Sign/date):

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SUCRALFATE ORAL SUSPENSION 1g / 5ml
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5.7 Recovery Results:
Product Test Inoculu Acceptance *Percentage
Positive Specimen Corrected m criteria of recovery Complies
Name of the
Control (Average Count Control (Factor of 2) when / Does not
organism
(Average CFU) ‘A - C’ (Average compared complies
B/2 BX2 with IC
CFU) ‘A’ ‘C’ CFU) ‘B’
Salmonella

Escherichia coli

P. aeruginosa

S. aureus

A. brasiliensis

C. albicans

Product positive control (A) - Test specimen(C)

*Recovery (%) on observation = _________________________________________X 100%
Inoculums control (B)
Acceptance criteria: Microbial Counts of each of the test strains obtained in Product Positive Control
(In presence of the product) should be within factor of two from the counts obtained in Inoculum control.

6.0 RECOVERY OF SPECIFIED MICROORGANISMS

6.1 Test for detection of Escherichia Coli
 Test Specimen Preparation:
Transfer_________ gm/mL of sample to ________________Soyabean casein digest medium
(Reference No)._____________________)

 Product Positive Control Preparation:

Transfer_________________ gm/mL of sample to _______________ Soyabean casein digest
medium (Reference No._______________________).
Mixed well and added ______ml of E. Coli culture suspension containing ________CFU.
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 Inoculum Control Preparation:
Added ______ml of E. Coli culture suspension containing _________CFU to _______ml of
Soyabean casein digest medium (Reference No.______________________).

 Test Negative Control Preparation:

Transfer _________ml of chosen sterile diluent (______) to ____________Soyabean casein digest
medium (Reference No._________________________)

 Media Negative Control Preparation:

Keep sterile conical flask/tube containing _____________mL of Soyabean casein digest medium as
a negative control. (Reference No.________________________).
Analyzed by Sign /Date: _____________________

 Product Positive Control & Inoculum Control:

Incubate Product Positive Control and Inoculum Control containers at ________OC (30 to 35OC for 18
to 24 hrs.) from ___________to _________in incubator No.___________________.

 Test Specimen & Negative controls:

Incubate test specimen and Negative Control containers at ___________OC (30 to 35OC for 24 to
48 hrs.) from _________________ to ______________ in incubator No._____________________.

Analyzed by Sign /Date: _____________________.

SCDM OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Product Positive Control: Growth observed / No Growth observed
Growth observed / No Growth observed
Inoculum Control:
Growth observed / No Growth observed
Test Specimen:
Growth observed / No Growth observed
Media Negative Control:
Growth observed / No Growth observed
Test Negative Control:
 Product Positive Control & Inoculum Control:
After completion of incubation, transferred ___ (1 ml) of suspension from each of the above culture
medium separately into tubes containing ____ (100 ml) of MacConkey broth.
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(Reference No.______________) and incubated at _________ (44.3 to 44.7OC for 24 hrs.) from
_____________to ______________ in incubator No.___________________.
Analyzed by Sign /Date: _____________________.

 Test Specimen & Negative controls:

After completion of incubation, transferred ___ (1 ml) of suspension from of the above culture medium
separately into tubes containing ____ (100 ml) of MacConkey broth.
(Reference No.______________) and incubated at _________ (44.3 to 44.7OC for 24 hrs.) from
______________to _______________ in incubator No._________________.

Analyzed by Sign /Date: _____________________.

MCB OBSERVATIONS Observed By Checked By
(Sign/date): (Sign/date):
Product Positive Control: Growth observed / No Growth observed
Growth observed / No Growth observed
Inoculum Control:
Growth observed / No Growth observed
Test Specimen:
Growth observed / No Growth observed
Media Negative Control:
Growth observed / No Growth observed
Test Negative control

 Product Positive Control & Inoculum Control:

After incubation, subculture a loopful of each of the above media separately on plate of MacConkey
Agar Medium (Reference No.___________) and incubated at ______30 to 35OC for 72 hrs.) from
___________ to ___________ in incubator No.___________________.

Analyzed by Sign /Date: _____________________.

 Test Specimen & Negative controls:
After incubation, subculture a loopful of each of the above media separately on plate of MacConkey
Agar Medium (Reference No._________________) and incubated at _____ (30 to 35OC for 72 hrs.)
from ____________to _________in incubator No.___________________

Analyzed by Sign /Date: ____________________

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SUCRALFATE ORAL SUSPENSION 1g / 5ml
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MCA OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Characteristic Growth observed
Product Positive Control:
No Characteristic Growth observed
Characteristic Growth observed
Inoculum Control: No Characteristic Growth observed
Characteristic Growth observed
Test Specimen: No Characteristic Growth observed
Test Negative Control: Growth observed / No Growth observed

Media Negative Control: Growth observed / No Growth observed

Results:
 Product Positive Control: E. coli is Recovered / Not Recovered

 Inoculum Control: E. coli is Recovered / Not Recovered

 Test Specimen: E. coli is Recovered / Not Recovered

 Test Negative Control: Growth observed / No Growth observed

 Media Negative Control: Growth observed / No Growth observed

6.2 Test for detection of Salmonella species

 Test Specimen Preparation:
Transfer_________ gm/mL of sample to __________________ Soyabean casein digest medium
(Reference No)._________________________)

 Product Positive Control Preparation:

Transfer_________________ gm/mL of sample to _______________________ Soyabean casein
digest medium (Reference No._______________________)
Mixed well and added ______ml of Salmonella species culture suspension containing
________CFU.

 Inoculum Control Preparation:

Added ______ml of Salmonella species culture suspension containing _________CFU to
_______ml of Soyabean casein digest medium (Reference No._____________________).
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 Test Negative Control Preparation:
Transfer_________ mL of chosen sterile diluent (_____) to ________ ml Soyabean casein digest
medium (Reference No._________________________)

 Media Negative Control Preparation:

Keep sterile conical flask/tube containing ____________________ml of Soyabean casein digest
medium as a negative control. (Reference No.____________)

Analyzed by Sign /Date: _____________________.

 Product Positive Control & Inoculum Control:

Incubate Product Positive Control and Inoculum Control containers at ___________OC (30 to
35OC for 18 to 24 hrs.) from _____________ to ____________in incubator No.________________.

 Test Specimen & Negative control:

Incubate test specimen and Negative Control containers at _____________OC (30 to 35OC for 24 to
48 hrs.) from _________________ to _____________ in incubator No.______________________

Analyzed by Sign /Date: _____________________.

SCDM OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Growth observed / No Growth observed
Product Positive Control:
Growth observed / No Growth observed
Inoculum Control:
Growth observed / No Growth observed
Test Specimen:
Growth observed / No Growth observed
Test Negative Control:
Growth observed / No Growth observed
Media Negative Control
 Product Positive Control & Inoculum Control:
After completion of incubation, transferred ___ (0.1 ml) of suspension from each of the above culture
medium separately into tubes containing ____ (10 ml) of RVSEB (Reference No.______________)
and incubated at_______(30 to 35OC for 18 to 24 hrs.) from _____________to_________________
in incubator No.________________________.

Analyzed by Sign /Date: _____________________.

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 Test Specimen & Negative control:
After completion of incubation, transferred ___ (0.1 ml) of suspension from each of the above culture
medium separately into tubes containing ____ (10ml) of RVSEB (Reference No.______________)
and incubated at ________(30 to 35OC for 18 to 48 hrs.) from ______________to _____________
in incubator No.____________________.

Analyzed by Sign /Date: ____________________

RVSEB OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Growth observed / No Growth observed
Product Positive Control:
Growth observed / No Growth observed
Inoculum Control:
Growth observed / No Growth observed
Test Specimen:
Growth observed / No Growth observed
Test Negative Control:
Growth observed / No Growth observed
Media Negative Control:
 Product Positive Control & Inoculum Control:
After incubation, subculture a loopful of each of the above media separately on plate of Xylose
Lysine, Deoxy cholate Agar (XLDA) (Reference No.___________________) and incubated at (30 to
35OC for 18 to 24 hrs.) from____________ to___________ in incubator No.___________________.

Analyzed by Sign /Date: _____________________.

 Test Specimen & Negative control:
After incubation, subculture a loopful of each of the above media separately on plate of XLD A
(Reference No._________________) and incubated at _____________ (30 to 35OC for 24 to 48
hrs.) from _______________to _______________in incubator No._________________________.

Analyzed by Sign /Date: ____________________

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XLDA OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Characteristic Growth observed /
Product Positive Control:
No Characteristic Growth observed
Characteristic Growth observed /
Inoculum Control: No Characteristic Growth observed
Characteristic Growth observed /
Test Specimen: No Characteristic Growth observed
Test Negative Control: Growth observed / No Growth observed

Media Negative Control: Growth observed / No Growth observed

Results:
 Product Positive Control: Salmonella species is Recovered / Not Recovered

 Inoculum Control: Salmonella species is Recovered / Not Recovered

 Test Specimen: Salmonella species is Recovered / Not Recovered

 Test Negative Control: Growth observed / No Growth observed.

 Media Negative Control: Growth observed / No Growth observed.

6.3 Test for detection of Staphylococcus aureus

 Test Specimen Preparation:
Transfer_________ gm/mL of sample to ______________________________ Soyabean casein
digest medium (Reference No).__________________)

 Product Positive Control Preparation:

Transfer_________________ gm/mL of sample to ____________________ Soyabean casein
digest medium (Reference No._____________________)
Mixed well and added ______ml of Staphylococcus aureus culture suspension containing
________CFU.

 Inoculum Control Preparation:

Added ______ml of Staphylococcus aureus culture suspension containing _________CFU to
_______ml of soybean casein digest medium (Reference No.____________).
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 Test Negative Control Preparation:
Transfer_________ mL of chosen sterile diluent (_______) to ________Soyabean casein digest
medium (Reference No._________________________).

 Media Negative Control Preparation:

Keep sterile conical flask/tube containing ____________________ml of Soyabean casein digest
medium as a negative control. (Reference No.____________)

Analyzed by Sign /Date: _____________________.

 Product Positive Control & Inoculum Control:

Incubate Product Positive Control and Inoculum Control containers at _____OC (30 to 35OC for 18
to 24 hrs.) from ________________ to ______________in incubator No.___________________.

 Test Specimen & Negative control:

Incubate test specimen and Negative Control containers at _____________OC (30 to 35OC for 24
hrs. from _________________ to _______________ in incubator No.________________________

Analyzed by Sign /Date: _____________________.

SCDM OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Growth observed / No Growth observed
Product Positive Control:
Growth observed / No Growth observed
Inoculum Control:
Growth observed / No Growth observed
Test Specimen:
Growth observed / No Growth observed
Test Negative Control:
Growth observed / No Growth observed
Media Negative control
 Product Positive Control & Inoculum Control:
After incubation, subculture a loopful of each of the above media separately on plate of Mannitol salt
Agar (Reference No._____________) and incubated at ________ (30 to 35OC for 18 to 72 hrs.) from
________________ to ________________ in incubator No._____________________________.

Analyzed by Sign /Date: _____________________.

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 Test Specimen & Negative control:
After incubation, subculture a loopful of each of the above media separately on plate of Mannitol salt
Agar Medium (Reference No._________________) and incubated at _______ (30 to 35OC for 72
hrs.) from _______________to _______________in incubator
No.___________________________.

Analyzed by Sign /Date: ____________________.

MSA OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Characteristic Growth observed /
Product Positive Control:
No Characteristic Growth observed
Characteristic Growth observed /
Inoculum Control: No Characteristic Growth observed
Characteristic Growth observed /
Test Specimen: No Characteristic Growth observed

Test Negative Control: Growth observed / No Growth observed

Media Negative Control Growth observed / No Growth observed

Results:
 Product Positive Control: Staphylococcus aureus is Recovered / Not Recovered

 Inoculum Control: Staphylococcus aureus is Recovered / Not Recovered

 Test Specimen: Staphylococcus aureus is Recovered / Not Recovered

 Test Negative Control: Growth observed / No Growth observed

 Media Negative Control: Growth observed / No Growth observed

6.4 Test for detection of Pseudomonas aeruginosa

 Test Specimen Preparation:
Transfer_________ gm/mL of sample to _________ Soyabean casein digest medium (Reference
No)._________________________).
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 Product Positive Control Preparation:
Transfer_________________ gm/mL of sample to _______ Soyabean casein digest medium
(Reference No._______________________)
Mixed well and added ______ml of Pseudomonas aeruginosa culture suspension containing
________CFU.

 Inoculum Control Preparation:

Added ______ml of Pseudomonas aeruginosa culture suspension containing _________CFU to
_______ml of soybean casein digest medium (Reference No.____________________).

 Test Negative Control Preparation:

Transfer _________ mL of chosen sterile diluent (______) to _________ Soyabean casein digest
medium (Reference No._________________________)

 Media Negative Control Preparation:

Keep sterile conical flask/tube containing ____________________ml of Soyabean casein digest
medium negative control. (Reference No.__________________________).

Analyzed by Sign /Date: _____________________.

 Product Positive Control & Inoculum Control:

Incubate Product Positive Control and Inoculum Control containers at ________OC (30 to 35OC for
18 to 24 hrs.) from ________________ to ______________in incubator
No.___________________.

 Test Specimen & Negative control:

Incubate test specimen and Negative Control containers at _________OC (30 to 35OC for 24 hrs.)
from _________________ to _______________ in incubator No.________________________.

Analyzed by Sign /Date: _____________________.

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SCDM OBSERVATIONS Observed By Checked By

(Sign/date): (Sign/date):
Growth observed / No Growth observed
Product Positive Control:
Growth observed / No Growth observed
Inoculum Control:
Growth observed / No Growth observed
Test Specimen:
Growth observed / No Growth observed
Test Negative Control:
Growth observed / No Growth observed
Media Negative Control:

 Product Positive Control & Inoculum Control:

After incubation, subculture a loopful of each of the above media separately on plate of Cetrimide
Agar Medium (Reference No._____________) and incubated at ______(30 to 35OC for 24 to 48
hrs.) from________________to ________________ in incubator No.________________________.

Analyzed by Sign /Date: _____________________.

 Test Specimen & Negative control:

After incubation, subculture a loopful of each of the above media separately on plate of Cetrimide
Agar Medium (Reference No._________________) and incubated at _________ (30 to 35OC for 72
hrs.) from _______________to _______________in incubator No._________________________.

Analyzed by Sign /Date: ____________________

CA OBSERVATIONS Observed By Checked By

Product Positive Control:
Inoculum Control:
Test Specimen:
Test Negative Control:
(Sign/date): (Sign/date):
Characteristic Growth observed /
No Characteristic Growth observed
Characteristic Growth observed /
No Characteristic Growth observed
Characteristic Growth observed /
No Characteristic Growth observed
Growth observed / No Growth observed

Media Negative Control: Growth observed / No Growth observed

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Results:
 Product Positive Control: Pseudomonas aeruginosa is Recovered / Not Recovered

 Inoculum Control: Pseudomonas aeruginosa is Recovered / Not Recovered

 Test Specimen: Pseudomonas aeruginosa is Recovered / Not Recovered

 Test Negative Control: Growth observed / No Growth observed

 Media Negative Control: Growth observed / No Growth observed.

 Note: All Inoculum Controls and product positive controls were shown proper recovery at shortest
incubation period.

7.0 VALIDATION TESTS AND RESULTS COMPILATION:

7.1 Microbial Enumeration test results Compilation (PPC when compared with IC):
Total Aerobic Microbial Count
1 E. Coli Complies / Does not comply
2 Salmonella species Complies / Does not comply
3 Staphylococcus aureus Complies / Does not comply
4 Pseudomonas aeruginosa Complies / Does not comply
Total Yeast and mould Count
1 Candida albicans Complies / Does not comply
2 Aspergillus brasiliensis Complies / Does not comply
7.2 Test for specified Microorganisms (PPC When compared with IC):
1 E. Coli Complies / Does not comply
2 Salmonella species Complies / Does not comply
3 Staphylococcus aureus Complies / Does not comply
4 Pseudomonas aeruginosa Complies / Does not comply
Total Yeast and mould Count
1 Candida albicans Complies / Does not comply
2 Aspergillus brasiliensis Complies / Does not comply
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7.3 Test Specimen Results:
1 Total Aerobic Microbial Count Complies / Does not comply
2 Total Yeast and mould Count Complies / Does not comply
3 E. Coli Present / Absent Complies / Does not comply
4 Pseudomonas aeruginosa Present / Absent Complies / Does not comply
5 Staphylococcus aureus Present / Absent Complies / Does not comply
6 Salmonella Species Present / Absent Complies / Does not comply
7 Candida albicans Present / Absent Complies / Does not comply
8 Aspergillus brasiliensis Present / Absent Complies / Does not comply

7.4 Negative Control Results:

Test details Test Negative control Media Negative control

1 Total Aerobic Microbial Count
2 Total Yeast and mould Count
3 E. Coli
4 Pseudomonas aeruginosa
5 Staphylococcus aureus
6 Salmonella Species
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply
Complies / Does not comply

Compiled by sign/date: Checked by sign/date:

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7.5 Summary and Conclusion:

Summary: The product does not exhibit any antimicrobial activity as the recovery of microorganisms
inoculated is observed to be within the acceptance criteria.
a. For TAMC (Total Aerobic Microbial Count) & TYMC (Total Yeast & Mold Count)

Acceptance criteria (Factor of 2) *Percentage of recovery Complies / Does

Name of the organism
B/2 BX2 when compared with IC not comply
Salmonella species
Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus
Aspergillus brasiliensis
Candida albicans

b. For Specified Microorganisms:

Name of the organism Growth Observed / Not Observed Complies / Does not comply
Salmonella species
Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus
Aspergillus brasiliensis
Candida albicans

Conclusion:____________________________________________________________________________
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Recommendation:______________________________________________________________________
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Summarized by (Sign & Date): Reviewed by (Sign& date):