FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
1 of 8
TESTING PROCEDURE OF CAPS
Written by
Reviewed by
Reviewed by
Approved by
1.
Title
A.M. Microbiology
Manager Quality Control
Manager Quality Assurance
Director Quality Operations
Signature
Date
OBJECTIVE: Objective of this work instruction is to define a testing procedure
for caps both physical and microbiological evaluation.
2.
SCOPE
This work instruction describes the execution of routine microbiological analysis
and physical analysis of caps.
3.
GLOSSARY
mL
= Milliliter
cm
= Centimeter
WI
= Work Instructions
= Degree Centigrade
CFU
= Colony Forming Unit
COA
= Certificate of Analysis
GPT
= Growth Promotion Test
4.
RESPONSIBILITIES
4.1
ANALYST:
To interface this work instruction to the actual practices of flow patterns.
To ensure that the work instruction is updated & reflects the actual execution.
To review the work instruction in case of any change or whenever it is due for
revision.
4.2
Microbiologist:
-
To interface this work instruction to the actual practices of flow patterns.
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
2 of 8
TESTING PROCEDURE OF PLASTIC CAPS
4.3
4.4
To ensure that the work instruction is updated & reflects the actual
execution.
To review the work instruction in case of any change or whenever it is due
for revision.
A. M. Microbiology:
-
To follow the instructions lay down by this work instruction.
To keep the relevant work instructions valid and updated.
Manager Quality Control:
MQC is responsible to implement this work instruction.
4.5
Director Quality Operations:
To provide adequate resources for the implementation of this work instruction
as defined.
5.
PROCEDURE:
6.
HEIGHT: Measure the height in mm of 03 units and note the average height
in the report Register QC/RG-012
7.
EXTERNAL DIAMETER: Measure the outer diameter of 03 units with vernier
Caliper and note the average external diameter in the report Register
QC/RG-012
8.
INTERNAL DIAMETER: Measure the internal diameter of 03 units with vernier
Caliper and note the average internal diameter in the report Register QC/RG- 012
Reviewed by: MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
3 of 8
TESTING PROCEDURE OF PLASTIC CAPS
9.
WEIGHT: Check the weight of 03 units, measure the average weight and note it
in the Report Register QC/RG-012
10. THREADING: Check the threading of 10 units individually, the threading of all 10
caps should be OK to well fit on the bottle.
11. CLEANLINESS CHECK: Check the cleanliness of 10 units. The test
passes if the caps are not dirty or do not contain any foreign particles in it.
12. MICROBIOLOGICAL ANALYSIS:
12.1
REQUIREMENTS
12.1.1
Oven
12.1.2
Incubator
12.1.3
Autoclave
12.1.4
Peptone Water
12.1.5
Cetrimide Agar
12.1.6
Tryptic Soy Agar
12.1.7
Tryptic Soy Broth
12.1.8
MacConkey Agar
12.1.9
MacConkey Broth
12.1.10
Sterile petri dishes/plates (9 cm in diameter)
12.1.11
Sterile latex gloves
12.1.12
Sterile micro tips having 1 mL capacity with micropipette/1 mL sterile
pipette
12.1.13
Sterile lint free duster
12.1.14
Sabouraud Dextrose Agar
Reviewed by: MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
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fQ-509
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TESTING PROCEDURE OF PLASTIC CAPS
12.1.15
L shaped sterile glass rod
12.1.16
Xylose Lysine Deoxycholate Agar
12.1.17
Rappaport Vassiliadis Salmonella Broth
12.1.18
Sterile screw-capped glass bottles 250 mL
12.1.19
Filtered 70% Isopropyl Alcohol spray bottle
13.
13.1
TESTING PROCEDURE / ACTION
PREPARATION OF SAMPLE: PACKING MATERIALS (Caps)
Dip aseptically 10-20 cap pads into the Sterile Peptone Solution / Sterile Tryptic Soy
Broth. Shake well, further dilutions, where necessary, are prepared with the same diluent.
13.2
TOTAL AEROBIC MICROBIAL COUNT (TAMC): Pipette 1 mL of the prepared
sample into each of two sterile petri-dishes. Add 15 - 20 mL cooled Sterile
Liquefied Tryptic Soya Agar to each plate. Cover the dishes, mix the sample
with agar by tilting or rotating the dishes, and the contents to solidify at room
temperature. Invert the petri-dishes and incubate these two plates at 30 - 35 C
initially for 3 days.
LIMIT:
13.3
As per COA.
TOTAL COMBINED YEAST/ MOULD COUNT (TYMC): Pipette 1 mL of the prepared
sample into each of two sterile petri-dishes. Add 15 - 20 mL cooled Sterile Liquefied
Sabouraud Dextrose Agar to each plate. Cover the dishes, mix the sample with agar by
tilting or rotating the dishes, and the contents to solidify at room temperature.
Invert petri-dishes and incubate these two plates at 20 25 C for 5 days.
Reviewed by: MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
5 of 8
TESTING PROCEDURE OF PLASTIC CAPS
CALCULATION: Record the number of colonies per plate and calculate the result by
multiplying by a dilution factor of 10 to give results in CFU/100 cm2.
13.4
SAMPLE PREPARATION AND PRE-INCUBATION FOR ESCHERICHIA COLI /
PSEUDOMONAS AERUGINOSA / SALMONELLAE: Prepare a sample as mentioned
above in 100 mL Tryptic Soy Broth, mix and incubate at 30 35C for 24 hours.
13.5
TEST FOR ESCHERICHIA COLI: Shake the bottle, transfer 1 mL of Tryptic Soy
Broth to 100 mL of MacKonkey Broth and incubate at 42 44 C for 24 hours.
After completion of 24 hours incubation, shake the bottle and transfer 1 mL from
MacConkey Broth to MacConkey Agar plates, incubate at 30 35 C for 24 hours.
If colonies grow on MacKonkey Agar plates these indicate the possible presence of
Escherichia coli. This is confirmed by identification tests and also subculture on
Eosine Methylene Blue Agar medium.
The product complies with the test if no colonies are present OR if the identification
tests are negative.
13.6
TEST FOR SALMONELLA: Transfer 0.1 mL of Tryptic Soy Broth to 10 mL of
Rappaport Vassiliadis Salmonella Enrichment Broth and incubate at 30 35 C for 24
hours. After completion of 24 hours incubation, subculture a small aliquot on plates of
Xylose Lysine Deoxycholate Agar and incubate at 30 35 C for 48 hours.
The possible presence of Salmonella is indicated by the growth of well-developed, red
colonies with OR without black centers. This is confirmed by identification tests.
The product complies with the test if no colonies are present OR if the identification
tests are negative
Reviewed by: MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
6 of 8
TESTING PROCEDURE OF PLASTIC CAPS
13.7
TEST FOR PSEUDOMONAS AERUGINOSA: After completion of 24 hours
incubation, subculture a small aliquot on plates of Cetrimide Agar and incubate at
30 35 C for 24 hours.
Growth of colonies on Cetrimide Agar plates with yellow-green to blue-green OR
yellow-green to green coloration these indicate the presence of Pseudomonas
aeruginosa. This is confirmed by identification tests.
The product complies with the test if no colonies are present OR if the identification
tests are negative.
13.8
INTERPRETATION OF RESULTS:
FOR TOTAL AEROBIC MICROBIAL COUNT (TAMC):
If the fungi are detected / observed on Tryptic Soy Agar plates, they are counted as
part of TAMC.
When an acceptance criterion for microbiological quality for Bacteria of product is
prescribed, it is interpreted as follows:
13.9
10 CFU
Maximum Acceptable Count
20;
10 CFU
Maximum Acceptable Count
200;
103 CFU
Maximum Acceptable Count
2000, and so forth..
FOR TOTAL COMBINED YEAST / MOLD COUNT (TYMC):
If the bacteria detected / observed on Sabouraud Dextrose Agar plates, they are
counted as part of TYMC.
When an acceptance criterion for microbiological quality for Yeast and Mold of product
is prescribed, it is interpreted as follows:
10 CFU
Maximum Acceptable Count
20;
102 CFU
Maximum Acceptable Count
200;
Reviewed by: MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
7 of 8
TESTING PROCEDURE OF PLASTIC CAPS
103 CFU
Maximum Acceptable Count
2000, and so forth.
13.10 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.
TRAINING
Training of the concerned work instruction shall be given to the personnel who will be
exercising the work instruction. And training record is to be maintained
15.
APPENDICES
Log Register No. QC/RG-48
Form No. FZ-164
Folder No. QC/FR-81 (Packing Materials)
16.
REFERENCE
United States Pharmacopoeia USP 35, NF 30.
British Pharmacopoeia 2012.
Center for Drug Evaluation and Research (CDER 1999).
WHO Guidelines 2012
17.
DISTRIBUTION
Reviewed by: MQA
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
FEROZSONS LABORATORIES LIMITED
Work Instructions
WI No.
Effective Date
Review Date:
Page No:
fQ-509
October 1, 2015
October 1, 2018
8 of 8
TESTING PROCEDURE OF PLASTIC CAPS
Distribution
Title
18.
Signature
Date
Retrieval
Copy No.
Signature
Date
HISTORY
Date
April 3, 2015
Reviewed by: MQA
Reason of Change
New version
Sign:
Date
All or part of the information contained in this document should be treated as the confidential property of FEROZSONS
LABORATORIES LIMITED. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd
parties, in any form without the prior written permission from DQO FEROZSONS LABORATORIES LIMITED.
COPY NO.
