FEROZSONS LABORATORIES LIMITED

Work Instructions

WI No. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 1 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

Title Signature Date
Written by A.M. Microbiology
Reviewed by QCM Microbiology
Reviewed by Manager Quality Assurance
Approved by Director Quality Operations

1. OBJECTIVE
Objective of this work instruction is to define a testing procedure for aluminum
tube both physical and microbiological evaluation.

2. SCOPE
This work instruction describes the execution of routine microbiological analysis
and physical analysis of Aluminum Tube.

3. GLOSSARY
mL = Milliliter
cm = Centimeter
WI = Work Instructions
C = Degree Centigrade
CFU = Colony Forming Unit
COA = Certificate of Analysis
GPT = Growth Promotion Test

4. DESCRIPTION
Aluminum tube having printed with color(s) as per approved bromide.

5. DIMENSION: This test includes with

5.1 LENGTH:

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. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 2 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

Measure the length in mm of aluminum tube and note it in the
Register QC/RG-012
Limit: As per Approved Bromide.

5.2 TEXT MATTER:

Check the over printing matter of tube. It should meet the approved
BROMIDE note it in the Register QC/RG-012.

5.3 CLEANLINESS CHECK:

Check the cleanliness of tube. The test passes if the tubes are not dirty,
mutilated, torn or stained. Note it in the Register QC/RG-012.

5.4 OUTER DIAMETER:

Measure the outer diameter of aluminum tube with vernier caliper and note it in
the Register QC/RG-012.
Limit: As per Approved Bromide

6. TRIAL ON MACHINE:
Conduct trial on tube filling machine and note it in the Register QC/RG-012.

11. THREADING:
Check the caps for threading and note it in the report Register QC/RG-012.

12. MICROBIOLOGICAL ANALYSIS:

12.1 REQUIREMENTS

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. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 3 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

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
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

12.2 TESTING PROCEDURE / ACTION

12.2.1 GROWTH PROMOTION TEST:

See WI for GPT (WI No. M-26-01).

12.2.2 PREPARATION OF SAMPLE: PACKING MATERIALS (ALUMINUM TUBE)

Pour aseptically 10 ml Sterile Peptone Solution / Sterile Tryptic Soy Broth to

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. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 4 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

10 empty tube. Shake well, then transfer 1 ml from each tube to Sterile Peptone
Solution / Sterile Tryptic Soy Broth, mix sample well. If necessary, adjust the pH
to 6 - 8. Further dilutions, where necessary, are prepared with the same diluent.

12.2.3 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: As per COA.

12.2.4 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.

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.

12.2.5 SAMPLE PREPARATION AND PRE-INCUBATION FOR ESCHERICHIA COLI /

PSEUDOMONAS AERUGINOSA / SALMONELLAE: Prepare a sample using a 1 in
10 dilution of aluminum tube in 100 ml Tryptic Soy Broth, mix and incubate at
30 35 C for 24 hours.
12.2.6 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.

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. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 5 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

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.

12.2.7 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

12.2.8 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.

12.3 INTERPRETATION OF RESULTS:

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. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 6 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

12.3.1 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:
10 CFU = Maximum Acceptable Count = 20;
102 CFU = Maximum Acceptable Count = 200;
103 CFU = Maximum Acceptable Count = 2000, and so forth..

12.3.2 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;
3
10 CFU = Maximum Acceptable Count = 2000, and so forth.

12.4 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.

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. fQ-503-01
Effective Date 01st Dec, 2013
Review Date: 30th Nov, 2016
Page No: 7 of 7

TESTING PROCEDURE OF ALUMINUM TUBE

13. 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

14. APPENDICES
LOG Register No. QC/RG-48
Form No. FZ-164
Folder No. QC/FR-81

15. REFERENCE
United States Pharmacopoeia USP 35, NF 30.
British Pharmacopoeia 2012.
Center for Drug Evaluation and Research (CDER 1999).
WHO Guidelines 2012

16. DISTRIBUTION

Distribution Retrieval

Title Signature Date Copy No. Signature Date

17. HISTORY
Date Reason of Change

08 March, 2014 New format, addition of microbial limit test.

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.