Documente Academic
Documente Profesional
Documente Cultură
: Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
COVER SHEET
Total pages : 08
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
LIST OF CONTENTS
1. Objective
2. Scope
3. Responsibilities
4. Requirements
6. Precautions
7. Training
8. Distribution
9. Related Document
10. History
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
1. OBJECTIVE
Objective of this SOP is to define a preparation procedure for cultural media for microbiological
evaluation of raw materials, bulks, purified and drinking water, intermediates and finished
products.
2. SCOPE
This SOP describes the execution of preparation of cultural media in microbiology laboratory.
3. RESPONSIBILITIES
4.1. Microbiologist:
- To ensure that the SOP is updated & reflects the actual execution.
- To review the SOP in case of any change or whenever it is due for revision.
4.2. AM Microbiology:
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
4. REQUIREMENTS
4.1.
4.2.
4.3.
4.4.
4.5.
4.6.
4.7.
4.8.
4.9.
4.10.
4.11.
4.12.
4.13.
5.1.1. Before preparation check the expiry date and label the bottle with
name and date of preparation.
5.1.2. Complete instructions for the preparation of culture media are given
on the label of each bottle, according to it,
5.1.3. Open the culture medium bottle away from direct air flow and
moisture. Weigh the desired quantity of required medium quickly,
accurately and without creating 'clouds of dust'.
5.1.4. Reclose the medium bottle as soon as possible.
5.1.5. Always use freshly prepared purified water.
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
5.1.6. Pour half of the required volume of purified water in a clean bottle
which is twice the final volume of the medium to allow the adequate
mixing.
5.1.7. Then transfer the weighed quantity of medium slowly along with
agitation as the medium can not accumulate to make clump.
5.1.8. Pour the rest of the purified water down the sides of the vessel to
wash any adherent medium back into solution. This is an important
step because dry culture media powder above the level of the water
may not be sterilized in the autoclave and may be a source of
contamination.
5.1.9. Sterilize using a validated process of autoclave (SOP #. ), then
check its pH value, if adjustment required then adjust it by using
NaOH/HCl.
5.1.11. Broth medium is kept in the same medium bottle whereas agar
medium is poured in pre-sterilized petri dishes when the medium
temperature drops at 45 50 C.
5.1.12. Mix the medium gently by rotating the flask or bottle. Avoid forming
air bubbles. Dispense aseptically about 15 20 mL medium into
petri dishes (90 100 mm diameter) under the laminar airflow
cabinet.
5.1.14. When the medium has gelled and cooled, stack the plates and pre-
incubate them for 3 5 days, if plates show any sign of colony then
DO NOT use it for testing purpose.
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
5.1.15. Record the medium preparation activity in its specified log book.
* Required
Required ** Sterilization C, Time
Media Quantity
% & pH & Pressure
per 100 mL
Enterobacteria Enrichment Mossel Broth 4.5%, 7.2 4.5 g 121 C, 5 minutes, 15 psi
Reinforced Medium for Clostridia 3.8%, 6.8 3.8 g 121 C, 15 minutes, 15 psi
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
* Weigh medium as your volume required. ** Sterilization time can increase up to 20 min.
Avoid inhaling the powder and prolonged skin contact.
6. PRECAUTIONS
6.1. During weighing, care must be taken and weigh accurately according to
manufacturers specifications.
6.2. Before weighing, properly label the bottles with name, %age and date.
6.3. Weigh the desired quantity of required medium quickly, accurately and
without creating 'clouds of dust'.
6.5. Always wear mask and gloves for avoiding inhalation and skin contact.
6.6. After sterilization, Do Not make heavy agitation for mixing as air bubbles not
form, mix in gentle clockwise motion especially agar medium.
7. TRAINING
Microbiology
BF/SOP/Mic
BF Biosciences Limited Doc. No. : Mic-SOP-009-00
Effective Date: 30-06-2009
Name Muhammad Adnan Khan Name Asadullah Khan Name Ejaz Ahmad
Title Microbiologist Title Assistant Manager Microbiology Title Manager Quality Operations
Training about the contents of this SOP must be imparted to all the concerned personnel
once in a year and also to new employees before starting with the job and the records
documented according to training SOP.
8. DISTRIBUTION
Issuance of New Copy Retrieval of Old version
Department /
Signature Copy # Retrieved from Retrieved by
Person
Original Copy
Copy # 1
Copy # 2
Copy # 3
Copy # 4
9. RELATED DOCUMENT
NA
10. HISTORY
Microbiology
BF/SOP/Mic