SOP FOR RECEIVING, LABELING AND STORAGE OF MICROBIAL CULTURE MEDIA

SOP FOR RECEIVING, LABELING AND STORAGE OF MICROBIAL CULTURE MEDIA

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1.0       OBJECTIVE

To lay down a standard procedure for receipt, storage, stock maintenance and labeling of culture media used in Microbiological laboratory.

2.0       SCOPE:

This Standard Operating Procedure is applicable in Microbiology laboratory of Quality Control Department.

3.0       RESPONSIBILITY

                Microbiologist shall be responsible to follow the procedure mention in this SOP.

4.0       ACCOUNTABILITY:

Department Head & QA Head shall be accountable for the compliance of this SOP.

5.0       ATTACHMENTS

Format for media receipt and media stock record                                                     – Attachment-I

Format for media issuance record                                                                                 – Attachment-II

Format for daily temperature monitoring record of media storage room.          – Attachment-III

Format for media reconciliation or consumption record                                         – Attachment-IV

Label for media container                                                                                               – Attachment-V

6.0       PROCEDURE

6.1           Receiving and labeling of De-hydrated media

6.1.1        After receiving of media from the supplier, check the media container for intactness and

manufacturing date, expiry date & Lot no.

6.1.2        Enter the quantity of media received with its batch no., received date, use before in media stock

record as per attachment-I.

6.1.3        Paste the label on each media containers as following e.g. if 5 containers of same media from same

supplier or manufacturer are received, label the media containers as 1/5, 2/5, 3/5, 4/5, 5/5. Affix the

label to the media container should have the following details;

  • Container No.
  • Received on
  • Opened on
  • Use before
  • Growth promotion test
  • Sign & Date

6.1.4        Ensure that the expiry dates of the media container are maintained in media receiving and stock

record & media issuance record,  in chronological order if more than one batch is received.

6.1.5        Ensure that the media stock is used on a “First in First out” or “First Expiry First Out” basis.

6.1.6        On opening a new pack, enter the date of opening on label of the media container.

6.1.7        If the opened container of media left unused after one year from the date of opening it can be further

used after performing and complying the growth promotion test of the media as per SOP no.

SOP/ML/028.

6.1.8        For each new batch of dehydrated media received, carry out the growth promotion test of the media

before using for microbiological analysis.

6.1.9        Maintain the media reconciliation or consumption record as per attachment-IV.

6.2           Storage of dehydrated media

6.2.1        Store the media containers at temp.10°C-30°C or as per the storage condition given by the

manufacturer, whichever is less. Note the temperature daily in attachment-III.

6.2.2        Place the media containers on a separate rack provided in the media storage, cabinet/room in the

following category:

  • To be tested for Growth promotion test.
  • Media under growth promotion test.
  • Growth promotion test passed media in use.
  • Growth promotion test passed media in stock

Note: Assign in house use before date as 2 years from the date of opening or use before date given by

manufacturer, whichever is earlier.

6.2.4        Before every use, check the media for having lumps formation or change in color, if any, discard the

media.

6.3           Issuance of Media

6.3.1        Issuance of media shall be controlled by laboratory by maintaining the record of issuance and

reconciliation  record.

6.3.2        Enter the date of opening  in the media issuance record On opening a new pack.

6.4.3        Before issuance a new media container to laboratory check the media reconciliation record.

6.4.4        If the media container is nil as per media reconciliation record then issue a new media container.

Maintain the media issuance record as per attachment-II.

7.0           REFERENCES

In-house

8.0       ABBREVIATIONS

SOP: Standard operating procedure

°C   : Degree Celsius

QA  : Quality Assurance

QC : Quality Control

9.0       DISTRIBUTION LIST

Quality Assurance Department

Quality Control Department

10.0     HISTORY OF REVISION

Version Number Effective Date Reason for Revision
Title : Media Issuance Record
Version No. : 00 Page No. : Page 1 of 1

 
Effective Date :   Review Date :  
NAME OF MEDIA :
S. No Date of Issuance

 

 Batch No. /Lot No. Container No. Balance Qty. Opened on To be Used Before Issued to Consumed on

 

 Checked by
Title : Media reconciliation or consumption record
Version No. : 00 Page No. : Page 1 of 1

 
Effective Date :   Review Date :  

 

Name of media:                                                                                        Batch No.:

Container No.                                                                                           Use before:
Date Opening Qty. (g) Quantity taken (g) Closing Qty. /balance Qty. (g) Volume prepared (ml) Used for Used by Checked by Remarks
Title : Media receipt and Media Stock Record
Version No. : 00 Page No. : Page 1 of 1

 
Effective Date :   Review Date :  

 

 

NAME OF MEDIA:

 
S. No  Date of receipt Batch No./Lot No. Make Quantity Received Use Before Opened On Emptied On Received by Checked by Remark

 

Title : Daily Temperature monitoring record of media storage room
Version No. : 00 Page No. : Page 1 of 1

 
Effective Date :   Review Date :  

 

Temperature condition for media storage : 10°C to 30°C
S.No Date Morning Time Temp. () Evening Time Temp. (°C) Recorded By Checked By Remarks
                 

 

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