1.0 Objective
To lay down a procedure for Receipt, issuance, storage, stock maintenance & preparation of media.
2.0 Scope
This SOP is applicable in microbiology lab of QC department at pharmaceuticals formulation plant.
3.0 Responsibility
3.1 Microbiologist shall responsible to follow the procedure mention in this SOP.
3.2 Quality Control & QA Heads shall be responsible for implementation of this SOP.
4.0 Accountability
4.1 Quality Control Head & QA Head shall be accountable for compliance of this SOP.
5.0 Abbreviations and Definitions
| QA | : | Quality Assurance |
| SOPs | : | Standard Operating Procedure |
| QC | : | Quality Control |
| ºC | : | Degree Celsius |
| Temp. | : | Temperature |
| NaOH | : | Sodium hydroxide |
| Hcl | : | Hydrochloric acid |
6.0 Procedure
6.1 Receipt, Issuance, Storage and Stock Maintenance of Media:
6.1.1 After receiving of media check the media container for intactness and expiry date.
6.1.2 The receipt of microbiological media shall be entered in logbook in chronological order if more than one batch is received with following details i.e. date of receipt, media name, Batch no., make, quantity received, storage temp. and received by as per annexure-I.
6.1.3 Paste the label on each media container after receiving as per Annexure-II
6.1.4 The media shall be issued as per Annexure-III
6.1.5 Ensure that the media stock is used on a “First in First out” or “First Expiry First Out” basis and that only one pack of medium is in use at any given time.
6.1.6 On opening a new pack, mention the date of opening on label.
6.1.7 Enter the date of opening on the label of the media container and in the media Issuance record.
6.1.8 Enter to be used before date on the label of the media container and in the media record and that should be one year from the date of opening of the media Issuance record.
6.1.9 If media left in an opened container after one year from the date of opening it can be further used after performing and complying the Growth promotion test of the media.
6.1.10 For each new batch of dehydrated media received, carry out the growth promotion test of the media before using for Microbiological analysis.
Precaution:- The microbiological media shall be stored appropriately as per manufacturer Instructions, away from other laboratory chemicals and reagents.
6.2 Media Preparation:
6.2.1 Take required number of bottle or conical flask which is available for media preparation.
6.2.2 Fill the vessel with one third water of required volume. Calculate the quantity of media required for desired volume.
6.2.3 Take the media according to manufacturer’s instruction.
6.2.4 Mix and makeup the required volume.
6.2.5 Check the pH of media before and after autoclave if it is not in limit maintain the pH with 0.1N NaOH /0.1N Hcl before sterilization.
6.2.6 Sterilize the media at 121 ºC/15 lbs for 20 min. Use the media for further testing.
6.2.7 Record the details about preparation and consumption in Annexure-IV.
7.0 Forms and Records (Annexures)
- Media Receipt Record – Annexure-I
- Format for Media Containers Label – Annexure-II
- Media Issuance Record – Annexure-III
- Media preparation and Consumption Record – Annexure-IV
8.0 Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Control
8.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Name of Media: ____________________ Storage Temperature: _____________
| S. No. | Date of Receipt | Lot No. | Expiry Date | Make | Quantity Received | Received By | Remarks |
Annexure-II
Format for Media Containers Label
| MEDIA CONTAINER LABEL | ||
| Name Of Media | ||
| Media Lot No. | ||
| Container No. | of | |
| Date Of Opening | ||
| To Be Used Before | ||
| Sign / Date | ||
| Form No.: | ||
Annexure-III
Media Issuance Record
Name of Media: _______________________________
| Date | Media Lot No. | Cont. No. | Opened On | To be used before | Balance Quantity | Issued to | Consumed On | Checked By |
Annexure-IV
Media Preparation and Consumption Record
| Date | Name of Media | Batch No.
|
Opened Quantity
(g) |
Quantity
Taken (g) |
Closing Quantity
(g) |
Volume prepared (ml) | pH before sterilization | Autoclave lot No. | pH after sterilization
|
Prepared
By |
|
|
