Dehydrated Media SOP for the receipt, labeling, storage, GPT, routine use, expiry control, and disposal of dehydrated media in a microbiology laboratory.
Objective for Dehydrated Media
The purpose of this SOP is to describe the procedure for procurement, receipt, identification, labeling, storage, issuance, growth promotion testing, routine use, and disposal of dehydrated microbiological media.
This procedure helps ensure that dehydrated media used in the microbiology laboratory remains properly identified, protected from deterioration, and suitable for its intended use.
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Scope
This SOP applies to all dehydrated microbiological media received, stored, tested, issued, and used in the microbiology laboratory of the organization.
The procedure covers the complete handling of media, starting from procurement and receipt through storage, Growth Promotion Test (GPT), routine use, expiry, and final disposal.
Responsibility
QC Manager / Designee
The QC Manager or designated person is responsible for ensuring implementation and compliance with this SOP.
Microbiologist
All microbiologists are responsible for following the procedure described in this SOP, maintaining the required records, and ensuring proper handling of dehydrated media.
Procedure for Dehydrated Media
Procurement of Media
The microbiologist shall review the available stock of dehydrated media against the applicable media consumption record.
Based on the available balance and expected laboratory requirements, a purchase requisition shall be raised.
For enrichment media such as SCDA, SCDM, and R2A, the purchase request should normally be initiated when two containers remain in stock.
For selective media, the purchase request should normally be raised when one container remains in stock.
The purchase requisition shall be submitted to the QC Manager or designated person for review and further processing.
The stock level should be monitored regularly to avoid interruption of microbiological testing due to non-availability of media.
Receipt of Dehydrated Media
The dehydrated media shall initially be received at the security gate. The security personnel shall inform the QC department about the arrival of the consignment.
The concerned microbiologist shall visit the receiving area and verify the details of the media against the supplier invoice and purchase requisition.
The following details should be checked during receipt:
- Name of the media
- Quantity received
- Manufacturer or supplier
- Lot number
- Container condition
- Expiry date
- Storage requirements, where applicable
- Details mentioned on the invoice and purchase requisition
The quantity received shall be reconciled with the approved purchase requisition.
After verification, the microbiologist shall instruct the laboratory attendant to transfer the media safely to the designated media preparation or storage area.
Physical Inspection of Containers
Each container shall be visually inspected before acceptance.
If the seal is broken, the container is damaged, the packaging is compromised, or there is any other condition that may affect the quality of the dehydrated media, the material shall not be released for laboratory use.
Such material shall be segregated and returned to the manufacturer or supplier through the Purchase Department, as applicable.
The receipt and disposition of rejected or damaged containers shall be appropriately documented.
FIFO Principle
The media shall be used following the First In, First Out (FIFO) principle unless there is a specific quality or expiry-related reason to use another container first.
Labeling and Numbering of Containers
Every container of dehydrated media shall be appropriately identified using the approved media container label.
The label should contain sufficient information to maintain traceability throughout the storage and use period.
Media Container Label
The following information should be included on the container label:
- Name of the organization
- Media lot number
- Container number
- Date of receipt
- Date of opening
- Opened by/signature and date
- GPT passed on
- Use-before date
The organization details may be printed on the approved label format as applicable.
Media Lot Number
The manufacturer’s or vendor’s lot number shall be entered in the Media Lot No. field of the label.
The lot number should be checked against the original container and receiving documentation before entry.
Storage condition
After completion of the receipt and documentation process, the media shall be stored in the designated storage area.
Unless otherwise specified by the manufacturer, dehydrated media should be stored in a cool and dry location and protected from direct light.
The storage conditions specified by the manufacturer on the container or product documentation shall always be followed.
The following precautions shall be observed:
- Keep containers tightly closed when not in use.
- Protect the media from moisture.
- Avoid unnecessary exposure to atmospheric humidity.
- Store containers away from direct sunlight.
- Do not store media under conditions different from those specified by the manufacturer.
- Maintain proper segregation and identification of different media.
- Follow FIFO while issuing media for use.
Any container showing signs of deterioration shall be segregated and evaluated before further use.
Issuance of Dehydrated Media for Routine Use
The first container of a newly received media lot shall be considered for Growth Promotion Testing (GPT), as applicable.
The date on which the container is opened shall be recorded on the container label.
The required quantity of dehydrated media shall be accurately weighed for preparation of the medium required for GPT.
The media shall not be released for routine use until the applicable GPT requirements have been satisfactorily met.
Growth Promotion Test (GPT)
Growth Promotion Testing shall be performed as per the approved microbiological testing procedure applicable to the particular medium.
After satisfactory completion of GPT, the container may be released for routine laboratory use.
The date of successful GPT shall be recorded on the media container label under “GPT Passed On.”
The applicable use-before date shall also be recorded on the label.
The GPT result and release details shall be documented in the relevant record.
Use-Before Date of Media
For routine laboratory use, the use-before date shall be assigned based on the approved internal procedure and applicable manufacturer’s requirements.
Where the established internal practice specifies a one-year period from GPT release, the use-before date shall be calculated accordingly.
Use of Media After the Assigned Use-Before Date
If the dehydrated media is not completely consumed before the assigned use-before date, it shall not automatically be considered suitable for further use.
The media shall be evaluated and GPT shall be repeated in accordance with the approved laboratory procedure.
If the repeat GPT is satisfactory, the media may be considered for continued use for an additional period as permitted by the approved procedure, provided that the manufacturer’s original expiry date is not exceeded.
Where the media fails the applicable GPT, it shall be immediately segregated and disposed of as per the approved disposal procedure.
The extension of use shall be properly documented.
Disposal Procedure for Media
Before disposal, the label shall be removed or appropriately cancelled to prevent unintended reuse of the container.
The expired, rejected, or otherwise unsuitable dehydrated media shall be collected in a suitable designated container.
A sufficient quantity of water shall be added to disperse the dehydrated media completely.
An approved disinfectant shall then be added in accordance with the site’s validated or approved waste-disposal procedure.
The contents shall be mixed thoroughly to ensure proper contact between the disinfectant and the material.
The treated waste shall be allowed to remain for the defined contact time. Where the established in-house procedure specifies a 60-minute contact period, the waste shall be maintained for that duration.
After completion of the treatment, the disinfected waste shall be transferred to the designated waste-treatment or ETP system in accordance with the site’s approved waste-management procedure and applicable environmental requirements.
The disposal activity shall be recorded in the appropriate disposal record.
Abbreviations
| Abbreviation | Full Form |
| QC | Quality Control |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| GPT | Growth Promotion Test |
| SCDA | Soybean Casein Digest Agar |
| SCDM | Soybean Casein Digest Medium |
| R2A | Reasoner’s 2A Agar |
| FIFO | First In, First Out |
| NA | Not Applicable |
| °C | Degree Celsius |
| % | Percentage |
| SS | Stainless Steel |
| CCF No. | Change Control Format Number |
| ETP | Effluent Treatment Plant |
Change History
| Effective Date | Details of Revision | Change Control No. | Reason for Revision |
Reference
Applicable manufacturer’s instructions.
USP Chapter 61 <MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS>
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