Confidentiality level: xxx

STANDARD OPERATING PROCEDURE

CODE XXX

Refrigerator Maintenance

Author: Accepted:
dd Mmm yyyy dd Mmm yyyy

Name of responsible analyst Name of approver

Responsible analyst Approver/Position
Pharmaceutical Testing Laboratory Pharmaceutical Testing Laboratory

Version Number XX
Supersedes version: XX
Dates of validity: dd Mmm yyyy –
dd Mmm yyyy

Name of Manager
Quality Manager

Replaced by version: XX

1. Objective
The obtain a detailed guideline for refrigerator maintenance.
Standard Operating Procedure Version No XX
CODE XXX Refrigerator Maintenance Dd Mmm yyyy Confi Level XXX

2. Responsibility
1. The person assigned to be in charge of this instrument should follow the instructions in
this procedure. Any changes should be reported to the head of the laboratory. Proper
revisions should be done immediately upon approval of the head of the laboratory.
2. The person assigned to be in charge of this instrument should train staff and students
on the operation of this equipment and to ensure adherence to the working instruction.
3. The person assigned to be in charge of this instrument is identified on the logbook
cover pages for this instrument.

3. Definitions

None

4. References

 USP 35-NF 30[1]

 WHO TRS 937 (2006) [2]

5. Procedures

FUNCTION VERIFICATION
Read and record daily the internal temperature as seen in the digital temperature display.
1
The acceptable range for refrigerators is 2-8˚C and 0-25˚C.

2 Check daily the blower fan if it is operating.

3 Check door gasket and seals every 6 months to ensure that door closes and seals properly.
INSTRUMENT MAINTENANCE
1 Defrost unit and clean interior at least every 6 months.
2 Wash interior with a solution of warm water and baking soda; rinse with clean water.
3 Dry the interior.
4 Ensure that the drain tubes remain open if the unit is self-defrosting.
5 Clean the exterior with mild soap in water, rinse, and dry.
Apply a 50% solution of bleach with small brush if the gasket accumulates black mold or
6
fungus. Rinse and dry thoroughly.
7 Check for level installation, ensuring the door closes properly and seals.
8 Check power cord monthly to ensure there is no fraying of wire covering.
PRECAUTIONS
1 Ensure the unit is properly grounded.
2 Do not store explosive chemicals inside the unit if it is not explosion proof.
Standard Operating Procedure Version No XX
CODE XXX Refrigerator Maintenance Dd Mmm yyyy Confi Level XXX

3 Keep contents properly wrapped, covered, or stoppered to prevent frost build-up.

4 Do not store food and drinks in a refrigerator that is used to hold reagents and chemicals.
CORRECTIVE ACTION
1 Use wheels or screws to level the unit
2 Adjust and record the temperature if it is outside its acceptable temperature range.
Notify other personnel/supplier when adjustments fail to correct problem or gaskets and/
3
seals are faulty.

6. Distribution and Retrieval

DISTRIBUTION RETRIEVAL
CONTACT
NAME No. SIGNATURE DATE SIGNATURE DATE
           
           
           
           
           
           
           
           
           
           

7. Revision History

Date/Initials* Version Section, page: Change / Reason to change** New version

Dd Mmm yyyy/XXX

*Initials of the person making the change

**When not self-evident