Refrigerator Unit Requirements

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1.0 Purpose 
 
 The purpose of this procedure is to describe the operation of the raw materials warehouse
 
 refrigerator units and walk-in cooler. 
 
 2.0 Scope 
 
 This procedure applies to the raw materials warehouse refrigerator units and walk-in cooler at
 
 Ion Labs, Inc. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all warehouse staff to follow this procedure.
 
 3.2 It is the responsibility of production management or designee to implement this
 
 procedure and to ensure that the procedure is being followed. 
 
 3.3 It is the responsibility of QC Laboratory management or designee to implement the
 
 environmental monitoring. 
 
 4.0 Definitions 
 
 4.1 CofA — Certificate of Analysis 
 
 4.2 Cold — Any temperature not exceeding 8°C (46°F) 
 
 4.3 Refrigerator — A cold place in which the temperature is maintained thermostatically
 
 between 2°C and 8°C (36°F and 46°F). Note: the walk-in cooler is considered a
 refrigerator and falls under the scope of this procedure. 
 
 
 Oenty error Ke osloulag 
 

[SOP 

 Standard Operating Procedure SOP No | Rev es kee 
 Refrigerator Unit Requirements E-401 6 neta” 
 
 5.0 References 
 
 5.1 F-505, SOP, Environmental Monitoring Program 
 
 Siz C-201, SOP, Deviation and Investigation Procedure 
 
 6.0 Procedure 
 
 6.1 Initial Operation of refrigerator unit 
 
 6.1.1 Ensure that the doors can close completely. 
 
 6.1.2 Plug the refrigerator unit’s cord into a 115 volt outlet for power. The unit should
 
 come on with a humming sound. 
 
 6.1.3 Allow temperature to equilibrate for approximately one hour.
 
 6.1.4 After one hour, verify the temperature on the thermometer. Assure that is it less
 than 8°C (46°F). 
 
 6.1.5 Adjustments to the unit’s temperature can be made from the front command
 panel. Hold the SET key for more than 2 seconds to change the set point value.
 
 The value of the set point will be displayed and the LED starts blinking. To
 change the set value, push the UP or DOWN key within 10s. To set new point
 
 value, push the Set key again or wait 10s. 
 
 6.1.6 Contact Facility management if, after the adjustment, the temperature readings
 cannot be maintained within 24 hours. 
 
 Note: These steps do not apply to the walk-in cooler. 
 
 6.2 Temperature Monitoring 
 
 6.2.1 Quality Management or designee routinely utilizes an environmental monitoring
 device and follows SOP F-505 Environmental Monitoring Program.
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 E-401 Page 3 of 3 
 Refrigerator Unit Requirements 
 6.3 Storage Use 
 
 6.3.1 All incoming materials received will have the outside labeling reviewed by the
 
 warehouse department to ensure proper storage conditions. 
 
 6.3.2 If there is any question on the correct storage requirements of a material, the
 
 warehouse staff will contact quality for additional assistance to determine
 storage conditions. 
 
 6:3:3 Items requiring “cold” storage will be moved to the refrigerator or walk-in
 cooler. 
 
 6.3.4 Ensure that the loaded containers do no block the overhead cooler fans or the
 thermometer for the unit. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 09/01/10 | New - - 02/20/13 New format. Updated SOP operation. 13-080 B. Mosall | - | - |
| 2 | 09/03/14 | Added section for temperature excursions. Updated SOP format. | 14-0606 | D. Popp |
| 3 | 07/24/17 | Biennial review: Revised sections 6.1.5 and 6.1.6 | 17-0826 | I. Ilchev |
| 4 | 10/01/20 | Yearly Review. Updated Logistics and Facility Manager title to Cc- Facility Manager | 20-0700 | J. Murphy |
| 5 | 03/02/21 | Add walk-in cooler requirements. Revise to reflect current CC- environmental monitoring process. | 21-0011 | J. Murphy |
| 6 | 01/06/22 | Revised to include the walk-in cooler. CC- | 22-0005 | J. Murphy |