SOP on cleaning, maintenance and calibration of Cooling cabinet

SOP on cleaning, maintenance and calibration of Cooling cabinet

Objective:

  • To lay down a procedure for Cleaning, maintenance and calibration of Cooling cabinet.

Scope:

  • This SOP is applicable for the cleaning, maintenance and calibration of cooling cabinet

Responsibility:

  • QC Chemist or above
  • Electrician or above

Accountability:

  • Head – Quality Control
  • Head – Engineering

Procedure:

Cooling cabinet

Cleaning :

  • Only trained and skilled persons shall maintain the cleaning of Cooling cabinet.
  • Cleaning of cooling cabinet shall be done once in a day.
  • PT-100 sensor shall be cleaned with polish paper in every four month.
  • Condensor shall be Clean by blowing air through it after every four months.
  • Cleaning record of the cooling cabinet shall be maintained as per Annexure No.A01.

Maintenance :

  • Any problem in stability chamber shall be intimated to Engineering department and fill  the maintenance work permit as per Annexure No. A02.
  • Chamber fan and condensor fan shall be checked in four months. If found loose, tighten it.
  •  Working of safety cut off shall be checked in four month by giving external heat to the dry bulb sensor.
  • Maintenance shall be done if any problem appears in the chamber.
  • Preventive maintenance of stability chamber shall be done by the service engineer in four months and record shall be maintained as per Annexure NoA06.
  • If any abnormality observed by service engineer then action for rectification shall  be done immediately.
  • Check the incoming electric supply of 230 V AC with Neutral and proper earthing.
  • Maintenance record shall be maintain as per Annexure No. A02

TROUBLE SHOOTING:

REASONCORRECTIVE ACTIONS
COOLING EFFECT NOT ACHIEVED WITH REGULAR COOLING SYSTEM
MCB may have trip.Check the MCB5 (604 & 605), if found trip, switch it ON.
DC output not available.Check the DC output from the temperature controller.
SSR not working.The DC supply comes from the temperature controller terminal 13 (351) and 14 (352) to SSR terminal 3(+) & 4(-). The output of the SSR is provided with a phase connection coming from the Time delay and the other output goes to the compressor. If the controller is giving DC volt to the SSR input and the SSR output terminal is (606) not showing the phase (230 Volts) that means the SSR is not working, this has to be replaced.
Overload or the capacitor of the compressor not working.Check the compressor for overload and starting and running capacitor for the supply to the compressor. If found faulty, replace it.
Time delay faulty

 

The supply from compressor switch (S/W5) is given to the time delay. The output of the time delay is given to the compressor through relay. Check the supply at 604. If the supply is not coming then NO point is not working. Hence time delay has to be replaced.
Condenser Motor not workingCheck the motor winding.
 

CHAMBER MOTOR NOT WORKING

MCB may have trip.Check the MCB1 (401 & 402).  If found trip, Switch it ON.
Starting capacitor not working.Check the starting capacitor, If found faulty, replace it.

 

Motor burned out.Check the Motor winding, if found burned out or found any problem replace it.
CONTROLLER NOT WORKING
MCB may have blown off.Check the MCB2(312 & 313).If found blown replace it.
Display card or inside component looseIf the display card or any of the inside components is loose, the controller will not show any display or will work erratic. Replace the controller.
CVT not workingCheck the CVT out put Voltage, it should be 230 VAC. If it is not obtained then replace the CVT.
CONTROLLER SHOWING OPEN
Sensor wire broken.Check the sensor wire. If found broken, replace the sensor.
Sensor wire having loose connections.Check the sensor wire connections on the controller. If found loose, tighten it.

Calibration:

  • Calibration of the stability chamber shall be done by outside party once in a year.
  • Calibration shall be reported as per Annexure No. A02

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List of Annexure / Format :

Sr.

No.

Format TitleAnnexure

Number

1 Cooling cabinet Cleaning

Record

A01
2 Cooling cabinet Maintenance

Record

A02
3Cooling Cabinet calibration

Record

A03

References :

  • Cooling cabinet Manual.

Reason for Revision :

  • Not applicable due to first version of SOP

Abbreviation :

  • QC                    :    Quality control
  • SOP                  :    Standard Operating Procedure

Annexure 1

Cooling Cabinet cleaning Record

Cooling Cabinet Id. No.:

Sr.

No.

Date

 

ChamberPT-sensor tipCondensorCondensor

motor

Chamber

fan

Condensor

fan

Cleaning done  byChecked by

 

Remarks

 

           

Annexure 2

Cooling Cabinet maintenance record

Cooling Cabinet Id. No. :                                                                   Date :

Cooling Cabinet Model No.Capacity
 

 

 

 

Problem Identified :

Action for rectification :

Is calibration required after maintenance :

Remark ( if any ) :

 

Service Engineer ( Sign / Date )Checked By ( Sign / Date )Approved By ( Sign / Date )
   

Annexure 3

Calibration record of Cooling Cabinet

Cooling Cabinet Id. No.:

Calibration Done On :                                            Next Calibration due On :

Set TemperatureActual TemperatureCalibrator Temperature
   

The above equipment has been found / not found within the permissible limits for temperature ±2°C .

Calibrator Details :

Calibrator No.Detail of CalibratorCalibration DetailsCalibration due date
    

Remark if Any :

Instrument Calibration comply / does not comply.

Reported By / DateChecked By / DateApproved By / Date
  
  

 

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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