SOP on cleaning, maintenance and calibration of stability chamber

SOP on cleaning, maintenance and calibration of stability chamber

Objective:

  • To lay down a procedure for Cleaning, maintenance and calibration of stability Chamber.

Scope:

  • This SOP is applicable for the cleaning, maintenance and calibration of stability chamber

Responsibility:

  • QC Chemist or above
  • Electrician or above

Accountability:

  • Head – Quality Control
  • Head – Engineering

Procedure:

stability chamber

Cleaning:

  •  Chamber shall be cleaned from outside daily.
  • Boiler tank shall be cleaned weekly or after maintenance.
  •  Water reservoir tank shall be cleaned weekly or after maintenance.
  •  Boiler heater shall be cleaned weekly or after maintenance.
  •  PT-100 sensor tip shall be cleaned with the help of polish paper in 3 month.
  •  Condensor, condensor motor and radiator shall be cleaned in 3 month with the help of  blowing air.
  • Control panel shall be clean by blowing air in 3 month.
  • Cleaning record of the stability chamber 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 three months. If found loose,tighten it.
  • Working of safety cut off shall be checked in 3 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 3 months and record shall be maintained as per Annexure No. A06.
  • If any abnormality observed by service engineer then action for rectification shall  be done immediately.
  • Water level of the reservoir tank as well as of the main tank shall be checked at the  start of shift and at end of shift.
  • Maintenance record shall be maintain as per Annexure No A02

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 Stability Chamber Cleaning

Record

A01
2 Stability Chamber Maintenance

Record

A02
3Stability Chamber calibration

Record

A03

References :

  • If any

Reason for Revision :

  • Not applicable due to first version of SOP

Abbreviation :

  • QC                    :    Quality control
  • SOP                  :    Standard Operating Procedure

 

Annexure 1

Stability Chamber cleaning Record

Stability chamber Id. No.:

Sr.

No.

Date

 

ChamberBoiler

tank

Boiler

Heater

Reservoir

tank

PT-sensor

tip

CondensorCondensor

motor

Chamber

fan

Condensor

fan

Cleaning done  byChecked by

 

Remarks

 

              

Annexure 2

Stability chamber maintenance record

Stability chamber Id. No. :                                                                   Date :

Stability Chamber 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 stability Chamber

Stability chamber Id. No.:

Calibration Done On :                                            Next Calibration due On :

Set TemperatureActual TemperatureCalibrator Temperature
   
Set RHActual RHCalibrator RH
   

The above equipment has been found / not found within the permissible limits for temperature ±2°C and for relative humidity ±5% and hence acceptable.

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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