SOP on Operation of Cooling cabinet

SOP on Operation of Cooling cabinet

Objective:

  • To lay down a procedure for the operation of Cooling cabinet.

Scope:

  • This SOP is applicable to quality control laboratory

Responsibility:

  • Chemist or above of QC Laboratory.
  • Electrician or above of Engineering.

Accountability:

  • Head – Quality Control.
  • Head – Engineering

Procedure:

Cooling cabinet

Following points shall be checked before starting the Cooling cabinet :

  • Cooling cabinet shall be 2 feet away from the wall for better air circulation.
  • The environmental temperature shall be below 30° C.
  •  Single phase UPS supply shall be given to PLC and complete input and output supply shall be checked.

If above points found OK, put ON the mains switch on the control panel  and check the  Following :

  • Display on temperature controller shall be ON.
  • Display on printer interfacing unit shall be ON.
  • Inside chamber motor shall be ON.

If above points found OK, switch ON the cooling switch and check following :

  •  Compressor shall be started immediately after 2 minutes.
  •  Compressor motor shall be started immediately after 2 minutes.

 Temperature shall be set on temperature controller

  •  Now 5°C temperature shall be set on the temperature controller by pressing the increment and decrement key, which will display the set point.
  • Now the bottom display will show the set temperature and the top display will show the actual temperature.

Printer / PC Interface Unit shall be SET:

 Password Setting:

  •  Printer Interface Facility to change or set any parameter one has to open the  Enviro using the password. Selection key shall be press until you go to the  password parameter. After that increment key shall be press to enter the  password and then ‘ENTER’ shall be press. The Interface Unit shall display.
  • Log in Ok.
  •  Now we can change or set the parameters.

Date and time setting :

  • Selection key shall be pressed to go to the parameters ‘SET TIME DATE’ the interface unit will display the current time and date. Increment key shall be used to change the time and date. Decrement key shall be used to shift and Enter key shall be used to select.

Print time interval setting :

  •  Selection key shall be pressed to, go to parameter PRINT INTERVAL, Increment and decrement key shall be pressed to change the print intervals. Enter key shall be pressed to select. One can set the time interval from 1 to 254 minutes. Print time interval shall be in minutes.

Print Page setting:

  • The unit will now display. If you require the previous reading then press the  increment / decrement key for the required no. of pages and then press  enter to check the print out.
  • E.g. If parameter set is 5 then the 5th previous page data will be printed from the current location. (Last 5th page)

Print Function setting :

  •  Selection key shall be pressed  to go to parameter “PRINT CONTROL” and  following functions shall be used to change the settings of printouts :
  • This function shall be used to set the page for printer header to be printed  at the beginning of the page. ‘ENTER’  shall be for yes. Increment key shall be used to go to the next parameter.
  • This function shall be used to print the current value of the controller. ‘ENTER’ shall be pressed for yes. Increment key shall be pressed  to go to the next parameter.
  • This feature shall be used to stop the printing of previous pages under  printing. It shall be used if print commanded to previous pages, which are  needed to be cancelled.
  •  This function shall be used to delete all memory (Printer or PC) Enter shall be pressed to delete all data.
  • This function shall be used to reset the stored print data. Enter shall be pressed to reset all stored print data.

Set Safety Thermostat :

  • The safety thermostat with the range of 0°C to 100°C shall be set 10°C ( 5°C above the set point 5°C). The safety thermostat will cut off the mains contactor on overshoot of the temperature.
  •  Daily printout of the temperature shall be taken with the help of computer. And manual monitoring of Temperature shall be done as per AnnexureA09.
  • Door of the cooling cabinet shall be opened for less than 1 minute at a time and for very necessary work it can be open for maximum 5 minutes more than that shall not be allowed. If there will be need to open the door for more than 5  minutes that shall be explained as per Annexure No A01
  • Door of the cooling cabinet shall remain locked. These shall be opened only at the time of storage and withdrawn of samples.
  •  If there is found any fault at any point then inform to Engineering department.

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List of Annexure / Formats :

Sr.

No.

Format TitleAnnexure

Number

1Explanation of the door opening of cooling cabinet more than 5 minutesA01

References (if any):

Reason for Revision:

  • Not Applicable due to new SOP

Abbreviation:

  • QC        :   Quality Control
  • SOP      :  Standard Operating Procedure
  • UPS      :   Un tripped power supply
  • PLC      :   Programmable logic controller
  •  PC        :   Print controller

Annexure 1

Explanation of the door opening of cooling cabinet more than 5 minutes

Explanation of the door opening of cooling cabinet more than 5 minutes
Reason for door opening:

Requested By / Date:

Permitted By / Date:

Open from time………..   to …………

Opened By / Date:

Effect on temperature:

Remarks (if any):

Checked By / Date:                                              Approved 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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