Monday , September 25 2023

Cleaning and operation of static pass box.

  • Objective :To lay down procedure for cleaning and operation of static pass box.
  • SCOPE The standard operating procedure is applicable to the static pass box  present in manufacturing plant .
Equipment no.
Make klenziad
Capacity 915X610X915mm
Location Under test area


Production executive/supervisor shall be responsible for implementing the sop for cleaning and operation of static pass box.


Head of Production

5.0       PROCEDURE

  • Procedure for cleaning
  • Switch “off” the static pass box.
  • Mop the static pass box from inside using a lint free mop and 70% IPA.
  • Mop the static pass box from outside by using a lint free mop and 70% IPA
  • Mop the glasses from both sides by using a lint free mop and 70% IPA.

Frequency: After end of operation, at end of the shift ,in case of any spillage.

5.2        Procedure for Operation

  • “Power indicator” on panel glows indicating the power is “on” from the mains.
  • Open the door from one side by pushing “release door” soft touch button on panel and U.V lamp will “off” as door opens.
  • Put the material inside pass box. Close the door.
  • “Door locked” indicator will glow on panel and U.V lamps will be “on”.
  • Open pass box from another side by pushing “release door” soft touch button on panel U.V lamps will be “off” and take out the material and again close the door.
  • As the door closes the U.V lamp will start up and door locked” indicator will glow.
  • “Opposite door” open indicator on panel glows when opposite door is open.
  • In case when one of the doors is not locked properly and remains open for some time alarm will start automatically, check the doors and close the door whichever door is open.
  • Press, “Null alarm” to stop the alarm
  • Replace the UV tubes after every 4000 h and record it in the format  at the time of replacement.
  • The first five digits of UV meter shows reading in hours showing the period for which the UV light has burn.
  • Under test material after approval shall be brought in the raw material area through static pass box.


    • Do not use force while closing and opening the door.
    • Incase of alarm indication check the doors and close the door immediately, which ever is open.
    • Incase if any indicator is not working properly then do not use the pass box for any operation and report for necessary maintenance immediately.
    • In case when opposite door is open do not try to open the door.
    • Check that U.V get started when both doors are closed.
Revision No. Reason for Revision



Copy No. Issuance Record Withdrawal Record Destruction record
Date Dept. issued Name / Signature of receiver Issued By

Name / Signature

By Sign /Date By Sign/Date

Not applicable 

  • SOP-Standard operating procedure
  • U.V lamp-Ultra violet lamp
  • QA-quality assurance
  • IPA- Iso- propyl alcohol


            Annexure –1                                                                      

U.V. lights replacement record

Frequency: 4000 hours

S.No. Date Make of U.V. meter


Replacement date Done by Checked by Verified by QA

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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