SOP for Pass Box used in sterile area

This Document describes (Standard Operating procedure) SOP for operation, cleaning of statice and Dynamic Pass boxes and recording of UV burning hour.

Pass Box used in sterile area

I. Purpose & Scope:

• The Purpose of this SOP is to lay down the procedure for operation, cleaning of statice and Dynamic Pass box and recording of UV burning hour.
• This procedure is applicable production Department personnel for operation and cleaning of Dynamic Pass box and recording of UV burning hour.

II. Responsibilities:

• All production personnel’s shall be responsible to follow and implement this SOP.

III . Introduction and Procedural Part :

Procedure :

Material required:

• Lint free mop.
• 70% IPA.
• Scheduled disinfectant solution.

For static pass box:

For transferring material from one sterile area to another sterile area :

• Clean outer surface of material to be transferred to sterile area with lint free mop dipped in 70% IPA.
• Open the door of pass box.
• Ensure UV light is switched OFF.
• Ensure passbox is clean and no other material present in passbox.
• Place the material in passbox.
• Close the door of passbox.
• Ensure UV light is switched ON.
• Inform sterile side operator to take out material.

For Dynamic pass box:

For transferring material to sterile area.

• Clean outer surface of material to be transferred to sterile area with lint free mop dipped in 70% v/v IPA.
• Open the door of passbox.
• Ensure UV light is switched OFF and LAF is switched ON.
• Ensure passbox is clean and no other material is present in passbox.
• Place the material in the passbox.
• Close the door of passbox.
• Switch on the UV light and Wait for NLT 05 Minutes.
• Inform sterile side operator to take out material.

For transferring material from sterile area:

• Open the door of passbox.
• Ensure UV light is switched OFF and LAF is switched ON.
• Place the material in the passbox.
• Close the door of passbox.
• Switch on the UV light and Wait for NLT 05 Minutes.
• Inform non sterile side operator to take out the material.

Note: UV lamp burning hours shall be recorded in Annexure I  round the clock on working days except during cleaning. UV lamp should be replaced after 5000 hours.

Cleaning of passbox:

• Open the door of passbox.
• Ensure UV light is switched OFF.
• Ensure LAF is switched ON. (For dynamic pass box only)
• Ensure no material is present in pass box.
• Clean entire surface of pass box with  a lint free mop dipped in scheduled disinfectant solution.
• Spray 70% IPA in entire surface.
• Wipe the UV tube with dry lint free mop.

Note: Do not spray 70% v/v IPA on UV light.

ANNEXURE I

UV Burning Hours Record

Area :                                                                                                              Equipment ID :

ANNEXURE-II

Pass box usage log record for material entry

Area :                                                                                                        Equipment ID :