Measures Taken during power failure in Aseptic Area

This Document describes (Standard Operating procedure) SOP for Measures taken during power failure in Aseptic Area.

Table of Contents

SOP for Measures Taken during power failure in Aseptic Area.

The Purpose of this SOP is to lay down the procedure for Measures Taken during power failure in Aseptic Area.
This procedure is applicable Engineering Department personnel for Sop for Measures Taken during power failure in Aseptic Area.

Procedure for measures taken during power failure in Aseptic Area :

Short time power failure:

If power failure occurs for duration up to 5 minutes, immediately stop all production activities in the aseptic area.
Close all the open containers of rubber plugs.
Wait steady till power restores and avoid opening the door of room and unnecessary movement.
Check differential pressure of aseptic area and LAF’s.
Allow LAF to stabilize for 30 minutes.
Discard the filled vials laying on the conveyor in between filling machine and bunging machine.
Spray entire area with 70% IPA solution before starting any activity.

Longer duration of power failure:

If power failure occurs for duration more than 5 minutes stop all production activities.
Take the opened vials and discard them.
Take out the rubber stoppers from the hopper and discard them.
After power restores allow LAF’s to stabilize for 30 minutes.
Collect Raw material from hopper into sterile container in which material had been taken into machine.
Take out all the machine part from Aseptic area for re-sterilization
Close all the equipments, with their respective closers.
Clean machines and entire area as per respective SOP’s.
If power failure exceeds for more than 30 minutes, fogging should be performed in area as per the SOP.
Ensure all the equipments must be in closed condition before fogging.
Clean the entire area after fogging with 2 % Cidex /20 % Virosil solution.
Put remark of time in the respective BMR for the power shut down & resume of power.