Management of sterile area after power resume
Management of sterile area after power resume
PURPOSE : To describe the procedure for management of sterile area after power resume.
SCOPE : This SOP will be applicable for resuming of sterile area after power failure at sterile area of SVP section
RESPONSIBILITY
Operator:
To follow all the instructions described here in.
Production Person/Designee:
To verify that employees are trained before performing or operation any task relevant to this SOP.
To Maintained the record.
Production Head:
To ensure the compliance of SOP.
Quality Assurance Persons:
To verify that all the instructions are followed properly as per the given SOP..
To ensure implementation of the SOP.
DISTRIBUTION
Production
Quality Assurance
Engineering
DEFINITION & ABBREVIATION(S)
Definition
Clean Area :Clean area is the area in which defined environmental control of particulate & microbial contamination, constructed & used in such a way to reduce the introduction, generation & retentions of contaminants within the area.
Abbreviations
SS : Stainless Steel.
IPA : Iso Propyl Alcohol
LAF : Laminar Air Flow
AHU : Air Handling Unit
UPS : Uninterrupted Power Supply
PROCEDURE:
Maintaining sterile area environment is mandatory requirement for aseptic operation.
To comply this requirements AHU system should be continuous run, positive pressure to be maintained & cleaning & disinfection to be perform at regular interval to avoid the particulate as well as microbial load.
During manufacturing & filling activities in sterile area, if AHU stop due to power failure or break down sterile area can be contaminate with increasing viable and non-viable load and product sterility can be affected.
There are certain steps to be followed to recover the sterile area after power resumes.
If Power failure less than 2 minutes
When power goes “OFF” for less than 2 minutes do not move from your places and don’t open the door of any of the rooms until power resumes.
As the power resumes, first engineering person start AHU & sterile area person wait for 5 minutes for area recovery.
LFR/SFS of FFS machine will be on UPS supply, so that will be in continuous operation during power failure.
Engineering person should be trained to operate AHU system of most critical area or higher class first followed by lesser class.
Engineering person should start AHU immediately as the power resumes in order to maintain the room pressure and temperature & to avoid ingress of particulate matter in clean area.
After 5 minutes sterile area person will sanitize the hand gloves with 70% v/v IPA solution.
Start the filling operation.
If Power failure up to 5 minutes
When power goes “OFF” for 5 minutes do not move from your places and don’t open the door of any of the rooms until power resumes.
As the power resumes, first engineering person start AHU & sterile area person wait for 5 minutes for area recovery.
LFR/SFS of FFS machine will be on UPS supply, so that will be in continuous operation during power failure.
Sanitize the hand gloves with 70% v/v IPA solution.
Start the filling operation & discard initial 10 cycles from the machine & afterwards run the machine continuously.
If power failure from 5 minutes to 30 minutes
When power goes OFF more than 5 minutes first switch “OFF” the PLC and all the utilities of the machine.
Come out from the filling room & wait till power resumes & differential pressure, temperature/humidity of the area come within specified limit.
Clean and sanitize the area with the schedule disinfectant solution as per SOP.
Change the gloves & sanitize with the hand disinfectant solution of 70% v/v IPA solution.
Start all the utilities of the machine and start machine.
Discard initial 10 strokes from filling machine & continue start the operation.
If power failure more than 30 minutes
When power goes “OFF” for more than 30 minutes first switch “OFF” the PLC and all the utilities of the machine.
Close the holding tank tightly.
Attach the mendral unit to filling nozzles.
Come out from the filling room & wait till power resumes & differential pressure, temperature/humidity of the area come within specified limit.
As the area maintain start the machine LFR/SFS.
Clean and sanitize the area with the schedule disinfectant solution as per SOP
Change the gloves & sanitize with the hand disinfectant solution of 70% v/v IPA solution.
Send the bulk sample from tank for BET and bio burden.
After release from QC/micro start filling operation.
Separate out all previous filled & sealed units by denoting the label of lot no. LOT-A.
Start filling machine & discard initial 15 strokes from filling machine & continue run the machine.
Separate lot no. “LOT-B” shall be given to the units filled after power resumes & perform separate sterility test of the same lot.
REVISION HISTORY
New SOP