Management of sterile area after power resume

Management of sterile area after power resumes

In the fast-paced and technology-driven world of healthcare, maintaining sterility in critical areas is paramount. The disruption of power supply in healthcare facilities can pose significant challenges, potentially compromising the integrity of sterile environments. When power is restored, a well-thought-out plan is essential to ensure that sterile areas are promptly and effectively managed to prevent contamination. In this blog, we will explore the key considerations and best practices for managing sterile areas after a power outage.

1. Assessment and Inventory:

The first step in managing a sterile area after power resumption is a thorough assessment. Verify the status of critical equipment, supplies, and pharmaceuticals. Conduct an inventory to identify any potential damage or compromised items during the power outage. This step is crucial to ascertain the safety and sterility of the environment.

2. Communication Protocols:

Clear communication is vital during the post-power-resumption phase. Ensure that all relevant personnel are informed promptly. Establish a communication protocol to disseminate critical information, including the status of sterile areas, any compromised equipment or supplies, and instructions for resuming normal operations.

3. Quality Assurance and Validation:

Conduct a comprehensive quality assurance check to validate the sterility of the environment. This may involve microbial testing, air quality assessments, and equipment functionality checks. Collaborate with the facility’s infection control team to ensure that all necessary precautions are taken to maintain a sterile atmosphere.

4. Personnel Training and Preparedness:

Empower healthcare personnel with training programs focused on emergency response and the specific protocols to follow after a power outage. This includes proper donning and doffing of personal protective equipment (PPE) and adherence to aseptic techniques. Preparedness minimizes the risk of contamination during the critical post-power-resumption period.

5. Emergency Power Backup Systems:

Investing in reliable emergency power backup systems is a proactive measure to prevent disruptions in critical areas. Regularly test and maintain these systems to ensure their effectiveness. The quicker the transition to backup power, the lower the risk of compromising the sterility of vital environments.

6. Documentation and Reporting:

Maintain detailed records of actions taken during and after the power outage. Documentation should include the status of sterile areas, any deviations from standard procedures, and steps taken to rectify issues. This information is valuable for post-incident analysis and can aid in refining future response strategies.

7. Collaboration with Suppliers:

Engage with suppliers of critical sterile supplies and equipment to understand their recommendations for handling items after a power outage. Follow their guidelines meticulously to minimize the risk of compromised sterility.

8. Continuous Improvement:

After managing the immediate aftermath of a power outage, conduct a comprehensive review of the incident. Identify areas for improvement in emergency response plans, equipment resilience, and personnel training. Continuous improvement ensures a more robust response to future incidents.

 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

SOP : Standard Operating Procedure

PROD. : Production

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.

In Conclusion:

In the high-stakes realm of healthcare, the management of sterile areas after power resumption demands careful planning, effective communication, and a commitment to quality and safety. By implementing the best practices outlined above, healthcare facilities can minimize the risk of contamination, safeguard patient well-being, and maintain the highest standards of sterility in critical environments. As technology advances, so too must our strategies for ensuring the uninterrupted integrity of sterile areas in healthcare settings.