Pharmaceutical Manufacturing Facilities – Aseptic Critical Airflow Visualization (Smoke Studies)

The Challenge:

This challenge was to complete Critical Airflow Visualization/Verification Studies for an entire aseptic processing area.  The aseptic processing area consisted of fifteen separate areas that needed to be examined for critical airflow, including filling lines, lyophilization loading/unloading areas, locally controlled environments, and stopper processing equipment.  All spaces classified as Grade A were to be examined and verified as acceptable.

To avoid any disruption in the supply of life saving-medicine manufactured at this facility, the critical airflow visualization studies needed to be completed in a 7-day window.

The video evidence of the Critical Airflow Visualization studies are typically reviewed during regulatory inspection and thus must be of sufficient detail and quality.

 The Solution:

Performance Validation provided qualified Team Leaders who provided complete solutions to critical airflow visualization projects (smoke studies).  For this project the solution consisted of:

Planning:

  • Performance Validation provided a Project Leader who completed the planning of the smoke study effort.  This included leading multiple meetings with Operations, Maintenance, Engineering and Quality to determine the final scope of the smoke studies.
  • The PV Project Leader developed and maintained the schedule that was used throughout the project to plan equipment, supplies and personnel.
  • Performance Validation developed training materials and led multiple training sessions to ensure that all necessary personnel were fully trained in the Critical Airflow Visualization effort.  Documentation of this training was also completed by Performance Validation.
  • Performance Validation assisted with the evaluation and selection of smoke generators and video cameras to be used for the smoke studies.

Execution:

  • Performance Validation Project Leader provided first and second shift execution oversight and management of 6 separate visualization teams, each consisting of personnel from Validation, Engineering, Operations, and Quality.

Review / Summary:

  • Performance Validation developed all deliverables for the smoke studies, including Verification Protocols, Execution Plans (scripts), Final Reports (narratives), and DVDs with detailed indexes.
  • Performance Validation helped the client by developing methodologies that reduce errors and improve the quality of the deliverables.  SOP updates and subsequent training for these improvements were completed by PV.

 The Results:

The Critical Airflow Visualization/Verification studies were completed within the allowed 7-day execution window.  A review of the video evidence identified that the execution team had provided complete, multi-angle, video evidence of critical airflow.  The project team indexed the video evidence which enables the end users the ability to easily and quickly reference executed tests and present this video evidence to auditors.

 The Benefits:

Performance Validation coordinated with multiple stakeholders to successfully complete the Critical Airflow Visualization/Verification Studies within a short execution window.  The studies were completed within budget, on schedule and enabled the facility to resume the manufacturing of life-saving medicines.  Meeting the production schedule for restart resulted in no medicinal shortages and no interruption in the supply of these medicines.

For more information please contact:

John Underwood
Michigan Division Director
5168 Sprinkle Road
Portage, MI 49002
Office – (269) 393-9112 X 2752
Cell – (269) 217-0353