Embedded Files
The purpose of the airflow visualization test is to show the actual airflow pattern throughout the unidirectional clean room. The test can also be used to demonstrate the effects on airflow caused by equipment. The test determining the airflow patterns within a room using iso 14644 guides. Air flow visualization test (smoke study) in static & dynamic condition in the area, LAF’s, mobile LAF and dynamic pass boxes etc.
Prerequisites before initiating test:
Airflow direction test shall be conducted after operational airflow velocity is checked and certified before going for the test and the air handling system shall be operating and balanced with respect to the differential pressures required.
Room pressure balancing must be completed for the room where smoke testing will occur and any adjacent areas with openings or doors to the room being tested.
Equipment and rooms must be set up to simulate an actual having change parts and all sterile filling machine parts, and all carts, racks etc. In the room that would normally be present during operation.
Studies must be carefully planned to ensure the airflow is visible at all locations by selecting proper camera angles, locations for introducing smoke, appropriate lighting, and use backgrounds to provide better visibility of smoke.
There may be require a multiple camera, multiple angles and generators to demonstrate the correct air flow pattern.
Video Recording:
Smoke studies must be video recorded with HD Camera.
The video captured during the air flow visualization must be maintained and archived in like CD, DVD, or Hard Drive.
The video captured during the air flow visualization must be adequately labelled to communicate the time, location, and activity being video .
Air flow visualization in static conditions
Hold the smoke pipe near the filter face approximately 2 to 4 inches below the filter grill perpendicular to air flow for which the smoke test is to be done and operate the smoke generator as per manual, The dense smoke will come out from hose pipe.
Check the uniformity in the centre of the filter and at the periphery of the filter.
No airflow should penetrate to higher grade area from lower grade area.
All entire test shall be video graphed (using CD/DVD or equivalent medium) so that it will provide video evidence of unidirectional or non-unidirectional airflow if any.
Dynamic smoke study requirements for filling line:
Equipment shall be operated as per existing site procedures.
Initiate the operation under the respective LAF. Operators should follow site procedures for operation, setup, teardown, cleaning, etc. Prepare the area as required for the production run.
Setup of the filling equipment must be evaluated, to include any aseptic connections that must be made prior to the start of the filling process.
Environmental monitoring sites must be evaluated to assure they represent the environment where sterile product and components are exposed.
Unloading of sterilized items under cool zone LAF. Preparation of filtration assembly under filtration LAF.
Airflow over all conveyor and accumulator tables where sterile components and product are exposed, during operation.
Airflow at component infeed and filled product outfeed ports, during operation.
Confirm airflow direction at ports, doors, and transitions between Grade A and B areas, to ensure the preferential flow of air is from clean to dirty, or Grade A to B.
Infeed turn table loaded within empty vials.
Above the point of fill with the containers in motion, Above the bunging station with the containers in motion, Above the path of filled & plugged containers movement.
Microbiologist intervention with the active air sampling.
Below the cool zone LAF with unloaded materials kept under LAF, Pass boxes.
Flow over every environmental monitoring sample location verified to assure that airflow appropriately represents airflow over sterile product and components. Environmental monitoring locations may be adjusted based on the results of these studies. Airflow at final sample locations will be confirmed prior to performing dynamic studies.
Interventions performed during manufacturing / testing must be simulated during dynamic smoke testing. Part of the assessment process is to evaluate the potential risk to aseptic processes during the execution of the operator interventions, based upon airflows, where personnel stand to perform the interventions in relationship to the airflow, location of exposed product, or sterile containers, components, etc.
For interventions that required the opening of RABS doors, the airflow patterns during opening of RABS doors shall demonstrate movement of air out of the enclosure and shall demonstrate that external air to the enclosure does not enter while the door(s) is open.
Airflow shall be assessed for each intervention to determine risk for back flow or turbulence that could risk contamination of sterile product, components, or sterilized parts and equipment. The smoke source should be positioned above operators during interventions to visualize how airflow behaves during interventions.
Placement of environmental equipment and media, including settle plates, active air samplers, and particle count probes.
Consideration shall also be given to areas such as curtains/ doors and other opening where there is possibility of ingress of grade B air into grade A. For testing such zones, smoke shall be generated in grade B and its visualization shall be verified for ingress into grade A.
In a displacement design, “dirty” air is displaced by “cleaner” air, i.e., unidirectional airflow.
Procedure for conducting the test:
Setup the Air Steam Pipe as shown in Images or as convenient.
Align the smoke generator in such a way that the smoke will be introduced properly in to the air stream.
Operate the smoke generator to generate thick smoke, adjust the knob to set required smoke output as per manual.
If required setup camera multi angel view as shown below or as possible best view at site.
Perform all operational activities and interventions in respective area to determine the impact on airflow.
Air flow visualization test to be performed in dynamic operating conditions.
Airflow direction test shall be conducted after operational airflow velocity is checked and certified.
Equipment: WFI smoke generator or water-based propylene glycol smoke generator shall be used for smoke study.
Set up the video camera and record the room conditions.
The placement of video camera shall be such that it will best capture the activities being performed and shall assist for effective impact assessment of the airflow.
During smoke study activity in order to demonstrate a clear visualization of smoke, video camera to be focused at the correct angle, position and the view (i.e., long view wherever possible) and ensure the availability of smoke at the area of activity. Multiple cameras may be used to shot correct air flow pattern.
Take care of multiple intervention done simultaneously by operator/operators using the LAF.
Care shall be taken to ensure that the generated smoke does not obscure or mask the activity being performed.
Perform the air flow pattern mentioned location.
Observe the flow of smoke from generation point till it reaches the aseptic processing zone/object.
Entire test shall be video graphed (using CD/DVD) such that it will provide video evidence of airflow direction.
Acceptance:
Acceptance:
Clean air from the HEPA filters must wash directly over sterile components, products, and surfaces in a unidirectional flow to maintain first air concept always.
When the airflow nears, flat equipment surfaces the airflow should sweep across the flat surface to areas of less criticality.
Dead spots (no air flow) and turbulence or eddies (air that swirls or is otherwise not unidirectional) are not desirable in the Grade A area and should be identified and eliminated, when possible.
Within the Grade A area, airflow should be assessed for unidirectional flow from the filter face, continuing to where the air flows across the working surface and outward from the Grade A area.
For Grade A areas having Grade B backgrounds, the air from the Grade B area should not enter the Grade A area.
Curtains, hard barriers, RABS, or partitions are all useful in preventing the ingress of Grade B air into the Grade A areas.
Airflow at RABS doors (open or closed) will not draw air from the outside of the enclosure.
The smoke shall travel from cRAB to the surrounding areas from doors, access ports and from mouse hole.
Airflow during interventions will sweep away from exposed sterile parts, product, and components. Turbulence around the operator arms and hands or around implements and tools will not cause air to re-enter into the clean airflow over sterile product, components, or machine parts.
The airflow pattern in surrounding areas will demonstrate movement of air from critical locations to less critical locations.
The following information and data should be recorded in below formats or as agreement between the customer and the supplier. Smoke studies must be video recorded with HD Camera.
The video captured during the air flow visualization must be maintained and archived in like CD,DVD, or Hard Drive.
The video captured during the air flow visualization must be adequately labelled to communicate the time, location, and activity being video.
Page updated
Report abuse