Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations For Aseptic Processing Areas

Title:
Unplanned Cleanroom Power Outage Time Limit and Recovery

Determinations for Aseptic Processing Areas
Guidance Number: 118

Prepared by:
Date:
Supersedes:
Checked by:
Date:
Date Issued:
Approved by:
Date:
Review Date:
Unplanned Cleanroom Power Outage Time Limit and Recovery

Determinations for Aseptic Processing Areas
Introduction
How can the time between a cleanroom power outage and loss of environmental
control in the critical area be determined? Once the power is restored, how can the
time it takes to recover the desired environmental conditions be determined?
An interruption of power supply to the HVAC systems may produce a loss of
control which can be defined as a breech in the integrity of the controlled areas in
sterile manufacturing. Appropriate steps to be taken during and after an
interruption of air supply to the aseptic processing area (APA). (These steps should be
placed into site procedures before the studies recommended in this document are
executed.)
Qualification studies should be carried out to define a time limit after which the
controlled environment reaches or exceeds action levels for particulates, temperature,
humidity, and pressure differential.
To assist in meeting these requirements, this guidance will provide recommendations:
To assist in the qualification of an in control time period after power loss to

a controlled environment.
To assist in the qualification of a time period for full recovery of the controlled
environment following power restoration.
It should be noted that this guidance is intended for Aseptic Processing Areas which
are defined as those controlled environments consisting of Grade A or Grade B
classifications. The recommendations of this document can be applied to other
classifications (e.g., Grade C) depending upon a risk analysis by the site.
In addition, this guidance is primarily concerned with pressure drops in a controlled
environment due to a power outage to the central HVAC system. A Power failure
occurrence in an individual air handling unit is beyond the scope of this document.
Recommendations & Rationale for Recommendations
interruption. For example, the power interruption study should take into account the
potential maximum number of personnel that may be present in the APA and what
actions the personnel would perform during the interruption, such as exiting the APA
or reducing all movements to nominal tasks.
o Air Quality
Non-viable particulate and viable microbiological air tests used to determine a power
interruption time limit are quite similar to the qualification studies used to classify the
area. The monitors are placed in the controlled area while the air handling system is
operational. At time zero, power to the air handling system is shut down and the air is
continuously monitored for a defined length of time.
For non-viable particulate monitoring, the number of locations can be determined by
taking the square root of the total controlled surface area.
It is also prudent to place additional particulate monitors at critical locations based on
a risk analysis.
The number and placement of passive and/or active viable microbiological monitors
can be determined by risk analysis. The risk analysis placement should include
locations that have a high potential for microbial presence based upon areas that are
difficult to clean, historical data, production activities, previous qualification data,
traffic patterns, and line configurations.
Uniform coverage of the controlled area may also be utilized by the inclusion of
additional monitoring points to ensure that the viable particulate profile is accurately
represented throughout the area.
Acceptance criteria for air quality tests should be no higher than the action
levels employed during routine production.
o Pressure differentials and smoke studies
Another key parameter in defining a power interruption time limit is the flow of air
through the classified area. Pressure differentials are ideal for this purpose since data
can be monitored continuously and can give an indication of the potential change in
the flow of particulates from adjacent areas. As in air quality tests discussed above,
pressure differentials are monitored after the air handling system is shut down and the
time measured until the differential reaches a predetermined acceptance criterion.
However, unlike the air quality test, the routine production action levels may not be
appropriate, especially in controlled environments with openings (e.g. mouseholes).
The minimum acceptance criterion should be pressure equilibrium between the test
area and an adjacent controlled area of lower classification (i.e. no reversal of air
flow).
As with air quality testing, a safety margin should be built into the acceptance criteria
(i.e. requiring slight positive pressure in room being tested). For example, if nonviable particulates levels reach the action limits for the room at a pressure differential
of 2 Pascals, then the acceptance criteria should have a minimum pressure differential
greater than 2 Pascals.

Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations For Aseptic Processing Areas

Uploaded by

Copyright:

Available Formats

Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations For Aseptic Processing Areas

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Unplanned Cleanroom Power Outage Time Limit and Recovery Determinations For Aseptic Processing Areas

Uploaded by

Copyright:

Available Formats

Title:

Unplanned Cleanroom Power Outage Time Limit and Recovery

Guidance Number: 118

Unplanned Cleanroom Power Outage Time Limit and Recovery

To assist in the qualification of an in control time period after power loss to

You might also like