Performance Qualification of A Clean Room From A Quality Perspective PDF
Performance Qualification of A Clean Room From A Quality Perspective PDF
PERFORMANCE
QUALIFICATION OF
A CLEAN ROOM
FROM A QUALITY
PERSPECTIVE
Every facility design is unique for its specific
needs , and validation programs must be customized to meet these challenges. While there is
no one right way to write a clean room validation
protocol, the key is to develop documentation
using common sense and according to the specific
requirements for an operation and esta.blished regulatory standards. After a brief discussion of
important validation concerns, this paper will
focus strictly on the performance of clean room
facilities.
FUNDAMENTAL VALIDATION ISSUES
55
Omeo Chatterjee
GETI1NG STARTED
Beginning any validation project is a crucial issue
because companies do not want to do a lot of
work only to find out it is not acceptable. With an
adequate plan or procedure, carrying out a validation program becomes a matter of time and people resources.
Initially, during the drafting stage, make sure
that the validation plan is flexible so that changes
and team input can be incorporated. The goal is to
achieve the best design and ensure successful
results. Once the plan is finalized, it must be capable of withstanding critical review and satisfy
future company needs.
The validation team must start working at
ground level to establish specifications, guidelines,
schedules, as well as to identify appropriate inh~use expertise and outside resources, such as
contractors, subcontractors, and vendors. These
outside resources must have prior knowledge and
experience in clean room construction. Without
such knowledge, projects will become bogged
down by mistakes, additional costs, and delays.
The validation team jointly should establish a
validation program as follows:
1. Establish Parameters
2. Draft Protocols
3. Review and Approve Protocols
4. Conduct Tests and Collect Data
5. Evaluate Data
6. Document Results
7. Approve and File Results
Certification
- In-place HEPA Filter, Housing, and Frame
Leak Tests
- Airflow Velocity Profile of HEPA Filter
- Certification Label
2. Pressure Control Test
3. Temperature Control Test
4. HUmidity Control Test
5. Smoke Profile Test
6. Inter-Room Air Velocity Test
7. Detection/Monitoring of Particulate Matter
8. Sanitation
9. Clean Room Employee Training
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not damaged or improperly placed during installation. A properly applied HEPA Filter produces a
fairly uniform discharge of air velocity and direction. The HEPA filter test should be performed
only by certified personnel.
Conduct the leaker test using a DOP (Dioctyl
Phthalate) aerosol generator of the Laskin
Om eo Chatterjee
57
Omeo Chatterjee
Pressure differentials should be within design tolerances under static and simulated operating conditions.
The system is not acceptable if, at any time during static, stress, or dynamic conditions, the pressure in the primary environments becomes less
than zero or negative. The report from these readings is to be kept as part of the validation documentation.
Keep the following points in mind for clean room
air handling systems:
Always purchase systems from a reputable
manufacturer and hire well-experienced technicians
to perform installation and certification. These measures will reduce the risk of potential major disruption of systems and the possibility of product failure
due to environmental contaminants.
Do not cut costs on a pre filtration system.
Use a high grade prefilter which will extend the life
span of expensive final HEPA filters. Ultimately,
there will be less down time in production.
In clean room laminar airflow, parallel
streaming of air is an important factor for effective
removal of contaminants. The presence of nonunidirectional flow of air within the laminar air
system can impose a substantial risk. Most stan, dards for laminar flow systems take this into
account and impose definite requirements on
velocity distribution. Watch for uneven air distribution. It is caused by a poorly designed ventilation
systems or by uneven flow of air from the filter.
58
(65C, 5()C during the activity stage). Take temperature readings at static and dynamic states.
Leave on all air handling systems and lights for at
least 24 hours prior to conducting the tests.
Temperature readings should be recorded at various locations every 15 minutes for two hours over
a period of ten days. A summary of results for
each room tested should be prepared. Make sure
that the system is capable of maintaining the
desired temperature range (65C, 5C or other
preset specification) at all times.
Omeo Chatterjee
59
Omeo Chatterjee
CONCLUSION
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