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Edited Clean Room Checklist (ISO 14644)

The document outlines requirements for clean room certification and testing according to ISO 14644 standards. It specifies that clean room personnel must: 1) Perform clean room, clean bench, and controlled environment certification per ISO 14644-2, including maintaining filter replacement logs. 2) Document clean area classifications per ISO 14644-1. 3) Conduct particle counting, air velocity, and differential pressure testing as outlined in ISO 14644-1. 4) Record testing information and make recommendations when airflow is deemed insufficient.

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100% found this document useful (1 vote)
450 views

Edited Clean Room Checklist (ISO 14644)

The document outlines requirements for clean room certification and testing according to ISO 14644 standards. It specifies that clean room personnel must: 1) Perform clean room, clean bench, and controlled environment certification per ISO 14644-2, including maintaining filter replacement logs. 2) Document clean area classifications per ISO 14644-1. 3) Conduct particle counting, air velocity, and differential pressure testing as outlined in ISO 14644-1. 4) Record testing information and make recommendations when airflow is deemed insufficient.

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© © All Rights Reserved
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IL Contract ATTRIBUTE METHOD OF VERIFICATION Supplier Results REMARKS

Document
Para. Req.

REQUIREMENTS

2.1 Certification requirements for Clean Rooms


2.1
Contamination Control Laboratory personnel shall Verify that certification
perform Laminar Flow Clean Room, Clean Bench and requirements have been performed
Controlled Environment Certification for the JPL per ISO/DIS 14644-2 :1998
community per the ISO/DIS 14644-2 : 1998 (E) Standard Standard.
(available through http://standards.nasa.gov/).

2.1.1
The Contamination Control Services Laboratory shall Request to see the filter replacement
maintain the certification, High Efficiency Particulate Air log or database and verifty the status
Filter (HEPA)/Ultra Low Penetration Air Filter (ULPA), on frequency replacement of filters.
and pre-filter replacement status for all of these sites in
order to comply with the documentation requirements of
ISO.

2.2
The Classification of the Clean Areas shall be Ensure that the log or database
documented per the ISO 14644-1 standard (available identifies the classification of the
through http://standards.nasa.gov/). Clean Areas.
2.3
The ISO 14644-1 tests shall include but are not limited to Select random samples and verify
airborne particulate counting and sizing, air velocity that tests are performed per ISO
testing, and differential pressure testing. standard above.
2.5
The Controlled Environment areas (> class 100,000) shall Verify records that particulate
require only particulate testing unless otherwise requested testing has been performed on Clean
by the customer. Rooms Class 100,000 or greater.

3.0 REQUIRED TESTING


3.1
Contamination Control personnel shall measure the Verify testing records show evidence

RESULTS CODES; M = MAJOR NONCONFORMANCE C = COMMENDATION


N = MINOR NONCONFORMANCE S = VERIFIED SATISFACTORY
O = OBSERVATION N/A = NOT AUDITED
IL Contract ATTRIBUTE METHOD OF VERIFICATION Supplier Results REMARKS
Document
Para. Req.

square footage of each Clean Room or Controlled that the square footage has been
Environment to establish the number of samples to be measured and recorded.
taken in the area.
3.2
The Contamination Control personnel shall take the Select a ramdom sample of test
proper number of samples at each location as defined by results and verify that the
the ISO 14644-1 Annex B Section B.4.1.1 using a (DPC) appropriate number of samples were
Calibrated particle counter (Calibrated within 180 days taken per the ISO standard.
designated to count the required particle sizes for the area
which will determine the classification of the clean area.

3.3
Contamination Control personnel shall perform a velocity Ensure that the velocity test was
test in the clean area. performed.

3.4
The number of tests performed shall be based on the Verify that the number of tests
square footage of the area. coincide with square footage of the
area.
3.5
Testing information shall be recorded on the certification Review the certification document
data or memo to the customer. and verify that testing information is
included.

3.6
Contamination Control personnel shall determine if the Seek evidence that
flow is adequate for the specified area and make recommendations have been made in
recommendations to the customer in writing where the writing by reviewing test records.
flow is deemed to be low or out of specification.

3.7
Differential pressure readings shall be performed in all Ensure that differential pressure test
clean areas to determine the existence of positive was performed and the resulting data
pressure. was provided to the cusotmer.

3.10
The Contamination Control personnel shall perform a Ensure that a visual for cleanliness
visual cleanliness survey of the Clean Area to be tested has been performed per specification
under the ISO standard. and recorded and filed.

Note :
RESULTS CODES; M = MAJOR NONCONFORMANCE C = COMMENDATION
N = MINOR NONCONFORMANCE S = VERIFIED SATISFACTORY
O = OBSERVATION N/A = NOT AUDITED
IL Contract ATTRIBUTE METHOD OF VERIFICATION Supplier Results REMARKS
Document
Para. Req.

This visual cleanliness survey shall be conducted per the


SN-C-0005 Contamination Control Requirements for
the Space Shuttle (Section 1.4) for visual cleanliness.
3.11
The Contamination Control Laboratory shall perform When required by the customer,
Low-Volatile Residue sampling by providing a clean ensure that the Low-Volatile
sample plate (for airborne collection) or (wipe samples) Residue sampling has been
for product testing if required by the customer. performed.

Note :
The following testing shall be optional.

 The Contamination Control Lab can provide


particulate fallout plates to determine the larger
size particulates that may be entering the clean
area.
 Tapelift samples can be provided for testing
hardware cleanliness, cleanliness of the walls ,
floors or any equipment in the clean area.

4.0 GARMENT REQUIREMENTS


4.1
Minimum Garment Requirements for Clean Rooms,
Controlled Environments and Work Stations.

Table 1 (below) shall be used as the minimum Review the specification and verify
requirements for clean rooms, controlled environments, that the requirements listed in Table
and workstations (as specified in ASTM E2352-04, 1 have been met as a minimum.
available through http://standards.nasa.gov/)

5.0 OUTSIDE CONTRACTOR CLEAN ROOM


CERTIFICATIONS AND REQUIREMENTS
5.1
Contractors who perform work on JPL clean rooms shall Refer to ISO documents referenced
comply with all the applicable requirements set forth in and ensure requirements have been
the ISO 14644-1 and ISO/DIS 14644-2 : 1998 (E) complied with.
controlling documents.

5.3
The contractor shall supply to the JPL Contamination Ensure that the contractor satisfies
RESULTS CODES; M = MAJOR NONCONFORMANCE C = COMMENDATION
N = MINOR NONCONFORMANCE S = VERIFIED SATISFACTORY
O = OBSERVATION N/A = NOT AUDITED
IL Contract ATTRIBUTE METHOD OF VERIFICATION Supplier Results REMARKS
Document
Para. Req.

Control Laboratory a documentation package that this requirement and verify that it is
certifies the work complies with all the ISO standard per ISO.
requirements, and specifies the type of work performed,
and any optional tests performed.

5.4
The contractor shall build the new Clean Room facility in Review the documents supplied to
accordance to the ISO 14644 documents and supply the the JPL Contamination Control
JPL Contamination Control Laboratory documentation Laboratory documentation and
which shall include all tests in accordance with that verify that requirements in ISO have
document, and sizes, part number of manufacturer been met.
number, and statement that the filters were not tested
with Dioctylphthalate (DOP), plasticizer test materials or
other non-approved JPL test methods with a CNC for the
HEPA or ULPA filter installation.

6.0 HEPA/ULPA AND RELATED FILTER


REPLACEMENTS
6.1
HEPA filters that are over the manufacuturer’s Under such condition, verify that
recommended life expectancy of 5 years shall be tested filter degradation has been tested
for large particulate by deploying witness plates in the and recorded.
clean room area to determine if the HEPA filter is
degrading.

Note:

The HEPA/ULPA filters have a life expectancy of 3-5


years in accordance with the manufacturer’s
recommendations. Typically the filters at JPL require
replancement in 6-7 years. There are some filters that
have been purchased by JPL that hve a life expectancy
of 10 years, warranted by the manufacturer, at
additional costs.

6.2
The Contamination Control personnel shall determine by Ensure that Contamination Control
the tests performed in the certification process when the certification includes tests
filter require replacement based on the airflow or the performed to determine when filter
differential pressure drop of the filter. replacement is required.

RESULTS CODES; M = MAJOR NONCONFORMANCE C = COMMENDATION


N = MINOR NONCONFORMANCE S = VERIFIED SATISFACTORY
O = OBSERVATION N/A = NOT AUDITED
IL Contract ATTRIBUTE METHOD OF VERIFICATION Supplier Results REMARKS
Document
Para. Req.

6.4
All HEPA filters older than 7 years old shall be replaced. Review filter log/records and verify
that these fitlers have been replaced
Notes: at the 7th year of use or before.
Waivers for filters older than 7 years shall be reviewed
on an individual basis.

Clean rooms that have fitlers older than 7 years shall be


put in non-compliance.

7.0 CERTIFICATION CLASS LEVELS


7.1
The Clean Room, Controlled Environment or Clean Verify that the designated area is
Bench shall have a designated class level number N marked with the class number.
which corresponds to the ISO 14644-1 Table 2
cleanliness classes.

7.7
Re-certification tests shall be performed on the clean Select a sample of records and verify
rooms at specific intervals to demonstrate compliance that re-certification tests were
with ISO 14644-1 according to the classification of the performed at specific intervals.
installation.

8.0 CERTIFICATION LABEL


8.2
This label shall identify the location, (NASA I.D. # on Ensure that the label identifying the
clean benches or clean tents) Classification, Date of location has all the proper
Certification, the next Certification date and other tests information.
performed.

10.0 RECORD KEEPING


10.2
The certification or non-compliance tests data shall be Request to see the database
entered into the computer database. information and verify it.

Note:

The data shall include the certification classification or


non-compliance data of the clean room, clean bench or
controlled environment, the date of the test, re-
certification date, the standard to which the test was
RESULTS CODES; M = MAJOR NONCONFORMANCE C = COMMENDATION
N = MINOR NONCONFORMANCE S = VERIFIED SATISFACTORY
O = OBSERVATION N/A = NOT AUDITED
IL Contract ATTRIBUTE METHOD OF VERIFICATION Supplier Results REMARKS
Document
Para. Req.

performed, the location and identification code or


NASA property number.

10.4
An Inter-Office Memo shall be initiated with the Request a copy of the memo and
classification, differential pressure and velocity data, verify all the pertinent information
customer’s name, charge number, location of the work has been included.
performed and the calibration date of the particle counter.

11.0 REPORTING TO THE CUSTOMER


11.1
The Contamination Control Laboratory shall provide the Ensure that the customer has been
customer with all the data related to the customer’s clean informed of clean room compliance
room, controlled environment or clean bench for to ISO.
compliance with the ISO standards in a memo form.

RESULTS CODES; M = MAJOR NONCONFORMANCE C = COMMENDATION


N = MINOR NONCONFORMANCE S = VERIFIED SATISFACTORY
O = OBSERVATION N/A = NOT AUDITED

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