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Calibrate's
4 Unique
Levels of Pipette Service
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As North America's first and largest on-site pipette calibration and
repair company, Calibrate, Inc. is servicing over 15,000 labs
across the US and Canada, each of which has a different set
of documentation and servicing needs. In order to meet those
needs we have developed a unique 4 level servicing system that
is designed to meet even the highest standards and most stringent
compliance requirements in the industry. This system is at the
heart of our unparalleled Quality Assurance Program
and is just one of the reasons so many labs call Calibrate,
Inc their Pipet People |
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Use the
following guide to determine the appropriate level of service
required at your facility and use the links on the left to
move to the detailed description of each level of service.
To request
service call 800-253-7064 or submit
a service request online. Our Canadian customers can use
the toll free number above for immediate service.
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4
Unique Levels of Pipette Service
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In addition
to the standardized levels of service below, we offer custom-designed,
validated computerized documentation packages for specific
licensing and accreditation requirements.
For more information on how we can customize an package for
your facility call 800-253-7064 for immediate service
in the US or Canada.
To learn more about our SOP's please
submit a QAP Request
online or call 800-253-7064 to contact our Quality
Assurance Director.
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Level 1: |
Level 1 service is most often used by those labs engaged in
teaching and research at the University level. |
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| Level
2: |
Level
2 service is most often used by labs who want level 1 service,
and require the additional documentation of the calibration
event provided by our Quality Assurance Certificate. |
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| Level
3: |
Level 3 service is most often used by private and public labs
involved in doing supportive research, perhaps by contract,
with laboratories regulated by the FDA, CLIA, or some other
regulatory body. These labs require documentation of each data
point, the relative calculations, environmental conditions,
and the pass/fail status of each pipette serviced. |
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| Level
4: |
Level 4 service is used by laboratories operating in a regulated
environment. These labs are typically involved in clinical trials,
QA studies, Quality Control, and manufacturing, and require
complete documentation of both the As Found and As Left status
of each pipette. |
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1.
Pipette Identification:
Calibration
reports are indexed by the serial number of the pipette, manufacturer,
and size. The next recommended service date is based on a
semi-annual maintenance schedule, unless otherwise specified
by the client.
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Preventative Maintenance and Accuracy Verification for non-GMP/GLP
Applications: |
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- Complete
Disassembly (as applicable), Inspection and Cleaning Instrument
- Replacement
of wet or dry Seal and O-Ring.
- Calibration
of Instrument to Calibrate, Inc.'s SOP - QAP 125 - Level
1
- Specifications
or to a SOP Addendum developed to meet your unique calibration
needs.
- Sticker
Affixed to Pipette with Date of Service and Service Provider
- Toll
Free Service Center Telephone Number
- All Measuring and Test Equipment used for Calibration is traceable to the SI (Système International d'unités) through N.I.S.T. (Copies of Measurement and Test Equipment Calibration Certificates are Available Upon Request)
- Accuracy
Verification Shall Consist of Three Readings at Three Different
Volumes
that Cover the Range of the Instrument.
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1.
Pipette Identification:
Calibration
reports are indexed by the serial number of the pipette, manufacturer,
and
size. The next recommended service date is based on a semi-annual
maintenance
schedule, unless otherwise specified by the client.
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| 2.
Preventative Maintenance and Accuracy Verification for non-GMP/GLP
Applications: |
- Complete
Disassembly (as applicable), Inspection and Cleaning Instrument
-
Replacement of wet or dry Seal and O-Ring.
- Calibration
of Instrument to Calibrate, Inc.'s SOP - QAP 125 - Level
2
Specifications, or if required, to that of an SOP Addendum
developed to meet your
unique needs.
- Sticker
Affixed to Pipette with Date of Service and Service Provider
- Toll
Free Service Center Telephone Number
- All Measuring and Test Equipment used for Calibration is traceable to the SI (Système International d'unités) through N.I.S.T. (Copies of Measurement and Test Equipment Calibration Certificates are Available Upon Request)
- Accuracy
Verification Shall Consist of Three Readings at Three Different
Volumes
That Cover The Range Of The Instrument.
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3.
Quality Assurance Certificate:
Level
2 service provides a Quality Assurance Certificate, (reference
SOP QAP 125-2,
Attachment A-2), for each group of pipettes provided by the
end user.
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| 1.
Pipette Identification:
Calibration
reports are indexed not only by the serial number of the pipette,
but also by
any additional identification codes (such as property tag
numbers) or identifying
markings found on the pipettes (such as initials or lab name).
The next recommended
service date is based on a semi-annual maintenance schedule,
unless otherwise
specified by the client.
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| 2.
Preventative Maintenance and Accuracy Verification for non-GMP/GLP
Applications: |
- Complete
Disassembly (as applicable), Inspection and Cleaning Instrument
-
Replacement of wet or dry Seal and O-Ring.
- Sticker
Affixed to Pipette with Date of Service and Service Provider.
An optional
sticker is available at the level which provides the serial
number of the instrument,
technician's initials, date of calibration, and next calibration
due by month, day and
year.
- Calibration
of Instrument to Calibrate, Inc.'s SOP - QAP 125 - Level
3
Specifications, or if required, to that of an SOP Addendum
developed to meet your
unique needs.
- Toll
Free Service Center Telephone Number
- All Measuring and Test Equipment Used for Calibration is is traceable to the SI (Système International d'unités) through NIST (Copies
Of Measurement and Test Equipment Calibration Certificates are Available Upon Request)
- Accuracy
Verification Shall Consist of up to Five Readings at Three
Different
Volumes That Cover the Range of the Instrument.
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| 3.
Calibration Certificate:
Calibrate, Inc. provides the Level 3 customer with a computer generated data sheet, entitled Calibration Certificate. This certificate provides valuable information concerning the pipette, including serial number, size, manufacturer, cost center, and location; the environmental conditions; and the N.I.S.T. traceability information concerning the Calibrate, Inc. Measuring and Test Equipment used in the calibration of the pipette. All Measurement and Test Equipment is traceable to the SI (Système International d'unités) through NIST. Detailed Post Calibration Data is provided for each pipette serviced.
Reference SOP QAP 125-3 Sample Level 3 Certificate |
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| 1.
Pipette Identification:
Calibration
reports are indexed not only by the serial number of the pipette,
but also by
any additional identification codes (such as property tag
numbers) or identifying
markings found on the pipettes (such as initials or lab name).
The next recommended
service date is based on a semi-annual maintenance schedule,
unless otherwise
specified by the client.
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| 2.
Preventative Maintenance and Accuracy Verification for GMP/GLP
Applications: |
- "As
Found" data collected prior to Inspection, Cleaning
and Disassembly of the instrument.
- Complete
Disassembly (as applicable), Inspection and Cleaning of
the Instrument.
- Replacement
of wet or dry Seal and O-Ring.
- Calibration
of Instrument to Calibrate, Inc.'s SOP - QAP 125 - Level
4 Specifications, or if required, to that of an SOP Addendum
developed to meet your unique needs.
- Sticker
Affixed to Pipette with Date of Service, Service Provider,
the Serial Number of the Instrument, Technician's Initials,
and Next Calibration Due by Month, Day and Year.
- Optional
Out of Service Report prepared for each instrument that
cannot be repaired or is taken out of service.
- Toll
Free Service Center Telephone Number
- All Measuring and Test Equipment Used for Calibration is is traceable to the SI (Système International d'unités) through NIST (Copies
Of Measurement and Test Equipment Calibration Certificates are Available Upon Request)
- Accuracy
Verification shall consist of three readings at the high
and low volumes that cover the range of the instrument for
"As Found" Data and five readings at three different
volumes that cover the range of the instrument for "Corrected
To" Data. Reference Calibrate, Inc. SOP QAP 124-4,
Enclosure C-6 and C-7.
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| 3.
Calibration Certificate:
Calibrate, Inc. provides the Level 4 customer with a computer generated data sheet, entitled Calibration Certificate. This certificate provides valuable information concerning the pipette, including serial number, size, manufacturer, cost center, and location; the environmental conditions; and the N.I.S.T. traceability information concerning the Calibrate, Inc. Measuring and Test Equipment used in the calibration of the pipette. All Measurement and Test Equipment is traceable to the SI (Système International d'unités) through NIST. Detailed As Found and As Left data is provided for each pipette serviced.
Reference SOP QAP 125-4. Sample Level 4 Certificate
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| 4.
Failure Report:
If an
instrument fails the "As-Found" data check, the
failure is noted on the Data Sheet
for that pipette, under Pre-Calibration Data. In addition,
Calibrate, Inc. Representatives
notify the end user of the failure through personal contact
in person or via the phone.
If a pipette cannot be repaired and/or fails to meet the required
tolerances, the
instrument is tagged as failed or out of service. The end
user must determine the
disposition of the instrument. As part of the Level 4 Service,
Calibrate, Inc. will complete
an Out of Service report for each pipette that fails or cannot
be repaired, for a small
additional fee.
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| To
request service call 800-253-7064 or submit
a service request online. Our Canadian customers can use
the toll free number above for immediate service. |
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Find
out why over 15,000 labs call us The Pipet People -
Call today!!!
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