Attachment 1 - Statement of Work (SOW) - Amendment 2.pdf

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Amendment 2 Attachment #1 – Statement of Work (SOW)

Annual Onsite Laboratory Pipette Preventative Maintenance and Calibration Requirements

Contractor shall provide two (2) onsite maintenance visits per yearon an annual basis, the first visit during June 2020 and the second visit occurring in December 2020. The pipette services will be performed at Bldg. 52/72, 10903 New Hampshire Ave., Silver Spring, MD 20993. The pipettes contain 1, 8 and 12 channels. The contractor shall provide calibration of the pipettes in accordance with current ISO 17025 standard and FDA requirements. The contractor shall maintain current ISO 17025 accreditation for the entire duration of the order, including any option periods. Refer to Attachment #2, Sample Pipette List, for specific details, i.e. make, model, use, type, on pipettes to be maintained and calibrated. The Contractor will be provided all pipettes requiring maintenance and calibration during each visit upon their arrival onsite. The pipettes will be provided in “as-is” condition as received from the laboratories where used, and may require charging, consumable replacements, etc.

For multi-channel pipettes, the Contractor shall perform calibration of each channel using the same procedure as used for a single channel pipette.

Environmental Considerations Temperature of the pipettes, the rooms, the purified water, and the balance to be used for calibration shall be stable (± 5 ◦C). The temperature shall be measured using a National Institute of Standards and Technology (NIST) traceable thermometer capable of displaying the temperature to 0.1◦C. This value of temperature shall be inserted in the formula where “T” is used in calculations (see Calculations). The ambient relative humidity shall be between 35 to 75%. The humidity shall be ascertained with a NIST traceable hygrometer capable of displaying the humidity within 0.1% RH. This measurement shall be inserted in the formula where “H” is used in calculations (see Calculations). The Contractor shall provide the balances and other devices necessary for the conduct of pipette calibrations. Contractor shall use a 5-decimal place-balance to calibrate pipettes of nominal volume 5 µL or less. Contractor shall use a 4-decimal place-balance for pipettes of larger nominal volumes. The balances used by the Contractor shall be appropriately calibrated and checked against NIST traceable weights to ensure proper function and reliability.

The Contractor shall measure the barometric air pressure directly or obtain from a credible local weather service or a national weather website. This value shall be inserted in the formula where “P” is used in calculations (see Calculations). The Contractor shall notify the Technical Point of Contact (TPOC)Contracting Officer’s Representative (COR) or designee immediately upon discovery of adverse readings.

Pre-calibration or “as found” Measurement At the time of the scheduled calibration, a pre-calibration measurement or pipettes in “as found” condition shall be performed to assess the calibration status of a pipette following the procedure stated below in the “calibration procedure” section.

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Each pipette requiring calibration shall meet the applicable acceptance criteria for Inaccuracy and Imprecision (Table 1) to pass pre-calibration or calibration testing in “as found” condition.

Adjustable volume pipettes shall be tested for performance check before calibration by ten (10) consecutive measurements each at three (3) volumes (the Minimum Working Volume, 50% Nominal Volume, and the Nominal Volume) for the pipette following the procedure described.

Fixed volume pipettes shall also be tested before calibration by ten (10) consecutive measurements at its nominal volume following the procedure described in the calibration procedure.

If a pipette fails pre-calibration (in “as found” condition), the Contractor shall immediately inform and obtain authorization from the TPOC or delegate and repair it, if deemed repairable, before performing preventative maintenance and calibration. When a pipette is determined to be irreparable or does not meet the acceptance criteria listed in Table 1, even after efforts are made to repair it, a “Not in Operation” label shall be affixed and returned to the TPOCCOR.

Preventive Maintenance Following pre-calibration (“as found”) testing, and after the pre-calibration test results meet the acceptance criteria in Table 1, routine preventative maintenance shall be performed as per pipette manufacturers’ instructions. This includes disassembling the pipette, cleaning all parts, and replacing defective parts and seals (including consumables such as batteries, ejectors, pistons, o-rings, filters, shafts, etc.), as applicable. The piston shall be re-greased (grease also provided by the Contractor), where vacuum grease is the seal.

Calibration Procedure Each pipette shall then be calibrated with ten (10) consecutive measurements at three (3) volumes to evaluate the range of operation. The Calibration Volumes of an adjustable volume pipette shall be its Minimum Working Volume, 50% Nominal Volume and the Nominal Volume. For a fixed volume pipette the Calibration Volume shall be its Nominal Volume.

Note:

1. Applicant shall submit ISO 17025 accreditation certificate/documents to show the pipette calibration range of at least 0.5 to 10,000 uL is accredited.

1.2.Applicant shall submit a sample report with the application to show that the applicant’s calibration software is capable of analyzing 10 replicates per volume and other calculations, as required.

Contractor shall place a weighing vessel on the weight tray of the analytical balance.

Contractor shall pre-rinse a fresh tip with deionized water (water source provided onsite by the FDA).

Contractor shall tare the balance.

Contractor shall draw up purified water and dispense into the weighing vessel.

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Contractor shall record the weight from the balance.

Using the same tip, the contractor shall repeat the calibration steps until ten (10) consecutive, replicate measurements have been taken for each channel to reduce variability.

For adjustable volume pipettes, contractor shall change the pipette tip and repeat calibration steps with the remaining required Calibration Volumes.

Contractor shall calculate values of Imprecision and Inaccuracy at each Calibration Volume using appropriate software or formulae as follows:

Calculations

1.1 Parameters:

Wi = Weight of test liquid (water) in a measurement W = Mean weight V = Mean volume, in µL Ve = Selected Volume Z = Environmental correction factor, in cm3/g T = Temperature of liquid in °C Pa = Air density at T, in g/cm3 Pb = Density of balance weights, Pb = 8.0 g/cm3 P = Barometric Pressure, in mm of Hg H = Relative humidity, in % A = Cubic expansion coefficient in cm3/°C K = Expansion factor, no units SD = Standard Deviation CV % = Coefficient of variation Pw = Density of the Test Liquid at Temperature T in g/cm3

1.2 Air Density

Pa = [ ] 10 15.273

)(0037960.046460.0

T esHP -3

Where, (es) = 1.3146 10× 9 × Exp[-5315.56/(T+273.15)]

1.3 Expansion Factor

K = 1 – A (T-20) Where K = Expansion factor

A = Cubic expansion coefficient (Constant = 0.00010000) T = Temperature, degrees Celsius

1.4 Density of Test Liquid (purified water):

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Pw = 0.001x(999.83952+16.945176T-7.9870401x10-3T2-46.170461x

10-6T3+105.56302x10-9T4-280.54253x10-12T5)(1+16.879850x10-3T)

1.5 Environmental Correction Factor

Z = K Pb Pa

PaPw

1.6 Mean weight

W = n Wi∑

Where n is the number of samples

1.7 Mean volume

V = W×Z

1.8 Standard Deviation

SD = Z

n

WWi

2)(

1.9 Imprecision

CV% =

V

SD 100×

1.10 Inaccuracy

E% = ( ) e e

V

VV −100

Acceptance Criteria The acceptance criteria for Inaccuracy (E%) and Imprecision (CV%) are indicated in Table 1 for each Calibration Volume.

A pipette is considered calibrated, if the acceptance criteria for Inaccuracy and Imprecision are met at each applicable Calibration Volume.

Data Reporting / work product delivery Contractor shall provide a calibration report for each pipette the contractor calibrates, which shows its serial number, type, all measurements, mean, standard deviation, inaccuracy, imprecision, sample size, , environmental conditions (including device used to measure), traceability, and expanded uncertainties, K = 2 at 95% CL, with the conclusion (pass/fail) about acceptability for operation. Additionally, the technician who performed the service shall print, date and sign the report by close of business the same day the report is generated. This certificate allows the FDA QA to audit and release the

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Upon successfully completion of the calibration, a calibration label shall be affixed on the pipette. A calibration label shall contain information pertaining to the contractor identification, initials of the analyst performing the calibration, the date of calibration and due date of next calibration (180 days after the successful calibration date) shall be affixed on the pipette. The information on the calibration label shall match the information on the calibration report.

Table 1: Maximum Permissible Errors at Different Calibration Volumes

Calibration Volume (µL)

Inaccuracy (Systematic Error)

Imprecision (Random Error)

< 1 12.0 12.0

1 to 1.5 6.0 6.0

2.0 to <5.0 5.0 5.0

≥ 5.0 3.0 3.0

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