SPECIFICATION SHEET

D06363 ver. 1.1

Qualification of Thermo Scientific Multidrop Combi nL unit

Qualification operation list
-

Qualification protocol review and approval

Qualification content review
Verifier and client responsibilities review

Installation qualification content list* Protocol N07836 IQ

DELIVERED WHEN IQ / OQ ORDERED
-

Certified reference testing equipment or apparatus required (supplied by the engineer

when the service package is ordered with calibration certificate if applicable at the time
of the qualification):
o Thermometer for ambient air temperature
o Hygrometer for ambient air humidity
o Multimeter for main voltage and hertz

Verification of order form and deliveries

Verification of goods received
Verification of installation site and ambient conditions
Verification of equipment power supply
Verification of equipment and associated accessories installation
Verification of equipment power-up
Delivery of user training if requested
List of components, service contract and documentation
Test equipment calibration certificate or verification report
Verifier training certificate
Installation qualification report review and approval

* For additional test(s), please contact us.

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SPECIFICATION SHEET
D06363 ver. 1.1

Qualification of Thermo Scientific Multidrop Combi nL unit

Operational qualification content list* Protocol N07836 OQ
DELIVERED WHEN IQ / OQ or IQ / OQ / PQ or MQ ORDERED
-

Verification of the general functionalities

Adjustment (calibration) if required
Test equipment calibration certificate or verification report
Verifier authorization certificate
Operational qualification report review and approval

* For additional test(s), please contact us.

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SPECIFICATION SHEET
D06363 ver. 1.1

Qualification of Thermo Scientific Multidrop Combi nL unit

Performance qualification content list* Protocol N07836 PQ
DELIVERED WHEN IQ / OQ / PQ ORDERED
-

Certified reference testing equipment or apparatus required (supplied by the engineer

when the service package is ordered with calibration certificate if applicable at the time
of the qualification). All the required relevant instruments/reagents/consumables are the
responsibilities of the customer:

For the Dispense Accuracy Test you need:

o PC with FILLit Software installed
o An appropriately calibrated analytical balance, readable to 0.0001 g
o A 96-well strip plate, for example, Thermo Scientific Microtiter Strip 1 x 8
Assembled (Cat. No. 95029350) or another similar plate
o Disposable gloves
o Deionized or distilled and filtered high-purity water
For the Dispense Precision Test you need:
o A microplate photometer set to measure absorbance at 540 nm (measurement
range 0 2 Abs, resolution 0.001 Abs)
o A 384-well plate, for example, Thermo Scientific Immulon 1 B 384 Well
Microplate (Cat. No. 8555) or another similar clear square well plate
o Ponceau S reagent (Merck product # 1,15927.0025 or equivalent); you will need
a 0.25% working solution. Use filtered and preferably fresh reagent. Refer to
Appendix A: Preparation of Ponceau S and Tween Solutions using syringe and
0.45m syringe filter
o A 0.02% v/v solution of Tween (Fluka product # 93773 or equivalent) in
deionized or distilled water (see Appendix A: Preparation of Ponceau S and
Tween Solutions)
o Deionized or distilled and filtered laboratory grade water
o A 50 ml conical centrifuge tube (for example, Nunc, Cat. No. 373687 or 334940)
o A microplate dispenser for plate filling with Tween buffer (for example, Multidrop
Combi, Cat. No. 5840300, with a standard tube cassette) or a pipette that
dispenses a 100 l at a time
o A plate centrifuge (for example, Thermo Scientific IEC CL30 Cat. No. 11210904)
- Dispense Accuracy Test (repetition of one (1) predefined volume on a 96-well plate)
- Dispense Precision Test (repetition of one (1) predefined volume on a 384-well plate)
- Adjustment (calibration) if required
- Test equipment calibration certificate or verification report
- Verifier authorization certificate
- Performance qualification report review and approval
* For additional test(s), please contact us.

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SPECIFICATION SHEET
D06363 ver. 1.1

Qualification of Thermo Scientific Multidrop Combi nL unit

Catalog number
Product

Multidrop Combi nL
Microplate Dispenser

Qualification

Document English

IQ / OQ

NA

IQ / OQ / PQ

IOPQDOCEN07836

MQ

N.A.

Package English

Please contact your

local Thermo Fisher
representative

Document You receive the qualification binder customized for your equipment (protocols
included), you complete the document.
Service Package The local Thermo Fisher Scientific authorized verifier completes the
customized document on site (document and labor included).
The customer is responsible for service and maintenance of the instrument in accordance with
the user manual if the IQ/OQ/PQ test is performed on a used instrument.

Change control
Version

Author

Date

Summary of Change

1.0

Ari Kukkonen

10-Dec-08

Original Document

1.1

Benoit Limon

2-Feb-09

Removing Trademark

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SPECIFICATION SHEET
D06363 ver. 1.1

Qualification of Thermo Scientific Multidrop Combi nL unit

Customer overall responsibilities:
Provide one dedicated professional representative to obtain all necessary records and
documentation
Provide and assure ready access to all relevant equipment, related documentation, work orders,
etc
Provide training on the required policies and procedures
Provide with the appropriate workspace, computers and building access
Provide installation site meeting unit ambient condition requirements listed on user manual.
Approve all documents as soon as possible

Thermo Fisher Scientific qualification warranty policy:

Repair Cost
Responsibility

Re-Qualification
Cost

Unit is under warranty, but failed the qualification test

due to the unit

Thermo Fisher
or representative

Thermo Fisher
or representative

Passed qualification, but a performance component

fails during warranty period

Thermo Fisher
or representative

Thermo Fisher
or representative

Customer

Customer

Thermo Fisher
or representative

Thermo Fisher
or representative

---

Customer

Product Age & Qualification Performance

Not under warranty, not under service contract

including qualification
Not under warranty, under service contract including
qualification
Qualification test is interrupted due to customer
intervention or power loss

All other scenarios will be based on the discretion of Thermo Fisher Scientific Regional Service
Manager & Qualification Manager

Customer signoff:
Customer reviewed / approved terms for qualification listed on that specification sheet:

Customer Name

Date

Customer Signature

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