Barnstead D11911 Bedienungsanleitung PDF herunterladen (Seite 18)

Title

Barnstead



Thermolyne

NANOpure® DIamond™

Ultrapure Water System

Installation/Operation

Qualification

Protocol

BT.001.01.A

Customer

Protocol

____________

Revision

Customer

Revision

____________

Equipment ID

NANOpure®

DIamond™

Ultrapure

Water

System 1

Customer

____________

BT.001.01.A

09262000 Page 18 of 21

7 General

Comments

actual conditions. All discrepancies must be

presented to authorized customer company

personnel for resolution and/or statement of

acceptability.

General Comments:

__________________________________________________

Operation Qualification

Date:____________________________ Completed by: ___________________________

The installation and operational qualifications will be performed as stated in this

protocol and all raw data sheets will be completed concurrently with the

execution of the protocol.

All documentation (approved protocol, completed data sheets, lab reports) will

be maintained in a single Validation Project File. Upon completion of the

protocol, the data will be analyzed and presented, along with substantiating

documentation, in a summary report to be reviewed and approved by

designated _____________ personnel.

Any modifications to the NANOpure



DIamond™ Ultrapure Water System made

during the course of the protocol execution will be documented as per

__________________change control standard operating procedure. An

assessment will be made after the change to determine if re-validation is

required. All change control forms should be filed and reviewed at least yearly

to determine if re-validation is required.

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