ENODEST OENOLOGIC DESTILLER

OPERATION QUALIFICATION
 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION

Objectives:
Qualification (O/Q) is used to verify that the Enodest Oenologic Destiller and component accessories
(where applicable) have been installed to the manufacturer’s requirements.

Equipment:
Enodest Oenologic Destiller consists of the following components:
 Main Unit
 Vessel Destillation
 Glass accessories
 Customer optional accessories

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
Correcting Long Entries:

To correct a long entry or information block on a form:

1. Draw a diagonal line, bottom left to upper right, through the miss entered or incorrect
information.
2. Write the correction on a separate addendum page.
3. Give a brief explanation of the change.
4. Initial and date the changes.
5. Number the page alphanumerically.
6. Place the addendum page behind the original page.

Marking Elements That Are Not Applicable:

Some elements may not apply to your system’s configuration. The elements that are not required may
be a procedure or part of a procedure and/or a form or part of a form. Mark each element carefully
according to the instructions below, so that it will be clear that the element is unnecessary and that you
have not skipped or forgotten the element.

1. Draw a diagonal line, bottom left to upper right corner, through the element that is not
required.
2. Write the letters NA (Not Applicable), you initials, and the date above the line. Include
comments above the line or on the form to document the reason the element is not
required.
3. Where NA is indicated as an option, select this field.

The performer and reviewer must sign and date all forms, as usual, even when part or all of the form is
marked “NA.”

Note: All original entries must remain legible after any corrections have been made.

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
CAUTION:

The following conditions require “re-qualification:”

 When a system modification has been completed, it affects the installation qualification.
 When the software or firmware has been upgraded or changed.
 When this system is being removed from where it was originally installed.

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
Operation Qualification Program

Section (1) – Personnel Information

This section identifies the user of the equipment, personnel who have installed and that are approved
for certification of this system being qualified, materials required and end user information to complete
qualification.

Section (2) – Operation Qualification

This section includes the qualification procedures (including the test protocols, test results, in a pass/fail
format for each test). When accrediting the calibration of the equipment being qualified, this procedure
will be referenced.

Where applicable, copies of these procedures are available, upon request, from Raypa.

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION

Section 1.0 – Personnel Information

Section 1.1 Qualification Protocol Approval

The ENODEST Operation Qualification has been reviewed and approved by the following:

Performer: Date:
Signature mm/dd/yy

Approved By: Date:

Signature mm/dd/yy

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
Section Identifies Personnel

Installation Engineer: (1) .

Name (Print) Initials

Signature Date

Installation Engineer: (2)

(optional) Name (Print) Initials

Signature Date

Installation Engineer: (3)

(optional) Name (Print) Initials

Signature Date

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION

Approved By:

Title

Name (Print) Initial

Signature Date

Section End User Information

Company Name

Address

Department

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
Location

Contact

Telephone

Fax

E-mail

Customer PO Number

Supplier Invoice Number

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION

Section 2.0 Operation Qualification

Routine Qualification

The equipment should be checked every 6 months as a routine procedure after passing the first
qualification. The appearance of the machine should be inspected daily. Please contact maintenance at
Raypa, if any problems arise.

Requirement for Re-calibration and Re-qualification

The machine needs a Re-qualification if any of the following happens:

 When there is any change, which may null previous Test Procedure.
 When the system is upgraded and revised.
 When the machine is moved from the original location.

The machine needs Re-calibration if any of the following takes place:

 After maintenance.

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION

Section 2.1 Process of Operation Qualification

2.1.1 Power Switch

Turn the unit on, the indicator will light up and you will hear the water pump turn on. The
button A is lit with green. The light alarm is off.
Pass □ Fail □ N/A □

2.1.2 “Start” Button and “Stop” Button

Put water in sample vessel. Press the button, there would be flow in water drain. After some
minutes you can see the water sample bubbles.
Pass □ Fail □ N/A □

Press the “Stop” button while the distillation is course and the process is stopped.
Pass □ Fail □ N/A □

2.1.3 “Addition” Button

The “Addition” button can make the machine put more water into distilled vessel, press this
button and see the water addition.
Pass □ Fail □ N/A □

2.1.4 “Manual” Switch

Put the manual switch in position of on and distill, you would have to see the instrument is
stopped when the distilled level achieves the sensor position.
Pass □ Fail □ N/A □

2.1.5 Automatic water refilled

Open the drain valve on the vapor generator, put the tubing into chloride sodium solution and
turn on the instruments, you would have to have the water pump running and the min light on.
Pass □ Fail □ N/A □

Performer: Date:
Signature mm/dd/yy

Approved By: Date:

Signature mm/dd/yy

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
2.1.6 Distillation Test

Put 100mL of the ethanol solution to 10% (v/v) into vessel sample and running
distillation, after measure alcohol grade, the maximum error is 1.0% (this is minimum
measured grade is between 10.1% and 9.9% v/v).

Alcohol Grade:

Actual error:

Pass □ Fail □ N/A □

Performer: Date:
Signature mm/dd/yy

Approved By: Date:

Signature mm/dd/yy

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 ENODEST OENOLOGIC DESTILLER
OPERATION QUALIFICATION
3. Comments

This completes the Operation Qualification of the Enodest Oenologic Distiller.

Performer: Date:
Signature mm/dd/yy

Approved By: Date:

Signature mm/dd/yy

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