Operational Qualification

for the Bin Washer

(Location)
(Tag #)
 Protocol Number:
Date: Rev #: Document #: 123456 Page 2 of 11

Table of Contents

1.0 Operational Qualification Approval................................................................................3

2.0 Scope of Qualification........................................................................................................4
2.1 Introduction.....................................................................................................................4
2.2 Objective...........................................................................................................................4
2.3 Acceptance Criteria.........................................................................................................4
2.4 Procedure.........................................................................................................................4
3.0 Validation Team.................................................................................................................5
4.0 Equipment Description and Operation...........................................................................5
5.1 Items to Include................................................................................................................6
6.0 Operational Checks...........................................................................................................6
6.1 Utility Connections..........................................................................................................6
6.2 Operational Check...........................................................................................................7
7.0 Challenge Testing...............................................................................................................8
7.1 Interlock and Challenge Checkout.................................................................................8
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Attachments

Deviation and Discrepancy Report...........................................................................................................11


 Protocol Number:
Date: Rev #: Document #: 123456 Page 3 of 11

1.0 Operational Qualification Protocol Approval

Name Signature Initials Date

Validation Manager

Engineering Manager

Project Engineer

QA/QC Director
 Protocol Number:
Date: Rev #: Document #: 123456 Page 4 of 11

2.0 Scope of Qualification

2.1 Introduction

This Operational Qualification (OQ) is applicable to the Bin Washer (Tag #) located in
(location) of …………………….

2.2 Objective

The objective is to document that all key aspects of the Bin Washer (Tag #) operation
adhere to approved design documents, manufacturer’s recommendations and Kronos
specifications and intended use.

2.3 Acceptance Criteria

The acceptance criteria will depend on the certification that the operation of this
equipment is consistent with the requirements of this protocol.

The Installation Qualification has been completed and approved.

Testing instrumentation and equipment utilized during the Operational Qualification must
be calibrated and calibration documentation stored in the validation file.

Training program for operators/users of Bin Washer has been completed per appropriate
SOP.

2.4 Procedure

The operation of this equipment will be qualified by following test procedures outlined in
this protocol.

A test technician’s initials and date within the designated areas indicate that the particular
item(s) have been checked and found to be acceptable. Section 3 identifies the validation
team.

If the inspection or verification test is not satisfactory, complete a Deviation and

Discrepancy Form located at the back of this protocol. Indicate any corrective action or
other appropriate action taken and obtain approval.

Upon successful completion of the Operational Qualification the Final Approval section
will be completed signifying acceptance that the system operates according to design
documents and associated specifications.
 Protocol Number:
Date: Rev #: Document #: 123456 Page 5 of 11

3.0 Validation Team

The following personnel comprise the validation team responsible for the execution of the
Operational Protocol.

Name Signature Initials

4.0 Equipment Description and Operation

This unit is designed to clean, sanitize and dry pharmaceutical bins. Bins are placed in the wash station
by lift truck and set into place. The wash station door is closed and secured and the operator initiates
the wash cycle. The wash cycle consists of pre-rinse, detergent wash, post rinse, final USP water
internal rinse, compressed air purge of water piping, hot air dry, and wash station self-clean.
 Protocol Number:
Date: Rev #: Document #: 123456 Page 6 of 11

5.0 Preliminary Checks

5.1 Items to Include

Description Verified By/Date

All test instrumentation and equipment utilized during the Operational
Protocol has been calibrated prior to testing of Bin Washer.
Document Location:
Motors have been checked for proper rotation.
List:

(Clockwise or Counter Clockwise)

6.0 Operational Checks

6.1 Utility Connections

Procedure

Confirm the utility connections to the Bin Washer.

Acceptance Criteria

Measured values should conform to specifications (+/-5%) unless otherwise noted.

Amperage not to exceed maximum nameplate data value.
Electrical
Description Specified Actual Result/OK Verified By/Date
Voltage to Panel
Working Amperage Measured
PLC Voltage 120

Utility
Description Specified Actual Result/OK Verified By/Date
Hot Potable Water
USP Water
Steam
Compressed Air
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Date: Rev #: Document #: 123456 Page 7 of 11

6.2 Operational Check

Procedure

Follow instructions in the O&M manual to program the Bin Washer Washer as required
for Kronos intended process and use. Attach a copy of the programmed wash cycle
parameters to the back of this protocol for reference. Run two separate wash cycles one
for a 300 liter bin and another for a 1700 liter bin. Place bins inside unit, secure door and
initiate wash sequence. Verify that the spray heads extend properly to clean the interior
of each side bin.

Acceptance Criteria

Unit will operate as intended for all wash cycle steps. All valving for water, steam and
drains function as intended. All detergent pumps must activate during the wash cycle and
provide adequate cleaning solution to wash unit. Blower fan will operate as specified and
bins will be completely dry upon removal from wash station after cycle completion. All
panel indicator lights are functional.

Pass / Fail
Expected Result Verified By/Date
300 Liter 1700 Liter
Bin Wash Cycle executes as specified at
programmed cycle times. Spray heads
extends properly during cleaning.

Expected Result Pass/Fail Verified By/Date

Self Clean Cycle runs as specified at
programmed cycle times.
 Protocol Number:
Date: Rev #: Document #: 123456 Page 8 of 11

7.0 Challenge Testing

7.1 Interlock and Challenge Checkout

Procedure

Using computer simulation or other safe and acceptable test methods, test the Bin Washer
safety stops, interlocks and challenges as outlined. Test each interlock, one at a time.
Reset the machine as necessary to insure the unit is fully operational before each check.
Record the results in the table below.

Acceptance Criteria

Unit operates within expected parameters.

Interlock Expected Result Actual Result Verified By/ Date

E-Stop Unit stops and resets cycle
Wash Station Door Opening door stops and resets cycle
Critical Alarm
Timers will not count
Condition
Critical Condition Units stops and resets cycle.
Low Detergent Unit displays alarm and/or stops and
resets cycle
Low Air Pressure Unit displays alarm and/or stops and
resets cycle
Low Steam Unit displays alarm and/or stops and
Pressure resets cycle
High Pressure Unit displays alarm and/or stops and
across HEPA Filter resets cycle
Spray wand not Unit displays alarm and/or stops and
aligned correctly resets cycle
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Date: Rev #: Document #: 123456 Page 9 of 11

8.0 Final Approvals

Based on all testing completed, we the undersigners certify that the Bin Washer located in
(location), operates as designed and complies with Kronos’s process requirements.

Final Approvals

Name Signature Initials Date

Validation Manager

Engineering Manager

Project Engineer

QA/QC Director
 Protocol Number:
Date: Rev #: Document #: 123456 Page 10 of 11

Attachments
 Protocol Number:
Date: Rev #: Document #: 123456 Page 11 of 11

Attachment #1
Deviation and Discrepancy Report

The following is a description of the deviations and/or discrepancies to this Operational Qualification
protocol. Use additional pages as necessary.

Reference (Section & Page):

Discrepancy/Variation:

Resolution:

Acceptable:  Yes  No
Signature Date

Reference (Section & Page):

Discrepancy/Variation:

Resolution:

Acceptable:  Yes  No
Signature Date