MiniCapt Mobile Microbial Microbial Air Sampler and ... · The purpose of this installation and...

Document 1000021474

Revision B

Date May 2015 Page Cover

MiniCapt® Mobile Microbial Microbial

Air Sampler and Accessories Measuring what matters™ — simply

Installation Qualification (IQ) and

Operational Qualification (OQ)

http://pmeasuring.com/products/minicapt-mobile-microbial-air-sampler/#0

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Document 1000021474 Revision B Date May 2015 Page i of ii

MiniCapt® Microbial Air Sampler and Accessories IQ/OQ Manual

HEADQUARTERS 5475 Airport Blvd Boulder, Colorado 80301 USA T: +1 303 443 7100, +1 800 238 1801 Instrument Service & Support E: +1 800 557 6363 Customer Response Center T: +1 877 475 3317 E: [email protected] GLOBAL OFFICES BRAZIL T: +55 11 5188 8227 E: [email protected]

CHINA T: +86 21 6113 3600 E: [email protected] FRANCE T: +33 (0)6 82 99 17 98 E: [email protected] GERMANY T: +49 6151 6671 632 E: [email protected] ITALY T: +39 06 9053 0130 E: [email protected]

JAPAN T: +81 3 5298 8175 E: [email protected] KOREA T: +82 31 286 5790 E: [email protected] MEXICO T: +52 55 2271 5106 E: [email protected] NORDIC T: +45 707 028 55 E: [email protected]

PUERTO RICO T: +1 787 718 9096 E: [email protected] SINGAPORE T: +65 6496 0330 E: [email protected] TAIWAN T: 886-3-5525300 Ext: 301 E: [email protected] UNITED KINGDOM T: +44 1684 581 000 E: [email protected]

Document 1000021474 Revision B Date May 2015 Page ii of ii

DO NOT REPRODUCE OR DISTRIBUTE MiniCapt® Microbial Air Sampler and Accessories Installation Qualification (IQ) and Operational Qualification (OQ) Manual Part number (P/N) 1000021474 Rev B

© 2015 Particle Measuring Systems, Inc. All rights reserved.

BioCapt® and MiniCapt® are registered trademarks of Particle Measuring Systems, Inc.

All trademarks appearing in this manual are the property of their respective owners. The absence of any trademark or service mark from this manual does not constitute a waiver of Particle Measuring Systems trademark or other intellectual property rights with respect to that trademark or service mark.

Confidential document This confidential document contains proprietary information, which is protected by copyright. All rights are reserved. No part of this document may be reproduced, distributed, or transmitted in any form without the prior written consent of Particle Measuring Systems. The information contained in this document is subject to change without notice.

Quality statement The Quality Policy of Particle Measuring Systems is to strive to meet or exceed the needs and expectations of our customers and to align the activities of all employees with the common focus of customer satisfaction through continuous improvement in the quality of our products and services.

IQ/OQ Installation Qualification and Operational Qualification MiniCapt® Microbial Air Sampler

Document: Revision: Date: Page:

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Installation Qualification and Operational

Qualification Protocol

for

MiniCapt® Mobile Microbial Air Sampler

P/N: 790045 Serial Number:

Client:

PMS Protocol

PARTICLE MEASURING SYSTEMS (PMS)

Document Prepared By:

Name:

Signature:

Date:

Global Products Manager, Microbiology /

Sterility Assurance

Validation Team Leader

Global Products Specialist - Aerosol

L. Ceresa

F. Lalla

D. Pandolfi

May, 2015

May, 2015

May, 2015

CUSTOMER

Document Approved By:

Name:

Signature:

Date:



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Table of Contents

1 PURPOSE .......................................................................................................................................................3

2 DESCRIPTION ..............................................................................................................................................3

2.1 GENERAL CHARACTERISTIC ...........................................................................................................................3 2.2 SAMPLING ......................................................................................................................................................3 2.3 WARNINGS AND ALARMS ...............................................................................................................................4

3 RESPONSIBILITY ........................................................................................................................................4

3.1 CLIENT........................................................................................................................................................4 3.2 PARTICLE MEASURING SYSTEMS ..................................................................................................................4

4 SAFETY RELATED ISSUES .......................................................................................................................5

5 DOCUMENTATION PROCEDURES ............................................................................................................5

5.1 DATA PREPARATION ...............................................................................................................................5 5.2 ACCEPTANCE CRITERIA .........................................................................................................................6 5.3 DEVIATIONS – CORRECTIVE ACTION .................................................................................................6 5.4 PERSONNEL ...............................................................................................................................................6 5.5 SIGNATURES OF FINAL ACCEPTANCE ................................................................................................6

6 LIST OF VERIFICATIONS FOR INSTALLATION QUALIFICATIONS .............................................7

6.1 PRE-REQUISITES OF THE INSTALLATION QUALIFICATION ...........................................................8 6.2 VERIFICATION OF MANUFACTURER’S DOCUMENTATION .........................................................15

6.3 VERIFICATION OF THE INSTALLATION OF THE SYSTEM’S MAIN COMPONENTS ..................12

6.4 VERIFICATION OF LIGHT DISPLAYS ........................................................................................... … 15

6.5 VERIFICATION OF SOFTWARE’S VERSION ......................................................................................15

7 LIST OF VERIFICATIONS FOR OPERATIONAL QUALIFICATIONS ............................................18

7.1 PRE-REQUISITES OF THE OPERATIONAL QUALIFICATION ..........................................................19 7.2 FUNCTIONALITY TEST .........................................................................................................................21 7.3 ALARM TESTING ....................................................................................................................................25 7.4 POWER LOSS TESTING ..........................................................................................................................27 7.5 COMPUTER CONNECTIVITY TEST .....................................................................................................29 7.6 DATA DOWNLOAD .................................................................................................................................31

8 FINAL REVIEW OF PROTOCOL - PMS ................................................................................................35

9 REVIEW AND FINAL APPROVAL OF PROTOCOL - CLIENT .........................................................35

APPENDIX NO 1: LIST OF PERSONNEL INVOLVED IN THE QUALIFICATION .........................36

APPENDIX NO 2: DATA COLLECTION SHEET ...................................................................................37

APPENDIX NO 3: DEVIATIONS/CORRECTIVE ACTIONS ................................................................38



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1 PURPOSE

The purpose of this installation and operational qualification protocol (IOQ) is to provide

documented evidence that the MiniCapt® Mobile Microbial Air Sampler is supplied as per

requested and will be properly installed and operate in a consistent manner.

2 DESCRIPTION

2.1 General Characteristic

The MiniCapt Mobile is a portable instrument that uses the BioCapt® Impactor sampler head

with unique design which enables efficient biological sample collection in sterile environments.

Airflow into the BioCapt Impactor is controlled by a mass flow controller, thus ensuring an

operating flow-rate of either 25L/min, 50 L/min or 100 L/min as per model specifications. This

mass flow controller ensures the fluid dynamic conditions are maintained throughout the sample,

and allows for tubing and altitude corrections.

2.2 Sampling

The MiniCapt Mobile requires programming of the following operating parameters for sampling:

Choice of sampling mode (time or volume)

o Sampling duration (time mode)

25L/min: from 1 to 400 minutes



o Sampling volume in liters (volume mode) from 1 to 9999 L

Start delay: time delay before sample is started 0 to 139 minutes

Number of sampling intervals: from 1 to 1000 intervals

Waiting (pause) between an interval and the next, from 0 to 139 minutes

The MiniCapt Mobile makes it possible to pre-set sampling programs that can be activated from

the touchscreen or via Modbus.

The data saved from previous samplings are stored in memory, which can then be downloaded via

the USB connection, or printed using the USB connect for a printer.

When there is not enough system memory to store data from a new sampling session the oldest

sample record is deleted and automatically overwritten.



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From a software point of view, the MiniCapt Mobile is equipped with non-modifiable firmware

that provides the basic functionality.

2.3 WARNINGS AND ALARMS

The MiniCapt Mobile has operating alarms that automatically manage anomalous events that do

not compromise the sampling (warnings), could compromise the sampling quality (alarms). Both alarms and warnings are signaled if the event takes place for more than 10 seconds. They

are stored in memory by the system when triggered.

3 RESPONSIBILITY

The verification and documentation process are as follows:

3.1 CLIENT

Approve the protocol before tests are started.

Provide technical-operative assistance during the execution of the qualification protocol.

Approve the possible deviations arisen during the execution of this protocol.

Approve the corrective actions proposed and approve the resolution of the deviations.

Proceed to the review of the results and to the final approval (Section 8) at the end of the

activities.

Develop and approve the Final Qualification Report.

Archive all documentation.

3.2 PARTICLE MEASURING SYSTEMS (PMS)

Prepare the Qualification Protocol including all recommendations suggested by the Client

and proceed to its initial approval.

Submit the protocol to the Client for initial approval.

Start verification action and proceed with the protocol only after the official approval by

the Client.

Ensure that the verifications and / or tests are carried out by qualified personnel.

Ensure that the results of the tests are accurately recorded in an acceptable format in the

worksheets.

Ensure that all original data are signed and dated and that they are included in the

document.

Ensure that all instruments are calibrated beforehand with traceable references to primary

standard samples, and that a copy of the calibration certificate is included in the protocol.

Communicate any possible deviations to the client in a timely manner.

Propose corrective actions for the deviations.

Carry out the corrective actions after they have been approved by the Client and present

the results for the resolution of the deviations.

Review the results.



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4 SAFETY RELATED ISSUES

All persons involved in the qualification activities must know and observe the safety-related

norms established by the Client.

Possible specific precautions, the required personal protection equipment, and the measures to be

observed in the activities related to the execution of the present protocol must be indicated in

advance by the Client’s authorized personnel.

Each operation of use, maintenance, cleaning, etc. of the instrumentation or of the system must be

carried out by or under the supervision of the Client’s specifically trained personnel.

5 DOCUMENTATION PROCEDURES

5.1 DATA PREPARATION

Each test must be carried out by qualified personnel, following the instructions detailed in the

appropriate section of the protocol.

Use the worksheets from #6.1 to #7.6 to collect the results.

Use APPENDIX No 2: Data Collection Sheet for additional comments.

All chapters of this protocol must be assembled in proper order, including the original data

collected and all other relevant documents.

This protocol, with the original data and all documents collected during the qualification phase,

must be kept in an access controlled place following the norms established by the Client.

NOTE:

The modification “after the fact” of the validation data can seriously compromise the

approval by the Regulatory Authorities.



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5.2 ACCEPTANCE CRITERIA

The acceptance criteria are listed in the sections corresponding to each test. At the end of each

verification and/or test, there will be a check and an indication as to whether the results comply

with the acceptance criteria.

5.3 DEVIATIONS – CORRECTIVE ACTION

During the execution of the tests each possible deviation found, together with the corrective

action taken and the corresponding assessment of acceptability, is documented in APPENDIX

No 3: Deviations / Corrective Actions.

5.4 PERSONNEL

Use APPENDIX No 1: List of Personnel Involved in the Qualification to record the personnel

involved in this execution of this protocol.

5.5 SIGNATURES OF FINAL ACCEPTANCE

The final acceptance should be documented in Section 8 “final review of protocol – PMS” and

Section 9 “review and final approval of protocol – client”



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6 LIST OF VERIFICATIONS FOR INSTALLATION QUALIFICATIONS

TITLE SECTION

Pre-requisites of the installation qualification 6.1

Verification of manufacturer’s documentation 6.2

Verification of installation of the system’s main components 6.3

Verification of the light displays 6.4

Verification of the software version 6.5



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6.1 PRE-REQUISITES OF THE INSTALLATION QUALIFICATION

Objective

To provide the list of pre-requisites that can slow down the execution of this protocol if they are

not met. If the answer to some of the following questions is “NO”, ask the Client’s appropriate

personnel for authorization before proceeding.

Method of Verification

To verify the compliance of the list of pre-requisites.

Acceptance Criteria

The list of pre-requisites are satisfied.

Collection of Results

Use the worksheet # 6.1



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6.1 PRE-REQUISITES OF THE INSTALLATION QUALIFICATION WORKSHEET

IQ TEST: Equipment Pre-requisites

Form #: 6.1 Equipment #: Page of

Title of Test: Equipment Pre-requisites

Purpose:

To verify the compliance of list of pre-requisites of the MiniCapt® Mobile Microbial Air

Sampler.

Method:

Verify that the protocol is approved.

Verify the availability of the manufacturer’s instrument documents and the equipment

manual.

Acceptance Criteria:


Results:

Document

Result Verified by Date

Has the present protocol of the MiniCapt

Mobile Microbial Air Sampler been approved?

Are the manufacturer’s documentation and the

equipment’s manuals available?

Rational for the Qualification:

Comments:

Executed by: Date:

Authorized by (Client): Date:



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6.2 VERIFICATION OF MANUFACTURER’S DOCUMENTATION

Objective

To determine if the documentation provided by the manufacturer is proper for the instrument

and for the its use.

Verification Method

Provide a list of operating manual, maintenance manuals (if applicable), compliance certificates,

and any other type of documentation provided by the equipment manufacturer.

If the provider’s documentation is not sufficient, it must be complemented by documents prepared

by the equipment user.

Acceptance Criteria

The documentation must be adequate to describe the critical functionalities, to identify and to

characterize the main components of the equipment.





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6.2: VERIFICATION OF MANUFACTURER’S DOCUMENTATION WORKSHEET

IQ TEST: Equipment Documentation


Title of Test: Equipment Documentation

Purpose:

To verify the availability and location of all appropriate documentation associated with the

MiniCapt Mobile Microbial Air Sampler and its installation. Typical documents include

calibration certificate, operator manual and eventually the packing list and may include, but are

not limited to, drawings, schematics, purchase orders, warranty or guarantee documents

maintenance contracts, maintenance or service reports are discretional.

Method:

Ensure that all “vendor supplied documents” listed below have been issued to site and are

physically available.

Record the revision number and the revision date (where applicable), the location of the file

(its physical whereabouts) and sign and date the entry for each required document.

Any additional documents available or relevant should be recorded in the space available or

in the comments field.


The specified “vendor supplied documents” for the unit are available

Results:

Document

Revision Date Location Verified by Date

User manual of the MiniCapt Mobile

Microbial Air Sampler P/N:

Calibration certificate: attach

certificate to this document

Comments:

Executed by: Date:

Reviewed by (Client): Date:



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6.3 VERIFICATION OF THE INSTALLATION OF THE SYSTEM’S MAIN

COMPONENTS

Objective

The objective of this document is to record the inspection of the different components of the

installation.


Visually inspect the equipment and its main components listed into the following check list:

Item Quantity

MiniCapt Mobile Microbial Air Sampler 1

BioCapt Impactor Sampler Head 1

Lithium Ion Battery Pack 1

Power Supply 1

Visually inspect the printer and its main components listed into the following check list (if

applicable):

Item Quantity

Thermal Printer Kit 1

Printer Datamax Microflash 1

Cable Power Supply Microflash 1

Connection Cable USB/ RJ45 to the Printer

Microflash

1

Acceptance Criteria

The equipment and its components correspond to what is recorded in the reference

documentation.





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COMPONENTS (CONTINUED)

IQ TEST: Equipment Inventory


Title of Test: Equipment Inventory

Purpose:

This section is intended to document the inspection of the different components and the

completed installation of the MiniCapt Mobile Microbial Air Sampler and to demonstrate that

the unit complies with the Component Data Sheets and Specifications.

Method:

Enter the product code, model, the serial number, type and flow rate in the spaces below of

the MiniCapt Mobile.

Enter the details of the options also supplied (if these options have not been purchased

record ‘N/A’.


The equipment has not been damaged during shipping and the specifications stated below in

the column “Results” have been met for the following different parts of the system.

Results:

Document

Result

Verified by

Date

Record the product code and model of the

MiniCapt Mobile Microbial Air Sampler

Record the serial number of the MiniCapt Mobile

(found on bottom of instrument)

Record the flow rate of the MiniCapt Mobile

Sampler type

Record the availability of the external AC to DC

power supply of the MiniCapt Mobile

Record the serial number of the #1 battery supplied

Record the serial number of the thermal printer and

the availability of external AC to DC power supply

and connecting cable

Record the serial number of the head impactor

Record the serial number of the additional head

impactor (if applicable)

Comments:

Executed by: Date:




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6.4 VERIFICATION OF LIGHT DISPLAYS

IQ TEST: Equipment Inventory


Title of Test: Equipment Start-Up Test

Purpose:

To check that the MiniCapt Mobile powers up and displays the current status.

Method:

Ensure that main adaptor and battery(s) supplied are available.

Remove the cover of the battery chamber in the bottom pf the sampler and install the

battery supplied into the battery chamber of the MiniCapt Mobile (see user manual for

details).

Insert the main adaptor cable into the main socket (see user manual for details).

Turn on the equipment power for the MiniCapt Mobile.


The MiniCapt Mobile powers up. The home screen is visible. The MiniCapt Mobile and

powers down suitably.

Results:

Document

Description

Result (YES/NO)

Verified by

Date

POWER BUTTON On /off

STATUS (green

LED)

Signals the

instrument’s operating

status: on/off

SAMPLING (green

LED)

Signals the instrument

is sampling: on / off

STATUS (red LED)

of the printer

Signals the printer

status: on / recharging

STATUS (green

LED) of the printer

Signals the printer

status: on/charged

Comments:

Deviation # Description Date

Executed by: Date:




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6.5 VERIFICATION OF SOFTWARE’S VERSION

Objective

To check that the MiniCapt Mobile Microbial Air Sampler, after power up, can display the

current status: screen displays information about the software version currently installed.

Verification Method

Execute the test procedure specified in the “method” section of form 6.5 “equipment start-up”.

Record the results as required.

Acceptance Criteria

Turn on the instrument and observe the touch screen displaying identification number of the

version of software installed.

Data Collection

Use worksheet # 6.5



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6.5 VERIFICATION OF SOFTWARE’S VERSION WORKSHEET

IQ TEST: Equipment Start-up


Title of Test: Equipment Start-up Test

Purpose:

To check that the MiniCapt Mobile displays the current status

Method:

Please, refer to Operational Manual section “About screen”.

Turn on the MiniCapt Mobile.

Enter the submenu followed by pressing the icon to enter into the Submenu and

then 2 times the icon.

Record the equipment and version of the instruments software.

Press to exit.

Shut down the MiniCapt Mobile


The MiniCapt Mobile powers up and the home touch screen is visible.

The navigation to the about icon is accessible and the instrument information is available

to view.

It is possible to identify the software version.

The MiniCapt Mobile exits and powers down suitably.



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6.5 VERIFICATION OF SOFTWARE’S VERSION (CONTINUED)

IQ TEST: Equipment Start-up


Results:

Test

Result

Pass/Fail

Verified by

Date

MiniCapt Mobile

powers up. The home touch

screen is activated

The about screen can be

accessed via the touch

screen and suitable icons

The software version is

displayed on the screen

The instrument exits the

status screen

The instrument shuts down

Comments:

Executed by: Date:




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7 LIST OF VERIFICATIONS FOR OPERATIONAL QUALIFICATIONS

PRE-REQUISITES OF THE OPERATIONAL QUALIFICATION 7.1

Functionality test 7.2

Alarm testing 7.3

Power loss testing 7.4

Local Area Network (LAN) connectivity test 7.5

Data download 7.6



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7.1 PRE-REQUISITES OF THE OPERATIONAL QUALIFICATION

Objective

The objective of this section is to provide the list of pre-requisites that can slow down the

execution of this protocol if they are not met.

Acceptance Criteria

If the answer to some of the following questions is “NO”, ask the Client’s appropriate personnel

for authorization before proceeding

Data Collection

Use worksheet #7.1



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7.1 PRE-REQUISITES OF OPERATIONAL QUALIFICATION WORKSHEET

OQ TEST: Pre-requisites Test


ITEM Yes No Not Applicable

Has the present protocol been approved?

Has the Installation Qualification been

completed and have its results been reviewed and

approved?

Have the possible deficiencies detected during

the Installation Qualification been corrected in

such a way that they do not negate the validity of

the tests of the Operational Qualification?

Comments:

Executed by: Date:




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7.2 FUNCTIONALITY TEST

Objective

To check that the MiniCapt Mobile Microbial Air Sampler is capable of being configured to

operate in different modes.

Verification Method

Execute the test procedure specified in the “Method” section of form 7.2, functionality test.

Record the result as required.

Acceptance Criteria

The date, time, units, sample volume, start delay, interval and pauses are all independently

configurable for the counter.

Data Collection

Use worksheet #7.2

How to Run the Sampler for One Cycle to Ensure the Date is Associated with the Sample:

Please refer to Operator Manual Table 3.2.

Touch the clock and input sampling time: 1 minute as “01:00” by touching on the value.

Delete the value ( ) and then to enter a number of minutes and seconds (mm:ss).

Press to exit.

Touch the test tube and input 25 liter volume by touching on the value.

Delete the value ( ) and then enter a numbers.

Press to exit.

To run the test alwys press:



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7.2 FUNCTIONALITY TEST WORKSHEET

OQ TEST: Functionality Test


Title of Test: Functionality Test

Purpose:

To check that the MiniCapt Mobile Microbial Air Sampler is capable of being configured to

operate in different modes.

Method:

DATE:

Insert the current date by change the date on the counter. Press and then .

Select the TIME AND DATE icon using the touch screen navigation change the

date to one week advanced. Save. Press to exit .

Run the sampler for one cycle to ensure the date is associated with the sample.

TIME:

Insert the current time by change the time on the counter. Press and then

Select the TIME AND DATE icon using the touch screen navigation change the

time to one hour advanced. Save.

Run the sampler for one cycle to ensure the time is associated with the sample. Press

to exit.

UNITS:

Press then and then

Change L to m3

Run the sampler for one cycle to ensure the units are associated with the sample. Return to

the units setup screen

Change m3 to L. Press to exit.

Run the sampler for one cycle to ensure the units are associated with the sample. Press

to exit



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7.2 FUNCTIONALITY TEST (CONTINUED)



START DELAY:

Sampling test with delay is possible by touching the screen where indicated the value of

“start delay”.

Change the time to 30 seconds as: “00:30” and select “done”.

Run the sampler for one cycle to ensure the sample begins after the start delay.

INTERVAL AND PAUSES:

Ensure the sample time is at least 1 minute (01:00).

Change the interval by touching the screen on the values of “Interval” where indicated by

the letter “a”.

Change the interval to 4 and select “done”.

Change the pauses by touching the screen on the values of “Pause” where indicated by the

letter “b”.

Change the pauses to 10 and select “done”.

Run the sampler for one cycle to ensure the pauses and interval function is working.



configurable for the sampler.

a b



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7.2 FUNCTIONALITY TEST WORKSHEET (CONTINUED)



Results:

Test

Result

Pass/Fail

Verified by

Date

Setting Time and Volume

Current date

Date changed to

MiniCapt Mobile operates after

date change

Current time

Time changed to


time change

Current unit:

Unit change to m3 units

Unit change back to L

MiniCapt Mobile operates after unit

change


requested start delay

MiniCapt Mobile operates the

number of intervals requested

MiniCapt Mobile operates pauses

as a requested time between

intervals

Comments:

Executed by: Date:




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7.3 ALARM TESTING

Objective

To verify that the MiniCapt Mobile Microbial Air Sampler will display flow warnings and alarms

and aborts the sample in the event of a flow alarm.

Verification Method

Obstruct the flow of the instrument to create a flow warning and a flow alarm.

Acceptance Criteria

The instrument will display a flow warning when the flow is partially obstructed. The instrument

will display a flow alarm and abort the sample when the flow is completely blocked.

Data Collection

Use worksheet # 7.3

7.3 ALARM TESTING WORKSHEET



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OQ TEST: Alarm Testing


Title of Test: Alarm Test

Purpose:

To verify that the MiniCapt Mobile Microbial Air Sampler will display flow warnings and

alarms and aborts the sample in the event of a flow alarm.

Method:

Start a sample.

Partially obstruct the flow to create a flow warning.

After flow warning stop the sample.

Start a new sample.

Completely obstruct the flow to create a flow alarm.

Sampler should show flow alarm and stop the sample.

Acceptance criteria:

The MiniCapt Mobile screen displays an orange flow warning message and emits a beep

warning when the instrument flow is partially obstructed.

The MiniCapt Mobile screen displays a red flow alarm message, emits a beep alarm and

aborts the sample when the instrument flow is completely obstructed.

Results:

Test

Result

Pass/Fail

Verified by

Date

Screen displays warning after flow is

partially obstructed

Sound system response after flow is

partially obstructed

Screen display alarm after flow is

completely obstructed

Sound system response after flow is

completely obstructed

Comments:

Executed by: Date:




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7.4 POWER LOSS TESTING

Objective

To verify that each MiniCapt Mobile Microbial Air Sampler shuts down during a catastrophic

power failure and after the power is restored, the instrument starts up and functions normally

without any error. Typically the instrument would be powered down and not have power

disconnected.

Verification Method

Power down the system, after a few minutes power the system back up. Record the system

behavior during a power loss.

Acceptance Criteria

Upon power restoration, the system starts up and resumes normal operation

Data Collection

Use worksheet #7.4



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7.4 POWER LOSS TESTING WORKSHEET

OQ TEST: Power Loss Testing


Title of Test: Power Loss Testing TEST

Purpose:

To verify that each MiniCapt Mobile Microbial Air Sampler shuts down during a catastrophic

power failure and after the power is restored, the instrument starts up and functions normally

without any errors. Typically the instrument would be powered down and not have power

disconnected.

Method:

Ensure the battery supplied with the MiniCapt Mobile is removed, connect the MiniCapt

Mobile to the main power supply using the adaptor provided, it is not required that both

power supplies be connected.

Power on the MiniCapt Mobile.

Remove the power connector from the MiniCapt Mobile.

Return the power connector to the socket on the MiniCapt Mobile.

Power on the instrument.


The MiniCapt Mobile screen is powered up on initial startup.

The MiniCapt Mobile screen is blank when the power cable is removed.

The MiniCapt Mobile restarts once the power is reconnected.

The system operates normally post repowering.

Results:

Test

Result

Pass/Fail

Verified by

Date

System response after power is

removed

Was the system integrity affected

due to power loss?

Comments:

Executed by: Date:




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7.5 COMPUTER CONNECTIVITY TEST

Objective

To verify that the MiniCapt Mobile Microbial Air Sampler can be connected to the Local Area

Network (LAN) via Modbus TCP.

Verification Method

Power up the instruments, connect the MiniCapt Mobile to the computer using Modbus TCP and

establishes the correct settings.

Acceptance Criteria

The MiniCapt Mobile can be connected to the local area network via Modbus TCP and the

connection is effectively displayed on the PC screen.

Data Collection

Use worksheet #7.5



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7.5 COMPUTER CONNECTIVITY TEST WORKSHEET

OQ TEST: Computer Connectivity Test


Title of Test: Computer Connectivity Test TEST

Purpose:

To verify that the MiniCapt Mobile can be connected to the Local Area Network (LAN) using

Modbus TCP.

CAUTION

This test is only to prove that a connection can be made using a direct link via Modbus TCP.

Various network configurations can be established according to site IT policies, if this is the

case then the setting below will need to be altered in compliance with site policy.

Method:

Power on the MiniCapt Mobile

Touch the network button on the setup submenu screen.

Set the network parameters:

Connect MiniCapt Mobile to a computer using the ethernet port and ping the instrument to

verify the network configurations

Results:

Test

Result

Pass/Fail

Verified by

Date

MiniCapt IP Address

MiniCapt Subnet Mask Address

MiniCapt Gateway Address

Executed by: Date:




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7.6 DATA DOWNLOAD

Objective

To verify that the data can be downloaded or printed via the USB port from the MiniCapt Mobile

Microbial Air Sampler

Verification Method

Attach a USB key and download the data and/or attach a printer and print the data.

Acceptance Criteria

The MiniCapt Mobile downloads the data to the USB key.

The MiniCapt Mobile prints the data.


configurable for the sampler’s counter and/or the data is printed on the designated printer.

Data Collection

Use worksheet #7.6



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7.6 DATA DOWNLOAD WORKSHEET

OQ TEST: Data Download


Title of test: Data Download

Purpose:

To verify that the data can be downloaded and/or printed via the USB port from the MiniCapt

Mobile

Method for download of saved data to USB key:


Select “data”

Select “report records”

Insert a USB key

Select the desired report record

Select the export key

Select desired location to save to, name the file and press the green export key

Attach USB to a computer and verify the data has been correctly downloaded.

Method for download of new sample


Run a sample

At the conclusion of the sample the report record will be displayed

Insert a USB key



Attach USB to a computer and verify the data has been correctly downloaded.

Method for printing saved data



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Select “data”

Plug the printer into the USB slot and ensure it is on.

Select a report record



Report will print

Method for printing new data


Run a sample

At the conclusion of the sample the report record will be displayed

Plug the printer into the USB slot and ensure it is on



Report will print



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7.6 DATA DOWNLOAD WORKSHEET (CONTINUED)

OQ TEST: Data Download


Results: Test Result Pass/Fail Verified by Date

Report downloaded

via USB key saved

as a csv file

Report printed

Report printed

correspond to the

saved data

Attach report

Comments:

Executed by: Date:




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8 FINAL REVIEW AND DELIVERY OF PROTOCOL - PMS

Name of the Executor: Title: Signature: Date:

__________ ____

9 REVIEW AND FINAL APPROVAL OF PROTOCOL - CLIENT

FINAL REVISION OF PROTOCOL

Name of the Reviewer (Client):

Title:

Signature:

Date:

_______ ________ ______ ____

FINAL APPROVAL

Protocol Approved by (Client):

Title:

Signature:

Date:

__________________________

Quality

Assurance ______



1000021474 B May 2015 36 of 39

APPENDIX NO 1: List of Personnel Involved in the Qualification

LIST OF PERSONNEL INVOLVED IN THE QUALIFICATION

Name Title Signature Initials

Executed by: Date:

Approved by (Client): Date:



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APPENDIX No 2: Data Collection Sheet

DATA COLLECTION SHEET

Page______ of ______

Section Name/No:

Name of Test:

Executed by: Date:




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APPENDIX NO 3: DEVIATIONS/CORRECTIVE ACTIONS

Reference Section____________________ Dev. N° ____ of ____

DEVIATION REPORT DEV. N° ____ OF ____

Reference Section: ______________________________Page_______of_______

Description:

Compiled by: Date:

Received by: Date:

CRITICALITY OF DEVIATION

Minor □

Major □

Compiled by: Date:

Approved by: Date:



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APPENDIX NO 3: DEVIATIONS/CORRECTIVE ACTIONS (CONTINUED)

CORRECTIVE ACTION

Description:

Executed by: Date:

Compiled by: Date:

Approved by: Date:

Result:

Compiled by: Date:

Approved by: Date:

IQ/OQ Installation Qualification and Operational Qualification MiniCapt® Mobile Microbial Air Sampler


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Qualification Protocol for

MiniCapt® Mobile Microbial Air Sampler Compressed

Gas Kit


Client:

PMS Protocol



Name:

Signature:

Date:


Sterility Assurance



L. Ceresa

F. Lalla

D. Pandolfi

May 2015

May 2015

May 2015

CUSTOMER


Name:

Signature:

Date:



1000021474 B May 2015 2 of 18

Table of Contents

1 PURPOSE .......................................................................................................................................................3

2 DESCRIPTION ..............................................................................................................................................3

2.1 GENERAL CHARACTERISTIC…………………………………………………………………………...3


3.1 PRE-REQUISITES OF THE INSTALLATION QUALIFICATION ...........................................................4 3.2 VERIFICATION OF MANUFACTURER’S DOCUMENTATION ...........................................................6 3.3 VERIFICATION OF THE INSTALLATION OF THE SYSTEM’S MAIN COMPONENTS ....................8


4.1 PRE-REQUISITES OF THE OPERATIONAL QUALIFICATION ..........................................................11

4.2 COMPRESSED GAS KIT FUNCTIONALITY TEST ..............................................................................12








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1 PURPOSE

The purpose of this appendix of installation and operational qualification protocol (IOQ) is to

provide documented evidence that the MiniCapt Mobile Microbial Air Sampler Compressed Gas

Kit Accessory is supplied as per requested and will be properly installed and operated in a

consistent manner.

For all the other sections, please refer to the installation and operational qualification protocol

(IOQ) of the MiniCapt Mobile Microbial Air Sampler.

2 DESCRIPTION


The Compressed Gas Kit Accessory allows for the MiniCapt to be connected to a compressed gas

line. It uses a critical orifice to decompress the incoming gas, this incoming gas (air or nitrogen)

then expands into a sampling plenum before being sampled through the same BioCapt® impactor

slit design, as found in the environmental version.


TITLE SECTION

Pre-requisites of the installation qualification of the kit 3.1

Verification of manufacturer’s kit documentation 3.2

Verification of installation of the kit’s main components 3.3



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Objective






Acceptance Criteria






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IQ TEST: Equipment Pre-Requisites


Title of Test: Equipment Kit Pre-Requisites

Purpose:


Sampler.

Method:

Verify that the protocol is approved .


manual.



Results:

Document



Mobile Microbial Air Sampler Kit been

approved?


equipment’s Kit manuals available?

Rational of the Qualification:

Comments:

Executed by: Date:




1000021474 B May 2015 6 of 18


Objective

To determine if the documentation provided by the manufacturer of MiniCapt® Mobile Air

Sampler is proper for the instrument’s gas kit and for the its use.

Verification Method

Provide a list of operating manual or instruction for use (if applicable) and any other type of

documentation provided by the kit manufacturer.



Acceptance Criteria



Collection of results




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3.2 VERIFICATION OF MANUFACTURER’S DOCUMENTATION WORKSHEET

IQ TEST: Equipment Kit Documentation



Purpose:


MiniCapt® Mobile Microbial Air Sampler Compresses Gas Kit installation. Typical

documents include calibration certificate, operator manual and eventually the packing list and

may include, but are not limited to, drawings, schematics, purchase orders, warranty or

guarantee documents maintenance contracts, maintenance or service reports are discretional.

Method:



Record the revision number and the revision date (where applicable), the location of the

file (its physical whereabouts) and sign and date the entry for each required document.

Any additional documents available or relevant should be recorded in the space available

or in the comments field.



Results:

Document


User manual section of the

MiniCapt Mobile Microbial Air

including the compressed gas

sampling accessory

Comments:

Executed by: Date:




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3.3 VERIFICATION OF THE INSTALLATION OF THE KITS’ MAIN COMPONENTS

Objective

To document the inspection of the different kit components of the installation.


Consult the available certificates and all catalogued documentation then visually the equipment

and its main components.

Acceptance Criteria

The equipment and its kit components correspond to what is recorded in the reference

documentation.





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3.3 VERIFICATION OF INSTALLATION OF THE SYSTEM’S MAIN COMPONENTS

WORKSHEET

IQ TEST: Equipment Kit Inventory


Title of Test: Equipment Kit Inventory

Purpose:

This section is intended to document the inspection of the different KIT components of the

completed installation and to demonstrate that the unit complies with the Component Data

Sheets and Specifications. Please refer to the Operational Manual for the description of the

various accessories parts.

Method:

Enter the model of the compresses gas kit.

Enter the serial number of the compresses gas kit.

Switch on the unit and ensure the status lights illuminate.


The equipment kit has not been damaged during shipping and the specifications stated below

in the column “Results” have been met for the following different parts of the system.

Requirement

Result

Verified by

Date

Record the model of

compressed gas sampling

accessory

Record the serial number of the

compressed gas sampling

impactor

Comments:

Executed by: Date:




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Pre-requisites of the operational qualification 4.1

Compress gas kit funtionality test 4.2



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OQ TEST: Pre-Requisites Test


ITEM Yes No Not Applicable




approved?





Comments:

Executed by: Date:




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4.2 COMPRESSES GAS KIT FUNCTIONALITY TEST

Objective

To verify that the MiniCapt Mobile Microbial Air Sampler can be connected to a suitable

compress air system using the Compressed Gas Sampling accessory and take a sample from the

system.

Verification Method

Attach the compressed gas sampling accessory to the MiniCapt Mobile following the installation

instructions. Power up the instrument, access the main screen and check the compressed gas

mode box. The instrument will then look to ensure the compressed gas sampling accessory is

attached and when running will require the gas regulator to be set to a suitable reading.

Acceptance Criteria

The MiniCapt Mobile can be connected to a compressed air line and take a sample.

Data Collection

Use worksheet # 4.2



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4.2 COMPRESSED GAS SAMPLE TEST WORKSHEET

OQ TEST: Compressed Gas Sample Test


Title of Test: Compressed Gas Sample Test

Purpose:

To verify that the MiniCapt® Mobile Microbial Air Sampler can be connected to a

compressed air line using the compressed gas sampling accessory and take a sample.

CAUTION

Ensure all safety measures are taken when connecting the MiniCapt and accessory to a

compressed air system.

Method:

Switch on the MiniCapt.

Install an agar plate onto the MiniCapt.

Install the dual connector plate onto the MiniCapt (this is the component part with the

BioCapt® impactor slits).

Install the diffusion chamber onto the dual connector plate.

Connect the solenoid valve tubing to the tube connector (behind the flexible cover).

Connect the solenoid cable to the electrical connection.

Connect the pressure tubing to the compressed air feed.

Select “Pressure Settings” from the Option Menu.

During this period the reading of the pressure in the diffusion chamber will be seen on the

front screen of the MiniCapt. Set the value to between 50 ÷ 200 for 25 Lpm Model and

100 ÷ 400 for 50 or 100 Lpm Model.

Exit the configuration when the pressure is within the above range.

Install an agar plate onto the MiniCapt.

Select a sample time of five minutes.

Select the compress gas accessory check box and ensure selection is active.

Press “START” to begin sampling.

Run the sample until completion.



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4.2 COMPRESSED GAS SAMPLE TEST WORKSHEET (CONTINUED)

Results: Test Result Pass/Fail Verified by Date

MiniCapt Powers up

Compressed Gas accessory installs

correctly onto the MiniCapt

The compressed gas is connected to an

infeed of compressed air

The instrument is configured to take a 5

minute sample

The sample runs as required and finished

once the sample cycle is completed

Comments:

Executed by: Date:




1000021474 B May 2015 15 of 18



__________ ____




Title:

Signature:

Date:

_____ ______ ______ ____

FINAL APPROVAL

Protocol approved by (Client):

Title:

Signature:

Date:

_______________________ Quality

Assurance



1000021474 B May 2015 16 of 18

APPENDIX NO 1: LIST OF PERSONNEL INVOLVED IN THE QUALIFICATION


Name: Title: Signature: Initials:

Executed by: Date:




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APPENDIX No 2: DATA COLLECTION SHEET


Page______ of _______

Section Name/No:

Name of Test:

Executed by: Date:




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APPENDIX NO 3: DEVIATIONS/CORRECTIVE ACTIONS

Reference Section____________________ Dev. N° ____ of ____



Description:

Compiled by: Date:

Received by: Date:


Minor □

Major □

Compiled by: Date:

Approved by: Date:



1000021474 B May 2015 19 of 18

APPENDIX NO 3: DEVIATIONS/CORRECTIVE ACTIONS (CONTINUED)

CORRECTIVE ACTION

Description:

Executed by: Date:

Compiled by: Date:

Approved by: Date:

Result:

Compiled by: Date:

Approved by: Date:



1000021474 B May 2015 1 of 19


Qualification Protocol for

MiniCapt® Mobile Microbial Air Sampler

Accessory Kits


Client:

PMS Protocol



Name:

Signature:

Date:


Sterility Assurance



L. Ceresa

F. Lalla

D. Pandolfi

May, 2015

May, 2015

May, 2015

CUSTOMER


Name:

Signature:

Date:



1000021474 B May 2015 2 of 19

Table of Contents

1 PURPOSE .......................................................................................................................................................3

2 DESCRIPTION ..............................................................................................................................................3

2.1 GENERAL CHARACTERISTIC……………………………………………………………………………..3


3.1 PRE-REQUISITES OF THE INSTALLATION QUALIFICATION ...........................................................4 3.2 VERIFICATION OF MANUFACTURER’S DOCUMENTATION ...........................................................6 3.3 VERIFICATION OF THE INSTALLATION OF THE SYSTEM’S MAIN COMPONENTS ....................8


4.1 PRE-REQUISITES OF THE OPERATIONAL QUALIFICATION ..........................................................11

4.2 ACCESSORY KITS FOR REMOTE SAMPLING ...................................................................................12








1000021474 B May 2015 3 of 19

1 PURPOSE

The purpose of this appendix of installation and operational qualification protocol (IOQ) is to

provide documented evidence that the MiniCapt® Mobile Microbial Air Sampler Accessory Kits

for remote sampling are supplied as per requested and will be properly installed and operate in a

consistent manner.

For all the other sections, please refer to the installation and operational qualification protocol

(IOQ) of the MiniCapt Mobile Microbial Air Sampler.

2 DESCRIPTION


The MiniCapt Mobile Microbial Air Sampler is a portable instrument that uses the BioCapt®

Impactor sampler head with unique design which enables efficient biological sample collection in

sterile environments.

The Isolator Monitoring Kit, Remote ISP Sampling Kit and Remote Connection to the BioCapt®

Stainless Steel (SS) and BioCapt® Single-Use are add-on adapter kits that enable the MiniCapt

Mobile Microbial Air Sampler to remotely sample inside aseptic environments where placement

of the MiniCapt Mobile Microbial Air Sampler is impractical due to space constraints or other

limitations.


TITLE SECTION

Pre-requisites of the installation qualification of the kit 3.1

Verification of manufacturer’s Kit documentation 3.2

Verification of installation of the KIT’s main components 3.3



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Objective






Acceptance Criteria


Collection of results




1000021474 B May 2015 5 of 19


IQ TEST: Equipment Pre-Requisites

Form #: 6.1 Page of

Title of Test: Equipment Kit Pre-Requisites

Purpose:


Sampler kits.

Method:

Verify that the protocol is approved


manual



Results:

Document



Mobile Microbial Air Sampler KIT been

approved?


equipment’s KIT manuals/assembly

description available?

Rational of the Qualification:

Comments:

Executed by: Date:




1000021474 B May 2015 6 of 19


Objective

To determine if the documentation provided by the manufacturer of MiniCapt® Mobile

Microbial Air Sampler is proper for the instrument’s kit and for the its use.

Verification Method

Provide a list of operating manual or instruction for use (if applicable) and any other type of

documentation provided by the kit manufacturer.



Acceptance Criteria







1000021474 B May 2015 7 of 19

3.2 Verification of Manufacturer’s Documentation Worksheet

IQ TEST: Equipment Kit Documentation



Purpose:


MiniCapt® Mobile Microbial Air Sampler Kit installation. Typical documents include

calibration certificate, operator manual and eventually the packing list and may include, but

are not limited to, drawings, schematics, purchase orders, warranty or guarantee documents

maintenance contracts, maintenance or service reports are discretional.

Method:



Record the revision number and the revision date (where applicable), the location of the

file (its physical whereabouts) and sign and date the entry for each required document.

Any additional documents available or relevant should be recorded in the space available

or in the comments field.



Results:

Document


User manual section of the

MiniCapt Mobile Microbial Air

including the remote sampling

accessory

Comments:

Executed by: Date:




1000021474 B May 2015 8 of 19


COMPONENTS

Objective

To document the inspection of the different kit components of the installation.


Consult the available certificates and all catalogued documentation then visually the equipment

and its main components.

Acceptance Criteria

The equipment and its kit components correspond to what is recorded in the reference

documentation.





1000021474 B May 2015 9 of 19

3.4 VERIFICATION OF INSTALLATION OF THE SYSTEM’S MAIN COMPONENTS

WORKSHEET

IQ TEST: Equipment Kit Inventory


Title of Test: Equipment Kit Inventory

Purpose:

This section is intended to document the inspection of the different kit components of the

completed installation and to demonstrate that the unit complies with the Component Data

Sheets and Specifications. Please refer to the Operational Manual for the description of the

various accessories parts.

Method:

Enter the model of the kit components.

Enter the serial number of the kit components.

Switch on the unit and ensure the status lights illuminate.


The equipment kit has not been damaged during shipping and the specifications stated below

in the column “Results” have been met for the following different parts of the system.

Requirement

Result

Verified by

Date

Record the codes/model of

sampling accessory KIT

Comments:

Executed by: Date:




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Pre-requisites of the operational qualification 4.1

Accessory kits for remote sampling 4.2



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OQ TEST: Pre-Requisites Test


Item Yes No Not Applicable




approved?





Comments:

Executed by: Date:




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4.2 ACCESSORY KITS FOR REMOTE SAMPLING TEST

Objective

To verify that the MiniCapt® Mobile Microbial Air Sampler and be connected to a suitable

accessory kit and take a sample.

Verification Method

Attach the accessory kit to the MiniCapt Mobile Microbial Air Sampler following the installation

instructions or list. Power up the instrument, access the main screen and take a sample.

Acceptance Criteria

The MiniCapt Mobile Microbial Air Sampler can be connected to an accessory kit and take a

sample.

Data Collection

Use worksheet #4.2



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4.2 ACCESSORY KITS TEST WORKSHEET

OQ TEST: Accessory Kits

From # : 4.2 Equipment #: Page of

Title of Test: Accessory Kits

Purpose:

To verify that the MiniCapt® Mobile Microbial Air Sampler and be connected to a suitable

accessory kit and take a sample.

Method for the Isolator Monitoring Kit:

Switch on the MiniCapt Mobile Microbial Air Sampler.

Install the remote sampling top to the MiniCapt Mobile Microbial Air Sampler.

Attach one end of the tubing to the remote sampling top.

Attach the other end of the tubing to the isolator monitoring kit.

Install an agar plate onto the isolator monitoring kit.


Press “START” to being sampling.


Method for the Remote ISP Sampling Kit


Install an agar plate onto the MiniCapt Mobile Microbial Air Sampler.

Install the dual connector plate onto the MiniCapt Mobile Microbial Air Sampler (this is

the component part with the BioCapt® Impactor slits).

Install the remote sampling top to the dual connector plate.


Attach the other end of the tubing to the remote ISP.




Method for the Remote Connection to the BioCapt SS Microbial Impactor




Attach the other end of the tubing to the BioCapt microbial impactor.

Install an agar plate onto the BioCapt microbial impactor.






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4.2 ACCESSORY KITS TEST WORKSHEET (CONTINUED)

Method for the Remote Connection to the BioCapt Single-Use Microbial Impactor




Attach the other end of the tubing to the BioCapt single use microbial impactor.

Install an agar plate onto the BioCapt single use microbial impactor.




NOTE: BioCapt Single-Use Microbial Impactor can be used with 25 and 50 LPM MiniCapt

Mobile Microbial Air Sampler.

Results:

Test

Result Pass/Fail Verified by Date

MiniCapt Mobile

Microbial Air Sampler

powers up

Isolator monitoring kit

installs correctly

Remote ISP sampling kit

installs correctly

Remote connection to

BioCapt microbial

impactor installs

correctly

Remote connection to

BioCapt single use

microbial impactor

installs correctly

The instrument is

configured to take a 5

minute sample

The sample runs as

required and finished

once the sample cycle is

completed

Executed by: Date:




1000021474 B May 2015 15 of 19



__________ ____




Title:

Signature:

Date:

_____ ______ ______ ____

FINAL APPROVAL

Protocol Approved by (Client):

Title:

Signature:

Date:

___________________ Quality

Assurance



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APPENDIX NO 1: LIST OF PERSONNEL INVOLVED IN THE QUALIFICATION


Name: Title: Signature: Initials:

Executed by: Date:




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APPENDIX NO 2: DATA COLLECTION SHEET


Page______ of _______

Section Name/No:

Name of Test:

Executed by: Date:




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APPENDIX NO 3: DEVIATIONS / CORRECTIVE ACTIONS

Reference Section:____________________ Dev. N° ____ of ____



Description:

Compiled by: Date:

Received by: Date:


Minor □

Major □

Compiled by: Date:

Approved by: Date:



1000021474 B May 2015 19 of 19

APPENDIX NO 3: DEVIATIONS / CORRECTIVE ACTIONS (CONTINUED)

CORRECTIVE ACTION

Description:

Executed by: Date:

Compiled by: Date:

Approved by: Date:

Result:

Compiled by: Date:

Approved by: Date:

MiniCapt Mobile Microbial Microbial Air Sampler and ... · The purpose of this installation and...

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