IQ / OQ Documentation

For

MAS 100 CG Ex Compressed

Gas Sampler

Supplied by

Merck KGaA
THIS PAGE TO BE REMOVED
AND REPLACED WITH A
DIVIDER TITLED
APPROVALS
 Validation Protocol Approval Sheet

Title: MAS-100 CG Ex Supersedes: Revision 0 Effective Date:

Compressed Gas
Micriobial Sampler Original Issue Date: Revision Number: 0
11/18/09
Serial No: Page Number: 1 of 1

This following individuals have reviewed the attached validation protocol for the
MAS-100 CG Ex Compressed Gas Sampler and their signature indicates approval of
the completed protocol after a review of all data, deviation and discrepancy
reports. Revisions to this document require a new approval sheet.

Protocol Approved By: Name:

Title:
Signature:
Date:

Protocol Approved By: Name:

Title:
Signature:
Date:

Protocol Approved By: Name:

Title:
Signature:
Date:

Protocol Approved By: Name:

Title:
Signature:
Date:
 Validation Protocol Approval Sheet

Title: MAS-100 CG Ex Supersedes: Revision 0 Effective Date:

Compressed Gas
Micriobial Sampler Original Issue Date: Revision Number: 0
11/18/09
Serial No: Page Number: 1 of 1

This following individuals have reviewed the proposed validation protocol for the
MAS-100 CG Ex Compressed Gas Sampler. Revisions to this document require a
new sign-off sheet. Review of this document doesn’t imply approval of the
completed validation protocol as discrepancies could exist.

Protocol Reviewed By: Name:

Title:
Signature:
Date:

Protocol Reviewed By: Name:

Title:
Signature:
Date:

Protocol Reviewed By: Name:

Title:
Signature:
Date:

Protocol Reviewed By: Name:

Title:
Signature:
Date:
THIS PAGE TO BE REMOVED
AND REPLACED WITH A
DIVIDER TITLED
PROTOCOL
A. Validation Protocol Revision History Sheet
Title: MAS-100CG EX Microbial Sampler

Revision Issue Date Issued By Revision Description

Number
0 11/18/2009 TA Original Issuance of Validation Protocol
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
B. OBJECTIVE

The objective of the Installation Qualification (IQ) of the Merck KGaA MAS-100 CG
EX Compressed Gas Sampler is to assure that the instrument has been correctly supplied
and installed according to the purchase order and Merck KGaA installation guidelines.

The objective of the Operational Qualification (OQ) of the Merck KGaA MAS-100 CG
Ex Compressed Gas Sampler is to assure that the instrument operates correctly over the
entire operating range according to defined procedures.

B. BACKGROUND INFORMATION, DESCRIPTION, AND FUNCTION

The MAS-100 CG Ex, Compressed Gas Sampler, is an easy to use instrument for precise
monitoring of microorganisms in compressed gasses. The MAS-100CG EX is a sieve
impaction type of instrument based upon the principles described by Andersen [1]. Gas
is aspirated through a perforated lid (300 X 0.6mm holes). The resulting gas stream,
which contains particles, is directed onto the agar surface of a standard Petri dish (90 mm
diameter). The instrument can be programmed for total collection volumes of up to 2000
liters, however most firms will run 1000 liter volumes. The MAS-100CG EX operates
with two integrated sensors, one for mass flow and the other for pressure. These sensors
continuously regulate gas flow to provide an accurate sample collection. The gas flow
rate is regulated at a constant rate 50 liters/min or 100 liters/minute which is determined
by the flow requirements of the gas system being sampled. The MAS-100CG EX is pre
programmed for compressed air, nitrogen, carbon dioxide, argon and Oxygen. Up to 10
gasses can be programmed and stored in the instrument. The instrument operates over
pressure range of 1.5 to 10 bar. The MAS-100CG EX compensates for all factors which
could influence gas flow, like the volume of agar in the Petri dish or the variation in the
Petri dish diameter. The impaction speed of the microorganisms on the agar surface is
approximately 11 meters/second which corresponds to stage 5 in the Andersen-Sampler
at 50 liters per minute.This velocity assures that all particles > 1 µm are collected. After
a collection cycle, the Petri dish is incubated and the colonies are counted and expressed
as colony forming units (cfu/m3) using the correction table from Feller (positive hole
conversion table).

A computer interface cable is included with the system to allow communication between
the MAS-100CG Ex and a compatible computer. Software is available from Merck
KGaA. Validation of the PC software is separate from the MAS-100 instrument
validation.

Reference

50833674.doc Page 1 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
[1] New Sampler for the Collection, Sizing, and Enumeration of Viable Airborne Particles,
A. Anderson, U.S. Army Chemical Corps Proving Ground, Dugway, Utah, 1958

50833674.doc Page 2 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09

C. INSTALLATION AND OPERATIONAL QUALIFICATION

1. SUPPLY VERIFICATION

Verify that the component supply is complete and undamaged. Fill-in the appropriate
boxes of the table, sign and date each entry. Complete a discrepancy report for each
missing or damaged component.
Supply Verification Pass/Complete Discrepancy/Incomplete Signature and Date
Not Applicable Damaged
Verify that the following
standard components have been
supplied.
MAS-100 CG EX sampler with
roller case.
Cat. No. 1.09327.0001
(1) Battery charger with mains
cable and appropriate power
cable for wall outlet.
Sampling head, low flow 50 to
100 L/min flow rate:
(1) Sampling cover (300 X 0.6
mm holes) , (1) bottom plate
with adjustable Petri dish holder,
(1) O Ring.
(1)Tri-Clamp (1), Rapid male
coupling attached to Tri-clover
flange coupling. (1) gasket
(1) Grounding cable

(1) Allen key, (1) extra O Ring

for sampling head, (1) extra O
ring for rapid male coupling
(1) Laminated positive hole
conversion table. (Feller
conversion table)
(1) Calibration Certificate

Supply Verification reviewed by: _______________________________ Date: ________________

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 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09

Supply Verification Pass/Complete Discrepancy/Incomplete Signature and Date

(Continued) Not Applicable Damaged
Verify that the following
optional accessories have been
supplied for the MAS-100CG
EX Compressed Gas Sampler, if
purchased. Reference the
purchase order.
Extra sampling head, for 50/100
L/min flow rate:
(1) Sampling cover (300 X 0.6
mm holes) , (1) bottom plate
with adjustable Petri dish
holder, (1) O Ring.
Cat. No. 1.09237.0001

Supply Verification reviewed by: _______________________________ Date: ________________

50833674.doc Page 4 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09

2. SET-UP VERIFICATION

Verify that the instrument is properly set-up for operation. Complete a discrepancy
report for any activity that fails this test. Complete a deviation report for any test that is
modified.
Set-Up Verification Pass/Complete Discrepancy/Fail Signature and Date
Not Applicable
1. Place the MAS-100 CG
EX on a solid base such as
a table so it doesn’t topple
over during set-up.

2. Serial
No.______________
3. Verify the firmware
version to the calibration
certificate.
Firmware Version___________
4. Calibration Verification:
Certificate not older than
24 months.
Calibration Date:___________
Expiration Date:____________
5. Set Time and Date
6. Plug in battery charger an
charge battery for 2.5 hrs.
7. Preset Standard Volume:
Volume 1 = 50 L
8. Preset Standard Volumes:
Volume 2 = 100 L
9. Preset e Standard
Volumes:
Volume 3 = 250 L
10. Preset Standard Volumes:
Volume 4 = 500 L
11. Preset Standard Volumes:
Volume 5 = 1000 L
12. Activate/Deactivate Delay
Time
13. Set Operation Mode:
Verify the system is set to
Manual mode.
Check instrument selects
automatically correct Flow-rate
50/100 Liters/minute (depends
on pressure of gas supply).

50833674.doc Page 5 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
Set-Up Verification (cont.) Pass/Complete Discrepancy/Fail Signature and Date
Not Applicable

14. Petri dish support jaw

check:
Remove sampling head cover
by loosening clamp screws and
removing the four clamps.
Press down on the clamps with
the red dots to lift sampling
head cover. Place a Petri dish
on to the dish support. Adjust
the blue jaw clamps with the
Allen key so the Petri dish is
held snug in place.
15. Reinstall the sampling
head cover and evenly
tighten the four clamps in
place.
16. Adjust the sampling head
so that it is in a vertical
position.
17. The unit may be operated
from a solid base such as a
table or trolly.

Set-Up Verification reviewed by: _______________________________ Date: ________________

50833674.doc Page 6 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
3. BASIC OPERATION VERIFICATION

Verify that the instrument performs the following basic operations. Complete a
discrepancy report for any activity that fails this test. Complete a deviation report for
any test that is modified.
Basic Operation Verification Pass/Complete Discrepancy/Fail Signature and Date
Not Applicable
1. Press the yes button when
the MAS-100CG EX is in
sleep mode. The gas type
and last volume used will
then be displayed.
2. Press no then the “change
gas” prompt will be
displayed.
3. Press yes to select a
different gas. Contimue to
press yes until desired gas
type is displayed (Air,
Nitrogene, CO2, Argon,
Oxygene)
4. Press no and “select other
volumes” is displayed.
5. Press no then “select
volume” is displayed.
6. Press yes to modify volume,
if more than one volume is
programmed, it must be
possible to choose among
the programmed volumes.
Contimue to press yes until
desired sampling volume is
displayed.
7. Press no then display shows
the gas type and sample
collection volume chosen.
8. Without connecting the gas
supply press yes and the
“Start?” prompt is
displayed.
9. Push yes and the MAS-100
CG Ex will start to run. The
green “run” LED is lit.
10. After the MAS-100CG Ex
has started to run press no,
the “Failed Repeat Test”
message must be displayed.
“Close gas supply and
decompress” is then
displayed. At the same time
the run and stop LED’s are

50833674.doc Page 7 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
flashing.
11. Push yes then “Press
Release Running” is
displayed. After a few
seconds ”Open sampling
head now” is displayed.
The red stop LED is now
on.
12. Push yes and the gas type
and sampling volume will
be displayed.
13. Press yes again and “Start?”
will be displayed. Press yes
again and the MAS-100 CG
EX will begin to run. The
green run LED will be on.
14. After a few seconds the
“Failed Repeat Test”
message must be displayed,
followed by “Gas flow too
low”. At the same time the
run and stop LED’s are
flashing.
15. Press yes then “Close gas
supply and decompress” is
then displayed. At the same
time the run and stop LED’s
are flashing.
16. Push yes then “Press
Release Running” is
displayed. After a few
seconds ”Open sampling
head now” is displayed.
The red stop LED is now
on.
17. Push yes and the gas type
and sampling volume will
be displayed.
18. Wait for 5 minutes then the
MAS-100CG Ex will go
into sleep mode, nothing on
display.

Results of tests reviewed by: _______________________________ Date: ________________

50833674.doc Page 8 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
4. DOCUMENTATION AND MAINTENANCE VERIFICATION

Complete the following table for the documentation and maintenance of the MAS-100 air sampler w/
data port.

Description Available Document Document Signature and Date

Yes/No or Located Number(s)
Not Applicable
Purchase Order

Technical Specification

Operation Manual

PM and Calibration
Program (optional)
Spare Parts List

Cleaning and Usage

Logbook
Operating SOP

Cleaning SOP

Training Records

Documentation and records reviewed by: _______________________________ Date:

________________

50833674.doc Page 9 of 8
 Installation and Operational Qualification
Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler
Protocol Revision: 0 18/11/09
Comments

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

D. CONCLUSION

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

Signature: ____________________________________ Date: ______________________________

50833674.doc Page 10 of 8
THIS PAGE TO BE REMOVED
AND REPLACED WITH A
DIVIDER TITLED
APPENDICES
Appendix A.

(1) Purchase Order

(2) Technical Specification (Vendor Literature)
(3) Operation Manual
(4) PM and Calibration Program Datasheet
(5) Spare Parts List
(6) Operating SOP
(7) Cleaning and Usage Logbook
(8) Cleaning SOP
(9) Training Records
Appendix B.

Calibration Certificate
Calibration Certificate of Instrument used to Calibrate the MAS-100CG EX
Calibration Certificate of Instruments used for Validation
Appendix C.

Summary of Cleanroom Classification Standards

Positive Hole Conversion Table Calculation
Anderson Report – New Sampler for the Collection, Sizing, and Enumeration of Viable Airborne
Particles
Swiss Pharma Paper, “Detection of Microorganisms in Compressed Gasses”, Validation of the MAS-
100CG Using Compressed Gasses.
C. Appendix D: References

Firmware Revision History Sheet

Title: MAS-100 CG EX Compressed Gas Sampler

Revision Issue Date Issued By Revision Description

Number
As Delivered
•
•
•
•
•
THIS PAGE TO BE REMOVED
AND REPLACED WITH A
DIVIDER TITLED
DEVIATION REPORTS
DISCREPANCY
REPORT
 Validation Deviation Report
Part I. Deviation Identification. (Completed by Initiator)

System Name: MAS-100 CG Ex Compressed Gas Microbial Sampler

Validation Protocol Section Number: ______________________________________

Deviation Number: _____________________________________________________

Provide Short Description of the Deviation:__________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________

Initiator’s Signature and Date

Part II. Impact on Protocol. (Completed by Person Resolving the Deviation)

Indicate the Impact the Deviation has on the System Protocols: __________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Reviewed by: _________________________ Date: ___________________________

Attach to the applicable validation protocol.

 Validation Deviation Report
Part I. Deviation Identification. (Completed by Initiator)

System Name: MAS-100 CG Ex Compressed Gas Microbial Sampler

Validation Protocol Section Number: ______________________________________

Deviation Number: _____________________________________________________

Provide Short Description of the Deviation:__________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________

Initiator’s Signature and Date

Part II. Impact on Protocol. (Completed by Person Resolving the Deviation)

Indicate the Impact the Deviation has on the System Protocols: __________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Reviewed by: _________________________ Date: ___________________________

Attach to the applicable validation protocol.

 Validation Deviation Report
Part I. Deviation Identification. (Completed by Initiator)

System Name: MAS-100 CG Ex Compressed Gas Microbial Sampler

Validation Protocol Section Number: ______________________________________

Deviation Number: _____________________________________________________

Provide Short Description of the Deviation:__________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________

Initiator’s Signature and Date

Part II. Impact on Protocol. (Completed by Person Resolving the Deviation)

Indicate the Impact the Deviation has on the System Protocols: __________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Reviewed by: _________________________ Date: ___________________________

Attach to the applicable validation protocol.

 Validation Deviation Report
Part I. Deviation Identification. (Completed by Initiator)

System Name: MAS-100 CG Ex Compressed Gas Microbial Sampler

Validation Protocol Section Number: ______________________________________

Deviation Number: _____________________________________________________

Provide Short Description of the Deviation:__________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________

Initiator’s Signature and Date

Part II. Impact on Protocol. (Completed by Person Resolving the Deviation)

Indicate the Impact the Deviation has on the System Protocols: __________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Reviewed by: _________________________ Date: ___________________________

Attach to the applicable validation protocol.

Validation Discrepancy Report
Part I. Discrepancy Identification. (Completed by Initiator)

System Name: MAS-100CG EX Compressed Gas Microbial Sampler____

Validation Protocol Section Number: ______________________________________

Discrepancy Number: ___________________________________________________

Provide Description of the Discrepancy Found and Possible Causes:_______________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________

Initiator’s Signature and Date

Part II. Corrective Action. (Completed by Person Resolving the Discrepancy)

Describe the Corrective Action Taken: _____________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Verified by: _________________________ Date: ___________________________

Was the Corrective Action Taken Satisfactory? _______________________________

Initiator’s Signature/Date
Attach to the applicable validation protocol.
Validation Discrepancy Report
Part I. Discrepancy Identification. (Completed by Initiator)
System Name: MAS-100CG EX Compressed Gas Microbial Sampler____

Validation Protocol Section Number: ______________________________________

Discrepancy Number: ___________________________________________________

Provide Description of the Discrepancy Found and Possible Causes:_______________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________

Initiator’s Signature and Date

Part II. Corrective Action. (Completed by Person Resolving the Discrepancy)

Describe the Corrective Action Taken: _____________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Verified by: _________________________ Date: ___________________________

Was the Corrective Action Taken Satisfactory? _______________________________

Initiator’s Signature/Date
Attach to the applicable validation protocol.
THIS PAGE TO BE REMOVED
AND REPLACED WITH A
DIVIDER TITLED
EXECUTIVE
SUMMARY
 Validation Protocol Execution Summary Sheet
System Name: MAS-100 CG EX
Validation Protocol Executed: IQ/OQ
Qualification Completed On (Date):
Number of Deviation Reports Issued:
Number of Discrepancy Reports Issued: #Resolved:
Remaining Corrective Action, Comments, and Recommendations:
What Corrective Action is remaining and provide timing
for the completion of each so that follow-up can be scheduled?

If Corrective Action is remaining,

is there a quick fix in place until Corrective Action is completed?

Comments and Recommendations:

Signed ________________________ Title ____________________________ Date _________________