EMT

TITLE
Environmental MonitoringT ECHNOLOGIES
(suggested) Verification Protocol
PAGE
INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 1 of 8
EMT R2S SAMPLING ASSEMBLY

INTRODUCTION/PRINCIPLE

The EMTECHNOLOGIES Remote-Slit-Sampler (R2S) is a self contained air sampling unit which is
designed to determine the presence and level of viable bacteria in environmental air. The R2S sampler
employs a base unit (R2S-C) with a vacuum pump and controller means to achieve the required air flow
of 60 Standard Cubic Feet of Air per Hour (SCFH) through a narrow sample slit located in the sample
conduit on top of the R2S’s dome. An agar test plate is placed on a turntable, which resides within the
dome. The surface of the agar test plate is adjusted to approximately 2.5 mm below the sample slit.
The distance from the slit to the agar test plates surface is critical to proper impingement and capture of
the bacterial organisms in the sampled volume of air. The agar test plate is also rotated at a set speed, 1
RPH, during the sample period to allow for easier enumeration of colonies, determination of time of
capture and to prevent desiccation of organisms captured. During the sample period, which can range
from 0-60 minutes, as set by the operator on the unit’s sample timer, the sampled volume of air drawn
through the sample slit is impinged upon the agar test plate. Bacterial organisms in the sampled
volume of air remain captured on the agar test plate. Upon incubation, the number of viable bacterial
organisms recovered from the environment can be counted and CFU per cubic foot of air can be
determined.

PURPOSE

This instrument installation qualification, operation qualification and performance verification serves to
insure the EMTECHNOLOGIES Remote-Slit-Sampler (R2S) as received meets and performs according to
the specifications and tolerances intended by the purchaser as described by the manufacturer. Slit-to-
Agar samplers are the industry standard to which other air viable sampling units are currently
compared. As such, it is not the intent of this document to prove the bacterial recovery ability of this
method of sampling but the document is designed to prove the bacterial recovery abilities of this unit
based on the verification and qualification of the proper functionality of the unit and it’s components.
The basic functionality of the unit will be qualified and verified as is necessary to operate within the
scope of Standard Operating Procedure [SOP#], Air Viable Monitoring with the EMTechnologies R2S
Sampling Assembly

EQUIPMENT PROCEDURE

Copies of the following Standard Operating Procedures and reference documents shall be on file with
[GROUP NAME] and / or Calibration/Repair Services:

•[SOP#]: Air Viable Monitoring with the EMTechnologies R2S Sampling Assembly
•[SOP#]: Calibration of the EMTechnologies R2S Sampling Assembly
•R2S General Information (Specifications and General Maintenance)
EMT Environmental MonitoringT ECHNOLOGIES
(suggested) Verification Protocol
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INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 2 of 8
EMT R2S SAMPLING ASSEMBLY

EQUIPMENT DESCRIPTION

Equipment
EMTechnologies Remote-Slit-Sampler (R2S) Sampling Assembly, includes (General Description):

Remote-Slit-Sampler Model: R2S.001

•R2S: (Components of White Polycarbonate and Stainless Steel)

-Housing and Base
-Turntable adjustment mechanism
-Turntable
-Motor Mount
-Turntable Motor (1 RPH)
-Electrical Connector
-Hose Connector (Barb)

•Dome Assembly:
-One Piece Clear Polycarbonate Dome and Sample Throat
-Slit to Test Plate Surface, Distance Indicator (Red PC) and mount (White PC)

•Dome-to-Base Seal (Blue Flourosilicone)

Remote-Slit-Sampler Controller Model: R2S-C.001

•Sample Elapsed Timer
• Rotometer (Sample Flow Controller) with Arbitrary Scale of 1 to 10
•6 or 12 Foot (up to 36 feet) Primary AC Power Supply Cable with GFCI Protection
•2.4 CFM Linear Vacuum Pump
•Cooling Fan
• Front Panel R2S Vacuum Hose Connector
• Front Panel R2S Power Cable Connector
• Twelve (12) Foot, R2S Vacuum Tubing / Power Cable Assembly

NOTE:
Additional Materials are required to perform this protocol. Refer to [SOP#], Air Viable Monitoring with
the EMT R2S Sampling Assembly, for other required materials.
EMT Environmental MonitoringT ECHNOLOGIES
(suggested) Verification Protocol
TITLE PAGE
INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 3 of 8
EMT R2S SAMPLING ASSEMBLY

EQUIPMENT REQUIREMENTS

The following are operational and storage requirements for the EMT R2S Sampling Assembly.

• Utilities: Power (AC): 120 V, 60 Hz, 1Amp

• Operating Temperature: 33° F to 100° F

• Storage: Store in a clean dry area with the sample throat of the dome
covered (i.e., bioshield, wipe all, stopper, or comparable clean
covering)

EQUIPMENT CALIBRATION / MAINTENANCE

The following are Calibration and Maintenance requirements for the EMT R2S Sampling Assembly:

• Calibration is to be performed by qualified personnel per Standard Operating Procedure [SOP#]:

“Calibration of EMTechnologies R2S,” at regularly scheduled intervals of 6-months.

• Maintenance is to be performed when required by qualified calibration personnel or by other

appropriate repair personnel (i.e., EMTechnologies Calibration/Repair Personnel).

EQUIPMENT SECURITY

The EMTechnologies R2S is a portable unit. It will be operated and / or stored in the Quality Control
Laboratories or Manufacturing facilities of [COMPANY NAME], [LOCATION]. Equipment will be
transported by appropriate personnel between each area or facility. The facilities and each of the areas
are access controlled.

CAUTIONS

The operator should not remove any of the covers of the R2S, or R2S-C. All repairs shall be performed
by appropriately trained personnel or EMTechnologies Calibration/Repair personnel. All standard
electrical hazard safety practices shall be followed when operating the unit.

PROCEDURE

1. Follow and complete the Standard Equipment Verification Checklist:

1.1 Complete the “Equipment Checklist” section located in Appendix A. Perform

and document verification of each step as you proceed.

2. Follow and complete the Performance and Operational Verification Checklist,

Appendix B, in a stepwise manner. Perform and document verification of each step as you
proceed.

Note: Refer to Standard Operating Procedure [SOP#]: Air Viable Monitoring with the
EMTechnologies R2S Sampling Assembly to perform procedures required to complete
Appendix B.
EMT Environmental MonitoringT ECHNOLOGIES
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INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 4 of 8
EMT R2S SAMPLING ASSEMBLY

2.1 Complete Section 1, “Calibration / Maintenance Verification”

2.2 Complete Section 2, “Power Up Verification”

2.3 Complete Section 3, “Test Procedure”:

3. A second qualified analyst shall review Appendix A and Appendix B following completion of
testing.

ACCEPTANCE CRITERIA

Checklist items must indicate a “YES” response for each applicable item. If “NO” is indicated for any
applicable item of the checklist, the instrument fails the qualification unless a plausible explanation is
given for the item in question. If the instrument fails, the qualification / verification must be repeated
after corrections to the equipment have been performed. Documentation of steps completed shall be
performed in a stepwise manner by the person performing the qualification / verification.
EMT Environmental MonitoringT ECHNOLOGIES
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INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 5 of 8
EMT R2S SAMPLING ASSEMBLY

Appendix-A
STANDARD EQUIPMENT VERIFICATION CHECKLIST

1. Equipment Checklist:

1.1 All equipment as described in the “Equipment Description” Section is present.

___Yes ___No Initial/Date__________

1.2 Model Number of R2S is R2S.001 ___Yes ___No Initial/Date__________

1.3 Serial number of R2S is [SERIAL #] ___Yes ___No Initial/Date__________
1.4 Model Number of R2S-C is R2S-C.001 ___Yes ___No Initial/Date__________
1.5 Serial number of R2S-C is [SERIAL #] ___Yes ___No Initial/Date__________
1.6 Manufacturers calibration documents and certificate agree with Model and Serial numbers.

___Yes ___No Initial/Date__________

COMMENTS_________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Performed By/Date: _________________________Reviewed By/Date________________________

EMT Environmental MonitoringT ECHNOLOGIES
(suggested) Verification Protocol
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INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 6 of 8
EMT R2S SAMPLING ASSEMBLY

Appendix-B
PERFORMANCE AND OPERATIONAL VERIFICATION CHECKLIST - Section 1

1. Calibration / Maintenance Verification:

Calibration procedures per SOP [SOP#], “Calibration of EMTechnologies R2S Sampling Assembly,”
verifies the following functionality and includes the following maintenance of the
R2S Sampling Assembly:

• Turntable Rotation
• Elapsed time accuracy of sample timer
• 60 SCFH of Airflow through the sample conduit of the dome @ specified flow rate on rotometer for
specified lengths of sample tubing (e.g., 6 feet, 12 feet, etc.)

1.1 Calibration sticker indicates current calibration (calibration within 6 months).

___Yes ___No Initial/Date__________

1.1.1 Calibration Date and Due Date on Calibration sticker at time of testing:

_____________ / _______________ Recorded by: Initial/Date__________

1.2 Current calibration documentation is on file.

___Yes ___No Initial/Date__________

1.3 Calibration report results show unit to be within the following specified operating
parameters:
• Turntable rotation is 360° ± 5° in 60 minutes
• Elapsed Timer Accuracy is ± 1 Minute @ 60 minutes
• Calibration shows 60 SCFH ± 5 SCFH are drawn through the sample slit
when flow rate is set to specified flow rate on unit’s rotometer as documented
on the calibration label and report.
___Yes ___No Initial/Date__________

1.4 Attach copy of original manufacturers original calibration reports and current
calibration report for the unit (if applicable)
Performed by: Initial/Date__________

COMMENTS_________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Performed By/Date: _________________________Reviewed By/Date________________________

EMT Environmental MonitoringT ECHNOLOGIES
(suggested) Verification Protocol
TITLE PAGE
INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 7 of 8
EMT R2S SAMPLING ASSEMBLY

Appendix-B
PERFORMANCE AND OPERATIONAL VERIFICATION CHECKLIST - Section 2

2. Power Up Verification:
2.1 Attach R2S power supply cable to power port on front panel of R2S-C.
Performed by: Initial/Date__________
2.2 Attach R2S power supply cable to connector on R2S.
Performed by: Initial/Date__________
2.3 Attach vacuum tubing to hose connector on front panel of R2S-C
Performed by: Initial/Date__________
2.4 Attach vacuum tubing to hose connector on R2S
Performed by: Initial/Date__________
2.5 Connect primary power supply cord with GFCI to AC Power supply and perform the
GFCI Functionality Test as described in the SOP, [SOP#]
Performed by: Initial/Date__________

2.6 GFCI Test shows proper functionality. ___Yes ___No Initial/Date__________

2.7 Turn R2S-C power switch to ON position Performed by: Initial/Date__________

2.8 R2S-C Sample timer display is on ___Yes ___No Initial/Date__________

2.9 R2S-C Cooling Fan is on ___Yes ___No Initial/Date__________

2.10 Pressing START/STOP key pad initiates vacuum pump and sample timer elapsed time
countdown.
___Yes ___No Initial/Date__________

2.11 Rotometer shows a volume of air flow ___Yes ___No Initial/Date__________

2.12 Pressing START/STOP key pad again stops the vacuum pump and terminates the sample cycle

___Yes ___No Initial/Date__________

2.13 Turn R2S-C power switch to OFF position Performed by: Initial/Date__________

2.13 R2S-C Sample timer display is off ___Yes ___No Initial/Date__________

2.14 R2S-C cooling fan is off ___Yes ___No Initial/Date__________

COMMENTS_________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Performed By/Date: _________________________Reviewed By/Date________________________

EMT Environmental MonitoringT ECHNOLOGIES
(suggested) Verification Protocol
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INSTALLATION, OPERATION AND PERFORMANCE QUALIFICATION OF THE 8 of 8
EMT R2S SAMPLING ASSEMBLY

Appendix-B
PERFORMANCE AND OPERATIONAL VERIFICATION CHECKLIST - Section 3

3. Test Procedure:

3.1 Sanitize and set up the R2S Sampling Assembly unit for testing per SOP [SOP#]

Performed by: Initial/Date__________

3.2 Take a 15 minute sample with the unit. Label the test plate with the validation protocol
number and serial numbers of the R2S and R2S-C
Performed by: Initial/Date__________

3.2.1 When the set sample period of 15 minutes has been completed on the elapsed
sample timer, the elapsed timer audible indicator beeps and the vacuum pump
turns off.
___Yes ___No Initial/Date__________

3.2.2 A distance indicator mark (small circular pattern) is present in the center of the
plate.
___Yes ___No Initial/Date__________

3.2.3 Air impingement marks are present on the plate’s surface and cover the
equivalent of 1 quarter of the plate’s surface originating near the start line.

___Yes ___No Initial/Date__________

COMMENTS_________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Performed By/Date: _________________________Reviewed By/Date________________________