veriDARTTM Certification Training Team Exercise: Dilution ...

veriDARTTM Certification Training Team Exercise: Dilution Test Project Plan

COMPLETED

January 2021

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“Confidential property of SafeTraces, Inc., do not copy or distribute without prior written consent from SafeTraces, Inc.”

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Table of Contents 1. Exercise Objectives .......................................................................................................... 3

2. Create the Project Plan for a Dilution Test ....................................................................... 4

I. Describe the Scenarios ............................................................................................................. 4

II. Test #1 Use the Facility Map to Select and Annotate Two Origin and Sample Points ................ 4

III. Test #1 Create the Project Plan Overview ................................................................................ 5

IV. Test #1 Document Project Plan Overview ............................................................................ 5

V. Test #1 Scenario 1 (HVAC Off) and OP Information .................................................................. 5

VI. Test #1 Scenario 1 (HVAC Off) and SP Information ............................................................... 6

VII. Test #1 Scenario 2 (HVAC On) and OP Information ............................................................... 6

VIII. Test #1 Scenario 2 (HVAC On) and SP Information ............................................................... 6

IX. Test #2 Use the Facility Map to Select Two Origin and Sample Points ...................................... 7

X. Test #2 Create the Project Plan Overview ................................................................................ 7

XI. Test #2 Document Project Plan Overview ................................................................................ 8

XII. Test # 2 Scenario 3 (HEPA Filter Off) and OP Information ..................................................... 8

XIII. Test # 2 Scenario 3 (HEPA Filter Off) and SP Information ...................................................... 8

XIV. Test #2 Scenario 4 (HEPA Filter On) and OP Information ...................................................... 9

XV. Test # 2 Scenario 4 (HEPA Filter On) and SP Information ...................................................... 9

3. Determine What Equipment is Needed to Complete the Project Plan ............................... 9

4. Complete the Project ..................................................................................................... 11

I. Execute the Project Plan ........................................................................................................ 11

II. Complete the QC Checklist ..................................................................................................... 12

III. Complete the Chain of Custody .............................................................................................. 13


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1. Exercise Objectives

Description Objectives

Create the Project Plan • Determine Origin and Sample Points and pinpoint on the

facility map.

Materials and Equipment Verification

• Identify Materials and Equipment that you will need to complete all facets of the project plan.

Origin Point and Sample Point Station Set-Up

• Use the equipment and materials needed to set-up an Origin and Sample Point station.

Project Start Time and Spray Release

• Understand project start-time, spray release protocol, techniques and quantity.

Project Stop Time and Sample Collection

• Understand project end-time protocol, Sample Collection and Handling techniques.

Shipping the Samples

• Complete the Chain of Custody Form if shipping to SafeTraces Lab.

• Handling and Packaging. • Verify Shipping Information accuracy for overnight lab

arrival. • Lab notification.


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2. Create the Project Plan for a Dilution Test

I. Describe the Scenarios In the Onsite Visit you and the Team have decided to conduct Dilution Testing (Over Three Intervals) in the Food Production Facility. The Facility Manager is concerned about the health of the employees and needs information about how effective air changes are in removing indoor air within high-risk areas in the facility. The Manager would also like to know how effective HEPA Filters will be in the facility. Here are your test scenarios:

• Test #1 o Scenario 1: HVAC Off o Scenario 2: HVAC On

• Test #2

o Scenario 3: HEPA Filter Off o Scenario 4: HEPA Filter On

II. Test #1 Use the Facility Map to Select and Annotate Two Origin and Sample

Points

OP/SP-2

OP/SP-1


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III. Test #1 Create the Project Plan Overview

Answer the questions below to help you begin creating your Project Plan. Then document on the “Project Plan Overview”.

1. What is the Test Name? Dilution Test 2. What is the Test Number? 1 3. How many Scenario(s)? 2 4. What are the Scenarios? HVAC Off/ HVAC On 5. How many Origin Points in the plan? 2 6. What Origin Point Tags will be used? C1, C2 7. How many Sample Points in the plan? 2 8. How many Intervals at each Sample Point? 3 9. What is the Interval Duration in minutes? 0-10 min, 10-20 min, 20-30 min 10. What is the total number of samples in the plan? 12 11. What are the Sample Numbers? SN-001, SN-002, SN-003, SN-004, SN-005, SN-006,

SN-007, SN-008, SN-009, SN-010, SN-011, SN-012

IV. Test #1 Document Project Plan Overview Use the information above and document on the chart below.

Test Name1

Test Number2

Scenarios3

OP Count5

OP Tag6 Tag Lot Number(s)

Dilution 1 2 2 C1, C2 122020 SP

Count7 Interval Count8

Interval Duration9

Sample Count10

Sample Number Starts11

Sample Number Ends11

2 3 10 min 6 x 2 = 12 SN-001 SN-012

V. Test #1 Scenario 1 (HVAC Off) and OP Information Use the Scenario information, annotated Facility Map and the Project Plan Overview to help complete the chart below.

Scenario OP OP Name OP Tag Tag Lot # 1 OP-1 QC: Chemistry/Microbiology C1 122020 1 OP-2 Aseptic Suite C2 122020


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VI. Test #1 Scenario 1 (HVAC Off) and SP Information

Airflow L/min

SP Count

Interval Count (I)

Sample Count

Interval Duration

Interval Times

2.5 2 3 6 10 min 0-10, 10-20, 20-30 Scenario Sample

Point Sample Point Name I1 I2 I3

1 SP-001 QC: Chemistry/Microbiology SN-001 SN-002 SN-003 1 SP-002 Aseptic Suite SN-004 SN-005 SN-006

VII. Test #1 Scenario 2 (HVAC On) and OP Information

Scenario OP OP Name OP Tag Tag Lot # 2 OP-1 QC: Chemistry/Microbiology C3 122020 2 OP-2 Aseptic Suite C4 122020

VIII. Test #1 Scenario 2 (HVAC On) and SP Information Airflow L/min

SP Count

Interval Count (I)

Sample Count

Interval Duration

Interval Times



2 SP-001 QC: Chemistry/Microbiology SN-007 SN-008 SN-009 2 SP-002 Aseptic Suite SN-010 SN-011 SN-012


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IX. Test #2 Use the Facility Map to Select Two Origin and Sample Points

X. Test #2 Create the Project Plan Overview

1. What is the Test Name? Dilution 2. What is the Test Number? 2 3. How many Scenario(s)? 2 4. What are the Scenarios? Hepa Filter Off/ Hepa Filter On 5. How many Origin Points in the plan? 2 6. What Origin Point Tags will be used? C3, C4 7. How many Sample Points in the plan? 2 8. How many Intervals at each Sample Point? 3 9. What is the Interval Duration in minutes? 10 minutes 10. What is the total number of samples in the plan? 12 11. What are the Sample Numbers? SN-013, SN-014, SN-015, SN-016, SN-017, SN-018,

SN-019, SN-20, SN-021, SN-022, SN-023, SN-024

OP/SP-2 OP/SP-1


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XI. Test #2 Document Project Plan Overview

Test

Name1 Test

Number2 Scenarios3

OP

Count5 OP Tag6 Tag Lot

Number(s)

Dilution 2 2 2 C5, C6 122020 SP

Count7 Interval Count8

Interval Duration9

Sample Count10

Sample Number Starts11

Sample Number Ends11

2 3 10 min 6 SN-013 SN-024 XII. Test # 2 Scenario 3 (HEPA Filter Off) and OP Information Use the Scenario information, annotated Facility Map and the Project Plan Overview to help complete the chart below.

Scenario OP OP Name OP Tag Tag Lot # 3 OP-1 Fermentation Suite C5 122020 3 OP-2 Purification Suite C6 122020

XIII. Test # 2 Scenario 3 (HEPA Filter Off) and SP Information Airflow L/min

SP Count

Interval Count (I)

Sample Count

Interval Duration

Interval Times



3 SP-001 Fermentation Suite SN-013 SN-014 SN-015 3 SP-002 Purification Suite SN-016 SN-017 SN-018


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XIV. Test #2 Scenario 4 (HEPA Filter On) and OP Information

Scenario OP OP Name OP Tag Tag Lot # 4 OP-1 Fermentation Suite C7 122020 4 OP-2 Purification Suite C8 122020

XV. Test # 2 Scenario 4 (HEPA Filter On) and SP Information Airflow L/min

SP Count

Interval Count (I)

Sample Count

Interval Duration

Interval Times



4 SP-001 Fermentation Suite SN-019 SN-020 SN-021 4 SP-002 Purification Suite SN-022 SN-023 SN-024

3. Determine What Equipment is Needed to Complete the Project Plan

Equipment Quantity

Labeled Bucko Sprayers with Tags (C1-C8) 8 (20 ml Each) Air Sample Pumps (2.5 L/min) 6 Cassette, 25mm, 3 Piece, Clear Styrene 24 Grade A-E Glass Microfiber Filter Media 2.5 cm Diameter 24 Labels (Origin Points, Sample Points and Samples) 4OP /4SP /SN: 1-24


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Complete the Materials and Equipment Needs Checklist

Tagging System Item Need Confirmed Checked By

Labeled Tag Spray Bottles C1-C8 C1-C8 MC Labeled Tag Spray Bottles A1-A2 A1-A2 MC SDS 1 1 MC

Air Sample Pumps Air Sample Pumps 6 8 MC

Energy Supply AA Batteries (3 each pump) 24 24 MC

Laboratory Materials Filters 24 1 Box MC Filter Cassettes 24 36 MC Filter Caps (Red) and Bottoms (Blue) 36 36 MC Ziplock Bags for Samples (Large) 36 36 MC

Cleaning Supplies Clean Gloves Large (Size Depends) 1 Box 1 Box MC Chlorine Bleach Wipes Bottle Bottle MC

Printed Materials Clean Floor Plans 4 4 MC Annotated Floor Plan 4 4 MC Data Collection Form 4 4 MC Materials and Equipment Checklist 1 1 MC QC Checklist 1 1 MC Chain of Custody Form 1 1 MC Origin Point Labels 4 4 MC Sample Point Labels 4 4 MC Sample Number Labels 24 24 MC Extra Set of OP/SP/SN Labels 1 Set Each 1 Set Each MC

Sharpies Yes Yes MC Pens Yes Yes MC Post-it-Notes 1 Pack Yes MC Face Masks 2 Yes MC Clip Board(s) 2 Yes MC


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4. Complete the Project

I. Execute the Project Plan Your Project Plan is now created. You have determined what Materials and Equipment are needed to complete the testing. Now you must execute the plan. Complete the project execution plan below.

What do you need to set up each Origin Point? Labeled Tag Solution, OP Label

What do you need to set up each Sample Point? Air Sample Pumps (3), SP Label

What should you do when setting up each SP stations? Turn on Air Sample Pumps

After each OP and SP stations have been set up, what do you need to check before you start the test?

• All labels match • First Air Sample Pump is turned on, Second and Third

Air Sample Pumps are turned off and Capped

After all stations are set-up and checked, what should the Team Leader do now?

• Verify that all OP and SP stations are ready • Ask if there are any issues and correct if yes Communicate start time: This is the time to start releasing the Tag solutions

What is your test start time? (I1)0900-0910, (I2)0910-0920, (I3) 0920-0930

What is your test end time? 0930 Before the end of the test, what should your Team Leader do? Reminder that tests end in 5 minutes

What are the most important steps to complete when the test time is up?

Turn off all Air Sample Pumps


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II. Complete the QC Checklist

Project Name: Dilution Test Facility Name: ABC Facility Address: 1234-L St. Date of Samples: 12-29-2020 Total Number of Samples: 24 Completed by (Print): Michael Clark Send Copy with COC and Samples Compare and verify sample quantity, locations, labels and integrity at each Sample Point.

Sample Point

Sample Number Sample Point Location Sampled

By Verified

By Comments

SP-001 SN-001 Test 1: Scenario 1 QC: Chemistry/Microbiology FL MC



SP-002 SN-004 Test 1: Scenario 1 Aseptic Suite PK MC









SP-001 SN-013 Test 2: Scenario 3 Fermentation Suite FL MC



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SP-002 SN-016 Test 2: Scenario 3 Purification Suite PK MC









III. Complete the Chain of Custody

Ship To: SGS Laboratory Attn: Laboratory Shipped By: UPS, Fed-Ex, USPS, Other: Shipping/Tracking Number: Phone: Lab Contact: QC Checklist Attached: Email Sample Information: Attach Completed QC Checklist

Line Sample Number

Plate Designation

(A, B, C)

QC Check List Verifier

Comments

1 SN-001 C1 MC 2 SN-002 C1 MC 3 SN-003 C1 MC 4 SN-004 C2 MC 5 SN-005 C2 MC


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6 SN-006 C2 MC 7 SN-007 C3 MC 8 SN-008 C3 MC 9 SN-009 C3 MC

10 SN-010 C4 MC 11 SN-011 C4 MC 12 SN-012 C4 MC 13 SN-013 C5 MC 14 SN-014 C5 MC 15 SN-015 C5 MC 16 SN-016 C6 MC 17 SN-017 C6 MC 18 SN-018 C6 MC 19 SN-019 C7 MC 20 SN-020 C7 MC 21 SN-021 C7 MC 22 SN-022 C8 MC 23 SN-023 C8 MC 24 SN-024 C8 MC

Relinquished/Received at SafeTraces By Print Name Signature Date & Time

Relinquished Date & Time

Received Michael Clark Michael Clark 12-29-2020 @ 1600 NA

Lori Signs Lori Signs NA 12-30-20 @ 1125 Received at Laboratory By

Print Name Signature Date Received Time Received Steve White Steve White 12-30-2020 1310

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