ATP Testing for Production Equipment

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1.0 Purpose 
 
 The purpose of this procedure is to define the use of the surface ATP cleanliness test using
 
 Neogen AccuPoint Advanced ATP Surface Test to demonstrate production equipment is
 sanitized properly. The system is designed to detect adenosine triphosphate (ATP) at set
 
 thresholds and to report the measurement in relative light units (RLUs). ATP is a chemical
 compound found in all living cells, including bacteria, food debris, yeast and mold. After
 
 swabbing, the swab is inserted into a device called a luminometer, which reads the amount of
 
 light produced by the sample. The light produced is proportional to the amount of ATP in it:
 the more bacteria or product residue on the surface, the more ATP; the more ATP, the more
 
 light produced. 
 
 2.0 Scope 
 
 This procedure describes the use of surface test methods in the verification of cleaning
 
 instructions to ensure each piece of production equipment is clean. These ATP test methods
 are not valid for the testing of cleaning fluids used in removing organics from production
 
 surfaces. This procedure is specific to the testing of dry production equipment surfaces. A
 general ATP test is the primary screen for detecting organic residues remaining on surfaces
 
 after cleaning of production equipment surfaces. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of QC Laboratory Management and/or designee to implement
 
 and maintain this procedure and to ensure that the procedure is being followed.
 
 3.2 It is the responsibility of Quality Unit to execute monitoring activities.
 
 
 

[SOP 

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 3.3. It is the responsibility of Production Personnel to clean production equipment as per
 
 SOP B-111 Cleaning of Manufacturing/Production Areas and Equipment and other
 
 applicable cleaning procedures. 
 
 3.4 It is the responsibility of Quality Management to review and approve all validation and
 
 test documentation and to notify production management when revalidation is required.
 
 4.0 Definitions 
 
 4.1 DC — Document Control 
 
 4.2 QC- Quality Control 
 
 4.3. AD-— Analytical Development 
 
 5.0 References 
 
 5.1 B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
 
 5.2 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.3 D-116-F1, Form, ATP Swab Test Ticket 
 
 6.0 Equipment/Materials 
 
 6.1 Surface ATP Test Kit 
 
 6.1.1 Product 
 
 6.1.1.1 AccuPoint Advanced ATP Surface Sampler, Cat #9405 
 
 6.1.1.2 AccuPoint Field Cleaning Kit, Cat #9612 
 
 6.1.1.3 Neogen AccuPoint Advanced ATP Sanitation Monitoring System, Cat
 
 #9903 
 
 

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 Standard Operating Procedure SOP No | Rev 
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 6.1.2 Equipment 
 
 6.1.2.1 Neogen ATP Test Method 
 
 6.1.3 Specifications (Neogen) 
 
 6.1.3.1 Test Time: 10 seconds 
 
 6.1.3.2 Storage: 2-8°C 
 
 6.1.3.3. Samplers must be warmed to room temperature prior to use for at least
 
 one hour. 
 
 6.1.3.4 Samplers may be stored for up to two weeks outside of the refrigerator.
 
 7.0 Procedure 
 
 Note: All employees performing ATP tests must be properly garbed (hair net, gloves, lab coat
 or frock, shoe covers, etc.) 
 
 7.1 Quality will conduct ATP Swab testing after a successful visual inspection as indicated
 by SOP B-111. 
 
 7.1.1 Quality will swab up to five (5) areas from each defined equipment grouping
 (see attachment 1) for the presence of ATP as defined in section 7.2. Some
 
 equipment groupings may not contain five (5) different areas for swabbing. In
 
 these cases, swabbing of each product contact area should be performed.
 
 7.1.2 Quality will prioritize hard to clean areas or any area in which accumulation of
 
 product may occur during the swabbing procedure. 
 
 7.2 ATP Swab Testing Procedure — Surface Sampling (ATP). The instructions below are
 
 generalized for the Neogen ATP Surface sampling test. 
 
 7.2.1 Remove sampler cartridges from refrigeration and warm to room temperature
 
 for at least one hour prior to use. Keep extra samplers in pouch, protected from
 light. 
 
 

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 Note: Swabs may remain out of refrigeration for 2 weeks. When a new pack of
 
 samplers is removed from refrigeration, they will be marked with a “Use By”
 
 date to ensure that samplers are not used that have remained out of refrigeration
 past the two week time period. 
 
 Orde Turn on the AccuPoint Advanced ATP Sanitation Monitoring System. Allow
 instrument warm up for 5-10 minutes before taking the first reading.
 
 Ta Check the display to make sure that the instrument is ready. 
 
 Note: If the instrument is not ready, there may be a used sampler cartridge inside.
 
 Press the eject button to discard the cartridge, close the sampler door, and turn
 
 the instrument off, then back on to clear the error. 
 
 7.2.4 Prepare to go to the first testing site. 
 
 7.2.5 Grasp a sampler by its handle and pull it out of the cartridge. To ensure
 accurate test results, do not touch the tip of the sampler, or let the tip touch any
 
 other surface prior to testing. 
 
 7.2.6 Swab the area of approximately 10cm x 10cm (if the equipment allows) for
 
 Organic Residuals. The surface should be swabbed firmly starting in one
 corner and forming a continuous line going back and forth across the square.
 
 Repeat the procedure with slightly less pressure starting at 90 degrees from first
 
 start point. 
 
 7.2.7 Reinsert the sampler into its cartridge and fully depress. Mix for 2 seconds in a
 
 side-to-side motion. 
 
 7.2.8 Press the EJECT button to open the top door on the instrument. Keep the unit
 
 upright while testing. Insert the sampler with its cartridge into the sampler
 compartment. The symbols are a green checkmark to indicate PASS, a yellow
 
 question mark to indicate a MARGINAL, and a red X to indicate a FAIL.
 Record the numeric RLU value and record “Pass” if the value is less than 300
 
 and “Fail” if the value is equal to or greater than 300 RLU. 
 
 

[SOP 

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 ATP Swab Testing for Production Equipment 
 Note: The manufacturer recommends the limit of 300 RLU. 
 
 7.2.9 Document testing information and report the result on Form D-116-F1 ATP
 
 Swab Test Ticket if not using Redzone. SOP B-111 provides details for using
 Redzone for cleaning documentation. 
 
 7.2.10 Report testing results to the appropriate personnel. 
 
 7.2.11 Press the EJECT button and remove the sampler from the chamber. Samplers
 
 and their cartridges are non-toxic and may be disposed of without any special
 considerations. 
 
 en©: Once all samples are finished for the day, turn the instrument off. Clean the
 
 outer surface of the instrument with mild detergent and a slightly moistened
 cloth. Turn the instrument upside down and use the AccuPoint Cleaning Kit
 
 Swab to clean the interior surface of the instrument. 
 
 8.0 Records 
 
 8.1 Redzone is the preferred method for documentation of ATP swab results. Use Form D-
 
 116-F1 ATP Swab Test Ticket if not using Redzone. Fill in information as follows:
 
 8.1.1 Room#- Location of equipment at the time of testing 
 
 8.1.2 Test Date — The date the test was performed 
 
 8.1.3 Description of equipment swabbed 
 
 8.1.4 Equipment Group — The cleaning instruction that will be impacted if the
 cleaning validation passes or fails on any one or combination of machine tests
 
 (See Attachment 1). 
 
 Initial Test / Retest- Identify the iteration of test for release of equipment.
 
 Major Clean Performed — Identify if a major clean was performed just prior to
 ATP testing 
 
 

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 ATP Swab Testing for Production Equipment D-116 0 BES’ 
 
 8.1.7 Results: The test passes if the green checkmark displays. The result fails if the
 
 red X displays. All marginal samples must be retested immediately and if still
 
 marginal the test fails. 
 
 8.1.8 Total Result - The combined result of all swab tests. If all tests are PASS, the
 
 survey passes. If one or more tests fail, the survey fails 
 
 8.1.9 Survey Failure —- Operational Management must be notified immediately of the
 
 failure. The equipment must be re-cleaned and retested. 
 
 8.1.10 Repeat steps 7.2.1-7.2.12. 
 
 8.2 ATP Test Records are maintained by the Quality Group following SOP C-502 Record
 Storage, Retention, and Destruction. 
 
 9.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 10/05/21 | New. N/A G. Shaw | - | - |

 10.0 Attachments 
 
 10.1. Attachment 1 — Major Equipment Grouping 
 
 Attachment 1 — Major Equipment Grouping 
 
 _______ Production Equipment Grouping List _ 
 Blending Tableting 
 Compression Encapsulation 
 Packaging Coating 
 Gummy Liquid 
 
 

[SOP 

 IAN LABS ATP Swab Test Ticket 
 
 Form: D-116-F1l CCR No. N/A Revision: 0 
 
 Room#: Test Date: 
 
 Sampler Lot#: Sampler Expiration Date: 
 
 Equipment Group: 0 Initial Test ORetest(1 23 _ ) 
 
 Type Test: Surface ATP Major Clean Performed (Y/N): 
 
 Previous Batch #: Formula#: 
 
 Swab 01 Value on screen 
 Equipment Description: Result : (circle one): Pass Fail 
 
 Swab 02 
 Equipment Description: Result : (circle one): Pass Fail 
 
 Swab 03 LI N/A 
 
 Equipment Description: Result : (circle one): Pass Fail 
 
 Swab 04 O N/A 
 
 Equipment Description: Result : (circle one): Pass Fail 
 
 Swab 05 LO) N/A 
 
 Equipment Description: Result : (circle one): Pass Fail 
 
 Final Result (Circle One): Pass Fail 
 
 Test Performed By/Date: Reviewed By/Date: