Cleaning of Manufacturing-Production Areas and Equipment

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1.0 Purpose 
 
 The purpose of this procedure is to define the process for the cleaning and sanitizing of the
 
 manufacturing/production areas and equipment. 
 
 2.0 Scope 
 
 This procedure applies to all manufacturing/production areas and equipment in use at Ion Labs,
 
 Inc. 
 
 3.0 Responsibility 
 
 3.1. It is the responsibility of all production personnel to strictly follow this procedure.
 
 3.2 It is the responsibility of department supervisors and managers to implement this
 procedure in their respective departments and to ensure that the procedure is followed.
 
 3.3 It is the responsibility of the QC inspectors to inspect and verify the cleaning of all
 manufacturing/production areas and equipment that have been utilized.
 
 4.0 Definitions 
 
 4.1 Redzone (RZ) — a software application used to collect data during the production
 process; used to track production data, as well as cGMP data 
 
 4.2 Data Sheet — an RZ component of the RZ Compliance Module, configured to collect
 
 data 
 
 4.3 BPR — Batch Production Record 
 
 
 

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 44 SKU — Stock Keeping Unit; a unique identifier for each product and each component
 
 used to manufacture a product 
 
 4.5 CDT — Cleaning Decision Tool; a tool used to help determine the level of cleaning
 needed 
 
 4.6 CIP — Clean in Place; refer to equipment that cannot be easily removed for cleaning
 and must be cleaned at its permanent location 
 
4.7 PPE — Personal Protective Equipment; equipment worn to reduce the risks of injury

 from chemical use during production or cleaning 
 
 Approved Chemical and Lube List — a list that has been approved by Quality
4.8 Management, containing current approved cleaning and sanitizing chemicals

 established for cleaning the facility 
 
 4.9 IPA — 70% Isopropyl Alcohol; used as a sanitizing agent 
 
 Non-PCS — Non-Product Contact Surfaces; equipment surfaces or parts that do not
4.10 contact product

 PCS — Product Contact Surfaces; equipment surfaces or parts that contact product; this
4.11 includes equipment that contacts items that contact product (i.e. cappers, bottle

 unscramblers, sorters) 
 
 PDT — Product Detail Tag; a document available as part of each batch production
4.12 record, which provides information about the product and includes all of the

 information necessary to answer questions in the CDT 
 
 Degreaser — chemicals found in the Approved Chemical List that are used for
4.13 loosening and removing soil and buildup from surfaces

 Primary Packaging Room — a room in which product is filled into primary packaging
4.14 containers as this is written; this does not include liquid bottling

 
 

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 4.15 Secondary Packaging Room — a room is which already packaged product undergoes
 
 further packaging (i.e. labeling, sleeving, cartoning, shrink wrapping)
 
 4.16 NOP OS — National Organic Program’s Organic Standards 
 
 4.17 QC — Quality Control 
 
 5.0 References 
 
 5.1 C-111, SOP, Redzone General Use 
 
 5.2 C-109, SOP, Redzone Operator Activities 
 
 5.3 C-110, SOP, Redzone QC Inspector Activities 
 
 5.4 C-107, SOP, Redzone Reviewer Activities 
 
5.5 B-111-F1, Form, Area Group 1 Cleaning Decision Tool

 5.6 B-111-F2, Form, Area Group 2 Cleaning Decision Tool 
 
 5.7 B-111-F3, Form, Area Group 1 Cleaning Form 
 
 3.8 B-111-F4, Form, Area Group 2 Cleaning Form 
 
 39 B-111-F5, Form, Area Group 4 Cleaning Form 
 
 5.10 B-111-F6, Form, Sanitization and Cleaning Approval Form 
 
 5.11 B-103, SOP, Small Parts Cleaning and General Sanitation 
 
 342 B-104, SOP, Floor Drain Cleaning and Sanitizing Procedure 
 
 B-105, SOP, Preparation of Cleaning and Sanitizing Chemicals for Production and
 = 
 Warehouse 
 
5.14 RPT-20-0033, Report, Production Cleaning Risk Assessment

 
 

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 5.15 D-111, SOP, Allergen Testing of Production Equipment 
 
 5.16 D-116, SOP, ATP Testing for Production Equipment 
 
 5.17 QS-106, SOP, Allergen Control 
 
 5.18 CV-LAB-19-186, Protocol, Cleaning Validation for Organic Products 
 
 5.19 PRTCL-20-0010, Protocol, Dry Clean Report for P1/P2 Powder Filling Rooms
 
 6.0 Procedure 
 
 6.1 Process Overview 
 
 6.1.1 This procedure defines different levels of cleaning (i.e. major, reduced major,
 minor) for various operations areas (area groups). This procedure provides a
 cleaning decision tool (CDT) specific to each area group, to determine the level
 
 of cleaning required based on information about the product used on the
 
 equipment before cleaning (previous SKU) and the product scheduled for the
 equipment after cleaning (next SKU). The CDT for each area is based on
 
 cleaning requirements associated with product characteristics of the previous
 and next SKU (i.e. allergen category, whether the product is classified as a drug
 
 or not, product certifications). 
 
 During normal operation, follow the steps below to complete cleaning:
6.1.2 6.1.2.1 Production collects information about the previous SKU and the next

 SKU. This information is available in the PDT for each product.
 
 6.1.2.2. Production completes the CDT applicable to the area group associated
 
 with the area subject to cleaning. Redzone initiates a CDT data sheet
 automatically when a “cleaning run” starts for the subject location.
 
 
 

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 6.1.2.3. Production will complete the level of cleaning determined by the CDT.
 Redzone automatically initiates the appropriate cleaning data sheet
 
 when CDT data sheets are completed. 
 
 6.1.2.4 Quality completes the visual inspection, ATP testing, and allergen
 
 testing as applicable and based on the result of the CDT. Redzone
 
 automatically initiates the appropriate inspection forms when the
 production cleaning data sheet is completed. 
 
 6.2 Documentation 
 
 6.2.1 Redzone data sheets are available to control the entire process. Production must
 
 initiate a “cleaning run” to start the process in the subject location. After the run
 starts, the CDT data sheets automatically initiate. As production completes the
 
 CDT data sheets, Redzone initiates additional data sheets as necessary,
 including the data sheets to document cleaning and inspection. After all data
 
 sheets are complete and the cleaning run ends, Quality will provide a final sign-
 
 off of the cleaning run. Redzone provides tools to review all completed runs.
 This tool allows for the review of both the previous SKU and the next SKU
 
 around the cleaning run and serves as a log for production and cleaning for that
 location. 
 
 62.2 The forms provided with this procedure give detailed content of the CDT for
 each defined area group and provide detailed content for cleaning of various
 
 areas. The forms provided also serve as a backup documentation option if the
 
 Redzone data sheets are not available for use. Use Redzone data sheets if
 available. When Redzone data sheets are not available, use the associated forms
 
 and store copies of the forms with both the previous SKU and next SKU batch
 records. 
 
 6:3 Cleaning Decision Tool 
 
 
 

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 6.3.1 This procedure provides a CDT as a form, specific for each area group. Use the
 applicable tool to determine the level of cleaning required. 
 
 6.4 Cleaning Levels 
 
 6.4.1 Major 
 
 6.4.1.1. Forms B-111-F3, B-111-F4, and B-111-F5 define steps required for a
 major clean for each specific area. 
 
 6.4.1.2 Major cleans are required when the CDT for the area determines that a
 major clean is required. 
 
 6.4.1.3 A major clean is required after maintenance activities that introduce
 dust, debris, or other materials that may affect the safety or purity of a
 
 product or production material. 
 
 6.4.1.4 A major clean is required after unplanned incidents that could
 contaminate drains. Examples include backflow of drains, plumbing
 
 leaks, roof leaks. 
 
 6.4.1.5 A major clean is required on equipment brought to the cleaning area
 
 prior to the return of that equipment to a production room.
 
 6.4.2 Reduced Major 
 
 6.4.2.1 Form B-111-F4 defines the steps requires for a reduced major clean
 
 6.4.2.2 Reduced major cleans are required when the CDT for the area
 
 determines that a reduced major clean is required. 
 
 6.4.3. Minor 
 
 6.4.3.1 Forms B-111-F3, B-111-F4, and B-111-F5 define the steps required
 
 for a minor clean. 
 
 
 

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 6.4.3.2 Minor cleans are required when the CDT for the area determines that a
 
 minor clean is required. 
 
 6.4.3.3. A minor clean is required after minor maintenance activities that are
 not likely to introduce dust, debris, or other materials that may affect
 
 the safety or purity of a product or production material.
 
 6.4.4 Sanitization 
 
 6.4.4.1 Form B-111-F6 defines the steps required for sanitization.
 
 6.4.4.2 After a cleaning operation is complete (major, reduced major, minor),
 
 a sanitization step is the last step of the process. 
 
 6.4.4.3 Sanitization is required prior to startup of manufacturing if the
 
 room/equipment remains idle for more than 36 hours. 
 
 6.4.4.4 Sanitization is required after minor maintenance activities.
 
 6.5 Cleaning Requirements based on Product Characteristics 
 
 6.5.1 The level of cleaning required depends on the properties of the previous SKU
 manufactured before the cleaning and the properties of the next SKU scheduled
 
 for manufacturing after the cleaning. The sections that follow define how the
 product characteristics of these SKUs determine the cleaning level required.
 
 Other parameters determine cleaning levels defined here. 
 
 6.5.2 General Requirements 
 
 6.5.2.1 A major clean with allergen testing is required if the previous SKU is
 
 not known. 
 
 6.5.2.2 A major clean is required if the next scheduled SKU is not known.
 
 6.5.2.3. A major clean is required at least every 10 days during a campaign of
 
 product that qualifies for minor or reduced major cleaning. Specific
 
 
 

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 products may require more frequent major cleans, or may be capable
 
 of supporting a longer timeframe between major cleans. The product
 
 batch record may override this timeframe. If the batch record does not
 specify a frequency for major cleans during a campaign, then the
 
 timeframe associated with this procedure applies. 
 
 6.5.3 Same SKU 
 
 6.5.3.1 A minor clean is required when the previous SKU and the next SKU
 are the same. As a special case, treat two different SKUs as the same
 
 SKU if all ingredients in the previous SKU are also present in the next
 
 SKU. 
 
 6.5.4 Drug Product 
 
 6.5.4.1 The same SKU rule applies to drug products. 
 
 6.5.4.2 Perform a major clean before and after the manufacturing of each drug
 
 product batch. 
 
 Note: For drug product manufacturing, a cleaning validation is required to
 
 assess that the removal of that product is complete and that subsequent
 products will have levels of actives below the maximum acceptable
 
 carryover limits (MACO). Prior to the completion of the cleaning
 
 validation, perform appropriate analytical testing before releasing the
 equipment for other manufacturing use. 
 
 6.5.5 Allergen 
 
 6.5.5.1 The same SKU rule applies to allergen products. 
 
 6.5.5.2 Perform a major clean, followed by allergen testing verification, after
 each batch of product containing an allergen. 
 
 
 

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 6.5.5.3 If the previous SKU and the next SKU are both allergens, a reduced
 major clean is acceptable as long as the previous SKU does not contain
 
 any allergen classes (i.e. dairy, soy, etc.) that is not also in the next
 SKU. 
 
 6.5.5.4 Ifamajor clean is required, allergen testing is also required.
 
 6.5.6 Probiotic 
 
 6.5.6.1 The same SKU rule applies to probiotic products. 
 
 6.5.6.2 Perform a major clean after each batch of product containing a
 
 probiotic. 
 
 6.5.7 Product Certifications 
 
 6.5.7.1. The same SKU rule applies to Non-GMO Project Verified, Certified
 
 Organic, Kosher, Halal and Gluten-Free products. 
 
 6.5.7.2 Always perform a major clean before manufacturing a product with
 
 one of these certifications. 
 
 6.5.8 Product Type 
 
 6.5.8.1 Ton Labs assigns each product a product type during the onboarding
 process for the product. The product type is based on the definitions
 
 below: 
 
 6.5.8.1.1 Type 1 — includes dietary supplement products, cosmetic
 
 products, or pet products that are not allergens and contain
 no probiotics. Type 1 products do not contain components
 
 with strong odors, colors, or flavors. 
 
 6.5.8.1.2 Type 2 — includes dietary supplement products cosmetic
 
 products, or pet products, products that are certified
 
 
 

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 organic, kosher, halal, gluten-free, contain allergens, and/or
 
 contain probiotics. Type 2 products include products that do
 
 not contain these characteristics, but do contain components
 with strong odors, colors or flavors, making them difficult
 
 to clean. 
 
 6.5.8.1.3. Type 3 — drug products. 
 
 6.5.8.2 The table below defines cleaning from a previous SKU to the next
 
 SKU based on the assigned product type. 
 
 If the Previous SKU is a 
 Product Type 
 Type 1 Type 2 Type 3 
 —— Type 1 Reduced Major Major Major 
 
 2 Z >) a 2 Type 2 Reduced Maj ‘ o r M f a o j r o t r f o / e F o e l x l ec o n w t C io D n T s Maj : or
 awa n : . Maj:or / Follow CDT 
 te Malar meee form for exceptions 
 
 6.6 Area Groups 
 
 6.6.1 Some areas and equipment accommodate all three cleaning types, while other
 areas do not. Area groups as defined below have similar functions and/or
 cleaning processes. 
 
 Area Group Description 
 This group defines different cleaning processes for major and minor cleans. This group
 does not define reduced major cleans. The CDT for this group is simple, requiring a major
 clean if the SKU processed prior to cleaning is not the same SKU processed after the
 cleaning. This group applies to manufacturing areas not defined in another are group. This
 
 is the default area group and includes areas like: 
 e Powder Blending e Tableting 
 
 e Liquid Blending e Coating 
 e Encapsulation e Liquid Packaging 
 
 
 

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 This group defines different cleaning processes for major cleans, reduced major cleans,
 7 and minor cleans. The CDT for this group includes additional decision steps when
 compared to area group 1, to accommodate the three cleaning options. The area group
 includes the following areas: 
 
 e Powder Packaging e Blister Packaging 
 e Solid Dose Packaging e Pouch Packaging 
 This group defines a single cleaning process. There are no direct product contact points in
 this area group. There is no CDT for this area group. The same cleaning process applies
 3 when changing batches processed in this area. This area group includes the following
 
 areas: 
 e Flexible Packaging 
 This group defines different cleaning processes for major and minor cleans. The CDT for
 this area is identical to area group 1, but a different cleaning process applies to this area.
 4 This group does not define reduced major cleans. This area group includes the following
 areas: 
 e Gummy Manufacturing 
 
 6.7 —Re-Cleaning 
 
 6.7.1 Re-cleaning is required under the following conditions: 
 
 6.7.1.1 Cleaning activity does not pass a visual inspection 
 
 6.7.1.2 Cleaning activity does not pass an ATP swab test 
 
 6.7.1.3 Cleaning activity does not pass an allergen test 
 
 6.7.2. Document a re-cleaning by issuing the appropriate Redzone data sheet or on
 
 applicable paper forms. 
 
 6.7.3 Repeat the inspection that failed (i.e. visual inspection, ATP testing, or allergen
 
 testing) after re-cleaning. 
 
 6.8 Post-Maintenance Cleaning 
 
 6.8.1 Quality and Operations will determine the level of cleaning required after
 maintenance activities conducted during a production run. 
 
 
 

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 6.8.1.1 Select major clean with sanitization after maintenance activities that
 introduce dust, debris, or other materials that may affect the safety or
 
 purity of a product or production materials. 
 
 6.8.1.2 Select a minor clean with sanitization after maintenance activities that
 
 are not likely to impact product contact surfaces. 
 
 6.8.1.3. Sanitization. 
 
 6.8.2 Document cleaning in Redzone on the applicable data sheet or on the
 
 appropriate paper forms if Redzone is not available. 
 
 6.9 QC Cleaning Inspection 
 
 6.9.1 Form B-111-F6 Sanitization and Cleaning Approval defines steps required for a
 QC inspection. 
 
 6.9.2 Complete a QC inspection after every sanitization is completed.
 
 6.9.3. Complete ATP swab testing during visual inspection per SOP D-116 ATP
 
 Testing for Production Equipment. 
 
 6.9.4 Complete allergen swab testing if the CDT indicates that allergen testing is
 
 required. Conduct allergen testing per SOP D-111 Allergen Testing for
 
 Production Equipment. 
 
 6.9.5 Swabbing is not required after a re-sanitization if previous swabbing results
 
 pass. 
 
 6.10 Hoses 
 
 6.10.1 All production hoses will be cleaned, sanitized, and stored so that they will not
 
 become contaminated. 
 
 
 

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 6.10.2 Production hoses should be stored in or as close as possible to the production
 
 room they are used in and hung in such a manner as to allow all water to freely
 
 drain. Water or liquids are not to pool inside the stored production hose.
 
 6.10.3 While the production hose is stored, a breathable, durable, and sanitary hose
 
 cover will be placed over each open end of the hose. 
 
 6.10.4 The hose cover should have an elastic opening which will allow for a snug fit
 
 over the hose end. Selection of the size hose cover will depend on the size of the
 hose and should fit snuggly over the end of the production hose and/or hose
 
 adapter. 
 
 6.10.5 Each hose cover will be disposed of after use. 
 
 6.11 Mobile Equipment 
 
 6.11.1 Any product contact equipment that is not returned to a production room must
 be covered and stored in a designated equipment storage area, wrapped and
 
 labeled indicating that it will need a minor clean if it is returned to production.
 Equipment that is not used for product contact (i.e. vacuums, dust filters) can be
 
 stored in the equipment storage area without being covered, but is not
 
 recommended. 
 
 6.11.2 Equipment that is covered should be loosely covered after it is completely dry
 
 so as not to harbor water on equipment surfaces and have an equipment status
 sign indicating the current state of clean. 
 
 6.12 Redzone Specific Details 
 
 6.12.1 Production must initiate a run in the location being cleaned as follows:
 
 6.12.1.1 Start a “cleaning” product to document initial cleaning. When a
 cleaning product run starts, all necessary data sheets will start
 
 automatically. 
 
 
 

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 Standard Operating Procedure SOP No | Rev 
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 6.12.1.2 Start a “cleaning continuation” product if the cleaning spans across
 
 sifts or into the next day. This product does not start any data sheets.
 
 Finish data sheets started under the cleaning product run (above) to
 continue documentation of the cleaning. 
 
 6.12.1.3 Start a “cleaning after idle” product to document re-sanitization after a
 cleaning has already completed, but the room has sat idle for too long
 
 before use. When the cleaning after idle product run starts, the re-
 
 sanitization data sheet will start without the CDT data sheets. The CDT
 data sheets are not necessary after a completed cleaning.
 
 6.12.1.4 When starting a cleaning, cleaning continuation, or cleaning after idle
 product run in Redzone, always use the previous batch number as the
 
 Redzone Run ID. If the previous batch number Is not known, use NA-
 MM/DD/YY, where MM/DD/YY is the current date for starting the
 
 cleaning run. Enter the estimated time in minutes as the required
 
 quantity field. 
 
 Note: the date format is not critical when providing a run ID for an
 
 unknown previous SKU. Dashes ( — ) or slashes ( / ) may be used to
 represent the date. 
 
 6.12.2 To Accommodate Schedule Changes 
 
 6.12.2.1 If a cleaning is in process and answers about the next SKU changes for
 
 any reason, the type of clean required may also need to change. For
 example, if the previous schedule identified a SKU that would require
 
 a minor clean, a schedule change may identify a SKU that may require
 
 a major clean. If this occurs, there are options to document this in
 Redzone. 
 
 6.12.2.2 One option is to start the cleaning process completely over again. The
 CDT process will start over and allows documentation of the updated
 
 
 

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 scheduled next run SKU. This is the preferred method. If the identified
 
 cleaning is identical to the cleaning already completed, cancel any
 
 redundant data sheets. 
 
 6.12.2.3 A second option is to retest data sheets that inquire about the next SKU
 
 and correct the information. Before completing this action, cancel
 incomplete data sheets, as retesting a data sheet will initiate the
 
 appropriate actions. Cancel any redundant or unnecessary data sheets
 
 generated in this process. 
 
 6.12.2.4 Add comments to explain the schedule change and any cancelled data
 
 sheets. 
 
 6.12.3 Redzone Run Signoff 
 
 6.12.3.1 Quality is responsible for signing off all cleaning runs.
 
 
 

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 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/27/10 | New - - | - | - |
| 1 | 07/10/13 | Updated SOP, added major and minor cleaning | 13-371 | M. Wienke |
| 2 | 02/17/14 | eee, and detailed cleaning agents, added cleaning agents to | 14-0127 | M. Wienke |
| 3 | 07/11/14 | Added step 6.1.5. and note to major cleaning Added post-maintenance cleaning steps. Added note to label all # oe chemicals. Defined contact and non-contact. L235 DsPope | 14-0567 | S. Millar |
| 5 | 12/11/14 | Added note to run the water outlet thirty seconds prior to use. | 14-1002 | S. Kovalik |
| 6 | 12/01/15 | Revised for clarification. i a hadi A A d d d d e e d d r r e e f f e e r r e e n n c c e e t to o l li a s b t o ch f e c m h i e c m a i l c s a l a s n , d s s o o l l u u t t i i o o n n s s , . a nd lubricants. ee een: s | 15-0968 | D. Popp |
| 8 | 06/21/16 | Added coating and liquid departments. Added new process for tagging equipment to be cleaned. | 16-0610 | V. Zelaya |
| 9 | 11/15/17 | Complete procedure rewrite. Removed sections mentioning specific hold times for equipment. Specific names of cleaning chemicals were removed and | 17-1246 | K. Tyrrell |
| 10 | 11/20/18 | substituted with the more general term “degreaser”. Clarified the Minor Clean process and when it is performed on idle equipment or duringa Lot# change in a production room. Added Organic Clean references, added references to cleaning risk | 18-0193 | K. Tyrrell |
| 11 | 12/09/20 | assessment as well as cleaning validation for the powder filling CC- rooms. Added Gummy Room cleaning procedure. Added form B-111-F3. | 20-0691 | J. Maignan |
| 12 | 08/05/21 | Added Certified Organic, Kosher, Halal, non-GMP Project CC- Verified to appropriate areas. | 21-0314 | P. Wilson |
| 13 | 03/08/22 | Complete rewrite to accommodate Redzone use. CC- | 22-0096 | K. Burris |
| 14 | 08/15/23 | Adding Gluten-Free to sections 6.5.7 and 6.5.8.1.2. CC- | 23-0413 | C. Horelle |

 8.0 Attachments 
 
 8.1 Attachment 1 - PDT Example 
 8.2 Attachment 2 — Room Placard Example for Completed Cleaning Level 
 
 
 

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 Page 17 of 18 
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 Attachment 1 —- PDT Example 
 
 IN LABS 
 
 PRODUCT DETAIL TAG 
 
 GARCINA CAMBOGIA TABLET 
 
 PRODUCT SKU 
 
 00001FGP01 
 
 BATCH NUMBER 
 
 PROBIOTIC: NO 
 
 ORGANIC: YES 
 
 DRUG: NO 
 
 ALLERGEN: YES 
 
 ALLERGEN GROUP: DAIRY 
 
 PRODUCT TYPE: 2 
 
 
 

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 Cleaning of Manufacturing/Production Areas and Page 18 of 18 
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 Attachment 2 — Room Placard Examples for Completed Cleaning Level 
 
 Minor Cleaning 
 
 CLEAN 
 
 AFTER MINOR 
 Date: 
 
 Major Cleaning 
 
 CLEAN 
 AFTER MAJOR 
 
 Date: 
 
 Reduced Major Cleaning 
 
 CLEAN 
 
 AFTER REDUCED 
 MAJOR 
 
 Date: 
 
 Allergen Cleaning 
 
 CLEAN 
 AFTER ALLERGEN 
 
 Date: 
 
 Secondary Packaging Cleaning 
 
 CLEAN 
 Date: 
 
 
 

[SOP 

 ION Cleaning Decision Tool — Area Group 1 and Area Group 4
 
 Nutritional 
 Labs Form: B-111-F1 CCR No. CC-23-0413 Revision: 1 
 Cleaning Decision Tool — Area Group 1 and Area Group 4 
 Blending, Encapsulation, Tableting, Coating, Liquid Packaging, Gummies
 Default Tool if Area is not defined in another group 
 
 What is the Product SKU? Oo N/A = o| Record Below | Pinas Oio eBelow 7 
 
 What is the Batch Number? C] N/A C) Record Below O N/A C) Record Below 
 
 Is the product a Probiotic? CO Yes [] No ON/A C) Yes ONo ONA 
 
 Is the product Organic, Kosher, or Halal [] Yes [ No O N/A C] Yes [ No CN/A 
 
 Is the product a Drug? C] Yes [O)No ON/A C] Yes ONo ONA 
 
 Is the product and Allergen? CO Yes [MO No ON/A OC Yes [No ONA 
 
 What Allergen Group is the product? CO] N/A C) Record Below [C) N/A C] Record Below
 
 What is the assigned product type? [C] N/A C) Record Below C) N/A CJ Record Below
 
 Section 2 — Decision ‘Questions 
 1A — Do you know the previGas SKU? ~ Cl Yes—Goto 1B 
 
 (If not, mark N/A in Previous SKU Product 
 1 No- Major Clean with Allergen Testing 
 Information section above) 
 1B — Do you know the next SKU? [LI Yes —Go to 1C 
 (If not, mark N/A in Next SKU Product Information | [] No—Go to 1D 
 section above) [] N/A — Question not executed 
 [] Yes — Minor Clean 
 1C — Are the previous and next SKUs the same? CO) No—Goto 1D 
 * Special case minor cleans require management LI N/A - Question not executed 
 approval prior to execution [] Special Case — Minor Clean* 
 * Management Approval: 
 C1 Yes— Major Clean with Allergen Testing
 
 1D — Is the previous SKU an allergen? [) No- Major Clean 
 C1 N/A — Question not executed 
 
 

[SOP 

 ION Cleaning Decision Tool — Area Group 2 
 py Nestionar Form: B-111-F2 CCR No. CC-23-0413 Revision: 1 
 
 Cleaning Decision Tool — Area Group 2 
 Powder Packaging, Solid Dose Packaging, Blister Packaging, 
 
 Tn 
 
 i UBrevious SOU Nest SIA 
 What is the Product SKU? C1 N/A CL) Record Below C1 N/A —_L) Record Below 
 
 What is the Batch Number? C1 N/A = (1) Record Below C1 N/A ~—_L) Record Below
 
 Is the product a Probiotic? [] Yes ONo ON/A C] Yes ONo ONA 
 
 Is the product Organic, Kosher, or Halal? | [] Yes MO No ON/A C] Yes [1No ONA 
 
 Is the product a Drug? [] Yes [C1 No ON/A [] Yes [1 No OIN/A 
 
 Is the product and Allergen? [] Yes C1 No ON/A C) Yes [C1 No CIN/A 
 
 What Allergen Group is the product? [C] N/A C1) Record Below C] N/A C] Record Below
 
 What is the assigned product type? [] N/A [1] Record Below O N/A C] Record Below
 
 Section 2 — Decision Questions 
 BiGtna Toi 
 1A — Do you know the previous SKU? CO Yes—Go to 1B 
 (If not, mark N/A in Previous SKU Product 
 Information section above) CO No- Major Clean with Allergen Testing 
 1B — Do you know the next SKU? [L] Yes —Go to 1C 
 
 (If not, mark N/A in Next SKU Product Information | [] No—Goto 1F 
 BC SUSH ALGVE) [C] N/A — Question not executed 
 [ Yes - Minor Clean 
 1C — Are the previous and next SKUs the same? C] No=Go fo 1D 
 
 * Special case minor cleans require management CI N/A — Question not executed
 approval prior to execution [1 Special Case — Minor Clean 
 * Management Approval: 
 (1 Yes — Minor Clean 
 1D — Is the previous SKUa Probiotic?? [1] No-Go to 1D 
 
 C] N/A — Question not executed 
 [] Yes—Go to 1F 
 1E — Is the next SKU Organic, Kosher, or Halal? [1] No—Go to 2A 
 
 [C] N/A — Question not executed 
 
 

[SOP 

 ION Cleaning Decision Tool — Area Group 2 
 
 Nutritional 
 Labs Form: B-111-F2 CCR No. CC-23-0413 Revision: 1 
 
 Section 
 
 1F —Is the previous SKU an Allergen? C] No— Major Clean 
 CO) N/A- Question not executed 
 
 C] Yes—Go to 1F 
 2A — Is the previous SKU a Drug? [1] No-Go to 2B 
 Ol N/A- Question not executed 
 
 C] Yes —Go to IF 
 2B — Is the next SKU a Drug? [I No—Go to3A 
 O N/A- Question not executed 
 
 [ Yes - Go to 3B 
 3A —Is the previous SKU an Allergen or Probiotic? [ No-—Go to 4A 
 
 C] N/A — Question not executed 
 [] Yes —Go to 3C 
 3B — Is the next SKU an Allergen? [] No - Major Clean with Allergen Testing
 
 (C1 N/A - Question not executed 
 [) Yes — Reduced Major Clean 
 3C — Are the previous and next SKUs in the in the same 
 [1 No-Go to 3D 
 Allergen Class? 
 CJ N/A — Question not executed 
 [) Yes — Major Clean with Allergen Testing
 3D — Are there any Allergens in the previous SKU that are 
 [1 No — Reduced Major Clean 
 not in the next SKU? 
 C] N/A — Question not executed 
 C] Yes — Reduced Major Clean 
 4A —Is the previous SKU classified as a Type 1 Product? [] No- Major Clean 
 [] N/A — Question not executed 
 
 

[SOP 

 io Area Group 1 Cleaning Form 
 — Form: B-111-F3 CCR No. CC-23-0413 Revision: 1 
 
 Room Name/Number: Asset Number: 
 
 By/Start Time/Date:
 
 e All detergents and degreasers are at concentrations required as outlined in SOP B-105 CO Cc
 e All appropriate PPE is worn while chemicals are in use and only clean, potable water used By/End Time/Date:
 
 e Proper signage (major, minor, allergen) is posted to identify the room By/Start Time/Date:
 e All power sources or water sensitive equipment is de-energized and/or covered Lockout/tagout
 procedures are performed as applicable CO CO 
 e All raw materials, product, utensils, and related documents are removed from the room By/End Time/Date:
 e When cleaning surfaces of the room and equipment, always start from the top and work
 downwards and from the back of the room and work towards the doors 
 
 By/Start Time/Date:
 e All excessive powder on equipment is removed using a clean and approved brush or cleaning rag.
 If needed, equipment is vacuumed internally and externally O oO 
 e Dust off safety glass as applicable By/End Time/Date:
 Sweep floor to clear area of any powder, debris or trash as needed 
 
 By/Start Time/Date:
 e All PCS on CIP equipment should be washed and rinsed using approved PCS degreasers and
 potable water. 
 ¢ Allremovable PCS and utensils are removed, placed on a cart labeled as dirty and cleaned at the | N/A [] ; ;
 i 5 ' By/End Time/Date:
 equipment cleaning area via SOP B-103 
 e All visible powder on non-PCS is removed using cleaning rag, vacuum or other approved method
 By/Start Time/Date:
 e Wash and rinse control panels, equipment motors, table tops, walls and scales using approved
 degreaser for PCS or non-PCS (depending on the location of use) and rinse with potable water.
 Ensure PCS surfaces are covered if using non-PCS degreasers. N/A [] : 
 By/End Time/Date:
 e All removable non-PCS are removed, placed on a cart labeled as dirty and cleaned at the
 equipment cleaning area via SOP B-103 
 
 

[SOP 

 io Area Group 2 Cleaning Form 
 
 i Form: B-111-F4 CCR No. CC-23-0413 Revision: 1 
 
 Room Name/Number: Asset Number: 
 
 By/Start Time/Date:
 
 e All detergents and degreasers are at concentrations required as outlined in SOP B-105 CO CO a
 e All appropriate PPE is worn while chemicals are in use and only clean, potable water used By/End Time/Date:
 
 e Proper signage (major, minor, allergen) is posted to identify the room By/Start Time/Date:
 e All power sources or water sensitive equipment is de-energized and/or covered Lockout/tagout
 procedures are performed as applicable Cc Cc Cc 
 e All raw materials, product, utensils, and related documents are removed from the room By/End Time/Date:
 e When cleaning surfaces of the room and equipment, always start from the top and work
 d ds the d 
 
 e All excessive powder on equipment is removed using a clean and approved brush or cleaning
 rag. If needed, equipment is vacuumed internally and externally oO 
 L By/End Time/Date:
 © Dust off safety glass as applicable 
 e Sweep floor to clear area of any powder, debris or trash as needed 
 e All PCS on CIP equipment should be washed and rinsed using approved PCS degreasers and By/Start Time/Date:
 potable water. 
 e All removable PCS and utensils are removed, placed on a cart labeled as dirty and cleaned at LJ By/End Time/Date:
 ; ; F N/A N/A 
 the equipment cleaning area via SOP B-103 
 e All visible powder on non-PCS is removed using cleaning rag, vacuum or other approved
 method 
 By/Start Time/Date:
 e Wash and rinse control panels, equipment motors, table tops, walls and scales using approved
 degreaser for PCS or non-PCS (depending on the location of use) and rinse with potable water.
 C By/End Time/Date:
 Ensure PCS surfaces are covered if using non-PCS degreasers. N/A N/A 
 e All removable non-PCS are removed, placed on a cart labeled as dirty and cleaned at the
 equipment cleaning area via SOP B-103 
 
 

[SOP 

 ION Area Group 4 Cleaning Form 
 — Form: B-111-F5 CCR No. CC-23-0413 Revision: 1 
 
 Room Name/Number: Asset Number: 
 
 By/Start Time/Date:
 
 e All detergents and degreasers are at concentrations required as outlined in SOP B-105 CO Ol
 e All appropriate PPE is worn while chemicals are in use and only clean, potable water used By/End Time/Date:
 
 ¢ Proper signage (major, minor, allergen) is posted to identify the room By/Start Time/Date:
 
 e All power sources or water sensitive equipment is de-energized and/or covered Lockout/tagout
 procedures are performed as applicable CO Cc 
 e All raw materials, product, utensils, and related documents are removed from the room By/End Time/Date:
 e When cleaning surfaces of the room and equipment, always start from the top and work
 downwards and from the back of the room and work towards the doors 
 
 e Steam clean and flush kettles / lines / pumps / hopper with hot water 
 e Clean the inside of tanks using a bristle brush 
 e Flush all components of the gummy line listed above with de-ionized water and drain
 e Run IPA through dosing pumps to flush lines and prevent microbial growth [| [] By Bad uneiDett:
 e Inspect condensate pan, bristle spinners, and blue belt to ensure cleanliness 
 e Spray IPA on brushes, under blue belt, and on condensate pan 
 ® Remove housing from high-sheer mixer and clean 
 e Disassemble and clean the inside of the pumps and high-sheer mixer By/Start Time/Date:
 e Disassemble and clean hopper and CFA mixer. 
 e Move ancillary equipment to the center of the room near the cooling tunnel 
 e Spray walls (including empty drying room) with Simple Green pump sprayer ByBoa dame Date)
 e Scrub walls with bristle brush and let stand for 10 minutes 
 e Rinse Walls with hot water and wipe down with a clean pad 
 © Mop or wet vacuum water from edge of the walls and place equipment back against the walls.
 e Remove condenser tray and wipe down entirety of tray with IPA rag 
 e Lightly spray IPA into condenser coils to sanitize heat transfer area N/A LJ 
 e Remove both product bristle brushes, remove any residual product with sprayer and liberally
 spray with IPA followed by water 
 e Spray Simple Green under the machine and on any product stains on the floor. Let sit for 10
 minutes. 
 ¢ Mop with hard water leaving the floor wet 
 e Squeegee water to drains or wet vacuum 
 e Mop over floor to soak up any excess water and allow to dry 
 e Clean drying room walls as described above and send drying racks for cleaning 
 By/Start Time/Date:
 e Wash and rinse control panels, equipment motors, table tops, walls and scales using approved
 degreaser for PCS or non-PCS (depending on the location of use) and rinse with potable water.
 Ensure PCS surfaces are covered if using non-PCS degreasers. N/A | : 
 By/End Time/Date:
 e All removable non-PCS are removed, placed on a cart labeled as dirty and cleaned at the
 equipment cleaning area via SOP B-103 
 
 

[SOP 

 ION Sanitization and Cleaning Approval Form 
 
 a Form: B-111-F6 CCR No. CC-23-0413 Revision: 1 
 
 Sanitization — All Areas and Equipment 
 
 This form is to be used after all other aspects of cleaning have been performed (major, minor, reduced major) or when a room has
 been idle for more than 36 hours 
 
 Room Name/Number: Asset Number: 
 
 Spray IPA 70% on touch points, scales, and utensils as needed 
 
 Spray IPA 70% on all product contact surfaces and allow to air dry 
 
 Spray IPA 70% on all surfaces and allow to air dry 
 
 Use germicidal bleach to mop floors 
 
 Cleaning Approval - QC 
 
 Section 2 (To be completed b 
 
 Are all aspects of clean performed adequately 
 
 There is no visible powder or odors in the room that may contaminate 
 subsequent batches 
 
 ATP testing has been performed and has passed 
 
 If applicable, allergen testing has been performed and has passed 
 
 Circle the appropriate choice: Pass Fail 
 
 Comments: