Facility Maintenance and Sanitation

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2.0 Scope 
 
 This procedure applies to all non-production areas of Ion Labs, Inc. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of the Facility Manager or designee to implement this procedure
 
 and to ensure that the procedure is being followed. 
 
 3.2 It is the responsibility of Warehouse and Facility personnel to follow this procedure and
 
 to ensure that the facility is in good sanitary condition at all times.
 
 4.0 Definitions 
 
 4.1 Office — areas used by office support staff that include: offices, cubicles, meeting
 
 rooms, QC Laboratory, restrooms, and breakrooms. 
 
 4.2 Production — all areas to include: manufacturing rooms, product storage, shipping, and
 
 receiving. 
 
 4.3 Manufacturing — all areas to include: rooms that are used to manufacture or process
 
 product. 
 
 4.4 Warehouse — area used to store raw materials, finished product, production supplies,
 
 receiving, and shipping areas. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Facility Maintenance and Sanitation F-506 6 Page 2 of 7 
 
 4.4.1. W1 warehouse is defined as storage racks, shipping area, and receiving area
 located at 8031 114 Avenue. 
 
 4.4.2 W2 warehouse area is defined as the storage area, shipping area, and receiving
 
 area located at 10950 S. Belcher Road. 
 
 4.5 Perimeter — outside area of building to include: parking lots, receiving/loading dock,
 
 compactor or dumpster storage, and landscaped areas. 
 
 4.6 PQV — Process Quality Verification 
 
 5.0 References 
 
 5.1 F-506-F1,Form, Office Area and Restroom Cleaning Log 
 
 5.2. F-506-F2, Form, Warehouse and Facility Floor Cleaning Log 
 
 5.3 F-506-F3, Form, Cleaning of Upper Areas in Production/Warehouse/Grounds Log
 
 5.4 A-106, SOP, Documentation Guidelines for cGMP Records 
 
 5.5 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.6 Master Cleaning Schedule 
 
 5.7 21 CEFR parts 111, 114, 117, 210 and 211 
 
 6.0 Procedure 
 
 6.1 General Requirements 
 
 6.1.1 Areas that need cleaning will be listed on the Master Cleaning Schedule.
 
 6.1.2 The Master Cleaning Schedule will be kept in the Sanitation Manual.
 
 6.1.3. The Master Cleaning Schedule will be maintained by the Facility Manager or
 
 designee. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Facility Maintenance and Sanitation F-506 6 Page 3 of 7 
 
 6.2 Ground Requirements 
 
 6.2.1 Properly store equipment, remove litter and waste, and cut weeds or grass and
 
 trim any bushes or trees within the immediate vicinity of the physical plant so
 
 that it does not attract pests, harbor pests, or provide pests a place for breeding.
 All vegetation must be cut back from the exterior perimeter of the facility to
 
 prevent pest harborage or debris accumulation. 
 
 6.2.2 Maintain roads, yards, and parking lots so that they do not constitute a source of
 
 contamination in areas where components, finished product, or contact surfaces
 are exposed. 
 
 6.2.3. Have adequately operating waste treatment and disposal systems so that they do
 
 not constitute a source of contamination in areas where components, finished
 product, or contact surfaces are exposed. 
 
 6.2.4 The exterior grounds maintenance shall be inspected and maintained monthly or
 as needed. Facility or Operations employees that are designated to cleaning and
 
 maintaining the Grounds area shall record their cleaning on F-506-F3 Cleaning
 of Upper Areas in Product/Warehouse/Grounds. 
 
 6.3. Facility Requirements 
 
 6.3.1 The facility must be in sufficient condition to prevent components, finished
 
 product, or contact surfaces from becoming contaminated. 
 
 6.3.2 Cleaning compounds and sanitizing agents must be free from microorganisms of
 public health significance, and must be safe and adequate under the conditions
 
 of use. 
 
 6.3.3 Toxic materials cannot be used or held in a facility in which components or
 
 finished product are manufactured, unless those materials are necessary as
 follows: 
 
 
 

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 Standard Operating Procedure SOP No Rev 
 Facility Maintenance and Sanitation F-506 6 Page 4 of 7 
 
 6.3.3.1 Those required to maintain clean and sanitary conditions
 
 6.3.3.2 Those necessary for use in laboratory testing procedures
 
 6.3.3.3. Those necessary for use in the plant’s operation 
 
 6.3.3.4 Those necessary for plant and equipment maintenance and operations
 
 6.3.4 Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be
 
 identified, held, and stored in a manner that protects against contamination of
 components and finished product. 
 
 6.3.5 The water supply shall be sufficient for the operations intended and shall be
 derived from an adequate source. Water intended for use or associated with the
 
 manufacture and production (or may become a component of a dietary
 supplement) will comply with all Federal, State, and Local requirements. Water
 
 for manufacturing is supplied by an in-house, purified DI water system.
 
 6.3.6 Any water that contacts components, finished product, or contact surfaces shall
 
 be safe and of adequate sanitary quality. 
 
 6.3.7 Running water at a suitable temperature, and under pressure as needed, shall be
 provided in all areas where required for the cleaning of equipment, utensils, or
 
 for employee sanitary facilities. 
 
 6.3.8 Hand washing stations shall be adequate and convenient with hot running water,
 
 hand soap, and paper towels. Hand washing stations shall be furnished in the
 
 manufacturing area. 
 
 6.3.9 Readily understandable signs directing employees to wash and sanitize their
 
 hands before they start work, after each absence from post of duty, and when a
 restroom is used. 
 
 
 

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 Standard Operating Procedure SOP No Rev 
 Facility Maintenance and Sanitation F-506 6 Page 5 of 7 
 
 6.3.10 Trash cans in all areas are to be properly maintained so that trash cans are clean
 with no visible buildup and excessive trash does not overflow from the can.
 
 Trash cans are to be marked or labeled as such and covers should be in place for
 
 trash receptacles in commonly shared areas. 
 
 6.4 Office Area Cleaning 
 
 6.4.1 Facility employees that are designated to clean the office areas shall record their
 cleaning on F-506-F1 Office Area and Restroom Cleaning Log. This should be
 
 done daily. 
 
 6.4.2 Office area cleaning may be performed by an external janitorial cleaning
 
 service. The contracted cleaning service has the option to provide external
 
 cleaning documentation, with the stipulation that it covers the scope of work for
 office cleaning listed on form F-506-F1 Office Area and Restroom Cleaning
 
 Log. 
 
 6.4.3 Carpet floors should be vacuumed a minimum of two times per week, or as
 
 needed. 
 
 6.4.4 Office cubicles should be dusted a minimum of | time per week, or as needed.
 
 6.4.5 Restrooms are to be cleaned and inspected for proper sanitation daily or as
 needed. 
 
 6.4.6 Walls are inspected for damage and/or cleaning (e.g. cobwebs) daily or as
 
 needed. 
 
 6.4.7 Employees with a private office may request cleaning from Facilities as needed.
 
 6.4.8 Breakroom refrigerators should be cleaned a minimum of one time per week.
 
 6.4.9 Breakroom sinks, tables, floors, and microwaves should be cleaned daily or as
 
 needed. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Facility Maintenance and Sanitation F-506 6 Page 6 of 7 
 
 6.5 Floor scrubbing and mopping for Production and Warehouse areas 
 
 6.5.1 Facility employees that are designated to scrub or mop Production Floors shall
 
 record their cleaning on F-506-F2 Warehouse and Facility Floor Cleaning Log.
 This should be done daily. 
 
 6.5.2 Floors in Production areas (not inside Manufacturing Rooms) need to be
 scrubbed with an electric floor scrubber or wet mopped a minimum of 1 time a
 
 day. 
 
 6.5.3 The warehouse area (to include shipping, receiving, and storage locations) will
 have the floors scrubbed as follows: 
 
 6.5.3.1 For high traffic areas — floors are to be scrubbed or wet mopped
 weekly. 
 
 6.5.3.2 Inactive areas — floors are to be scrubbed monthly or as deemed
 necessary by Management walkthroughs. 
 
 6.6 Cleaning of upper level areas in Production 
 
 6.6.1 Facility or Operations employees that are designated to upper levels shall record
 
 their cleaning on F-506-F3 Cleaning Log of Upper Areas in 
 
 Product/W arehouse/Grounds. 
 
 6.6.2 The ceilings, duct work, and piping above Manufacturing Rooms (e.g.
 
 Packaging, Blending, and Tableting) must be swept or vacuumed monthly to
 remove dust buildup. 
 
 6.6.3 The pallet racks located in the Shipping Warehouse and Production areas near
 Blending and in front of the Liquid rooms will be wiped down or vacuumed on
 
 a quarterly basis. 
 
 
 

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 Standard Operating Procedure SOP No Rev Pace 7 of 7 
 Facility Maintenance and Sanitation F-506 6 age ro 
 
 6.6.4 The rafters used to support the ceiling will be swept or vacuumed on a bi-annual
 basis. 
 
 6.6.5 All cleaning will be verified by the Facility Manager or Senior Operational
 
 Management. 
 
 6.7. Monthly GMP and Sanitation Audit 
 
 6.7.1 A monthly audit will be conducted by the Food Safety and Regulatory
 Supervisor or designee to ensure GMP and sanitation standards are in
 
 compliance. A copy of the GMP and Sanitation Audit Checklist will be kept in
 the Sanitation Manual. Audits will be maintained by the QA department.
 
 6.8 Documentation Requirements 
 
 6.8.1 A PQV check must be performed for each completed logbook page as outlined
 
 in SOP A-106 Documentation Guidelines for cGMP Records. 
 
 6.8.2 Documents will be maintained following SOP C-502 Record Storage, Retention,
 
 and Destruction. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 04/04/14 | New | 14-0295 | V. Iltcheva |
| 1 | 07/18/14 | Added Section 6.2.5 | 14-0574 | S. Millar |
| 7 | 03/11/16 | Revised to update source of water used in manufacturing and to update job titles. | 16-0233 | D. Popp |
| 3 | 06/03/16 | Removed hand sanitizing stations from 6.2.8 | 16-0568 | V. Zelaya |
| 4 | 11/20/17 | Complete rewrite to reflect current practices. | 17-1474 | K. Tyrell |
| 5 | 08/24/21 | Scheduled review: Updated titles and responsibilities. CC- Revise to include both warehouses. Add external janitorial service. | 21-0336 | W. Asbell |
| 6 | 01/16/23 | RCehvainsgee f woorrmdsi tnog stphlirto fuagchiloiuttie sf.o r claUprdiaftei cfaotrimoant,t iAndg deadn d log°o . CC- documentation requirements and SOP references. | 23-0019 | W. Asbell |

 
 

[SOP 

 Office Area and Restroom Cleaning Log 
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 Form: F-506-F1 CCR No. CC-23-0019 Revision: 3 
 
 Location: [_] 8031 114" Ave [__] 10950 Belcher Road 
 Directions: 
 All areas are to be cleaned or checked daily, unless otherwise noted. * Floors vacuumed 2 times per week
 Place your initials after you have performed cleaning or checked/refilled supplies for each section. ** Cubicles dusted 1 time per week
 Place N/A if the work was not performed. *** Refrigerator cleaned | time per week
 Place W/O if a Work Order was placed for repairs. 
 *Floors: Sinks Toilets Trash Sink Clean: ———s Tables Clean: 
 Walls: Clean: Clean: Soap: ——s Basket Available: Floors Mopped: 
 **Cubicles: Working: Working: Toilet Paper: Emptied: Microwaves Clean: 
 Trash: ss |:«sHot Water: Odor Free: Sign Posted: Trash Removed: 
 Entry: Paper Towel: ***R efrigerator Clean: 
 
 *Floors: Sinks Toilets Trash Sink Clean: Tables Clean: 
 Walls: Clean: Clean: Soap: ——s Basket Available: Floors Mopped: 
 
 **kCubicles: Working: Working: Toilet Paper: Emptied: Microwaves Clean: 
 Trash: ss |:«sHot Water: Odor Free: Sign Posted: Trash Removed: 
 Entry: Paper Towel: ***R efrigerator Clean: 
 
 *Floors: Sinks Toilets Supplies Trash Sink Clean: Tables Clean: 
 Walls: Clean: Clean: Soap: Basket Available: Floors Mopped: 
 **Cubicles: Working: Working: Toilet Paper: Emptied: Microwaves Clean: 
 Trash: ss |:«sHot Water: Odor Free: Sign Posted: Trash Removed: 
 Entry: Paper Towel: ***Refrigerator Clean: 
 
 *Floors: Sinks Toilets Trash Sink Clean: | 
 Walls: Clean: Clean: Basket Available: Floors Mopped: 
 **Cubicles: Working: Working: Toilet Paper: Emptied: Microwaves Clean: 
 Trash: ss |:«sHot Water: Odor Free: Sign Posted: Trash Removed: 
 Entry: Paper Towel: ***R efrigerator Clean: 
 OO) 
 *Floors: Sinks Toilets Supplies Trash Sink Clean: Tables Clean: 
 Walls: Clean: Clean: Soap: Basket Available: Floors Mopped: 
 **Cubicles: Working: Working: Toilet Paper: Emptied: Microwaves Clean: 
 Trash: ss |:«sHot Water: Odor Free: Sign Posted: Trash Removed: 
 Entry: Paper Towel: ***R efrigerator Clean: 
 
 

[SOP 

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 Warehouse and Facility Floor Cleaning Log 
 Form: F-506-F2 CCR No. CC-23-0019 Revision: 3 
 Location (check one): [_] 8031 114th Ave [__] 10950 Belcher Rd. 
 Directions: 
 Scrubbing or mopping of floors outside manufacturing rooms will be done a minimum of 1 time per day.
 Only use Tennant Degreaser or other Floor Scrubber approved cleaning chemicals in the electric floor scrubber.
 Only use Damp Mop Floor Clearer or Germicidal Bleach in mop buckets. 
 Place your initials when you have completed the floor scrubbing or mopping. 
 Place N/A if the floors were not scrubbed or mopped during that shift. 
 Spot cleaning or cleaning of spills do not require your initials. 
 High traffic areas to be scrubbed weekly. 
 Inactive areas to be scrubbed monthly or as deemed necessary by Management walkthroughs. 
 1° shift: 1“ shift: 1° shift: 1“ shift: 1° shift: 1° shift: 1° shift: 1° shift: 1° shift: 
 
 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 
 
 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 
 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 
 
 CRASH Ape Pa DPC CnT ; 
 1“ shift: 1° shift: 1“ shift: 1° shift: 1“ shift: 1“ shift: 1“ shift: 1° shift: 1“ shift: 
 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift:
 
 ag He ae 
 1“ shift: 1° shift: 1“ shift: 1° shift: 1“ shift: 1“ shift: 1“ shift: 1° shift: 1“ shift: 
 
 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift: 2TM shift:
 
 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 1“ shift: 
 
 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: 24 shift: _ 24 shift: 24 shift: 
 * This includes Shipping, Receiving, and Storage locations 
 
 

[SOP 

 Cleaning of Upper Areas in Production/Warehouse/Grounds Log 
 See NL PE Form: F-506-F3 CCR No. CC-23-0019 Revision: 2 
 
 y) 
 
 Liquid 
 Coating 
 
 Tableting 
 Encapsulation 
 Blending 
 Gummy NA NA NA NA 
 Packaging 
 Flex NA NA 
 
 EXTERIOR GROUNDS 
 Date: | Done by: 
 
 CLEANING OF WAREHOUSE RACKS (must be done quarter] 
 
 Rack 1 in front of Encapsulation Area 
 Rack 2 in front of Blending Area 
 Rack 3 in front of Liquid Area 
 Aisle 1 rack in Shipping Area 
 Aisle 2 rack in Shipping Area 
 
 Aisle 3 rack in Shipping Area 
 Aisle 4 rack in Shipping Area 
 Aisle 5 rack in Shipping Area 
 Aisle 6 rack in Shipping Area 
 
 CLEANING OF CEILING SUPPORT RAFTERS (must be completed bi-annually) 
 
 Work has been verified by: 
 (print name) (signature) (date)