Control of Glass, Brittle Plastics, and Ceramics

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1.0 Purpose 
 
 The purpose of this procedure is to define and establish a Glass, Brittle Plastics, Ceramics and
 
 Wood Control Program to ensure compliance and safety of all products manufactured and
 distributed by Ion Labs, Inc. 
 
 2.0 Scope 
 
 This procedure applies to all manufacturing and warehouse areas at Ion Labs, Inc.
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of the Production, Facility, and Maintenance Management to
 implement and maintain this procedure. 
 
 3.2 It is the responsibility of all personnel to ensure that this program is followed and that
 all glass, brittle plastics, ceramics and wood are controlled and disposed of in an
 
 appropriate manner. 
 
 3.3 It is the responsibility of the Facility Manager or designee to oversee and aid in the
 cleanup of all broken glass, brittle plastics, ceramics and/or wood; to ensure proper
 disposal and handling. This will reduce the chance for contamination and injury.
 
 3.4 It is the responsibility of the Maintenance Manager to ensure that all machinery and
 equipment where glass, brittle plastic or ceramic may be present are well maintained
 
 and secure. 
 
 3.5 It is the responsibility of the QS Manager or designee to review the affected area and
 perform an appropriate area clearance. The QS Manager or designee will also ensure
 that all associated documentation is reviewed with proper accountability.
 
 3.6 It is the responsibility of the QA Manager or designee to ensure that random areas are
 
 audited on a monthly basis. 
 
 4.0 Definitions 
 
 4.1 Contamination — the presence of an undesirable substance or material rendering that
 
 
 

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 material/product harmful or unsuitable for use. 
 
 4.2. QC-— Quality Control 
 
 4.3 QA-— Quality Assurance 
 
 44 HACCP- Hazard Analysis Critical Control Point 
 
 4.5 HARPC- Hazard Analysis Risk-based Preventative Control 
 
 5.0 References 
 
 5.1 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.2 QS-105, SOP, Food Safety Plan 
 
 5.3 F-508-F1, Form, Glass, Brittle Plastic or Ceramic Breakage Form 
 
 5.4 F-508-F2, Form, Glass/Brittle Plastic/Ceramics/Wood Audit Checklist
 
 5.5 Glass, Brittle Plastic, Ceramics and Wood Policy Statement 
 
 5.6 HACCP/HARPC Plan 
 
 5.7. GMP and Sanitation Monthly Audit 
 
 5.8 21 CFR1an1d 1117 
 
 6.0 Procedure 
 
 6.1 Ion Labs has implemented a Glass, Brittle Plastic, Ceramics and Wood Policy in order
 
 to assist in reducing the risk of contamination to our products. 
 
 6.2 Glass, Brittle Plastic, and Ceramics 
 
 6.2.1 Glass, Brittle Plastics and Ceramics are physical hazards and considered a
 significant food safety risk. To ensure the safety of the product, the following
 procedures are implemented. 
 
 6.2.1.1 All lights must be protected to effectively contain broken glass. To
 
 avoid contaminating food/product/packaging with glass materials, all
 fluorescent tubes and light fixtures are required to be fitted with
 diffusers, safety covers/shields, or shatterproof bulbs.
 
 
 

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 6.2.1.2 Lights should only be replaced during non-production hours when
 there is no exposed product. 
 
 6.2.1.3 If a light MUST be replaced during production hours: All product,
 packaging, and equipment must be covered or moved to a designated
 hold area that is a sufficient distance from the fixture to prevent
 
 accidental contamination (this area may be designated by the
 Production, Facility, or Maintenance management or designee).
 
 6.2.2 In the event of a breakage in the production or warehouse area, the following
 corrective actions are to be followed: 
 
 6.2.2.1 All glass, brittle plastic or ceramic breakage must be reported
 
 immediately to the area supervisor or manager. 
 
 6.2.2.2 Stop production where contamination of the product is possible. Stop
 operations and attempt to locate the source of the glass, brittle plastic
 or ceramic fragments. 
 
 Note: Uncovered/exposed product/packaging material in the immediate area
 
 will require a risk assessment to ensure that there is no contamination
 of product. Product that is contaminated and needs to be disposed will
 be at the discretion of VP of Quality/RA or designee. Affected product
 should be moved to a designated area for proper disposal. Facility
 maintenance will orchestrate this activity, ensuring containment. The
 
 QS Manager or designee will review and modify/approve all
 associated product documentation to ensure proper accountability.
 
 6.2.2.3 If removal of large pieces of glass, brittle plastics, or ceramic is to be
 by hand, appropriate gloves must be worn and pieces must be placed in
 a designated sharps container or proper disposal container.
 
 6.2.2.4 Carefully sweep up the glass/other fragments into a dustpan and
 transfer to a lined cardboard box to be marked “Broken Glass” or
 appropriate sharps container. Facility management or designee will
 dispose of glass/plastic properly and ensure tools used/uniforms worn
 (i.e. gloves, shoes/footwear covers, brooms, brushes, and dustpan) are
 
 cleaned/changed outside of the affected area to prevent further
 contamination. 
 
 
 

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 6.2.2.5 Ensure that the area is wiped clean with disposable wipes and an
 approved cleaner to further eliminate any residual fragments. Dispose
 of cleanup material properly. 
 
 6.2.2.6 Facility or Production management will make any needed
 
 modifications to the area or source to prevent any future introduction
 of glass, brittle plastic or ceramic fragments. 
 
 6.2.2.7 All equipment will be thoroughly cleaned should they be in the area of
 the breakage or become contaminated. This is at the discretion of the
 Maintenance Manager. 
 
 6.2.2.8 Resuming production/operations in the affected area will require a
 complete review of the area by the QS Manager or designee. This
 review will be documented on form F-508-F1 Glass, Brittle Plastic and
 Ceramic Breakage Form. 
 
 6.3 Wood 
 
 6.3.1 Wood is a physical hazard and considered a significant food safety risk. To
 ensure the safety of the product, the following procedures are implemented:
 
 6.3.1.1 As a general principle the use of wood should be avoided, however it
 is acknowledged that wood pallets maybe used for delivery and
 production areas. 
 
 6.3.1.2 Wood pallets must not be in areas where product is exposed. When
 
 there is an exception, wood pallets that are used in production areas
 (primary packaging) near exposed product/product contact surfaces,
 must be wrapped properly to prevent a risk of contamination.
 
 6.3.1.3 Pallets within the warehouse must be maintained in good condition:
 dry, clean, free from damage and contamination. 
 
 6.3.1.4 Pallets that are unacceptable to use are removed from the
 production/warehouse area and place in a designated location.
 
 6.3.1.5 Pallets that are acceptable to use are stored in the Warehouse.
 
 6.3.1.6 Pallets must not have, loose, damaged or missing boards or blocks.
 
 6.3.1.7 Pallets condition must be subject to regular inspections.
 
 
 

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 6.3.1.8 Wood pallets must not be treated with tainted chemicals.
 
 6.3.1.9 Pallets must not have any protruding nails. 
 
 6.3.1.10 Pallets must not have any large or protruding splinters or sharp edges.
 
 6.3.1.11 Pallets must not have any off odors or physical contamination.
 
 6.3.1.12 All loose, trailing shrink/stretch wrap must be removed, when
 
 applicable. 
 After handling wood pallets, hands should be washed prior to touching
6.3.1.13 any product or product contact surfaces.

 6.3.1.14 Wood utensils are not permitted in the warehouse and manufacturing
 facility areas (as they cannot be properly cleaned/sanitized and may be
 
 a source of foreign materials contamination). 
 
 6.4 Inventory, Internal Audits, and Hazard Analysis 
 
 6.4.1 An internal audit for Glass, Brittle Plastic, Ceramics and Wood will be
 conducted monthly using Form F-508-F2 Glass/ Brittle Plastic/Ceramic/Wood
 Audit Checklist (including internal Glass, Brittle Plastic, and Ceramic Register).
 The internal audit assesses random areas, ensuring that there is no risk for
 
 contamination from glass, brittle plastics, ceramic or wood. The QA Manager or
 designee will notify Production, Maintenance, and/or Facility Management or
 designee (as applicable) of any noted failure during the audit.
 
 6.4.1.1 Any action that is required as a result of a failure will necessitate
 immediate attention/correction, depending on the situation or risk. The
 
 corrective action will be documented on Form F-508-F2 Glass, Brittle
 Plastic, Ceramic or Wood Audit Checklist. A work order will be
 generated, if necessary. 
 
 6.4.1.2 Once the corrective action has been completed, the Quality Manager or
 designee will be notified to reassess the area. The reassessment will
 
 also be documented on the form. If the corrective action is not
 completed satisfactorily, a plan must be obtained by the respected
 department management; including a time frame for completion.
 
 6.4.2 Random checks are conducted during the GMP and Sanitation Audit. These
 checks ensure items (may contain/are glass, brittle plastic, ceramic and/or wood
 
 
 

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 Control of Glass, Brittle Plastics, Ceramics and Wood 
 
 pallet) are designed, constructed, and stored properly so they do not pose a risk
 to contaminating the product/product contact surfaces. These checks also ensure
 the surrounding areas near product/product contact surfaces are not at risk of
 
 being contaminated. 
 
 6.4.2.1 Any action that is required as a result of a failure will necessitate
 immediate attention/correction, depending on the situation or risk.
 Corrective action will be documented on the GMP and Sanitation
 Audit Observation Report. The QA Manager or designee will notify
 the Production Manager, Maintenance Manager, or Facility Manager
 
 (as applicable) of any noted failure during the audit. 
 
 6.4.2.2 Once the corrective action has been complete, the Quality Manager or
 designee will assess and verify. If the corrective action is not
 completed satisfactorily, a plan must be obtained by the respected
 
 department management; including a time frame for completion.
 
 6.4.3 A hazard analysis was performed and is documented in the HACCP/HARPC
 Plan. Each process step was assessed based off risk for physical hazards such as
 glass, brittle plastic, ceramics, and wood. Preventative Controls are in place to
 eliminate cross contamination. (see HACCP/HARPC Plan for details)
 
 6.5 Record Keeping 
 
 6.5.1 In the event of a breakage, complete form F-508-F1 Glass, Brittle Plastic, and
 Ceramic Breakage Form. The form will then be place in the batch record.
 Quality may hold a copy at their discretion. 
 
 6.5.2 Documents will be maintained following SOP C-502 Record Storage, Retention,
 
 and Destruction. 
 
 6.5.3 Internal Audits are maintained by the QA department. 
 
 6.5.4 A reassessment of the HACCP/HARPC Plan is conducted annually and
 maintained by the QA department. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/09/15 | New | 15-0396 | S. Millar |
| 1 | 01/25/16 | Changed and added responsibilities; added reference to equipment | 15-0994 | S. Millar |

 
 

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 Standard Operating Procedure SOP No | Rev re 
 Control of Glass, Brittle Plastics, Ceramics and Wood F-508 3 i 
 
 2 04/27/18 | Added reference to ceramics. Updated titles. Revised audit checklist. 18-0148 S. Millar
 Added reference 21 CFR 111 and 117, HACCP/HARPC, GMP and 
 Sanitation Audit, Glass, Brittle Plastic, Ceramic and Wood Policy
 3 07/13/21 | Statement, and QS-105 Food Safety Plan. Added a Glass, Brittle CC-21-0249 | C. Horelle
 Plastic, Ceramic and Wood Policy Statement. Revised procedure to
 add wood and current practices. Compliant to requirements. 
 
 8.0 Attachments 
 
 8.1 Attachment 1 - Glass, Brittle Plastics, Ceramics and Wood Policy Statement
 
 
 

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 Standard Operating Procedure SOP No | Rev 
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 Attachment 1 - Glass, Brittle Plastics, Ceramics and Wood Policy Statement
 
 Ion Labs operates to the highest possible quality standards. Glass, Brittle Plastic, Ceramics, and
 Wood are a significant physical food safety risk. To safeguard our products we have adopted the
 following policy to assist in reducing the risk of contamination of our products from glass, brittle
 plastics, ceramics and wood. 
 
 e By this commitment, Ion Labs minimizes the risk of potential product contaminations by glass,
 
 brittle plastics, ceramics and/or wood. 
 
 e Wherever possible, items constructed of glass, brittle plastics, ceramics and/or wood are
 avoided in the Production Areas. When no satisfactory alternatives can be found, such articles
 shall be protected in a manner which can be prevented from being shattered, broken or source
 of contamination. When in an emergency situation, shattered or broken fragments can be
 contained in a manner that would eliminate or prevent potential cross contamination.
 
 e Exceptions to this policy include Laboratory, Breakroom and Office Areas. These areas are
 separate from Contact Areas/Manufacturing Area. The Laboratory Area has a policy for broken
 glass. Glassware/blades/cutting instruments are disposed of in a separate waste disposal
 container. 
 
 e It is lon Labs policy to provide continual monitoring of glass, brittle plastics, ceramics, and
 wood articles within the manufacturing facility. This shall be accomplished by monthly self-
 inspection/audits to assess random areas, ensuring that there is no risk for contamination from
 glass, brittle plastics, ceramics, and wood. 
 
 e A Glass, Brittle Plastics, Ceramics, and Wood register has been established with assigned risk.
 The register identifies examples of glass, brittle plastic, ceramics, and wood in immediate
 
 contact areas/production. 
 e Lights and light fixtures suspended over product contact or product contact surfaces in any
 stage of process or exposed packaging material must be protected to prevent contamination of
 
 product in case of breakage. 
 
 e Other Foreign Body Control Policy: [Illness and Injury are covered under the Good
 Manufacturing Practices and Personal Hygiene Procedure. Personnel with exposed cuts, sores
 or lesions shall not be engaged in handling or processing products or primary packaging
 materials or food contact surfaces. Minor cuts or abrasions on exposed parts must be covered
 with colored bandages containing a metal strip or an alternative suitable waterproof and
 colored dressing. Gloves must be worn over bandages. 
 
 e Glass, Brittle Plastic, Ceramics, and Wood Policy will be applicable regardless if production is
 taking place or not. 
 
 
 

[SOP 

 a fs Glass, Brittle Plastic, and Ceramic Breakage Form
 
 AEE ee Form: F-508-F1 CCRNo. CC-21-0249 Revision: 3 
 
 This form must be completed whenever glass, brittle plastic or ceramic material is found broken in the
 warehouse or manufacturing areas. 
 
 Date of Incident: 
 
 Batch Number: 
 Person Performing Cleanup: 
 (Ensure proper gloves are worn to reduce the chance of injury) 
 Broken Item: 
 
 Material Type (Glass, Brittle Plastic, Ceramic) 
 
 Area Found: 
 Product Affected (if applicable): 
 
 Cleanup Procedure: 
 
 e Report all glass, brittle plastic or ceramic breakage immediately to the area Supervisor or Manager.
 e Stop production where contamination of the product is possible. Stop operations and attempt to locate the source of
 
 the glass, brittle plastic and/or ceramic fragments. 
 e Uncovered/Exposed Product/Packaging Material in the immediate area will require a risk assessment to ensure that
 
 there is no contamination of product. Product that is contaminated and needs to be disposed will be at the
 discretion of VP of Quality/RA or designee. Affected product must be moved to a designated area for proper
 
 disposal. Facility maintenance will orchestrate this activity to ensure containment. The QS Manager or designee will
 review and modify/approve all associated product documentation to ensure proper accountability.
 
 e If removal of large pieces of glass, brittle plastic or ceramic material is by hand, appropriate gloves must be worn
 and pieces must be placed in a designated sharps container or proper disposal container.
 
 e Carefully sweep the glass or brittle plastic fragments into a dustpan and transfer to a lined cardboard box to marked
 ‘Broken Glass/Brittle Plastic/Ceramic” or an appropriate sharps container. Facility maintenance will dispose of
 
 glass/plastic/ceramic properly and ensure tools used/uniforms worn (i.e. shoes, brooms, brushes, and dustpan) are
 cleaned/changed outside of the affected area to prevent further contamination. This area will be designated by the
 
 Director of Operations. 
 e Ensure that the area is wiped clean with disposable wipes and approved cleaner to further eliminate any residual
 
 fragments. Dispose of cleanup material properly. 
 e Resuming production/operations in the affected area will require a complete review of the area by the QS Manager
 
 or designee. 
 Facility Management/Operations: Date: 
 
 Comments: 
 
 Area Clearance: Area is free of contaminants and is acceptable
 
 Quality: Date: 
 
 

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