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Page 1: 2018 CIP for CPGs - opxleadershipnetwork.org · 2.3 Identify the test methods used to determine proper chemical ... Clean-in-Place Checklist ... 8.1 Verify level of visual inspection

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brought to you by:

PMMI | 11911 Freedom Drive, Suite 600 | Reston, VA 20190

CIP for CPGs Clean-in-Place Checklist

Page 2: 2018 CIP for CPGs - opxleadershipnetwork.org · 2.3 Identify the test methods used to determine proper chemical ... Clean-in-Place Checklist ... 8.1 Verify level of visual inspection

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CIP for CPGs: Clean-in-Place ChecklistLeadership NetworkMoving Operational Excellence Forward

INTRODUCTION AND PURPOSE:

This checklist is designed to provide assistance to small to mid-sized companies that are developing or revising their Clean-in-place (CIP) of processing equipment.

This document is not a comprehensive document on “how to” de-velop and validate a CIP cleaning procedure nor is it a summary of all the various cleaning and sanitation procedures, but rather is a tool to assist in the many activities associated with CIP systems. The intent of this document is to outline major activities that should take place and identify needs if any deficiencies are found. Several resources are listed to assist CIP activities. For sanitation strategies, it will be important to work closely with chemical suppliers in choosing the compounds and procedures used for cleaning equipment and prod-uct contact surfaces to remove target soils. In many situations, they can provide proven solutions to meet cleaning and sanitation needs.

This document does not outline the only approach to organizing, developing and validating a CIP system. Companies use different approaches to meet Corporate, customer and regulatory requirements.

Currently, FSMA rules do not have a mandatory validation requirement for CIP cleaning and sanitation. This document provides an outline for leading CPG companies, if they desire, to have validation evidence their CIP cleaning programs are effective. Developing a validation plan and documenting the results of CIP cleaning procedures can satisfy the needs the company’s food safety personnel, corporate management, consumers and support the argument that a company is pro-active in its food safety measures.

The methods and approach taken in the development of a CIP system should reflect the conditions mandated by the product, production schedule, or other special needs. In all cases, the CIP system should provide precise instructions that will ensure the proper cleaning and sanitizing of all equipment to remove contaminants and microorgan-isms that could cause harm to consumers.

This checklist is a companion document to CIP for CPGs: Clean-in-Place Guidelines for Consumer Products Companies published by PMMI’s OpX Leadership Network.cause harm to consumers.

Leadership NetworkMoving Operational Excellence Forward

SPONSORS

Facilitated by PMMI, the OpX Leadership Network is a dynamic community of manufacturing, engineering and operations profes-sionals dedicated to operational excellence. Through open dialogue between CPG manufacturers and OEMs, the OpX Leadership Network provides an exceptional forum where the best minds come together to identify and solve common operational challenges, and apply best practices and innovative solutions to the real-world context of manufacturing.

PMMI is a trade association of more than 600 member companies that manufacture packaging, processing and related converting machinery in the United States or Canada; machinery components and packaging containers and materials. PMMI’s vision is to be the leading global resource for the packaging and processing supply chain, and its mission is to improve and promote members’ abilities to meet the needs of their customers. Learn more about PMMI and the PACK EXPO trade shows at PMMI.org and Packexpo.com.

Copyright © 2018. PMMI. This publication was developed through the OpX Leadership Network, convened by PMMI. It may be downloaded, reproduced, and distributed for business or academic use, but not for license or sale, provided there is clear attribution to the OpX Leadership Network as the developer of the publication and PMMI as the copyright owner.

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CHECKLIST ITEM OR ACTIVITY – TASKS TO BE ACCOMPLISHED C O M P L E T E D

DATEYES NO

1. PRELIMINARY STEPS Discuss and review current operations, procedures and applicable regulations

1.1 Assemble the CIP Development/Review Team (may include outside resources)

1.2 Identify the products and associated soils to be cleaned.

1.3 Develop/review a processing diagram for that facility including equipment used for CIP

1.4 List all areas and parts to be cleaned, including areas requiring disassembly, such as clamps, gaskets, and guards

1.5 Develop/review the SOPs used for CIP

1.6 Outline the chemicals used for cleaning and sanitizing and their proposed functions

1.7 Identify who is responsible for each level of inspection from operator to final inspector

1.8 Identify if the current CIP procedures have been validated and discuss any documents describing validating procedures and results

1.8.1 All product contact surfaces should be verified to be cleanable. Validation should address hard to clean areas.

1.9 Identify any existing regulatory requirements or relevant Standards or guidelines are being addressed (e.g. cGMPs, EPA requirements, FSMA, ANSI, 3A, EHEDG, etc. etc.)

Date: _______________ Reviewed By: ______________________________ Product/ Facility: ______________________________

2. PREPARATION Stage chemicals and assemble equipment, set controls and check integrity of system. Empty the system.

2.1 Conduct a visual inspection that system is empty per SOP

2.2 Review design/and perform an Operations Maintenance QA and safety check the system.

2.3 Identify the test methods used to determine proper chemical concentrations.

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CHECKLIST

ITEM OR ACTIVITY – TASKS TO BE ACCOMPLISHED C O M P L E T E DDATE

YES NO

3. PRE-RINSE Water can remove soluble soils and under pressure many insoluble soils. Remove residual product and loose soils from the system within SOP criteria.

3.1 Verify temperature of water: warm for fat/soil solubility, but not too hot for equipment thermal shock

3.2 Verify flowrate requirements for spray balls or other equipment; (e.g. lines- flowrate required to achieve turbulent flow)

3.3 Conduct a visual and/or use analytical methods to check after rinse to get most of soil removed in initial step

3.4 Verify level of cleaning by visual inspection on equipment (e.g. tanks, pipe switching, assure that all steps and physical connections are in place to begin the CIP wash cycle). Have regulatory criteria at hand.

3.5 Verify parameters for recovery and reuse of the pre-rinse water, if applicable

Date: _______________ Reviewed By: ______________________________ Product/ Facility: ______________________________

4. WASH Conduct the primary wash to remove soluble soils and insoluble soils using parameters outlined in SOP.

4.1 Verify that wash time, temp, chemical concentration, surface coverage and flow rate parameters (turbulent flow) are met. Verify wash and rinse choices (4.1.1 to 4.1.4) based on soil characteristics

4.1.1 Alkaline Wash- Alkali is the principal detergent of most cleaning solutions and dissolves most soils

4.1.2 Intermediate Rinse- Removes alkaline detergent and brings pH closer to neutral

4.1.3 Acid Wash- Remove scale/buildup, if needed, and dissolves mineral deposits, films and scale. Used to neutralize any alkaline

4.1.4 Acid Rinse- Removes acid detergents and brings pH close to neutral and acceptable levels of chlorine and conductivity

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ITEM OR ACTIVITY – TASKS TO BE ACCOMPLISHED C O M P L E T E DDATE

YES NO

4.2 Fluid Characteristics- Pressure, temperature, chemical concentration and flow configurations give abrasive power to fluids

4.3 Verify cleaning by visual inspection on equipment (e.g. tanks, pipe switching, assure that all steps and physical connections are in place to continue the CIP wash cycle).

4.4 Consider if additional optional cleaning solution(s) and/or multiple washes are utilized and effective

5. FINAL RINSE Removes residual chemicals with temperature controlled water to ensure sanitizer is effective/ system is drained

5.1 Verify that rinse time, temp, surface coverage and flow rate parameters are met

5.2 Verify cleaning by visual inspection on equipment (e.g. tanks, pipe switching, assure that all steps and physical connections are in place to complete the CIP wash cycle)

5.3 If permissible, capture final rinse and store for reuse.

6. SANITIZER Destroys vegetative cells of microorganisms of public health significance that remain of food contact surfaces

6.1 Identify the approved sanitizer to use (verify use per label instructions)

6.2 Verify temperature of wash and rinse waters are adequate, as thermal methods are the first choice as a sanitizer

6.3 If utilized, verify chlorine or chlorine compounds are applied with temperature and pH controlled parameters to be effective

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ITEM OR ACTIVITY – TASKS TO BE ACCOMPLISHED C O M P L E T E DDATE

YES NO

7. FINAL FINAL RINSE (if utilized) Removes any residual sanitizer and sets condition for next start-up (uses temperature controlled water and system is drained – NA if no sanitizer@ 6.0 is used)

7.1 Verify that final rinse time, temp, surface coverage and flow rate parameters are met

7.2 Verify cleaning by visual inspection on equipment (e.g. tanks, pipe switching, assure that all steps and physical connections are in place to complete the CIP wash cycle)

8. FINAL INSPECTION AND TESTING FOR EFFICIENCY AND RESIDUALS Determines if visually clean and tests rinse water, if appropriate, for chemicals and/or conductivity

8.1 Verify level of visual inspection on final rinse (e.g. tanks, pipe switching, assure that all steps and physical connections are in place to complete the CIP wash cycle)

8.2 Document the inspection results including hard to clean or hard to access areas. Pictures are helpful to identify product hang-up points or areas difficult to view

9. VALIDATION, VERIFICATION AND MONITORING To ensure efficient, effective, and repeatable sanitation procedures are being executed the following should be addressed in the program

9.1 Although not a regulatory requirement, it may be desirable to develop and document a comprehensive “Initial Validation and Verification” report summarizing protocols followed and results collected for each specific line/system to properly manage the hazards of concern.

9.2 Collect and reference appropriate documentation to validate the effectiveness of the chemistry and/or cleaning method. Obtain product label directions and training for cleaning and sanitizing processes from the chemical and equipment suppliers.

9.3 Identify the verification processes to ensure proper execution of sanitation such as visual inspection, assessment of employee execution of the SSOP(s), e.g. measuring chemical concentrations, ATP swabs, microbial swabbing, record review, etc. Choose challenging (worst case) conditions and duplicate test results.

9.4 Verify monitoring activities that include overseeing, measuring and recording results to ensure that control measures are operating as intended. Critical elements of sanitation include time, temperature, flow, pressure, concentration/conductivity.

Footnote: Manual cleaning must follow plant-specific cleaning procedures

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ITEMS NEEDING FOLLOW-UP

Describe Item Describe Action to Correct

Who is Responsible

for Follow-up?

When Will Correction be Made?

Completed on (Date)

RESOURCES: _________________________________________________________________

_____________________________________________________________________________

_____________________________________________________________________________

_____________________________________________________________________________

_____________________________________________________________________________

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