You are on page 1of 23

Sanitation Manual ISSUE DATE Dec 2012

Part 1: Sanitary Design &


SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Global Sanitation Manual

Part 1

Sanitary Design & Commercialization

PAGE 1 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

TABLE OF CONTENTS

Section 1 Introduction
1.1 Purpose and Scope ___ 4
1.2 Exceptions 4
1.3 General Responsibilities_ 4
1.4 RACI Chart_ 6
1.5 Sanitation Gap Analysis 7
1.6 Global Sanitation Manual Update_ 7

Section 2 Sanitary Design Approval Process


2.1 Objective and Scope_ 8
2.2 Expected Program Requirements_ 8
2.3 Additional Guidance Information - Design Review Roles & Responsibilities_ 9

Section 3 Mondelz International Functional Sanitary Design Standards (Principles)


3.1 Objective and Scope_ 10
3.2 Expected Program Requirements 10
3.2.1 Separation 10
3.2.2 Clean-Ability 10
3.2.3 Compatible Materials 11
3.2.4 Smooth and Accessible 11
3.2.5 Self Draining 11
3.2.6 Sealed Framework and Joint Attachments 11
3.2.7 Proper Ventilation and Utility Air 11
3.2.8 Sanitary Design Standards for Equipment & Buildings & Grounds 12

Section 4 Construction Site GMPs


4.1 Objective and Scope 13
4.2 Expected Program Requirements 13
4.3 Additional Guidance Information 14

Section 5 100 Series Accepted Standards


5.1 Objective and Scope 15
5.2 Expected Program Requirements 15
5.3 Additional Guidance Information 15

Section 6 Stainless Steel Surface Treatment & Passivation


6.1 Objective and Scope 16
6.2 Expected Program Requirements 16
6.3 Additional Guidance Information 17

Section 7 Equipment Relocation


7.1 Objective and Scope 18
7.2 Expected Program Requirements 18
7.2.1 Additional Guidance for Idle Equipment 18
7.3 Additional Guidance 19

PAGE 2 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 8 Sanitation Frequencies for New Processes/Equipment


8.1 Objective and Scope 20
8.2 Expected Program Requirements 20
8.3 Additional Guidance Information 20

Section 9 Training
9.1 Objective and Scope 22
9.2 Expected Program Requirements 22
9.3 Additional Guidance Information
22

Appendix

Appendix A: Meat, Pizza and AMI Checklist


Appendix B: Equipment Design Checklist
Appendix C: Removed
Appendix D: Building and Grounds Checklist
Appendix E: Passivation Checklist
Appendix F: Equipment Passivation Method
Appendix G: Removed
Appendix H: Removed
Appendix I: Gap Analysis Part 1

PAGE 3 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Revision Log:
Date Revised: Supersedes: Summary of Revision:
Dec 2012 July 2012 Document re-branded with Mondelz International
Revision Log added
Section 1.6: Communication of changes changed from red
italic text to a blue line inserted in the left margin.

PAGE 4 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 1
Introduction
1.1 Purpose and Scope

1. This manual is designed to assist in the planning, execution and commercialization of new or
modified facilities, infrastructure and equipment to ensure Mondelz International sanitary
design standards and expectations are met.
2. The purpose of this document is to specify Mondelz International auditable requirements
and give guidance on the implementation of sanitary design. The following terms are used to
qualify requirements and recommendations (see also Global QCMS).
2.1. Shall (also Must) - Used to express an obligation or imperative, binding,
with no exclusions.
2.2. Will - Used to express an obligatory purpose or intent.
2.3. Should Used to express a recommendation among other possible
options
2.4. May Used to indicate an action or requirement which is permissible
within any stated limits, but not mandatory.
3. For a quick reference in view of roles and responsibilities (RACI) see the table at the end of
this section.

1.2 Exceptions

1 All exceptions from requirements laid down in this manual must be approved by the VP of
Quality by means of a letter of exception using the QP exception form. All requests for
exceptions should be submitted to Corporate Sanitation.
2 If so stated in this sanitation manual, there may be alternative programs, which yield the
same validated, functional results. These site specific programs must be approved by
Corporate Sanitation. Email is an acceptable form of approving these alternative programs;
however the e-mail needs to be kept for evidence purposes.
3 The letters of exception/approvals will be time appropriate, will not be granted for a period
longer than one year and if they need to be renewed, they must be resubmitted, from the
same source as the original exception request, prior to expiration. The letter of exception
must be filed and made available to quality auditors. Letters of Exception must follow the
exception process outlined in QP 4.2-02.

PAGE 5 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

1.3 General Responsibilities

Corporate Sanitation Ensures that this manual is posted on the Intranet, updated
and communicated. Will provide assistance to plants upon
request for the interpretation of the requirements laid down in
the manual and their implementation.
Reviews corrective action plans based on gaps identified by
the plants.
Consulted on proposals, risk assessments, baseline data,
controls, validation data, and review steps in dependence on
process and product being validated

Manufacturing Facilities Shall ensure that site-specific instructions and practices are
developed, documented, and that all requirements laid down in
this manual are followed accordingly.
Shall regularly do verification audits to ensure the Sanitation
program is working effectively.
Initiate and lead validation processes which includes, the
proposal, the risk assessment, data collection, coordinating,
and communicating activities between the stakeholders.
Make sure that Sanitation/Quality resources are available on
all projects. Quality/Sanitation will participate in design review
meetings when appropriate and provide information to the
Engineering/BD regarding cleaning chemicals/processes,
concerns over access to the equipment for cleaning, and
determine frequency of cleaning and all other GMP and quality
related issues. Quality/Sanitation reviews any compliance or
operational issues with the project team and adds comment to
the design approval form as appropriate.

Engineering/Bus. Development Engineering ensures projects (new and relocated asset


installations) are designed according to Mondelz International
Sanitary Design Standards by facilitating the completion of the
appropriate sanitary design review checklist. Engineering is
responsible for scheduling the reviews and providing technical
resources at the necessary gates for sanitation to complete
and document the sanitary design review.
For projects involving R&D and/or new technology notifies the
appropriate regional Quality contact and/or regional Corporate
Sanitation about the project.

Corporate Auditing During the audit process, auditors shall review the sanitary
design review process documentation and the appropriate
check lists utilized for a review.
As Auditors complete the inspection of the plant facility and
processes, areas of concern which pose a potential threat to

PAGE 6 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

product quality or safety because of the design should be so


noted.

1.4 RACI Chart

MF Manufacturing Facility
ENG* Engineering/Business Development
S/E Safety / Environmental
CSC Corporate Sanitation Contact
CM&FS Corporate Micro & Food Safety
R/BUQ Regional/BU Quality
DS Director Sanitation

* Engineering / Business Development might belong to MF or is a central service function.

R = Responsible for action. R can be shared


A = Formally approves the decision - has yes/no or power of veto. Not usually shared
C = Consulted about decisions/actions (2 way interaction)
I = Informed after a decision is taken.

Section R A C I

1. Introduction
2. Sanitary ENG MF CSC
Plant Design (Project team)
3. Sanitary ENG MF CSC
Equipment (Project team)
Design
4. Passivation ENG/MF MF CSC S/E
5. Sanitary ENG MF CSC
Design (Project team)
Approval CSC
Process (upon request)
6. Equipment ENG MF CSC R/BUQ
Relocation CM&FS
7. Sanitation MF MF CSC R/BUQ
Frequencies for CM&FS
New Processes
8. Training ENG MF CSC
MF

PAGE 7 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

1.5 Sanitation Gap Analysis

1. Sanitation Manuals 1 - 5 have a Gap Analysis checklist as an appendix to the manual.


The Gap Analysis checklist is a tool for the manufacturing facility to assess their
compliance to the requirements found in the manual.
2. It is recommended that a manufacturing facility complete and document a gap analysis
each year for high risk facilities (e.g. wet cleaned with micro sensitive products) and
every two years for low risk facilities (e.g. dry cleaned with non-micro sensitive
products). Since the gap analysis is a self assessment tool, it can be completed during
the time of year that makes sense for the facility (e.g. in November prior to setting the
facility goals for the next year).

1.6 Global Sanitation Manual Updates

1. Contact your Corporate Sanitation Contact (CSC) with recommendations for changes to this
manual. The CSC will forward the recommendation to the appropriate corporate sanitation
people for review. All changes or updates to the manuals will go through the global
sanitation team. Approved changes will be incorporated into future editions of this manual
2. Changes from the previous edition will be identified by a blue line in the left margin of the
document and will be described in the Revision History.
3. Updated manual requirements (Shall items) must be implemented within 6 months from
issue of the sanitation manual update, unless otherwise stated.

PAGE 8 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 2
Sanitary Design Approval Process
2.1 Objective & Scope

1. Documented design reviews are required for all projects affecting assets or the
processes, includes equipment, infrastructure, and grounds.
2. Documented design reviews must be applied to all R&D facilities & manufacturing
locations.
3. Critical items on the check lists that have been answered No must have a letter of
exception from the VP of Quality

2.2 Expected Program Requirements

1. Documented design reviews shall be conducted and documented during the


commercialization process. The review team shall agree on which gates are applicable,
based on project complexity and product sensitivity. It is possible that the review team
may find that no further design review is necessary, which shall be documented on the
cover page of the checklist.
2. These shall be documented on the appropriate equipment design, or buildings and
grounds checklists, (See links for check lists on page 3). Capturing the results of the
review in local language is acceptable.
3. Design reviews must consider and shall address:
3.1. Safety risks identified (food safety and/or personnel)
3.2. Regulatory compliance
3.3. Compliance to Mondelz International standards
3.4. Any known issues relating to clean-ability, functionality, material selection, and
workmanship.
3.5. Designs requiring excessive resources for sanitation (cost effective control for food
safety).
4. A copy of the projects Sanitary Design Review Checklist and supporting documentation
shall be kept at the manufacturing location. Keep in accordance with record retention
requirements.

PAGE 9 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

2.3 Additional Guidance Information - Design Review Roles & Responsibilities

The following is a guideline for a team based approach on projects. Specific practices may vary
from region to region, and between business units. Use this table as a guide to engage your
partners.

Gate 1 Gate 2 Gate 3 Gate 4


Project Development Project Pre-Engineering Project Execution Project
(ideation / risk assess) (design) (build) Commission
(accept /
installation)
Key Contributors: Key Contributors: Key Contributors: Key Contributors:
Project Lead, Project Lead and Project Lead and Project Lead, Plant
Business Quality Business Sanitation Business Sanitation
Designee Sanitation
Designee
Start Form Update Form & Update Form & Complete Form &
Applicable Checklist Applicable Applicable
Checklist Checklist
Project Lead Roles: Project Lead Roles: Project Lead Roles: Project Lead Roles:
Leads review, Leads review, Leads review, Leads review,
organizes meetings, organizes meetings, organizes organizes
facilitates, provides facilitates, provides meetings, meetings,
resources, technical resources, technical facilitates, provides facilitates, provides
support (engineering support (engineering resources, resources,
solutions) solutions) technical support technical support
(engineering (engineering
solutions) solutions)
Sanitation/Quality Sanitation/Quality Sanitation/Quality Sanitation/Plant
Roles: checklist review Roles: checklist review Roles: checklist Quality Roles:
content. Approval content. Approval review content. checklist review
Approval content. Approval

PAGE 10 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 3
Mondelz International Functional Sanitary Design Principles

3.1 Objective & Scope

1. Mondelz International Sanitary Design Principles shall be applied when designing and
developing any Mondelz International Projects that affects the facility, grounds, equipment
or process.

3.2 Expected Program Requirements


1. Apply sanitary design standards (100s series) and principles for the specific business or
application. Principles are derived based on product and environmental attributes (e.g. high
water activity in process Ready-to-Eat meats compared to low water activity in crackers) will
require sanitary design elements to support increase sanitation cycles and wet cleaning.
2. For specific product category requirements refer to the appropriate Sanitary Design Review
Checklist.

3.2.1 Separation

1. A food plant shall provide adequate space and separation from adjacent structures &
equipment to prevent (microbiological or allergen) cross-contamination and to facilitate
cleaning (allows for appropriate cleaning techniques for the application/design, which may
range from dry cleaning on secondary packaging equipment to wet cleaning of direct
product contact surfaces).
2. Environmental air handling systems shall provide separation where needed. Dust in the air
shall be minimized and allergen cross-contamination shall be prevented.
3. Where deemed necessary a production facility and its processes shall have physical
separation, including but not limited to, pasteurized, ready-to-eat, or ready to drink
equipment, from areas of raw process or raw material. Separation must include product
contact and non-contact surfaces, personnel and material traffic, locker / cafeteria / lavatory
rooms, raw or bulk receiving, air handling, process equipment, cooling media and utilities, or
other situations that could potentially carry microorganisms from a raw to a finished product
area as appropriate.

3.2.2 Cleanability

1. The plant structure (walls, floors, drains, ceilings, doors, insulation) and equipment
(batching, processing, storage, filling, transfer, piping) are constructed and maintained to
sustain clean-ability
1.1. To reduce bacterial survival, growth and reproduction
1.2. To reduce the risk of chemical (allergen) cross-contamination
1.3. To reduce the risk of extraneous matter contamination
2. Facility design shall include correct and effective placement of all utilities required for
sanitation.

PAGE 11 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

3. Equipment manufacturer shall provide clear, concise cleaning protocols. Protocols shall
include details for routine and non routine sanitation task(s) and shall specify the level of
disassembling of processing equipment for effective sanitation.

3.2.3 Compatible Materials

1. Construction materials used for the structure must be completely compatible with the
product, environment, cleaning materials used, and the method of cleaning.
2. Equipment materials of construction must be inert, nonporous and nonabsorbent.

3.2.4 Smooth & Accessible

1. All parts of the product zone shall be free of pits, cracks, corrosion, recesses, open seams,
gaps, lap seams, protruding ledges, inside threads, bolts, rivets and dead ends.
2. Equipment must be accessible for maintenance, cleaning, and inspection.
3. Non-product contact zones must be designed to ensure sanitary conditions are maintained
and must be accessible for periodic controls and includes control panels, guards, and gear
covers.
4. Wet cleaned equipment shall be CIP /COP compatible and/or can be disassembled easily
and efficiently with minimal use of simple hand tools.
5. Hand cleaned or manually set up designs shall be readily accessible for cleaning, sanitizing
and inspection. Assemblies should be designed ergonomically with the goal of one person
being capable of completing the task, if not ergonomic aides should be included in the scope
of the design.

3.2.5 Self Draining

1. Equipment and framework shall utilize appropriate shapes and angles so as not to form
traps, recesses or pocket that would allow water, dust, soil or product accumulation. Design
must be robust and can sustain the self draining properties over the life cycle.
2. It shall be assured that water, product, or CIP solutions does not pool in the product zones
and that liquid cannot drain, be drawn, or drip onto product zone areas.
3. Condensation control is required in exposed product zones.

3.2.6 Sealed Framework & Joint Attachments

1. Framework and joint design must prevent microorganisms, soils, liquids, and insects from
entering areas that are not accessible and cannot be cleaned.
2. Equipment framework and components, like tank and vessel linings, agitators, baffles, and
other hollow product contact equipment structure must be totally sealed and un-penetrated.
3. Continuous welding shall be used to join surfaces.
4. Bolts, studs, etc. must be welded to the surface of the tubing and not attached via drilled
and tapped holes.
5. Enclosures must maintain their seal.
6. Caulk (Silicon / Latex) shall not be used for sealing on processing equipment. Like or base
materials shall be used for joining surfaces.

PAGE 12 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

3.2.7 Proper Ventilation & Utility Air

1. Adequate ventilation of appropriately filtered air (by product sensitivity) must be provided to
prevent the formation of condensation, odor or mold, which could result in contamination of
raw materials or food. Reference accepted practice 105.
2. Compressed air contacting product or product surfaces or used to transport or treat product
must meet the 104 Standard.
3. Adequate air turns/ventilation shall be used to prevent condensation from forming at culinary
steam piping, during CIP, and during sanitation.

3.3 Additional Guidance for Equipment and Buildings & Grounds

1. Marginal or unsatisfactory ratings reported on the checklist (Appendix) require controls or


redesign of the area / component.
1.1. Controls typically take the form of periodic cleaning and pm tasks.
1.2. Resources may be required to complete further levels of disassembly and may require
additional time and resources to complete.
1.3. An evaluation of the total cost of ownership and capability to sustain these controls over
the life cycle of the equipment compared to the cost of redesign.
2. Applicable standards are located within the applicable equipment checklist and the
buildings and grounds checklist found in the Sanitary Design and Commercialization Index.
2.1. Additional detail also found within the Mondelz International Accepted Practices 100
series (see Section 5).
3. Butterfly valves can create a hygienic risk as product residue can migrate along the
support shaft, which is challenging to clean. In North America, Butterfly valves are not
permitted, as 3A standards indicate they are not acceptable. Most states in the US expect
dairy handling equipment to meet 3A standards even though the products may not fall under
3A requirements.
Butterfly valves have been customary within other regions, if higher level of concentration of
caustic (higher pH) and higher temperature are applied during CIP. In combination pathogens
are being inactivated while significantly reducing TVC, yeast and molds. In the absence of
elevated pH and high temperatures butterfly valves are not permitted.
See Sanitation Manual 2, section 10 on CIP/ACS controls for minimum conditions for time,
temperature and alkalinity.
If Butterfly valves are to be used a Preventative Maintenance Program to prevent seal
degradation and the Proactive Period Cleaning Program (PEC) must ensure that the hygiene
risk as managed accordingly.

PAGE 13 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 4
Construction Site GMPs

4.1 Objective & Scope

1. During construction (e.g. demolition, installation, remodeling) the production environment


must be maintained in a sanitary condition to insure products are manufactured in a GMP
compliant environment.
2. This section identifies the necessary minimum steps required to maintain the production site
during a construction project to minimize potential sources of contamination from the
construction process that could eventually lead to Quality / Food Safety issues.

4.2 Expected Program Requirements

1. Appropriate protection of adjacent lines or production areas must be provided to insure that
contaminants (such as dust, filth and debris) are kept out of the production environment.
2. All contractor personnel shall attend a brief training on plant GMPs before beginning work.
Plant Manufacturing shall provide the information for the training. The contractor shall
maintain a record of all trained personnel.
3. Traffic patterns for supplies, construction materials, waste, lunchroom and toilet facilities
must be established with plant Manufacturing. The project manager shall enforce
established routes with the construction crews.
4. All plant doors and entrances:
4.1. Must remain closed when they are not in use.
4.2. Must form an adequate seal when closed.
4.3. Must not be propped open.
4.4. Must be repaired immediately if damaged.
5. Equipment and handling devices that move between various areas of the facility (e.g., high
lifts, ladders, scaffolds, portable welders, supply carts, and tools that may contact active
processing systems) may only enter process and storage areas if they are adequately
cleaned and/or sanitized prior to entering (e.g., if they are passed over sanitizer mats).
6. All personnel must wear appropriate clean clothing in areas where food, food products and
packaging materials are stored, transported or manufactured.
7. The site must not pool or accumulate water. Adequate drainage or grading (exterior) must
be provided.
8. The conditioning of the construction site must not cause condensation on the temporary
walls or adjacent areas. Supplemental temporary ventilation equipment may be used as
required.
9. Any cleaning of infrastructure or equipment done by contractor personnel shall be
coordinated with plant sanitation and production staff.
10. All waste materials and rubbish shall be removed from the construction site on a daily basis
at minimum. Waste containers taken through the plant must be covered, and if these
containers are on wheels, the wheels must be sanitized. All rubbish and debris shall be
removed from pipe chases, plenums, attics, etc. prior to closing the space.
11. Dust and watertight partitions shall be provided at all construction sites to prevent the
migration of contaminants (such as dust, filth and debris) from the construction site to non-

PAGE 14 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

construction areas. After installation of the temporary partition, the production side of the
room shall be cleaned and sanitized (if required).

4.3 Additional Guidance Information

1. The construction site should be negatively pressured in comparison to the adjacent rooms
and halls. The construction area must be ventilated to prevent the accumulation of humidity,
dust, fumes vapors or gases.
2. Storage of idle equipment, contractor supplies, or other items should be minimized and
neatly stored off the ground.
3. Additional monitoring of areas adjacent to the construction site should be considered as
appropriate. Testing may include air exposures, walls, floors, compressed air, water, steam,
equipment, and people (finger plates). Limits and action plans should be set accordingly
(Reference Non PEM QP).
4. Temporary partitions should follow the construction standards as listed in the table below.
Doors should be provided with seals and shall be self closing. After cleaning and sanitizing
(if required) environmental swabs should be taken along the temporary partition installation
and documented for micro sensitive areas.

Duration Dry Area Wet Area


Up to 2 Weeks Wood 2x4 (inch)/ 5x10 (cm) and Wood 2x4 (inch)/ 5x10 (cm) and
poly sheet, taped joints. poly sheet, taped joints.

Up to 4 Weeks Wood 2x4 (inch)/ 5x10 (cm) and Wood 2x4 (inch)/ 5x10 (cm) and
plywood covered with poly sheet, plywood covered with poly sheet,
taped joints. taped joints.

Beyond 4 weeks w/o Wood 2x4 (inch)/ 5x10 (cm) and Steel 2x4 (inch)/ 5x10 (cm) and
Trucking plywood covered with poly sheet, fiberglass reinforced or similar
taped joints. construction panel wall, caulked
joints.

Beyond 4 week Wood 2x4 (inch)/ 5x10 (cm) and Steel 2x4 (inch)/ 5x10 (cm) and
w/Trucking plywood covered with poly sheet, fiberglass reinforced or similar
taped joints. Guard to protect from construction panel wall, caulked
trucking. joints. Guard to protect from
trucking.

Dry Area = Areas that have NO water clean up.


Wet Area = Areas that have water clean up.

PAGE 15 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 5
100 Series Accepted Standards

5.1 Objective & Scope

1. New installations shall apply applicable principles outlined in the Mondelz International
100 series Accepted Practices.

5.2 Expected Program Requirements

1. 102 Clean in Place (CIP) and Process Pipe Systems.


2. 103 Production of Culinary Steam
3. 104 Air Under Pressure in Contact with Product & Product Contact Surfaces (Compressed
Air)
4. 105 Environmental Air
5. 109 Electrical Equipment

5.3 Additional Guidelines

1. 107 Sanitary Equipment Supplemental Design Guidelines (Guidance Document)


2. 101 HTST Heat Processing Systems
3. 106 Supplying Air Under Pressure in Contact with Dairy & Non-Dairy Products & Product
Contact Surfaces (Pressurized Air)

PAGE 16 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 6
Stainless Steel Surface Treatment & Passivation

6.1 Objective & Scope

1. All Mondelz International locations shall protect newly installed or repaired stainless steel
(304 through 316L series) equipment from corrosion through passivation.
2. This includes newly installed stainless steel food contact piping, food contact tanks, CIP
piping, CIP tanks, and food contact equipment that is designed to be routinely wet cleaned
with a Clean In Place (CIP), in a COP tank or manually.
3. Stainless steel systems and piping that are not routinely wet cleaned (e.g. stainless edible
oil tanks) shall at a minimum be cleaned and sanitized prior to use, but are exempted from
the requirements laid down in this section.
4. Passivation of non product contact surface(s) is optional. However, equipment located in
highly corrosive environments like brine shall be considered. (Brine surfaces need to be
evaluated to determine if they are product contact or non product contact for the purpose of
determining the type of acid to use during the passivation process).
5. Certain installations can be exempted from this process noted above. In this case it must be
demonstrated and documented that
5.1. There is no contamination with ferritic particles during fabrication (can be
confirmed by the Ferroxyl test per ASTM A380).
5.2. There is no heat tint indicated by no or little (straw yellow) discoloration of welds.
5.3. Orbital welding with gas purging (O2-content below 40ppm) has been done.

6.2 Expected Program Requirements

1. The passivation process for new equipment installations shall be completed prior to use,
excepting:
1.1. Delays may be approved up to 14 days for line circuits by Corporate
Sanitation.
1.2. Delays may be approved up 7 days for tanks circuits or any other
equipment.
2. When a facility is planning any chemical treatment, their site Safety, Environmental and
Maintenance Professionals must review and sign off the proposed work.
3. The passivation process consists of:
3.1. Caustic Cleaning: removal of oil, grease and inorganic contaminants.
3.2. Acid Treatment/Pickling: chemical removal of impurities on the surface
(ferritic deposits, scales and discoloration).
3.3. Drying: required for the formation of the passive layer
3.3.1. Enclosed systems (where verification can not be done) require minimum of 8
hours of idle time after drying.
4. The completion of the passivation process shall be documented, whether done internally at
the Mondelz International facility or the equipment manufacturer, and shall be kept on file
at the plant that received the new equipment. Documentation shall include:

PAGE 17 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

4.1. Parameters of cleaning, acid treatment/pickling, and drying time.


4.2. Location/equipment repaired or installed, and the date of treatments.
5. Repairs to applicable equipment shall be passivated.
5.1. Major repairs (more than 10 welds) requiring a shutdown shall be treated,
as described, prior to reuse of the equipment.
5.2. Minor repairs (less than 10 welds), emergency repairs and replacement
parts shall be treated, as described, within:
5.2.1. 1 month for Equipment that handles micro sensitive product.
5.2.2. 3 months for Equipment that handles non-micro sensitive product.
6. Electro polishing is an acceptable alternative to the acid washing step in passivation. After
repairs, the use of pickling paste or electrochemical acid cleaning methods for pickling, (e.g.
portable electrolysis), are acceptable methods.

6.3 Additional Guidance Information

1. Details for executing passivation are found in the Appendix E & F of this document.
2. The completion of the passivation checklist (see Appendix E & F) is an acceptable form of
documentation. If this checklist is not used, its contents should be a guide for
documentation requirements.
3. The Ferroxyl test is a highly sensitive test method for a local check of traces of free iron or
iron oxide on stainless steel surfaces as outlined in ASTM A 380-99, section 7.3.4. The test
should only be carried out by specialists being familiar with its limitations & hazards.
4. For more information on the quality of tube welding in view of gas shielding and
discolouration see EHEDG guideline 35 Hygienic Welding of Stainless Steel Tubing in the
Food Processing Industry posted on the Sanitation web site.

PAGE 18 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 7
Equipment Relocation

7.1 Objective & Scope

1. Equipment removed from the process shall not pose a contamination risk for the plant where
it is being kept as idle or for the plant to where it will be transferred.
2. Before any equipment is received by a manufacturing site appropriate measures must be in
place to avoid any potential contamination.

7.2. Expected Program Requirements

1. Equipment shipped by manufacturing sites to storage or another site


1.1. Used equipment being relocated shall be cleaned and sanitized (if
required) after the final production. The plant of origin and the receiving
plant shall agree upon what equipment cleaning task shall be completed
at this time.
1.2. If the final production sanitation verification/validation swab results
(equipment or environmental) are not acceptable, appropriate corrective
actions and verification have to be completed.
1.3. Idle equipment shall be covered with plastic sheeting or appropriate
crated and shall be stored and transported under appropriate conditions.

2. Equipment received by manufacturing sites from suppliers, storage or another site


2.1. A sanitary design review shall be completed using the appropriate
checklist per section 2 of this manual. Before introducing the equipment
into the plant a visual inspection shall be performed in order to assure that
the equipment is free from product residues, pests, and moulds. In case
of any visible contamination the equipment shall be cleaned prior to
introducing into the plant.
2.2. After installation before start up the equipment shall be cleaned and
sanitized (if required).
2.3. Sanitation effectiveness shall be verified or validated, dependant on the
scope of the equipment relocation.The verification or validation program
shall be individually determined and approved by plant Quality/ plant
Sanitation. Corporate Microbiology and Corporate Sanitation shall be
consulted on a case by case basis.
2.3.1. The specifics of the verification or validation plan will depend on the micro-
sensitivity of the product. The validation plan shall include PEM and Non-PEM
sampling (equipment and environmental). Details can be found in Section 8 of this
Manual.
2.3.2. An allergen risk assessment shall be carried out for equipment that will be
transferred between facilities with different allergen profiles in order to identify any
allergen risk and to apply appropriate control mechanisms. If allergen contamination

PAGE 19 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

risks have been identified, an allergen cleaning shall be performed and its
effectiveness shall be verified according to requirements laid down in Sanitation
Manual part 2, Section 14.

7.3 Additional Guidance Information

1. Any equipment brought into a facility can be a source of pathogenic microorganisms, potential
foreign contaminates and or pest concerns.
2. Providing adequate time to conduct a comprehensive review of incoming equipment could
potentially save costly issues afterward.
3. Appropriate documentation should be sent to the receiving Mondelz International plants
sanitation manager/quality manager or their designee for review prior to shipping the
equipment. Documentation, if available should include clean equipment data, pathogen
environmental monitoring data, pest activity, and the documented cleaning methods.
4. The placement of a Released to Operations sticker on equipment is recommended.
Released to operations sticker should be placed in conspicuous location on equipment, date
and time of inspection to be included, as well as name of employee that inspected
equipment. This is recommended also, if microbial pathogen testing is to be performed (shall
be signed by micro representative).
5. It is recommended to break equipment that is intended to be scrapped, into parts small
enough to fit into trash containers and to cover the containers as they are transported
through the plant. Large pieces should be covered and removed.
6. If sanitary design gaps are found during the sanitary design review of used/relocated
equipment, corrective actions could include:
6.1. Sanitary design upgrades modifications.
6.2. If possible, clean and sanitize equipment again. This may require a tear
down clean depending on investigation findings.
6.3. Verify cleaning procedures, and concentration of sanitation chemicals
utilized complied with the documented procedures.
6.4. Collect Pathogen Environmental Monitoring swabs if required.
6.5. Update cleaning procedures (further disassembly, addition of cleaning
tools like COP).

PAGE 20 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 8
Sanitation Frequencies for New Processes/Equipment

8.1. Objective & Scope

1. All Mondelz International locations shall define and validate sanitation frequencies for new or
modified processes to ensure that the sanitation cycles deliver manufacturing equipment in a
state of cleanliness that meets Mondelz International Quality expectations and regulatory
requirements, considering the product attributes.

8.2 Expected Program Requirements

1.All newly installed equipment (new or relocated) shall undergo a deep


cleaning and verification of cleaning effectiveness before any product trials,
test runs, or production runs (e.g. sales samples) where the product can be
consumed. Dependant on product microbiological sensitivity, verification
shall include PEM and other applicable non-pathogen environmental
samples.
2. Sanitation for newly installed equipment or equipment design changes
shall use historical data from similar processes when determining the initial
run length. Once the initial run length is determined, a documented
validation study is required.
3. A validation study of sanitation effectiveness is performed by:
3.1. Conducting a detailed visual inspection of the processing equipment according to a
set validation sampling schedule.
3.2. Collection of microbiological data for micro sensitive product categories according
to a set validation sampling schedule (See Non PEM QP).
3.3. A collection of data for allergen sensitive product categories according to a set
validation sampling schedule.
4. The plant shall involve Corporate Sanitation, Corporate Quality and
Microbiology (for micro sensitive product categories) to develop the
validation study parameters.
4.1. The team shall decide if the microbiological data collected includes
equipment swabs, environmental swabs, finished product samples, work in progress
product samples, and/or air samples.
5. When the validation study is complete, the team shall determine the
sanitation frequency for the newly commissioned production line or
equipment.

PAGE 21 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

8.3 Additional Guidance Information

1 The sampling schedule in a validation study may vary due to regulatory requirements and
product sensitivity.
2 Validation sampling should be conducted when the line first begins production and at set
frequencies, with increasing times between validation sampling.
2.1. The following validation schedule is recommended for a wet clean
processes;
2.1.1. After the First Production run
2.1.2. Then at End of Week production runs if the plant cleans every 24 hours
and after 2 production runs if the plant cleans weekly.
2.1.3. After 30 days of production runs
2.1.4. After 3 months of production runs
3 Data collected from these validations shall be used to determine Sanitation Periodic
Equipment Cleaning (PEC) frequencies in the future.
4 The validation visual inspection and the microbial data collection should occur for 3
consecutive cleanings.
5 For processes that are cleaned via CIP or ACS, equipment disassembly may be required for
proper visual inspection (i.e. homogenizers, HTSTs, valves, etc).

PAGE 22 of 23
Sanitation Manual ISSUE DATE Dec 2012
Part 1: Sanitary Design &
SUPERSEDES July 2012
Commercialization
Not a Controlled Document if printed. Source: Mondelz International Intranet 5/6/17

Section 9
Sanitation Training

9.1 Objective & Scope

1. All Engineers dealing with equipment and infrastructure (for example Project Engineers, Civil
Engineers, Maintenance Engineers and all Sanitation Managers / Supervisors (a minimum
of one person per facility) shall be trained regarding principles of Sanitary Design.

9.2 Expected Program Requirements

1. Stakeholders as mentioned above will be required to attend a sanitary design training


course within the first 12 months of their position.
2. Appropriate documentation of the training record shall be maintained.

9.3 Additional Guidance Information

1. An internal training course as offered by Corporate Sanitation is recommended, however an


equivalent external one is acceptable (for example: EHEDG).
2. Additionally, it is recommended that all stakeholders mentioned above and their reporting
manager determine which of the following Global Quality Education and Training website
training courses apply to their position or validate their competency in each area:
2.1. Allergens 101: Controlling Unlabeled Allergens
2.2. Microbiology 101: Controlling Microbiological Hazards
2.3. QP Functional Training (appropriate QPs see section 1, Introduction)
2.4. GMPs 201: Production Practices
3. It is recommended to stakeholders repeating a sanitary design training every two years.

PAGE 23 of 23