Gate Deliverable List

F = final status for related phase

F1/F2/F3 = to be further defined/ extended in next phase
IFC = Issued For Construction
MC = Mechanical Completion
FD = Final Documentation
T = Title (no deliverable)

FEL 1 FEL 2 FEL 3

Phase Business Concept Basic
Planning Definition Design
R1 R2 R3.1
Review
Business Review Concept Review Approval Review

1T T T
1.03 T T T

01.05.01
01.05.03 F2 F3

3T T T

3.01 F1 F2 F

3.02 F1 F

3.03 F2 F
3.04 T T T

03.04.01 F1 F

03.04.02 F1 F

3.05 T T T

03.05.02 F1 F

03.05.03 F1 F

3.06 F1 F2 F

3.07 F2 F

3.08 F
 3.08 F

3.09 F

3.11 T T T

03.11.01 F1 F
03.11.02 F1 F

03.11.05 F1 F

03.11.06 F1 F

3.12 F2 F3

3.13 F

4T T T

4.01 F1 F

4.02 F

4.03 F2 F

4.04 F2 F

4.05 T T T

04.05.01 F2 F

04.05.02 F2 F

04.05.03 F2 F
04.05.04 F3
 4.06 F2 F

4.09 F3
4.1
4.11 F3

4.13 F2 F

5T T T

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5.02 F

5.04 F1 F2 F

6T T T
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6.03 F2 F

6.04 F2 F

7T T T
7.01 T T T

07.01.01 F2 F

07.01.02 F2 F

07.01.03 F2 F

9T T T
9.01 T T T

09.01.02 F2 F

9.04 T T T
09.04.05 F2 F3

09.04.06 F2 F

10 T T T

10.01 F1 F2 F

10.02 T T T

10.02.01 F2 F

10.02.02 F2 F

10.03 T T T

10.04 F2 F3

10.07 F2 F3

10.08 F2 F

10.12 F2 F3

11 T T T
11.02 T T T

11.02.01 F2 F3

11.02.06 F2 F

11.03 T T T
11.03.04 F2 F

11.05 T T T

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12 T T T

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12.02 F2 F

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12.25 T T T

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15 T T T

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15.05.02 F2 F

15.05.06 F2 F

15.06 T T T

15.06.01 F2 F

15 T T T
20.02 F2 F

30 T T T
15.06 T T T

30 T T T

15.06 T T T
32.02.11 F2 F

32.02.12 F2 F

32.02.13 F2 F

32.02.14 F2 F

32.02.15 F2 F

32.02.16 F2 F

32.02.17 F1 F2 F

32.03 F1 F2 F

33 T T T
33.03 T T T

33.03.04 F1 F2 F

70 T T T

70.13 F
e

Commissioning and
Execution
Qualification

R3.2 R4 MC R5

Detail Design Review Review Handover Review

T T T
T T T
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T T T

FD

T T T

T T T

FD
T T T

FD
FD

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FD

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FD

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IFC FD

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F FD
F FD
F FD

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IFC FD

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IFC FD

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T T T

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T T T

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IFC FD

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F FD

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T T T

FD

FD

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T T T

IFC FD

T T T

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IFC FD

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IFC FD

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F FD

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IFC

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Chapter Title

General Project Information

Requirement specificatons

Project Requirement specifications

Functional Specification

Design Basis

Battery Limits

Process Technology Opportunity Assessment

As-Built Documents and Status

Transfer Documents and Status

Process Description

Parameter List

Site Aspects / Location Evaluation

Local Design Conditions

Land Survey

Design Criteria/ Class of Facility Quality

(CFQ)

Special Design Criterias

Materials of Construction
Materials of Construction

Design Pressure and Temperature

List of Materials

Raw Materials Supply and Specifications

Intermediates Supply and Specifications

Final Product Specifications

Auxiliaries Supply and Specifications

First Fill and Test Materials

Process Control Concept

Process Engineering Documents

Block Flow Diagram

PFDs

Mass Balances

Energy Balances

PIDs

List of PIDs

Process and Utility PIDs

Legend Sheets
Package Unit PIDs
Process Description

Pressure Relief Safety Devices

Orifices
Fluid Dynamic Calculations

Physical Properties of Chemicals

Logistic

Volume Concept

Block Flow Diagram

Material-, Personnel and Waste Flow

Concept

Layout Plans
Layout Plans of Block

Layout Plans of Unit

Master Cross Sections

Plant Revamp and Shutdown

Plant Revamp

Plant Revamp Scope of Work

As-Built for Revamp

Demolition Activities

Health, Safety and Environment (HSE)

Process & Plant Safety

Basic Safety Review - A2

Occupational Safety and Health

Noise Protection

Hot Surfaces Protection

Equipment

Equipment Scope of Work

Equipment and Long Lead Lists

Equipment List

Long Leads

Equipment Engineering

User Requirement Specification

Package Units

Maintenance Equipment List

Equipment Layout Plan

Piping
Piping Specification

Special Parts

Fluid Code List and Piping Classes

Pipe Design
Pipe Racks

Lists

Line List

Process Control Technology and Electrical

PCT Scope of Work

Design Guideline PCT

Instrumentation

Instrument List

Infrastructure

Cable Trays and Routing

Grounding and Lightning Protection

Power Supply
Supply and Distribution Concept

Low Voltage Level

Instrument Power Supply

Uninterruptible Power Supply (UPS)

Calculations

Electrical Consumer List

Special Equipment

Civil, Structural and architectural (CSA)

CSA Scope of Work

Structural
Design Description

Load Definitions

Calculations

Civil and Infrastructure

Design Description

Site Preparation

Schematics and Single Lines

Plumbing

Plumbing Design

3D Model
3D Model Guideline

Project and Engineering Management

IP Protection
Change Management
Project and Engineering Management
Cost Estimation Scope of Work
Basis for Cost Estimation

Cost Estimation Overview

Discipline Reference Documents

Equipment and Machinery

Civil, Structural, Architectural
Piping
PCT and Electrical

Spare Parts

Engineering Field Support

Construction Management

Commissioning and Qualification

First Fill

Test Material

Others

Contingency

Project Controls
Scheduling

Project Schedule

Standards

AKZ Structure
Venture Manager
Project Manager
EPC Manager
PCT Control Lead
PCT Electrical Lead
CSA Lead
Piping Lead

Chapter Content

A description of the requirements and framework for the project execution, its systems and facilities in terms of product to be m
Required throughput, conditions (for example expansion & flexibility requirements), under which the product should be made o
executed.

Additionally, the following review (CR/ TR) relevant content

"Current situation, project justification and objectives"
"Overall divisional production concept, alternatives"
"Status of process, scale up, transfer"
"Status of product development, clinicals if applicable" may be part of this paragraph.
Specification document which describes how the project requirements will be realized and implemented.

Describe battery limits for project scope of work (consider utilities/ feedstock, energies, etc) and connections to infra
example Tie-In's and organizational connections such as alarm/warning system). Battery limits can also be shown in
chapter 06. In many cases the BL coordinates for pipe connections are fixed during FEL3 when close coordination w
utility suppliers are taken place.
Assess available technology knowhow, for example reports, development and user know-how, experts, etc.
Identify value drivers for the business case ( COGS, CapEx, quality, operability, flexibility, etc. Linked to chapter 03.
evaluate opportunities for alternative process designs/ technologies which result in advantages with respect to the id
drivers.
Tools are for example screening of existing studies/ ideas, technology evaluation, process (technology) and plant co
conceptual design workshops.
Process technology comparison can be treated as a Value Improving Practice (chapter 30.04).
Check documents in regard to completeness and accuracy. Especially important for chapter 07.

Process description for process units, describing the functionality of each piece of equipment, like reactors, columns
filters, heat exchangers, etc., provided by R&D or operations. Linked to chapter 03.13. For GMP governed projects t
relevant content
- "Process description";
and the gate reviews (CR/ TR) relevant content
- "Process description, basic flow diagrams" may be part of this paragraph.
Relevant operating parameters for equipment, processes, environmental conditions, etc.
For GMP governed projects the B-Review relevant content "Process parameter ranges/ design space"
may be part of this paragraph.

Earthquake (seismic) zone (linked to chapter 15.02.02), wind zone, snow load, climatic boundary conditions such as
temperature conditions (standard and extreme values), rain yield factor, humidity, etc.

From authorities/ surveying contractor (levelling, rain-, sewage-water, topographical maps, etc.). Geological and hyd
situation (for example soil and underground composition, groundwater aquifers present and their depth, groundwate
the site as well as potentially impacted receptors in the surrounding of the site including an initial assessment of the
information gathered). Part of land survey are so called "expert reports"; Refer to chapter 15.02.

Under consideration of chapter 01.01.:

Facility life time, likelihood of expansion and expandability, production rate changes with time, feedstock type and av
quality, product demand and yields (capacity/ product quantity), product flexibility, degree of automation, expected re
availability or uptime/ on- stream time (availability studies of same/ similar installations can be used). Maintenance, a
reliability concepts such as vibration monitoring, spare part concepts, inspections, turn around, change-over. HSE p
requirements and its impact on design, Mechanical Integrity reports and examinations. Project specific special desig
example measurements to be taken to avoid cross contamination; Refer to cross contamination prevention guideline
comparison. Note: Most of chapter 03.06 to be completed in FEL 2 as the design basis shall be clear. Maintenance
reliability choices can be finalized in FEL 3.
Beyond local law requirements, Bayer regulations and guidelines.
For example: Closed or open structure, building distances, canned pumps, safety (double wall) heat exchanger, fully
welded piping, special materials, etc.
General statement. Refer to experiences for same/ similar
processes, materials resistance reports, etc.
General statement. Refer to experiences for same/ similar processes. Consider also special operating and testing co
cleaning, etc.) as it can have influence on
integrity and testing (for example numbers of load cycles).

All final products and packaging specifications, intermediates, raw-material/ feedstock, utilities including hazardous c
chemical and physical properties and other characteristics and specific information. Material Safety Data Sheets (MS
demand sheets, utility specifications (for example min/max pressure, moisture, temperature, composition, etc.).

Final product specifications including packaging materials and quantities.

For GMP governed projects the B-Review relevant content
- "Product classification (for example parenteral/ oral, highly active, sensitizing, toxic)";
- "Product specification";
may be part of this paragraph.

What is needed as "first fill" (oil, lubricants, raw materials, solvents,etc.) for commissioning and start-up.To be comp
design (after order placement as vendor information are required). Opportunities to rationalize/ minimize the supplie
and lubricants.
Basic requirements for process control and overall process control strategies. Identify demand for dynamic simulatio
control strategies for individual process steps and equipment to be done in detail design. Chapter is connected to ch
12.11.04.

Overview of process, sub process relation are shown in blocks with lines.
Overview flow diagram of feedstock, intermediates, utilities, energies, final products, wastes (for wastes also refer to
For GMP governed projects the B-Review relevant content "Block diagrams indicating the GMP process steps"
may be part of this paragraph.

PFDs of process and utilities including mass (material) flow and operating conditions (temperature, pressure, density
Special operating conditions for regeneration, cleaning, shutdown, start-up, etc. to be reflected in seperate PFDs.

Detailed definition of amounts of process flows. For batch processes a SMZ ("Schritt Mengen Zeitschema") has to b
to chapter 05.04.
Consumption in- and outcoming amounts of utilities including peak consumption and demand for flushing/ cleaning a
demands can be summarized in a utility consumer list. For availability/ reliability of required utilities refer to chapter 0
consumption optimization in chapter 30.04.04.
PID management in chapter 30.07.03.
For GMP governed projects the B-Review relevant content "PID (Piping and Instrumentation Diagram)"
may be part of this paragraph.

List of all Process and Instrumentation Diagrams.

Storage of PIDs on restricted folder if requested by

Intellectual Property (IP); Refer to chapter 30.09.
Legend sheets with symbols.
Package Units can be also identified on PIDs in chapter 04.05.02.
Description of process with detail information including description of main process related controls (for example for
on the process description of the transfer documents in chapter 03.04.
List of pressure relief safety devices and for final documentation associated vendor documentation.
List of orifices.

For detail design necessary physical properties as required.

The volume concept transfers a general statement of the project scope in regard to capacity (for example 3t of API,
into relevant logistics information. It is based on a rough first estimate to receive information including number of ma
material category, number of pallets to be moved and stored. Covering of all material categories for example raw m
packaging materials, intermediates and finished products, wastes.
Logistics flows as block flow diagram.

Define expected material- and mass flow diagram (from outside to the site - through the plant - to the final shipping)
packaging materials, intermediates, finished goods and wastes. Visualize the material flow in a layout plan (for exam
Diagram). Consider specific hourly rates including peak rates as well as start-up, cleaning, seasonality, turn down. In
flows a dynamic simulation is recommended. Define material handling systems and equipment type for material mov

For GMP governed projects the B-Review relevant content

- "Logistics concept (material volumes to be handled)" and the Gate Review (CR/ TR) relevant content

Layout plan of the block (information of battery limits can be reflected in related drawings); linked to chapter 03.01.

Layout plan of the relevant production unit (all buildings, each floor, all equipment to be shown including dimensionin
maintenance areas, etc.). Building numbering (alignment with site master plan) and site code to be implemented.

Detailed layout and section of sewage, pipe racks, pipelines, roads, logistics, underground services, electrical power
equipment, etc.

Define scope of work and duration of each revamp activity. Revamp activities can be described in individual working
discipline.
Check "As-Built" status of existing documents (PIDs,
equipment documentation, etc.). Site checks on request. Linked to chapter 03.03.
Demolition PIDs (PID management in chapter 30.07.03), line list, PCT list, building, equipment, structure, etc. to def
costs. Working packages to be finalized in detail design.

The basic safety review is required before the submission of an Appropriation Request (AR). By the end of this step
aspects and relevant information that are necessary for the commencement of the detailed design phase should ha
and the basic safety concept developed. A safety criticality analysis conducted parallel to the Basic Safety Review d
criticality (or non criticality) of processes/ sub-processes. In case of "critical" a preliminary A3 certificate of the defin
recommended.
Noise protection guideline, noise conture mapping, main noise sources, internal noise protection from floor to floor a
To be completed in detail design as the final noise emission data will be given by vendor once orders are placed. Af
data the noise contour calculations shall be restarted and mitigations shall be defined. Depending on requirments so
certificates might be needed.
Concept for personal protection (for example define maximum surface temperature). Standard for hot surface protec
insulation in chapter 70.07.

Detailed description of scope of work in addition to overall scope of work in chaper 01.05. Detailed definition of deliv
planning borders (included, excluded)
and interfaces to others.

All EQP (including maintenance EQP such as lifting devices, cranes, workshop equipment, etc.) with major specifica
(dimensions, weights, design pressure, design temperature, materials, installed power, flow rate, delivery height, etc
generated in PEDW, in Excel, etc.
Long lead equipment list (in some cases, special PCT or piping devises have long deliveries. Those to be integrated
well). Long leads = Impact to project milestones, construction sequence, etc. Inquiry documentation (specifications,
materials, drawings, etc.) to be qualified to send out for inquiry purposes. Long lead equipment can be marked in the
chapter 10.02.01.
On inquiry group or tag list level.
Description of the requirements in terms of product to be manufactured, required throughput and conditions in which
should be processed. The URS may be focused on quality requirements only or contain comprehensively all require
purchasing specification.
For GMP governed projects the B-Review relevant content
"Material and surface finishes for product contact surfaces"
- "Standards to be followed" may be part of this paragraph.
Detailed description and specification (inquiry specification or technical part of quotation) of definded package units.
diagrams including interfaces to other disciplines (PCT,PIP,CSA and others). Detailed scope of PU functionality (inc
actors, control and operation concept, interface to DCS, piping, corrosion protection, insulation, testing, loads, etc.).
infrastructure, deliverable list (including documentation), decision on which standards to be used (suppliers or Bayer
relation to equipment performance guarantees, etc.

For major package units only: Guarantees by supplier for expected deliverables (amount, quality, energy and utility c

Cranes, tools, etc. Can also be integrated in equipment list in

chapter 10.02.01.

Can also be done in chapter 06.03.

Specification and drawings of special parts including all required certificates. For example sample valves, expansion
traps, special valves and others. Special parts are components which are not defined in Bayer standard specification
part list in chapter 11.05.03. The use of special parts shall be limited to the minimum.
Linked to chapter 20.04.
Fluid codes to be provided by process. Related piping, gasket and valve specification based on related piping classe
chapter 70.02.
Develop pipe rack layout (vertical and horizontal): Numbers of layers, pipe allocation of horizontal main pipe rack. In
cable trays and load calculation (forces and moments) as basis for for CSA calculation in chapter 15.04. Final adjust
design. Master cross sections can be integrated in chapter 06.04.

List of all crucial pipeline data like AKZ, PID, pipe size, pipe specification, fluid, insulation,etc. in FEL 3. Stress categ
(fluid and pressure), test package, NDT, etc. to be added in detail design.

Detailed description of scope of work in addition to overall scope of work in chaper 01.05. Detailed definition of deliv
planning borders (included, excluded) and interfaces to others.

General concepts and requirements that apply to multiple sub- sections.

List of sensors, actors and instruments

For GMP governed projects the B-Review relevant content "List of relevant instruments"
may be part of this pharagraph.

Quantities and layout of main cable trays. For layout plan also refer to chapter 06.07.

Grounding and lightning protection concept. Arrangement of

ground electrodes, description of equipotential bonding, design of internal and external lightning protection, surge pr

Detailed power supply and distribution concept including redundancies/ backup for all voltage levels, idle power
compensation. Detailed single line diagram including count of Engineering power users from transformer and power
For power Company capacity consider utilization/ simultaneity factor. Linked to.
chapter 12.31.
Specification of low voltage level (<1 kV) for transformers and switch gears. Required room capacity.
Capacity requirements for current including battery charging.
Specification of rectifier package and of batteries (type) for required time of process monitoring in case of power failu
Number of UPSs, batteries (type), fly wheel, ventilation,
maintenance bypass switch, UPS power distribution, single line diagram. Required room capacity.
Voltage drop of special consumer for example remote I/O, load per cabe tray, etc. Some calculations are already required in
FEL 2 such as single line diagram, short-circuit rating, transformer, etc.
Detailed list of electrical consumers. For example motors,
lighting, electrical heat tracing, package units, DC 24V power
supplies, etc.
Detail specifications for special electro-technical apparatus. For example electrostatic gas filter, electrolyzer rectifier,
power controllers for heater, weighing equipment, vacuum transportation, etc.

Detailed description of scope of work in addition to overall scope of work in chaper 01.05. Detailed definition of deliv
including planning borders (included, excluded) and interfaces to others. Can be visualized in a Work Breakdown Structure
General structural concept including stabilization, safety
factors, main connection principles, main loads of structural materials, etc.
Load definitions ("design load criteria") and load combinations (for dead loads, live loads including maintenance load
loads, piping loads, cable/ cable tray loads, catastrophe loads, etc.). Also consider traffic load (for
example forklift).

Calculations for structure, concrete, foundations, etc.

Definition of design criterias.

Technical scope desrciption for demolition, backfilling, decontamination, dewatering, compaction, etc.

Water supply and distribution for potable-, industrial-, sanitary-, various waste water, etc.

Defintion of design criteria.

Working instruction for 3D design with a CAE tool such as PDS ("PDS guideline") or S3D (SmartPlant 3D).
Nominate model owner.
Compatibility check of data coming from other CAE tools. Workflows for data exchange and change management w
disciplines to be done in chapter 30.03 and 30.10.

Engineering Change Request, Project Change Request, etc. Linked to chapter 35.08.

The Scope of Work for Cost Estimation needs to be defined in the template BTS KD PME 09 T03.
The Base of Estimate needs to be delivered in the template BTS KD PME 09 T03. It contains
1)  a description of all documents/information being available for the estimate including file names and revision dates
2)  information about the database used
3)  assumptions, benchmarks, budgetary quotations
4)  exclusions
For GMP governed projects the gate review (CR/ TR) relevant content "Benchmarking (infrastructure, utilities, facility
construction, HVAC, PCS, piping, etc.)" may be part of this paragraph.
A) Cost estimate carried out by ET PM PC CE Group: standard cost estimation software CLEOPATRA provides Cos
in standard cost reports, ET standard cost breakdown structure (CBS) is applied.
B) Cost estimate carried out by external partner: template BTS KD PME 09 T03 and work instruction BTS KD PME 0
be provided to the external partner. ET standard cost breakdown structure (CBS) needs to be applied (s. template BTS KD PM
For GMP governed projects the gate review (CR/ TR) relevant content
"Cost estimate and expenditure plan" may be part of this paragraph
All cost calculation documents per discipline that contributed
to the cost estimation overview. According GR11 allowances of related disciplines to be included.
For example priced equipment list. Linked to chapter 10.02.01.
Bill of quantity (BOQ) including quantities and unit rates/ prices.
For example priced line list (piping list). Linked to chapter 11.05.01.
For example priced PCT equipment list including costs for manufacturing IT and changes in global IT systems, if any

Based on the result of the reliability and mechanical integrity study and vendor recommendation.

Mainly manpower demand. Can be also integrated in chapter 32.02.07.

Mainly manpower demand. Can be also integrated in chapter 32.02.07.

Equipment needed for (pre) commissioning, for example leakage detector and manpower demand.

Heat transfer oil, lubricants, raw materials, solvents, catalyst, etc.

Cost for test materials.

For example: Leases, insurances, software, licenses, travelling, etc.

Conduct risk assessment/ list of risks as basis to calculate contingencies (for example Monte Carlo method). Linked

FEL 1 and 2: Level 1/ 2 sufficient (milestone schedule, master schedule, framework schedule).

FEL 3: Detailed time schedule ("integrated" Level 3) including project definition, permitting, detailed engineering, pro
construction, shutdown/ turnaround, pre- commissioning, cold/ hot commissioning, qualification and start-up/ validati

For GMP governed projects the gate review (CR/ TR) relevant content may be part of this paragraph "Project sched
milestones".

WN9060
Process Lead
QA Responsible
3D Modelist

Relevant Within the scope?

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YES
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E. Hinojosa + Engineering Companny YES

E. Hinojosa + Engineering Companny YES

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F. Vargas + Engineering Company
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F. Vargas + F.
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