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USER REQUIREMENTS Page 1 of 33
Doc ID: Granulator URS

JETT SPECIFICATION
TEMPLATE Rev.C1
Wet High-Shear Granulator September 2003
USER REQUIREMENTS TEMPLATE

for a
WET HIGH-SHEAR GRANULATOR
FOR PHARMACEUTICAL PRODUCTS
JOINT EQUIPMENT TRANSITION TEAM

JETT SPECIFICATION
TEMPLATE Rev.C1
REVISION HISTORY
Rev. Date Approval Revision Summary

A1 07/17/02 VRM Initial Draft
A2 10/14/02 VRM Incorporated comments by technical review team attended by P.
Coury, D. Rosendale, D. Noteboom, and V. Miller on July 18,
2002. This revision will focus the template on specific
granulator application, rather than providing general guidelines
on several granulator application options.
A3 02/14/03 VRM Edited to insert comments from review during October 2002
JETT meeting as noted by J. Lustri. Comments need to be
evaluated against blank template format and current URS
content guidelines.
A4 9/19/03 BAL Reviewed during September, 2003 meeting by all present and
incorporated comments
C1 09/25/03 MRR Format Review
The revision history section should be utilized during development to provide

information that will allow the reviewer/approver to understand what part/parts of the
document are being revised. For an initial release, provide a note that the document is
being routed for initial review/approval. This will ensure reviewers/approvers evaluate
the entire document. In the revision summary include the revision number of the
Blank Template used to create any equipment specific templates.
(Reminder of Page Intentionally Left Blank)

JETT SPECIFICATION
TEMPLATE Rev.C1
TABLE OF CONTENTS
1.0 INTRODUCTION..............................................................................................4
1.1 PURPOSE...........................................................................................................4
1.2 SCOPE...............................................................................................................4
1.3 GENERAL DESCRIPTION..................................................................................4
1.4 VALIDATION PLAN...........................................................................................4
2.0 OVERVIEW........................................................................................................5
3.0 OPERATIONAL REQUIREMENTS...............................................................6
3.1 CAPACITY.........................................................................................................6
3.2 PROCESS REQUIREMENTS...............................................................................6
3.3 PROCESS CONTROL.........................................................................................7
3.4 FUNCTIONS.......................................................................................................7
3.5 DATA AND SECURITY.....................................................................................14
3.6 ENVIRONMENT...............................................................................................18
4.0 CONSTRAINTS...............................................................................................19
4.1 MECHANICAL.................................................................................................19
4.2 MILESTONES AND TIMELINES.......................................................................20
4.3 EQUIPMENT CONSTRAINTS...........................................................................21
4.4 COMPATIBILITY AND SUPPORT.....................................................................22
4.5 AVAILABILITY................................................................................................23
4.6 PROCEDURAL CONSTRAINTS.........................................................................24
4.7 MAINTENANCE...............................................................................................25
5.0 LIFE-CYCLE....................................................................................................27
5.1 DEVELOPMENT...............................................................................................27
5.2 TESTING..........................................................................................................27
5.3 DELIVERY.......................................................................................................27
5.4 SUPPORT.........................................................................................................29
6.0 GLOSSARY......................................................................................................31
7.0 REFERENCES.................................................................................................32
8.0 APPROVAL.......................................................................................................33
9.0 ATTACHMENTS..............................................................................................34

JETT SPECIFICATION
TEMPLATE Rev.C1
Project No.:
Insert the unique project number associated with this particular URS.
Document No.:
Insert the Document Identification Number and Revision.
Document Description:
Insert description of document, e.g. GRANULATOR URS Template, JETT Example
User Requirements Specification.
1.0 INTRODUCTION
Note: Insert your own description and introduction. You may wish to include
your own requirements and specifics to allow the inexperienced reader,
contractors, and suppliers adequate explanation to understand the scope of the
equipment.
1.1 Purpose
This document was generated under the authority of the
___________________ Company for the purpose of specifying the user
requirement for an automated granulation system. The system shall be
used to perform a wet high shear granulation step in which active and/or
inactive pharmaceutical ingredients are combined with granulation fluid.
1.2 Scope
This user requirement specification will be recognized as an integral part
of the procurement agreement with the selected equipment vendor. The
equipment supplier or vendor will abide by the information and
conditions set forth by this document as well as the standard purchasing
term and conditions of the ____________________ Company.
1.3 General Description

The granulation system will be operated independently of other
equipment and systems and will be located in a designated operating
area.
1.4 Validation Plan

An equipment validation plan has been developed to outline the planned
tasks and expectations for validation of the granulation system. This
plan has been included as Attachment _____. The equipment supplier or
vendor has specific responsibilities as outlined by the Validation Plan
and this document.

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2.0 OVERVIEW
This document encompasses the normal range of equipment operations. This
section should be expanded to provide a high level description of the system
explaining why it is required and what is required of it. Include the background,
key objectives and benefits, main functions and interfaces, applicable GxP
requirements, and other applicable regulations. Obviously, technology
improvements and new applications may require deviation from this template.
The User should consider including information on the following:

2.1 Use: Describe what applications the equipment/system will be used to
support. Include a brief explanation of the general functions.
For example:
The granulation system shall mix a _____Kg batch consisting of
acetominophen, microcrystalline cellulose, starch, and hydroxypropyl
cellulose at a specified RPM and duration. After mixing, purified water
will be added slowly over an adjustable period of time at an adjustable
flowrate. Mixing will continue until a heavy mass is formed. The
mixture will be dried in-situ using a microwave generator until a
specific Loss On Drying (LOD) is reached. Final granulation step will
be carried out by milling.
2.2 Capacity: Provide a brief description of the equipment/system capacity
requirements.
For example:
The granulator shall be capable of handling batch sizes from ____ Kg
to ___ Kg.

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3.0 OPERATIONAL REQUIREMENTS

3.1 Capacity
Listed below are the capacity requirements for the system.
Note: Some granulators will have a minimum percent full load
requirement for an effective action, so it is important to clarify both the
minimum and maximum batch sizes.
3.1.1 ____Batches per day or ___ Kg per hour (Daily throughput)
3.1.2 Maximum volume/capacity required _____
3.1.3 Minimum volume/capacity required _____
3.2 Process Requirements
3.2.1 Range of products (i.e. density, moisture content, viscosity, etc.)
3.2.2 Commodities to be used (i.e. types of containers, or methods,

used to charge and discharge materials to and from the
granulation system.)
3.2.3 Processed Materials to be used or involved
3.2.4 Production rates
3.2.5 Binder Solution Flowrate
3.2.6 Power Requirements
3.2.7 Time of typical batch process
3.2.8 Quality of products and concentrations
3.2.9 Product limitations (i.e. temperature, humidity, pH, etc.)
3.2.10 Liquid flowrate, viscosity, temperature
3.2.11 Particle size
3.2.12 Moisture content
3.2.13 Granulation time
3.2.14 Mixer / agitator speed

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3.2.15 Feed and discharge hoppers
3.2.16 Jacket cooling requirements
3.2.17 Product cannot be exposed to temperatures above ____ C.
3.2.18 Clean In Place capability
3.3 Process Control

The critical process parameters are listed below. These parameters have
been determined through pilot scale testing.
3.3.1 Solution Flowrate (____ LPM within ___LPM range, accuracy

+/-)
3.3.2 Impeller Speed (___ to ____ RPM, accuracy +/-)
3.3.3 Chopper Speed (____ to _____ RPM, accuracy +/-)
3.3.4 Power Requirements (Endpoint Control (____ to ____KW or

Ft/lbs of Torque, accuracy +/-)
3.3.5 Time parameters Process Control Profile:
3.3.5.1 Premix (_____ Min/Sec, accuracy +/-)
3.3.5.2 Solution Delivery (_____ Min/Sec, accuracy +/-)
3.3.5.3 Wet Massing Time (______ Min/Sec, accuracy +/-)
3.3.5.4 Discharge Time (______ Min/Sec, accuracy +/-)
3.3.5.5 Discharge impeller speed adjustment (___ to ____

RPM, accuracy +/-)
3.4 Functions
3.4.1 Operation
The operational requirements for this granulation system include
the following:

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3.4.1.1 The granulator is to be loaded by gravity feed from a

hopper system provided by others with valve and fabric
transition to an opening of _____ size.
3.4.1.2 The system shall have a manual mode, which will allow
the operator control of all of the major functions of the
equipment.
3.4.1.3 The system shall have a maintenance mode, which will

allow troubleshooting of the equipment without an
excess of constraining interlocks.
3.4.1.4 The system shall have an automated mode utilizing

recipes for typical batch process operations having
minimal operator interaction.
3.4.1.5 The process control system shall have ____ number of

recipes.
3.4.1.6 The parameters listed above in section 3.3 shall be

configurable throughout the indicated ranges.
3.4.1.7 The recipe parameters are configurable using the HMI

terminal.
3.4.1.8 Operational parameters are defined the following table:

TABLE 3.4.1.8 - OPERATIONAL PARAMETERS
Ref. Parameter Indicated on Monitored Operator Determined Data
No. Local HMI remotely adjustable by recipe stored/trended
1 Target Granulation
run time:
Per operation
2 Actual Granulation
run time:
Per operation
3 Actual Granulation
run time:
Total Run
4 Product
temperature
5 Vapor Outlet
temperature
6 Shell in/out
temperature
7 Absolute Pressure

JETT SPECIFICATION
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TABLE 3.4.1.8 - OPERATIONAL PARAMETERS

Ref. Parameter Indicated on Monitored Operator Determined Data
No. Local HMI remotely adjustable by recipe stored/trended
8 Impeller speed
9 Chopper speed
10 Wet Massing time
11 Granulation system
load weight
12 Final product Yield
13 Batch ID
14 Recipe ID
15 Recipe step #
3.4.2 Hand-Wash
3.4.3 Cleaning and/or Sanitization
3.4.3.1 Clean in Place (CIP)

Describe how cleaning process is to be initiated and
controlled, i.e. locally or remotely. Describe any
remote control requirements, such as CIP Start, Stop,
Abort, etc.
3.4.3.1.1 The granulator shall be cleaned in place

using an automated sequence to be
initiated by the operator. An existing
centralized CIP system shall be utilized.
3.4.3.1.2 An automated clean-in-place system shall

be used to clean the vessel. The unit shall
provide connections and spray nozzles in
locations as needed to effectively clean the
equipment and vessel and route the
cleaning solution to a return header. CIP
solution supply and return is to be
provided by others.
3.4.3.1.3 The unit shall clean all product contact

areas automatically. Cleaning efficiency
shall be verified in FAT and Site
Acceptance testing using Riboflavin
solution.

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3.4.3.2 Sterilization Requirements

The granulator shall be steam sterilized using an
automated sterilize-in-place (SIP) sequence. Steam
shall be supplied to the unit from an existing clean
steam distribution system. Describe the type of
sterilization that will be performed on or within the
[equipment/system] and the duration the
[equipment/system] will be exposed.
3.4.3.3 Cleaning acceptance criteria

Add cleaning acceptance criteria
3.4.4 Power failure/Recovery

Power Failure: On power failure, the system shall fail into a
safe state *. On power restoration, the system shall not restart
without operator or communication-link input.
* A safe state shall be defined as:
1. All motion stopped on the machine
2. Reset required before machine can be restarted
3. Valves and actuating devices go to safe state (define).
3.4.4.1 No damage to machine will occur as a result of going to

the safe state.
3.4.4.2 There shall be no product loss when going to a safe

state.
3.4.4.3 In the event of a power failure, the system shall protect

in the following priority:
1. Personnel
2. Equipment
3. Product
3.4.4.4 Recovery Method:
3.4.4.4.1 Manually re-start based on operator inputs

(Operator initiates power recovery
sequence).
3.4.4.4.2 Re-start based on last state before loss of

power. (System runs through power
recovery sequence when operator start
signal is given)

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3.4.4.4.3 All equipment shall be designed to retain

the controller program in case of power
loss, and be able to recover with minimal
operator actions.
3.4.4.4.4 If there is an automatic batch reporting

system, the information shall be retained
in the event of a power failure (A UPS is
required for automatic batch reporting
systems for data retention). Refer to Table
3.4.1.7
3.4.5 Emergency Stop
3.4.5.1 Machine shall meet federal, state and local safety

requirements
3.4.5.2 The system shall have an E-Stop mechanism designed

to stop all physical movement of the equipment
immediately. The E-Stop mechanism(s) shall be
located in easily accessible areas around the equipment
as required by national and local safety standards.
3.4.5.3 Emergency-stop buttons shall be supplied within the

reach of the operator at normal operator stations. When
activated, the emergency stop shall shut the system
down immediately in accordance with the following
requirements:
3.4.5.3.1 Define applicable personnel access

controls that prevent the machine from
rotating when hazardous to personnel. For
example, access gate, light curtain, door
interlocks, and room air pressure sensor.
3.4.5.3.2 No damage to the machine or product will

occur as a result of an emergency stop.
3.4.5.3.3 Batch ID, batch status, and sequence

information shall not be lost as a result of
an E-Stop. Refer to Table 3.4.1.7
3.4.5.3.4 Emergency stop will seal product path or

take actions to prevent product
contamination if so equipped.

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3.4.5.3.5 The machine shall not be allowed to restart

without operator intervention. It shall be
necessary to restore the emergency stop
button to the original state, and reset the
system before restarting.
3.4.6 Alarms, Messages, and Alert

Operator prompts such as Alarms, Messages, and Alert signals
are identified in Table 3.4.4.5. Categories of operator prompts
are described in the following:
3.4.6.1 Critical alarms

Critical Alarms shall take action via interlock(s) and/or
operator procedural response to shut the equipment
down and notify the operator of the condition(s) both
audibly and visually. Operator action shall be defined
by standard operating procedure. The operator shall be
required to acknowledge the alarm before the alarm can
be reset and the system restarted. Once the alarm is
reset, the operator may restart the system.
Informational Messages
3.4.6.2 Non-critical Alarms

Non-critical alarms shall notify the operator both
audibly and visually to warn the operator of an
abnormal condition, and take no further action
automatically. Operator action shall be defined by
standard operating procedure. Critical alarms are
identified in the Table 3.4.6.5
3.4.6.3 Informational Messages

Informational messages shall notify the operator both
audibly and visually of a routine operational status or
event, and take no further action. Operator action shall
be defined by standard operating procedure. Critical
alarms are identified in the Table 3.4.6.5
Non-critical alarms shall notify the operator both

audibly and visually and take no further action.
Operator action shall be defined by standard operating
procedure. These alarms are identified in Table 3.4.6.5

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3.4.6.4 Operator Procedural Alert

Operator/ Procedural alarms allow the machine to
continue to run, but provide an alert message to be
displayed on the operator screen. The operator shall be
required to acknowledge the alert in order to remove
the warning message form the operator screen.
3.4.6.5 The following table by identifies all system critical and

non-critical alarms using the alarm definitions that
follow the alarm table. Supporting narrative defines
how the operator shall be notified and how the alarms
shall be presented to the operator. Status messages and
alarm logging requirements are described (alarm active,
process value and time/date, alarm acknowledged,
alarm cleared, process value and time/date).
TABLE 3.4.6.5
Non- Response
Critical Informational
Alarm or Informational Message Critical Operator
Alarm Message Interlock(s)*
Alarm Procedural
Emergency Stop X X E-Stop
Control Platform Communication Watchdog X E-Stop
Control Power Fault X E-Stop
Main Air Fault X E-Stop
PLC Battery Low X Cycle Stop X
Machine Overtorque E Stop
Rotation count error Cycle Stop
Safety gate lifted (or light curtain, door
E Stop
interlock, etc.)
Rotation time exceeds normal time limit Cycle Stop
Encoder fault Cycle Stop
Acceptable speed limitations exceeded Cycle Stop
Air pressure low Cycle Stop
Loading or unloading valves not closed.
Cycle Stop
(Proximity switches or limit switches failed.)
Control system fault X E Stop
Motor Faults X E Stop
CONTROL PLATFORM Battery Low
X
Warning
Notes: E-Stop alarms shall take action immediately to stop the equipment.
The operator shall be required to acknowledge the alarm before the alarm can be
reset and the machine restarted.

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Cycle-Stop alarms shall take action at the end of a rotation cycle to stop the
equipment. The operator shall be required to acknowledge the alarm before the
alarm can be reset and the machine restarted.
The list of critical alarms in the table is not intended to be a comprehensive list
of all alarms for the system. A complete alarm list will be developed and
included in the Functional Specification document. The equipment vendor is to
submit the complete alarm list and differentiate between critical and non-critical
alarms.
3.5 Data and Security

This section specifies requirements for data collection and security.
3.5.1 cGMP Requirements

Data Collection and security features of this system shall comply
with cGMP requirements and 21 CFR Part 11 and/or
_______________ Company policy and procedure. The supplier
shall stipulate the methods by which this criterion is met.
3.5.2 User Interfaces

This section addresses the issue of Operator interface access
levels, frequency of data point collection, hardcopy/electronic
data collection requirements, data retention time on the system,
and data storage media.
3.5.2.1 Access to all Input/Output values and system status bits

shall be provided through a data-communication link.
Security for data and operator access must be provided
using User ID/Password, Card Reader, Biometric
(Fingerprint, eye scan, voice recognition, etc.), or some
other agreed upon method.
3.5.2.2 Data shall be collected at _____ minute intervals and

shall be printed in hardcopy and retained and stored
electronically.
3.5.2.3 Hardcopy data reporting shall occur during each

granulator run and shall be formatted to include a log of
critical parameter and time information.
3.5.2.4 Sufficient data storage media shall be provided to

accommodate a ____day data retention period.

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3.5.3 User Interface with Supervisors and Operators

The user interface for Supervisors and Operators is described
below.
3.5.3.1 The Control Platform system shall include interfaces

with the Operator and Supervisor that ensures easy,
safe, and reliable operation.
3.5.3.2 An operator-interface panel shall be provided and

mounted near the equipment or on the equipment. This
panel shall provide the necessary switches, indicators,
and devices to operate the equipment.
3.5.3.3 Language Requirements

The language that information will be displayed in is
described below.
3.5.3.3.1 The language requirement shall be English

for all system functions requiring written
or displayed text.
3.5.3.4 Display Requirements
3.5.3.4.1 The granulator shall have a locally

mounted operator interface terminal (OIT)
capable of providing a configurable
graphical user interface in color.
3.5.3.4.2 Operational parameters to be displayed on

the OIT are listed in Table 3.4.1.8.
3.5.3.4.3 The system of measurement shall be

metric (SI) units.
Table 3.5.3.4.3
Reference Unit(s) of
Parameter Format
Number measurement
3.5.3.4.3.1 Rotation Count
Machine Drive Controls
3.5.3.4.3.2
(Auto. Manual, Run, Jog)
3.5.3.4.3.3 Drive Speed
3.5.3.4.3.4 Drive Torque
3.5.3.4.3.5 Machine Position
selection and indication
(Loading, Unloading,

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Table 3.5.3.4.3
Reference Unit(s) of
Parameter Format
Number measurement
Maintenance, etc.)
Loading/Unloading Valve
3.5.3.4.3.6
Controls and indications
3.5.3.4.3.7 Alarms and Warnings.
System Status (e.g. off,
3.5.3.4.3.8 on, standby states,
etc.).
Phase Logic commands
3.5.3.4.3.9
per ISA/ANSI S88.01
(Start, Stop, Hold,
3.5.3.4.3.10 Restart, Abort, Reset,
Pause, Resume)
3.5.4 Interface with Other Equipment

The control system shall include the following interfaces
necessary to facilitate operation and configuration.
3.5.4.1 A 10 Mbps Ethernet TCP/IP communication port shall

be provided. This port shall accept an RJ style 10 Base
T Unshielded twisted pair (UTP) connector. This port
shall provide access to all Input/Output values and
system status bits by an external computer system(s) to
be installed by others. The port shall be configured to
accept commands from, and provide status information,
to a supervisory control and data acquisition (SCADA)
node (Note: the SCADA system shall be supplied and
installed by Owner):
3.5.4.1.1 Phase Logic commands per ISA/ANSI

S88.01 (Start, Stop, Hold, Restart, Abort,
Reset, Pause, Resume)
3.5.4.1.2 Procedural status signals per ISA/ANSI

S88.01 (Idle, Running, Complete, Pausing,
Paused, Holding)
3.5.4.1.3 System Status (e.g. off, on, standby

states, etc.).
3.5.4.1.4 Process variables as defined in Table

3.4.1.8

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3.5.4.1.5 The PLC/OIP system shall include

interfaces with the Users control system
to facilitate recipe download and
configuration.
3.5.5 Security Levels

The total numbers of unique security access levels that will be
required are presented below along with a general description of
the access rights for each level (screen navigation, operational
control, control loop variable manipulation, alarm setpoint
manipulation, etc.).
3.5.5.1 System security access shall consist of the following

profiles.
3.5.5.1.1 Operator Provides operator access to

allow routine operation of all equipment
features.
3.5.5.1.2 Engineer Provides access to Operator

level features in addition to critical
operating parameters configuration.
3.5.5.1.3 System Administrator Provides access to

the Operator and Engineer level features in
addition to system security parameters.
3.5.6 Data Collection

Data collection requirements for process variables and
operational parameters are specified in Table 3.4.1.8. This
section describes the archiving and reporting requirements
associated data collection.

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3.5.6.1 Storage of batch ID number.
3.5.6.2 Storage of batch run time.
3.5.6.3 Storage and trending of temperature
3.5.6.4 Process Printout for each granulator run.
3.5.6.5 Electronic process printout (historical trending of

critical parameters).
3.5.6.6 Electronic process printout (historical trending and

interface to company network).
3.6 Environment
Details of the physical environment in which the granulator will be
operated are presented below.
3.6.1 Layout
3.6.1.1 The physical environment in which the granulator will

be operated shall consist of the following.
3.6.1.1.1 Allocated floor space for the equipment is

eight feet by eight feet space with at least a
three feet corridor around the periphery for
the equipment.
3.6.1.1.2 Vertical clearance is twelve feet.
3.6.1.1.3 See attachment _____ for drawing #

____________________.
3.6.2 Physical Conditions

The physical conditions in which the equipment will be operated
are listed below.
3.6.2.1 Room Electrical Classification

The room will be Class I Div II (Zone 2) (explosive
atmosphere present at known times).
3.6.2.2 Environmental Classification

The system shall be suitable to operate in a Class
_______ cleanroom environment.

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3.6.2.3 Rating of Enclosures

Enclosures shall be rated NEMA 4X (Wash down and
non-Corrosive).
4.0 CONSTRAINTS
4.1 Mechanical
4.1.1 Use Sanitary Connectors 3.2.9 3.2.12 are mechanical not

process
4.1.2 Use Gas purged seals
4.1.3 Use FDA-approved seals and gaskets
4.1.4 Use Dust-tight designs
4.1.5 Vendor is to provide a sanitary XX inch connection for dust

collector (dust collection system provided by others)
4.1.6 The granulation system will be unloaded via a XX inch

discharge port. Transfer to downstream fluid bed dryer is by
gravity assisted feed.
4.1.7 State the ASME Vacuum/pressure rating of vessels or tanks

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4.2 Milestones and Timelines

Based on the model outlined below, establish the project milestones with
a timeline:
4.2.1 The Supplier shall provide a written proposal within _____

weeks of receipt of this document at the Suppliers local office.
4.2.2 The Supplier shall provide a Functional and Design

Specifications within _____ weeks of receipt of the purchase
order.
4.2.3 The User shall review, comment and/or approve, and return the
Functional and Design Specification to the Supplier within
_____ weeks of receipt from the Supplier.
4.2.4 The Supplier shall provide the Factory Acceptance Test

Specification within _____ weeks of receipt of approved the
Functional and Design Specification. The User shall review,
comment and/or approve, and return the test specifications to the
Supplier within _____ weeks of receipt from the Supplier.
4.2.5 The granulator and all support equipment shall be delivered to

the Users receiving dock on or before _______________.
4.3 Equipment Constraints

The granulator will be required to meet the following conditions
For example:
4.3.1 Environmental Conditions

The granulator is to be used at the following environmental
conditions:
Altitude ________ ft above sea level.
4.3.2 HVAC Equipment Constraints
4.3.2.1 Indoor Temperature: _____ to _____C.
4.3.2.2 Outdoor Temperature
4.3.2.2.1 Minimum: C.
4.3.2.2.2 Maximum: C.

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4.3.2.3 Climatic Conditions
4.3.2.3.1 Winter dry bulb _____C.
4.3.2.3.2 Winter wet bulb _____C.
4.3.2.3.3 Summer dry bulb _____C.
4.3.2.3.4 Summer wet bulb _____C.
4.3.3 Equipment Generated Vibration

The maximum allowable equipment vibration generated during
operation is ____________.
4.3.4 The top of the granulator shall be accessible from a platform

height of six feet or less.
4.4 Compatibility and Support
The requirements for compatibility with other User systems are as

follows.
4.4.1 Control System Compatibility

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4.4.1.1 The Supplier shall utilize _____ Control Platform

Controllers that shall include _____ communications
port for each unit.
4.4.1.2 The Supplier shall provide documentation that the

program (embedded software) was developed and
coded utilizing ___________________ program
development and documentation software.
4.4.1.3 The supplier shall indicate the use of custom or

bespoke code within the equipment, and shall supply
licensing of the custom code for the life of the
equipment.
4.4.1.4 An escrow agreement shall be required in the event the

supplier cannot support the supplied custom software
any longer. In such instances, the source code and all
information regarding the source code shall be given to
the user in a timely fashion to prevent downtime of the
equipment.
4.4.2 Preferred Vendor List

This section describes preferred components, instrumentation,
and procedures.
4.4.2.1 If the supplier or vendor wishes to deviate from the

preferred component, instrumentation, or procedures
list (Attachment _____), a listing of the proposed
components, instrumentation, or procedure along with
sub-vendors indicating type and model numbers shall
be submitted with the quotation, along with an
explanation of why the deviation is recommended.
4.4.3 Utilities
The User shall ensure that the following utilities are available
and that the utility supply lines and piping are terminated with
fittings or connections, which are compatible with those
described on the Customer Connection Drawings.
4.4.3.1 The Supplier shall specify utility data as follows;
4.4.3.1.1 Electricity
4.4.3.1.1.1 _____ VAC, ____ Hertz,

Phases _____.
JETT SPECIFICATION
TEMPLATE Rev.C1
4.4.3.1.1.2 Current: _____ Amps.
4.4.3.1.1.3 _____ Minute Un-

interruptible Power Supply
(Define use).
4.4.3.1.2 Control Air
4.4.3.1.2.1 Pressure _____ Bar (must be

clean, dry ISA instrument
quality air, capacity to be
determined by size of
equipment). Recommend at
least 6 Bar constant air
pressure for all equipments,
unless specified.
4.4.3.1.3 Other Utility Requirements
4.4.3.1.3.1 Provide details regarding any

other utility systems that are
required to support operation
of the equipment/system.
4.5 Availability
Equipment availability based on anticipated usage is listed below.
4.5.1 The granulator is intended to operate regularly _____ hours per

day, _____ hours per week, _____ weeks per year.
4.5.2 Operation of the granulator shall be suspended, and the system

shall be available for preventative maintenance or routine service
_____ hours per week.
4.6 Procedural Constraints
4.6.1 Product Contact Materials

Describe any local procedural requirements such as local
standards, which must be adhered to if applicable.

JETT SPECIFICATION
TEMPLATE Rev.C1
4.6.1.1 All piping welds and product contact welds shall meet
ASME and 3A specification requirements.
4.6.1.2 Product contact metal to be (316L Stainless Steel, 316

Stainless Steel, 304 Stainless Steel, etc.)
4.6.1.3 List critical requirements for surface finish, roughness,

etc.
Other standards are attached. The Supplier shall adhere to the
indicated sections only.
4.6.2 Product in Contact with Materials
4.6.2.1 All product contact parts shall be constructed from

materials acceptable to the product and sterility
assurance methods.
4.6.2.2 Certificates for material, weld, and finish shall be

provided.
4.6.2.3 All product contact parts should be considered.
The [equipment/system] will be used for (aqueous solutions, low

LEL (lower explosion limit) solvents, high LEL solvents, etc.).
4.6.3 Noise Level Constraints

Insert your own noise level constraint requirements here.
For example:
The noise level generated during operation of the
[equipment/system] will not exceed 85 dB from 3 feet away.
4.6.4 EMI / RFI levels are:

Insert your own electrical and radio noise immunity requirements
here.
For example:
The [equipment/system] [will/will not] be used in an area where

two-way radio communication devices are in operation. The
[equipment/system] shall meet CE requirements for electrical
noise immunity and emissions.
4.6.5 Containment

JETT SPECIFICATION
TEMPLATE Rev.C1
4.6.5.1 Explosion Protection

This section is only valid if the product being used is
highly reactive. Insert containment guidelines here (i.e.
Bar Construction with isolation and suppression, 10 Bar
construction with isolation only, Closed-Loop Nitrogen
System, etc.).
4.6.6 Labeling
All equipment and control wiring shall be labeled and identified.
4.7 Maintenance
The expected hardware and software maintenance support including
ease of maintenance, expansion capability (software only), likely
enhancements (software only) expected lifetime and long-term support
are described below.
4.7.1 System shall be maintained on a schedule as indicated by the

supplier. Supplier is to provide (at minimum) the following
maintenance instructions.
4.7.1.1 Maintenance activities for all sub-systems provided

(Maintenance and operation manuals of vendor
equipment).
4.7.1.2 A comprehensive lubrication list and recommended

lubrication schedule.
4.7.1.3 A comprehensive recommended maintenance (regular

recommended inspection intervals, wear points,
recommended spare parts list).
4.7.1.4 Supplier shall supply ______copies of Operation,

Installation, Maintenance and de-commissioning
manuals.

JETT SPECIFICATION
TEMPLATE Rev.C1
5.0 LIFE-CYCLE
5.1 Development
This section lists the requirement for vendor involvement in the
equipment supply and includes testing, delivery, and support.
5.1.1 The Supplier shall provide a Quality and Project Plan as part of
their proposal. The Supplier shall have a quality system in place.
Internal quality procedures shall be available for the Users
review.
5.1.2 The Supplier shall provide a Project Manager for the project to
provide a single communication point with the User.
5.1.3 The project shall utilize the GAMP methodology when

developing the system and documentation.
5.2 Testing
This section describes the Supplier testing requirements and should
reference the Validation Test Plan, Factory Acceptance Test, special
tests, etc.
5.2.1 In order to verify system performance, the User shall witness the
execution of the Factory Acceptance Test (FAT) procedures. The
Supplier shall notify the User _____ weeks in advance of the
start of this test.
5.2.2 The FAT Specification shall be submitted to the User for review
and approval prior to execution. A minimum of _____ weeks
shall be allowed for the User to review and to comment and/or
approve the FAT Specification.
5.2.3 Refer to the Equipment Validation Plan for applicable

procedures.
5.3 Delivery
This section lists the delivery requirements of the equipment.
5.3.1 The granulator, with all options, equipment, and the

documentation listed below, shall be delivered to the Users
receiving dock.

JETT SPECIFICATION
TEMPLATE Rev.C1
5.3.1.1 Documentation
5.3.1.1.1 Installation, operation, and maintenance

instruction documentation for the system
shall be developed to a level that is
comprehensible to a high school graduate.
5.3.1.1.2 The Supplier shall use the formats

described in the current GAMP Supplier
Guide, Current Version, to produce the
documentation. The Supplier shall
provide the documentation for preliminary
review. The Supplier shall provide
documentation reflecting as-built
condition with final delivery.
5.3.1.1.3 All final documents shall be shipped with

transmittals that identify them as
contractually required documents. All
final documents and drawings shall reflect
as-built condition.
5.3.1.1.4 All documents shall in the language of the

destination country and supplied with hard
copies and electronic versions supplied in
the format identified for each document.
5.3.1.1.5 The documentation and format

requirements for this project are listed
below.
Project Plan Microsoft Word XX (*.doc)
User Requirements Specification Microsoft Word XX (*.doc)
Functional Specification/Requirement Microsoft Word XX (*.doc)
Design Specifications Microsoft Word XX (*.doc)
Controls Test Microsoft Word XX (*.doc)
Hardware Installation Test Microsoft Word XX (*.doc)
Operational Test Microsoft Word XX (*.doc)
Factory Acceptance Test Microsoft Word XX (*.doc)
Operator, Maintenance and Service Manuals Microsoft Word XX (*.doc)

JETT SPECIFICATION
TEMPLATE Rev.C1
Process and Instrumentation Diagram (P&ID) AutoCAD version XX.X (*.dxf)
Instrument Listing Microsoft Word XX (*.doc) or Excel XX (*.xls)
Control Schematics AutoCAD version XX.X (*.dxf)
Control Panel Assembly Drawings AutoCAD version XX.X (*.dxf)
Equipment Assembly Drawings AutoCAD version XX.X (*.dxf)
Bill of Materials Microsoft Word XX (*.doc) or Excel XX (*.xls)
Spare Parts List Microsoft Word XX (*.doc) or Excel XX (*.xls)
Component Cut Sheets Microsoft Word XX (*.doc) or Excel XX (*.xls)
CONTROL PLATFORM Program Printout and XXX Program Development format

Disk File
OIP Configuration Printout and Disk File XXX Program Development format
5.4 Support
The following support activities are required after acceptance. The
paragraphs outlined below provide the areas of consideration.
5.4.1 Start-up Support
5.4.1.1 Start-up support shall consist of _____ weeks of full

time assistance on the Users site for punch listing
activities and _____ weeks of commissioning support.
5.4.2 Training
5.4.2.1 User training shall consist of _____ hours of Operator

training and _____ hours of Maintenance training.
5.4.3 Post Start-up Support
5.4.3.1 Post start-up shall consist of monthly User site visits for
a period of _____ months after the completion of
commissioning activities.
5.4.4 Technical Support

JETT SPECIFICATION
TEMPLATE Rev.C1
5.4.4.1 Technical support shall be provided via telephone for a

period of _____ years following the completion of
validation activities.
5.4.4.2 A recommended replacement parts list including normal

lead times shall be provided for the machine and all
sub-assemblies.
5.4.5 User Site Support
5.4.5.1 The Supplier shall notify the User of preventative

maintenance system improvement availability on a
regular basis).

JETT SPECIFICATION
TEMPLATE Rev.C1
6.0 GLOSSARY
If necessary, attach a glossary, which includes definitions of terms that may be
unfamiliar to the Supplier or terminology that may have meanings specific to
entries on this User Requirements Check sheet.
For example (example list is not intended to be complete):
Acronym Definition
C Degrees Celsius
BL Biohazard Level
CFR Code of Federal Regulations
DB Decibels
EMI Electro-Magnetic Interference
Ft Feet
GUI Graphic User Interface
HMI Human Machine Interface
HVAC Heating, Ventilation, and Air Conditioning
ISO International Organization for Standardization
JETT Joint Equipment Transition Team
LEL Lower Explosion Limit
OIP Operator Interface Panel
RFI Radio Frequency Interference
URS User Requirement Specification
IBC Intermediate Bulk Container
Granulation The process of creating granules. The powder morphology is
modified through the use of either a liquid that causes particles to
bind through capillary forces or dry compaction forces. The
process will result in one or more of the following powder
properties: enhanced flow; increased compressibility;
densification; alteration of physical appearance to more spherical,
uniform, or larger particles; and/or enhanced hydrophilic surface
properties. (SUPAC IR/MR: US FDA, Jan. 1999.)
Wet High-Shear Wet high-shear granulator subclasses are primarily distinguished
Granulator by the geometric positioning of the primary impellers; impellers
can be top, bottom, or side driven.

JETT SPECIFICATION
TEMPLATE Rev.C1
7.0 REFERENCES
A list of references that were used in preparing this document or that provided
additional details is shown below.
7.1 Equipment Validation Plan

7.2 Current revision of GAMP Guidelines
7.3 Vendor Piping Certification (if applicable)
7.4 Customer Connection Diagram
7.5 Approved Instrumentation List
7.6 Process Flow Diagram
7.7 21 CFR Part 11
7.8 National Electric Code
7.9 S88

JETT SPECIFICATION
TEMPLATE Rev.C1
8.0 APPROVAL
This document has been reviewed by the User Project Manager and approved for use by the
Supplier.
Printed/Typed Name Signature Date
This document has been reviewed by the User Quality Assurance Group and approved for
use by the Supplier.
This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.
Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.

JETT SPECIFICATION
TEMPLATE Rev.C1
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USER REQUIREMENTS Page 1 of 33

Doc ID: Granulator URS

USER REQUIREMENTS TEMPLATE

JOINT EQUIPMENT TRANSITION TEAM

Rev. Date Approval Revision Summary

The revision history section should be utilized during development to provide

(Reminder of Page Intentionally Left Blank)

JOINT EQUIPMENT TRANSITION TEAM

JOINT EQUIPMENT TRANSITION TEAM

1.3 General Description

1.4 Validation Plan

JOINT EQUIPMENT TRANSITION TEAM

The User should consider including information on the following:

JOINT EQUIPMENT TRANSITION TEAM

3.0 OPERATIONAL REQUIREMENTS

3.1.1 ____Batches per day or ___ Kg per hour (Daily throughput)

3.1.2 Maximum volume/capacity required _____

3.1.3 Minimum volume/capacity required _____

3.2 Process Requirements

3.2.1 Range of products (i.e. density, moisture content, viscosity, etc.)

3.2.2 Commodities to be used (i.e. types of containers, or methods,

3.2.3 Processed Materials to be used or involved

3.2.4 Production rates

3.2.5 Binder Solution Flowrate

3.2.6 Power Requirements

3.2.7 Time of typical batch process

3.2.8 Quality of products and concentrations

3.2.9 Product limitations (i.e. temperature, humidity, pH, etc.)

3.2.10 Liquid flowrate, viscosity, temperature

3.2.11 Particle size

3.2.12 Moisture content

3.2.13 Granulation time

3.2.14 Mixer / agitator speed

JOINT EQUIPMENT TRANSITION TEAM

3.2.15 Feed and discharge hoppers

3.2.16 Jacket cooling requirements

3.2.17 Product cannot be exposed to temperatures above ____ C.

3.2.18 Clean In Place capability

3.3 Process Control

3.3.1 Solution Flowrate (____ LPM within ___LPM range, accuracy

3.3.2 Impeller Speed (___ to ____ RPM, accuracy +/-)

3.3.3 Chopper Speed (____ to _____ RPM, accuracy +/-)

3.3.4 Power Requirements (Endpoint Control (____ to ____KW or

3.3.5 Time parameters Process Control Profile:

3.3.5.1 Premix (_____ Min/Sec, accuracy +/-)

3.3.5.2 Solution Delivery (_____ Min/Sec, accuracy +/-)

3.3.5.3 Wet Massing Time (______ Min/Sec, accuracy +/-)

3.3.5.4 Discharge Time (______ Min/Sec, accuracy +/-)

3.3.5.5 Discharge impeller speed adjustment (___ to ____

JOINT EQUIPMENT TRANSITION TEAM

3.4.1.1 The granulator is to be loaded by gravity feed from a

3.4.1.3 The system shall have a maintenance mode, which will

3.4.1.4 The system shall have an automated mode utilizing

3.4.1.5 The process control system shall have ____ number of

3.4.1.6 The parameters listed above in section 3.3 shall be

3.4.1.7 The recipe parameters are configurable using the HMI

3.4.1.8 Operational parameters are defined the following table:

JOINT EQUIPMENT TRANSITION TEAM

TABLE 3.4.1.8 - OPERATIONAL PARAMETERS

3.4.3 Cleaning and/or Sanitization

3.4.3.1 Clean in Place (CIP)

3.4.3.1.1 The granulator shall be cleaned in place

3.1.1 __Batches per day or _ Kg per hour (Daily throughput)

3.3.1 Solution Flowrate (__ LPM within _LPM range, accuracy

3.3.2 Impeller Speed (_ to __ RPM, accuracy +/-)

3.3.3 Chopper Speed ( to _ RPM, accuracy +/-)

3.3.4 Power Requirements (Endpoint Control ( to KW or

3.3.5.5 Discharge impeller speed adjustment (_ to __