Tablet Coater Urs

JETT
USER REQUIREMENTS
SPECIFICATION
Tablet Coater System
Page 1 of 26
Doc ID: Tablet Coater
System URS Rev.0
June 2004
USER REQUIREMENTS TEMPLATE

FOR A TABLET COATER SYSTEM
JOINT EQUIPMENT TRANSITION TEAM
JETT
USER REQUIREMENTS
SPECIFICATION
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System URS Rev.0
June 2004
REVISION HISTORY
Rev.
Date
Approval
06-Jun-2004
Vince Miller
(JETT)
Revision Summary
Initial issuance of the URS for industry use.
JETT
USER REQUIREMENTS
SPECIFICATION
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TABLE OF CONTENTS
1.0
INTRODUCTION..............................................................................................4
2.0
OVERVIEW........................................................................................................5
2.1
USE....................................................................................................................5
2.2
PRODUCT CLASSIFICATION.............................................................................5
2.3
INTENDED USE..................................................................................................5
2.4
CAPACITY.........................................................................................................6
2.5
PRODUCTION....................................................................................................6
3.0
OPERATIONAL REQUIREMENTS...............................................................6
3.1
CAPACITY.........................................................................................................6
3.2
PROCESS REQUIREMENTS...............................................................................6
3.3
PROCESS CONTROL.........................................................................................6
3.4
FUNCTIONS.......................................................................................................7
3.5
DATA AND SECURITY.......................................................................................9
3.6
ENVIRONMENT...............................................................................................12
4.0
CONSTRAINTS...............................................................................................15
4.1
MILESTONES AND TIMELINES.......................................................................15
4.2
EQUIPMENT CONSTRAINTS...........................................................................16
4.3
COMPATIBILITY AND SUPPORT.....................................................................16
4.4
AVAILABILITY................................................................................................18
4.5
PROCEDURAL CONSTRAINTS.........................................................................18
4.6
MAINTENANCE...............................................................................................20
5.0
LIFE-CYCLE....................................................................................................20
5.1
DEVELOPMENT...............................................................................................20
5.2
TESTING..........................................................................................................20
5.3
DELIVERY.......................................................................................................21
5.4
SUPPORT.........................................................................................................22
6.0
GLOSSARY......................................................................................................23
7.0
REFERENCES.................................................................................................25
8.0
APPROVAL.......................................................................................................26
USER REQUIREMENTS
SPECIFICATION
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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. PURE STEAM GENERATOR, JETT Example
User Requirements Specification.
1.0 INTRODUCTION
Tablet coating systems vary in function and purpose. There are several uses of
coaters:
Strengthening coat
De-dust/flavor mask
Color and elegance
Active drug coats
Protective
Timed Release
Sugar coat
These systems range from a simple aqueous (water based) coat, to drug layers,
and solvent based coating systems.
Aqueous systems typically have less complexity, whereas active drug coating
layers have a need for more instrumentation and controls, and lastly solvent
based systems employ even more instrumentation and controls required
primarily for safety reasons (explosion protection).
Also, the product itself may pose environmental and exposure hazards that need
to be dealt with to implement the installation of the coating system.
Lastly, the utilities and space involved needs to be discussed prior to purchasing
the equipment. Obviously, the actual equipment size is but a small part of the
entire scope of work necessary to implement a larger coating operation. Small
coaters can be self-contained, depending upon the application. The unit and its
support equipment must be able to be installed in current building facilities.
This document encompasses the normal range of coater operations. Technology
improvements and new applications may require deviation from this template.
This is to be utilized as a guide for the user to answer the majority of questions
involved in specifying and using the equipment. Addendums may be used to
round out the requirements.
A typical Aqueous Process involves the following steps:
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SPECIFICATION
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Dedust/Preheat (blowers on, pan in jog mode, heat applied,

solution recirculating)
After reaching a preset exhaust temperature indicating tablet bed

is warm:
Spray Solution to Tablets (Pan in run mode)
After reaching desired weight gain on tablets:
Cooldown (Heat off, Pan in jog mode)
Unload Tablets
2.0 OVERVIEW
This document encompasses the normal range of equipment operations.
2.1 Use
The coater shall be used primarily for:
Strengthening coat
De-dust/flavor mask
Color and elegance
Active drug coats
Protective
Timed Release
Sugar coat
2.2 Product Classification

The products being used on the machine are of:
Low active (vitamins, supplements)

Medium active (eg. Asprin)
Highly active (eg. Morphine)
Exclusive (eg. Penicillin)
2.3 Intended use

The coater will be used for (Check all that apply):
Aqueous
Low LEL (Lower Explosion Limit) Solvents
High LEL Solvents
Sugar coat
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SPECIFICATION
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2.4 Capacity
The capacity of the machine is to be:
Extremely small (1 liter to 6 liters)

Small (7 liters to 30 liters)
Medium (30 liters to 60 liters)
Large (60 to 100 liters)
Larger (100 to 150 liters)
Largest (150, 170, and above)
2.5 Production
The coater shall be capable of producing
per 8-hour shift.
(unit)of coated tablets
3.0 OPERATIONAL REQUIREMENTS

3.1 Capacity
Range of products
Commodities to be used (i.e., tablets, etc.)
Processed Materials to be used or involved
Production rates
3.2 Process Requirements
Quality of products and concentrations

Product limitations (i.e. temperature, humidity, pH, etc.)
3.3 Process Control
Measurement Range (Accuracy of instrumentation desired)

Temperature:
+/- 2C (Standard)
+/- 1C (Special)
+/- 0.5C (Custom)
Airflow:
+/- 5% of Full Scale (Standard)
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+/- 2.5% Of Full Scale (Special)
Pan Pressure:
+/- 10% of Full Scale (Standard Negative pan pressure

maintained)
Solution Flowrate:
+/- 5% of Full Scale no feedback (Standard Peristaltic)
+/- 5% of Full Scale with feedback (Peristaltic with

flowmeter)
+/- 2% of Full Scale no feedback (Standard Gear Pump)
+/- 2% of Full Scale with feedback (Gear pump with

flowmeter)
+/- 1% of Full Scale with feedback (Gear pump with weigh
scale)
Inlet Air Humidity:
Not critical
Dry at least to
Within
C Dew point
C to C Dew point
3.4 Functions
3.4.1
Operation
The system shall operate with a minimum of operator involvement

(loading, unloading, gun calibration, monitoring of conditions).
Operation shall be safe both from an operator and environmental
standpoint.
The system shall be operated locally at the Coater machine itself.
Control system requirements
Manual only
Manual/automatic
Cleaning requirements
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Hand-Wash
Auto-Wash
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Special Requirements:
3.4.2
Power failure/Recovery
In the event of a power failure, the system shall protect product
against damage. The system will stop automatically upon loss of
electricity, air, or other major utility and will require operator
intervention to re-start.
Depending upon the options chosen in the overview section, the
system will:
3.4.3
Manually re-start based on operator inputs. (Operator

initiates power recovery sequence)
Re-start based on last state before loss of power. (System
runs through power recovery sequence when operator start
signal is given)
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).
Emergency Stop
The system shall have an emergency stop (E-Stop) function

designed to stop all physical movement of the machinery
immediately. The E-Stop buttons shall be located in easily
accessible areas around the machine as required by local safety
standards.
3.4.4
Alarms and Warnings
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). 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 shall notify the operator and take no
further action.
The Equipment shall have the following critical alarms, warnings
and informational messages:
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Alarm or Informational
Message
Emergency Stop
Critical
Alarm
NonCritical
Alarm
Information
al Message
Response
Operator
Interlock
Procedur
(s)
al
(Programmable Logic ControllerOperatorInterface Terminal)
Control Power Fault
Main Air Fault
Inlet Air Temperature High Fault
Inlet Air Temperature Low Fault
Inlet Airflow Low Fault
Plugged Gun (low flow or solution pressure

high)
Nozzle Airflow Low Fault
Inlet Dewpoint High Fault
PLCOIT Communication Watchdog
Inlet Dewpoint Low Warning

Motor Faults
Pan Pressure High Warning
Pan Pressure Low Warning
PLC Battery Low Warning
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.
For a standard equipment type application, request the supplier to
submit the complete alarm list and differentiate between critical
and non-critical alarms.
Note: Consider documenting how critical and non-critical
criteria were determined.
3.5 Data and Security
Controls provided with Data Collection systems intended for use in the
manufacture of pharmaceutical products shall be required to comply with
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21 CFR Part 11 . The supplier shall stipulate the methods by which this
criterion is met.
3.5.1
User Interfaces
Access to all Input/Output values and system status bits shall be

provided through a data-communication link. Security for data
and operator access is provided by (User ID/Password, Card
Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.),
etc.).
List the application that provides security functions to the system,
either internal via the local OIP or external via a SCADA system,
etc.
3.5.2
User Interface with Supervisors and Operators
The CONTROL PLATFORM system shall include interfaces with

the Operator and Supervisor that ensure easy, safe, and reliable
operation.
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.
3.5.2.1
Language requirements
Specify language in which information will be displayed
(i.e. English, Spanish, German, Bilingual, etc.)
3.5.2.2
Display Requirements:
State the system of measurement that will be used
(English or Metric (S.I.)).
Parameter
Unit(s) of
measurement
Format
Inlet Temperature
(###.#) units
Define the units
Exhaust Temperature
(###.#) units
Define the units
Inlet Airflow
(###.#) units
Define the units
Pan Pressure
(###.#) units
Define the units
Solution Flowrate
(###.#) units
Define the units
Total/Setpoint Spray
Amount
(###.#) units
Define the units
Nozzle Airflow
(###.#) units
Define the units
Alarms and Warnings
N/A
N/A
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Parameter
Unit(s) of
measurement
Format
System Status
N/A
N/A
Product Temperature
(###.#) units
Define the units
Inlet Dewpoint
(###.#) units
Define the units
Other (Specify)
(###.#) units
Define the units
3.5.3
Interface with Other Equipment
The control system shall include the interfaces necessary to

facilitate operation and configuration. For example:
shall be provided.
An RS-232 communications port
shall be provided.
A Modem communications port
A high-speed
configuration/monitoring connection shall be provided.
The port shall be capable of being configured to communicate the
following data to a supervisory control and data acquisition
(SCADA) node (Note: the SCADA system shall be supplied and
installed by the User):
All process variables
Alarms and Warnings.
System Status (e.g. off, on,

standby states, etc.).
3.5.4
Other
(specify)
Security Levels
List the total number of different access levels that will be

required. Provide 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
Data Collection
Consider any archiving and reporting requirements here.
None
Recorder
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Process Printout
Historical Trending
Electronic process printout,
Electronic process printout,

Historical Trending and interface to company network
The following shall be recorded:
3.6
Inlet Temperature
Exhaust Temperature
Inlet Airflow
Pan Pressure
Solution Flowrate
Total/Setpoint Spray amount
Nozzle Airflow
Alarms and warnings
etc.)
System Status (ready, running,
Product Temperature
Inlet Dewpoint
Other:
(Specify)
Environment
Provide details of the physical environment in which the Tablet Coater
System will be operated.
3.6.1
Layout
Allocated floor space for the equipment is _____ inches by

________ inches with at least a _______inch corridor around the
periphery for the equipment.
Vertical clearance is _________ inches.
See attached drawing #________________________ (if
applicable).
Layout is specific to the size equipment being used and system
requirements of the equipment.
USER REQUIREMENTS
SPECIFICATION
JETT

3.6.2
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Physical Conditions
Room Explosion Classification
List the critical explosion requirements for the room.
Room will be non-hazardous
Room will be Class I Div II (Zone 2) (explosive

atmosphere present at known times)
Room will be Class I Div I (Zone 1) (explosive

atmosphere present at all times)
Environmental Classification
List the critical air quality requirements for the environment.
Class 100, 10,000, or 100,000 (Federal Standard

209E)
ISO Class 5, 7, or 8 (ISO 14644-1 and ISO

14644-2)
Class A, B, C, or D (The Rules Governing

Medicinal Products in the European Union Annex 1)
Directional airflow
Airflow velocity
Number of air changes
Particle Ingress
Biohazard Level
List the critical biohazard level requirements for the
environment.
BL-1
BL-2
Rating of enclosures
List the rating requirements for enclosures in the
environment.
NEMA 1 (Open)
NEMA 12 (Oil tight)
NEMA 4 (Wash down)
NEMA 4X (Wash down and non-Corrosive)
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3.6.3
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Cleaning Requirements
Hand-Wash
Auto-Wash
Steam Clean
3.6.4
Sterilization Requirements
Describe the type of sterilization that will be performed on or
within the Tablet Coater System and the duration the Tablet Coater
System will be exposed.
3.6.5
Intended Operating Environment:
Describe the type of operating environment that the Tablet Coater

System will be exposed to following installation.
For example:
The Tablet Coater System shall be located in a GMP environment
with a temperature range of 15 to 25 C, non-condensing humidity.
Vibration levels in operating environment are <Negligible, Slight,
or Severe>
The Seismic Zone in the operating environment is <Zone 1, Zone
2, Zone 3, Zone 4, or Zone 4A>.
(Remainder of Page Intentionally Left Blank)
JETT
USER REQUIREMENTS
SPECIFICATION
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4.0 CONSTRAINTS
4.1 Milestones and Timelines
Based on the model outlined below, establish the project milestones with a
timeline:
BASELINE EQUIPMENT ACQUISITION MODEL

SUPPLIER
USER/(CONSULTANT if applicable)
User Audit of Supplier
Master Validation Plan

Equipment Validation Plan
Explanation to Supplier
(Living Document)
User Requirements Specification (URS)

(Living Document)
Proposal Analysis
User Initiates
RFQ
Proposal
RFQ
Quality Plan
Project Plan
l
o sa
p
o
Pr
P.O.
Approval
Review Functional Specification
Functional Specification
(Traceable to URS)
Detailed Design
Documentation
(traceable to Functional Specification)
Review Detailed Design

Review System
Acceptance Test Specifications
Integrate with Validation
Documentation (as appropriate)
Approval
System Acceptance Test

Specifications (IQ/OQ)
Hardware
Software
Approva
l
System Acceptance
Testing and Results
(User Witness Optional)
Maintenance & Support
Documentation
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4.2 Equipment Constraints

Describe the operating constraints that the [equipment/system] will be
required to meet.
For example:
4.2.1
Environmental Conditions
The Tablet Coater System is to be used at the following

environmental conditions:
Altitude ________ ft above sea level
4.2.2
Process air enters in from

C
Indoor Temperature:
Outdoor Temperature:
Minimum:
Maximum:
Climatic conditions:
4.2.3
Winter dry bulb
Winter wet bulb
Summer dry bulb
Summer wet bulb
Equipment Generated Vibration
The maximum allowable equipment vibration generated during

operation is <value>.
4.3 Compatibility and Support
Include any requirements for compatibility with other User systems. In
the examples provided below, fill in blanks with the appropriate
information. Delete areas that are not applicable to this application.
4.3.1
CONTROL PLATFORM Controllers
The Supplier shall utilize

Control Platform
Controllers that shall include a communications port.
The Supplier shall provide documentation that the program
(embedded software) was developed and coded utilizing
program development and documentation software.
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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.
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.
4.3.2
Preferred Vendor List
If necessary attach any critical preferred vendors. Refrain from

driving the supplier into customizing his equipment package.
If the vendor wishes to deviate from the Preferred Instrumentation
List, a listing of the proposed components and instrumentation
sub-vendors indicating type and model numbers shall be submitted
with the quotation, along with an explanation of why the deviation
is recommended.
4.3.3
Utilities
The utilities and space involved needs to be discussed prior to

purchasing the equipment. Obviously, the actual equipment size is
but a small part of the entire scope of work necessary to implement
a larger system. The unit and its support equipment must be able to
be installed in current building facilities.
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.
The Supplier shall specify utility data, which is marked with a
triangle. Utility data, which are not specified or marked with a
triangle, shall be brought to the attention of the User. These data
shall be specified (by the User or the Supplier) and shall be
approved by both the User and the Supplier before system design
begins.
Base Utilities Worksheet
Related Discharges
Volume
pH
Temperature
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Materials
Electricity
______ VAC ____ Hertz
Phases
Amperage
Uninterruptible Power Supply (Define Use)
Control Air
Pressure
For example:
_______ PSIG (must be clean, dry ISA instrument
quality air, capacity to be determined by size of
equipment). Recommend at least 90 PSIG
constant air pressure for all equipment, unless
specified.
Other Utility Requirements

Provide details regarding any other utility systems
that are required to support operation of the
equipment/system.
4.4 Availability
The Tablet Coater System is intended to be operated [Continuously,
Regularly, __ hours per day, __ hours per week].
Operation of the Tablet Coater System shall be suspended, and the system
shall be available for preventative maintenance or routine service [__
hours per week, __ continuous hours per week, __ days per month, __
weeks per year].
4.5 Procedural Constraints
4.5.1
Product Contact Materials
Describe any local procedural requirements such as local

standards, which must be adhered to if applicable.
All piping welds and product contact welds shall meet ASME and
3A specification requirements. Product contact metal to be (316L
Stainless Steel, 316 Stainless Steel, 304 Stainless Steel, etc.)
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List critical requirements for surface finish, roughness, etc..

Other standards are attached. The Supplier shall adhere to the
indicated sections only.
4.5.2
Product in Contact with Materials
All product contact parts should be considered. The Tablet Coater

System will be used for (aqueous solutions, low LEL (lower
explosion limit) solvents, high LEL solvents, etc.).
4.5.3
Noise Level Constraints
Insert your own noise level constraint requirements here.

For example:
The noise level generated during operation of the Tablet Coater
System will not exceed 85 dB from 3 feet away.
4.5.4
EMI / RFI levels are:
Insert your own electrical and radio frequency noise immunity and
emission requirements here.
For example:
The Tablet Coater System [will/will not] be used in an area where
two-way radio communication devices are in operation. The
Tablet Coater System shall meet CE requirements for electrical
noise immunity and emissions.
4.5.5
Containment
4.5.5.1
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.).
4.5.5.2
Product
This section is only valid if the product being used is
highly reactive. The system comes standard with inlet
prefilters and HEPA prefilters. Insert containment of
product guidelines here (i.e. HEPA filtration of exhaust,
HEPA filtration with bag in-bag out isolation of exhaust,
scrubber system, cyclone separator system, thermal
oxidizer system, evaporator, etc.).
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4.5.6
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Labeling
All equipment and control wiring shall be labeled and identified.

4.6 Maintenance
Describe 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.
System shall be maintained on a schedule as indicated by the supplier.
Supplier is to provide (at minimum) the following maintenance
instructions:
1.
2.
3.
4.
All sub-systems provided (Maintenance and operation manuals

of vendor equipment)
A comprehensive lubrication list and recommended lubrication
schedule
A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points, recommended
spare parts list)
Supplier shall supply ______ Copies of Operation, Installation,
Maintenance and de-commissioning manuals
5.0 LIFE-CYCLE
5.1 Development
If S88 is to be applied to the equipment being acquired, it should be
referenced in this section of the document.
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.
The Supplier shall provide a Project Manager for the project to provide a
single communication point with the User.
The project shall utilize the GAMP methodology when developing the
system and documentation.
5.2 Testing
Describe the Supplier testing requirements. Reference the Validation Test
Plan, Factory Acceptance Test, special tests, etc. This section should also
include required amount of demonstrated run time, any special materials
necessary to complete testing, integration testing, etc.
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In order to verify system performance, the User shall witness the

execution of the Factory Acceptance Test procedures. The Supplier shall
notify the User _______ weeks in advance of the start of this test.
The Factory Acceptance Test 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 Factory Acceptance Test Specification.
Refer to the Equipment Validation Plan for applicable procedures.
5.3 Delivery
The [equipment/system], with all options, equipment, and the
documentation listed below, shall be delivered to the Users receiving
dock.
5.3.1
Documentation
Installation, operation, and maintenance instruction documentation

for the system shall be developed to a level that is comprehensible
to a high school graduate.
The Supplier shall use the formats described in the GAMP
Supplier Guide, Current Version, to produce the documentation.
The Supplier shall provide the documentation for preliminary
review. The Supplier shall provide documentation reflecting asbuilt condition with final delivery.
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.
All documents shall be written in the language of the destination
country and supplied with hard copies and electronic versions in
the format identified for each document:
Project Plan
Microsoft Word 97 (*.doc)
User Requirements Specification
Functional Specification/Requirement
Design Specifications
Controls Test
Hardware Installation Test
Operational Test
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Factory Acceptance Test
Operator, Maintenance and Service Manuals
Process and Instrumentation Diagram (P&ID)
AutoCAD version 12.0 (*.dxf)
Instrument Listing
Microsoft Word 97 (*.doc) or Excel 97 (*.xls)
Control Schematics
Control Panel Assembly Drawings
Equipment Assembly Drawings
Bill of Materials
Spare Parts List
Component Cut Sheets
CONTROL PLATFORM Program Printout and Disk File
XXX Program Development format
OIP Configuration Printout and Disk File
XXX Program Development format
5.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
5.4.1
Start-up Support (list available options)
5.4.1.1
5.4.2
Training (list training options available)

Post Start-up Support (list post-startup support available)
5.4.2.1
Technical Support
Telephone (Voice or Modem)
Replacement Parts Availability List (Normal lead times
shall be listed)
5.4.2.2
User Site Support

Preventative Maintenance (list maintenance contracts
available)
System Improvements (supplier shall notify user of any
improvements available on a regular basis)
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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
SCADA
S.I.
NEMA
RFQ
Definition
Supervisory Control and Data Acquisition
International System of Units (Metric)
National Electric Manufacturers Association
Request for Quote
PO
Purchase Order
IQ
Installation Qualification
OQ
Operational Qualification
ISA
International Society for Measurement and Control
PSIG
Pounds per square inch gauge
ASME
American Society of Mechanical Engineers
HEPA
High Efficiency Particle Arrestance

HEPA filtered air is 99.97% free of all particulate down to 0.3
microns (including bacteria, fungal and other opportunistic
microbiological).
Degrees Celsius
BL
Biohazard Level
CFR
dB
EMI
ft
Code of Federal Regulations

Decibels
Electro-Magnetic Interference
Feet
GUI
Graphic User Interface
HMI
Human Machine Interface
HVAC
ISO
Heating, Ventilation, and Air Conditioning

International Organization for Standardization
Page 24 of 26
USER REQUIREMENTS
SPECIFICATION
JETT

System URS Rev.0
June 2004
Acronym
Definition
JETT
Joint Equipment Transition Team
LEL
Lower Explosion Limit
OIP
Operator Interface Panel
RFI
Radio Frequency Interference
URS
User Requirement Specification
VAC
Voltage Alternating Current
USER REQUIREMENTS
SPECIFICATION
JETT
Page 25 of 26
System URS Rev.0
June 2004
7.0 REFERENCES
List references that were used in preparing this document or that provide
additional details, such as:
Equipment Validation Plan
Current revision of GAMP Guidelines
Vendor Piping Certification (if applicable)
Customer Connection Diagram
Approved Instrumentation List
Process Flow Diagram
21 CFR Part 11
National Electric Code
S88
USER REQUIREMENTS
SPECIFICATION
JETT
Page 26 of 26
System URS Rev.0
June 2004
8.0 APPROVAL
Insert your companys standard approval page at the appropriate position in the
document or utilize the sample approvals listed below. The approval
process/requirements should be outlined in the Equipment Validation Plan.
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.
Printed/Typed Name
Signature
Date
This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.
Printed/Typed Name
Signature
Date
Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.

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JETT

Tablet Coater System

USER REQUIREMENTS TEMPLATE

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

Dedust/Preheat (blowers on, pan in jog mode, heat applied,

After reaching a preset exhaust temperature indicating tablet bed

Spray Solution to Tablets (Pan in run mode)

After reaching desired weight gain on tablets:

Cooldown (Heat off, Pan in jog mode)

2.2 Product Classification

Low active (vitamins, supplements)

2.3 Intended use

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

Extremely small (1 liter to 6 liters)

(unit)of coated tablets

3.0 OPERATIONAL REQUIREMENTS

3.2 Process Requirements

Quality of products and concentrations

3.3 Process Control

Measurement Range (Accuracy of instrumentation desired)

+/- 0.5C (Custom)

+/- 5% of Full Scale (Standard)

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

+/- 2.5% Of Full Scale (Special)

+/- 10% of Full Scale (Standard Negative pan pressure

+/- 5% of Full Scale no feedback (Standard Peristaltic)

+/- 5% of Full Scale with feedback (Peristaltic with

+/- 2% of Full Scale with feedback (Gear pump with

Inlet Air Humidity:

The system shall operate with a minimum of operator involvement

JOINT EQUIPMENT TRANSITION TEAM

Tablet Coater System

Manually re-start based on operator inputs. (Operator

The system shall have an emergency stop (E-Stop) function

Alarms and Warnings

Critical alarms shall take action via interlock(s) and/or operator

JOINT EQUIPMENT TRANSITION TEAM

Doc ID: Tablet Coater

Tablet Coater System

(Programmable Logic ControllerOperatorInterface Terminal)

Control Power Fault

Main Air Fault

Inlet Air Temperature High Fault

Inlet Air Temperature Low Fault

Inlet Airflow Low Fault

Plugged Gun (low flow or solution pressure

Nozzle Airflow Low Fault

Inlet Dewpoint High Fault

PLCOIT Communication Watchdog

Inlet Dewpoint Low Warning

Pan Pressure High Warning

Pan Pressure Low Warning

PLC Battery Low Warning

The list of critical alarms in the table is not intended to be a