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Doc ID: Tablet Coater


JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

USER REQUIREMENTS TEMPLATE


FOR A TABLET COATER SYSTEM

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

REVISION HISTORY

Rev. Date Approval Revision Summary

Vince Miller
0 06-Jun-2004 Initial issuance of the URS for industry use.
(JETT)

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

TABLE OF CONTENTS
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 EQUIREMENTS
1.1 Capacity
Range of products
Commodities to be used (i.e., tablets, etc.)
Processed Materials to be used or involved
Production rates

1.2 Process Requirements


Quality of products and concentrations
Product limitations (i.e. temperature, humidity, pH, etc.)

1.3 Process Control


Measurement Range (Accuracy of instrumentation desired)
Temperature:
+/- 2C (Standard)
+/- 1C (Special)
+/- 0.5C (Custom)

Airflow:
+/- 5% of Full Scale (Standard)
+/- 2.5% Of Full Scale (Special)

Pan Pressure:
+/- 10% of Full Scale (Standard Negative pan pressure
maintained)

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

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 C Dew point
Within C to C Dew point

1.4 Functions
1.4.1 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
Hand-Wash
Auto-Wash
Special Requirements:

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

1.4.2 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:
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).

1.4.3 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.
1.4.4 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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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

Response
Non-
Alarm or Informational Critical Information Operator
Critical Interlock
Message Alarm al Message Procedur
Alarm (s)
al
Emergency Stop X X
PLCOIT Communication Watchdog
(Programmable Logic ControllerOperator- X X
Interface Terminal)
Control Power Fault X X
Main Air Fault X X
Inlet Air Temperature High Fault X X
Inlet Air Temperature Low Fault X X
Inlet Airflow Low Fault X X
Plugged Gun (low flow or solution pressure
X X
high)
Nozzle Airflow Low Fault X X
Inlet Dewpoint High Fault X X
Inlet Dewpoint Low Warning X X
Motor Faults X X
Pan Pressure High Warning X X
Pan Pressure Low Warning X X
PLC Battery Low Warning X X

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.

1.5 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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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

21 CFR Part 11 . The supplier shall stipulate the methods by which this
criterion is met.
1.5.1 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.
1.5.2 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.

1.5.2.1 Language requirements


Specify language in which information will be displayed
(i.e. English, Spanish, German, Bilingual, etc.)

1.5.2.2 Display Requirements:


State the system of measurement that will be used
(English or Metric (S.I.)).
Unit(s) of
Parameter Format
measurement
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 (###.#) units Define the units
Amount
Nozzle Airflow (###.#) units Define the units
Alarms and Warnings N/A N/A

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

Unit(s) of
Parameter Format
measurement
System Status N/A N/A
Product Temperature (###.#) units Define the units
Inlet Dewpoint (###.#) units Define the units
Other (Specify) (###.#) units Define the units

1.5.3 Interface with Other Equipment


The control system shall include the interfaces necessary to
facilitate operation and configuration. For example:
An RS-232 communications port
shall be provided.
A Modem communications port
shall be provided.
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.).
Other (specify)
1.5.4 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.).
1.5.5 Data Collection
Consider any archiving and reporting requirements here.
None
Recorder

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USER REQUIREMENTS Page 9 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

Process Printout
Electronic process printout,
Historical Trending
Electronic process printout,
Historical Trending and interface to company network
The following shall be recorded:
Inlet Temperature
Exhaust Temperature
Inlet Airflow
Pan Pressure
Solution Flowrate
Total/Setpoint Spray amount
Nozzle Airflow
Alarms and warnings
System Status (ready, running,
etc.)
Product Temperature
Inlet Dewpoint
Other: (Specify)

1.6 Environment
Provide details of the physical environment in which the Tablet Coater
System will be operated.
1.6.1 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.

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USER REQUIREMENTS Page 10 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

1.6.2 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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USER REQUIREMENTS Page 11 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

1.6.3 Cleaning Requirements


Hand-Wash
Auto-Wash
Steam Clean
1.6.4 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.
1.6.5 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)

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USER REQUIREMENTS Page 12 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

2.0 CONSTRAINTS
2.1 Milestones and Timelines
Based on the model outlined below, establish the project milestones with a
timeline:

BASELINE EQUIPMENT ACQUISITION MODEL


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

Equipment Validation Plan RFQ


Explanation to Supplier
Proposal
(Living Document) RFQ Quality Plan
l Project Plan
User Requirements Specification (URS) po sa
o
(Living Document) Pr

P.O. Functional Specification


Proposal Analysis (Traceable to URS)

Approval Detailed Design


Review Functional Specification Documentation
(traceable to Functional Specification)

Approval
Review Detailed Design System Acceptance Test
Specifications (IQ/OQ)
Hardware
Software
Review System
Approva
Acceptance Test Specifications l System Acceptance
Testing and Results
(User Witness Optional)
Integrate with Validation
Documentation (as appropriate) Maintenance & Support
Documentation

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USER REQUIREMENTS Page 13 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

2.2 Equipment Constraints


Describe the operating constraints that the [equipment/system] will be
required to meet.
For example:
2.2.1 Environmental Conditions
The Tablet Coater System is to be used at the following
environmental conditions:
Altitude ________ ft above sea level
2.2.2 Process air enters in from
Indoor Temperature: C
Outdoor Temperature:
Minimum: C
Maximum: C
Climatic conditions:
Winter dry bulb C
Winter wet bulb C
Summer dry bulb C
Summer wet bulb C
2.2.3 Equipment Generated Vibration
The maximum allowable equipment vibration generated during
operation is <value>.

2.3 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.
2.3.1 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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USER REQUIREMENTS Page 14 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

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.
2.3.2 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.
2.3.3 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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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

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.

2.4 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].

2.5 Procedural Constraints


2.5.1 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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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

List critical requirements for surface finish, roughness, etc..


Other standards are attached. The Supplier shall adhere to the
indicated sections only.
2.5.2 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.).
2.5.3 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.
2.5.4 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.
2.5.5 Containment

2.5.5.1 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.).

2.5.5.2 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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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

2.5.6 Labeling
All equipment and control wiring shall be labeled and identified.

2.6 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. All sub-systems provided (Maintenance and operation manuals
of vendor equipment)
2. A comprehensive lubrication list and recommended lubrication
schedule
3. A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points, recommended
spare parts list)
4. Supplier shall supply ______ Copies of Operation, Installation,
Maintenance and de-commissioning manuals

3.0 LIFE-CYCLE
3.1 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.

3.2 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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USER REQUIREMENTS Page 18 of 23
Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

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.

3.3 Delivery
The [equipment/system], with all options, equipment, and the
documentation listed below, shall be delivered to the Users receiving
dock.
3.3.1 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 as-
built 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 Microsoft Word 97 (*.doc)

Functional Specification/Requirement Microsoft Word 97 (*.doc)

Design Specifications Microsoft Word 97 (*.doc)

Controls Test Microsoft Word 97 (*.doc)

Hardware Installation Test Microsoft Word 97 (*.doc)

Operational Test Microsoft Word 97 (*.doc)

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

Factory Acceptance Test Microsoft Word 97 (*.doc)

Operator, Maintenance and Service Manuals Microsoft Word 97 (*.doc)

Process and Instrumentation Diagram (P&ID) AutoCAD version 12.0 (*.dxf)

Instrument Listing Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

Control Schematics AutoCAD version 12.0 (*.dxf)

Control Panel Assembly Drawings AutoCAD version 12.0 (*.dxf)

Equipment Assembly Drawings AutoCAD version 12.0 (*.dxf)

Bill of Materials Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

Spare Parts List Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

Component Cut Sheets Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

CONTROL PLATFORM Program Printout and Disk File XXX Program Development format

OIP Configuration Printout and Disk File XXX Program Development format

3.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
3.4.1 Start-up Support (list available options)

3.4.1.1 Training (list training options available)


3.4.2 Post Start-up Support (list post-startup support available)

3.4.2.1 Technical Support


Telephone (Voice or Modem)
Replacement Parts Availability List (Normal lead times
shall be listed)

3.4.2.2 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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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

4.0 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
SCADA Supervisory Control and Data Acquisition
S.I. International System of Units (Metric)
NEMA National Electric Manufacturers Association
RFQ 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).
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

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System 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

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

5.0 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

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Doc ID: Tablet Coater
JETT SPECIFICATION
System URS Rev.0
Tablet Coater System June 2004

6.0 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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