Capsule Filler Urs

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USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

JETT Capsule Filler Rev. 0
October 18, 2005
USER REQUIREMENTS SPECIFICATION

for Capsule Filler
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October 18, 2005
Table of Contents
1 INTRODUCTION.......................................................................................................................................4
2 OVERVIEW.........................................................................................................................................5
3 OPERATIONAL REQUIREMENTS.................................................................................................5
3.1 FUNCTIONS.....................................................................................................................................5
3.2 DATA & SECURITY..........................................................................................................................8
3.3 ENVIRONMENT..............................................................................................................................11
4 CONSTRAINTS.................................................................................................................................12
4.1 MILESTONES AND TIMELINES.......................................................................................................12
4.2 COMPATIBILITY..............................................................................................................................14
4.3 AVAILABILITY...............................................................................................................................15
4.4 PROCEDURAL CONSTRAINTS.........................................................................................................15
4.5 MAINTENANCE..............................................................................................................................16
5 LIFE-CYCLE.....................................................................................................................................16
5.1 DEVELOPMENT..............................................................................................................................16
5.2 TESTING........................................................................................................................................16
5.3 DELIVERY......................................................................................................................................17
5.4 SUPPORT........................................................................................................................................18
6 GLOSSARY........................................................................................................................................20
7 REFERENCES...................................................................................................................................21
8 Approval...............................................................................................................................................22
JOINT EQUIPMENT TRANSITION TEAM

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October 18, 2005
REVISION HISTORY
Rev. Date Approval Revision Summary
0 10/18/2005 TGP Initial Release to JETT Website for use.

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October 18, 2005
Project No.: _______________________

Document No.: ____________________
Document Description: Capsule Filler User Requirements Description
1 INTRODUCTION
This document was generated under the authority of the ___________________ Company for the
purpose of specifying the user requirement for a capsule filler. The User Requirements Specification
(URS) is provided to aid the user through the important components, variables and options necessary
to procure a functional capsule filler that meets the users needs in the most cost-effective method
possible. The URS is then provided to the Supplier to provide a price quote for purchase of the
capsule filler including the design and manufacture of the equipment.
This URS 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.
An equipment validation plan has been developed to outline the planned tasks and expectations for
validation of the capsule filler. 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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October 18, 2005
2 OVERVIEW
The capsule filler is used to encapsulate product (dry/liquid) in gelatin capsules. Empty capsules are
loaded into the capsule hopper where they are fed into the magazine. Capsules initially enter the
magazine un-oriented. From the magazine, the capsules enter the sorting block where they are
properly oriented (smaller end on the bottom). The capsules are then separated by vacuum. The
lower portion of the capsule is filled. The upper portion of the capsule is inspected to ensure the
capsule is separated. (If the capsule is not separated or is faulty, a pin will dislodge the capsule and the
vacuum will remove it from the system.) The two halves are then joined together. The finished
capsule is discharged to a chute and the station is cleaned with an air blast.
The capsule filler can use all makes of capsules. Non-separated or improperly inserted capsules will be
automatically rejected. Capsule target fill weight can be adjusted quickly. At the end of a run, only a
small quantity of product will be remaining in the hopper.
3 OPERATIONAL REQUIREMENTS
3.1 Functions
3.1.1 Operation
The capsule filler is expected to satisfactorily fill capsules at production speeds up to and
including ______________ capsules per minute. Satisfactory performance is defined by
the following criteria:

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October 18, 2005
3.1.1.1 Capsules are to be transferred through the capsule filler without becoming
broken, split, crushed, dented or otherwise damaged in the encapsulating
process. Filled capsules should be defect free upon visual inspection.
3.1.1.2 Capsules will be filled to the target weight +/- _____%.
3.1.1.3 The machine shall not experience more than _____ % downtime at production
speeds up to and including the ______ capsules per minute specified, during an
eight-hour production run.
3.1.1.4 The machine changeover between capsule sizes by a single operator is expected
to take no longer than ______ hours from the last capsule out of the prior run to
the first capsule out of the next run.
3.1.1.5 Commodity Table
Rate
Capsule Size Fill Medium Fill Weight Comments
(Capsules/Min)
The capsule filler shall encapsulate at the sizes, fill mediums, fill weights and
output rates defined in the commodity table above.
The capsule filler shall be operable by one person, with safety related faults
stopping the machine immediately. The machine shall not be allowed to restart
without operator intervention.

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October 18, 2005
3.1.2 Product Output

The capsule filler shall have a machine efficiency rate of ________ %, as measured by the
weight of good capsules encapsulated during a one hour test run, divided by the
calculated weight of capsules at the rate defined in the commodity table (3.1.1.5)
Machine efficiency rate excludes downtime due to faulty commodities or supply issues.
3.1.3 Product Contact Parts

All product contact parts shall be constructed from materials acceptable to the product
and sterility assurance methods. Certificates for material, weld and finish shall be
provided. Product contact parts are defined as those parts which the fill material or
capsules come into contact with, during the encapsulation process.
3.1.4 Power Failure and Recovery

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.
All equipment shall be designed to retain the PLC program in case of power loss, and be
able to recover with minimal operator actions.
A safe state shall be defined as:
All motion stopped on the machine.

Reset required before machine can be restarted.
No harm shall come to the operator, machinery or product as a result of going to
the safe state during a power failure.
3.1.5 Emergency Stop

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:
All motion stopped on the machine.

No damage to the machine will occur as a result of an emergency stop.
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.

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October 18, 2005
3.1.6 Alarms and Warnings

The capsule filler shall be equipped with the following alarms and warnings:
Operator
Alarm Or Warning Immediate*
Alert**
Emergency stop X
Protective guards not in place X
No capsules X
Low product level X
Control power fault X
Main air fault X
PLC communication watchdog fault X
PLC battery low X
* Immediate alarms shall take action immediately to stop the capsule filler. The operator shall be
required to acknowledge the alarm before the alarm can be reset and the machine restarted.
** Operator Alert allows the machine to continue to run, but provides 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 from the operator screen.
3.2 Data & Security
3.2.1 Controls provided with a data collection system intended for use in the manufacture of
pharmaceutical products shall comply with 21 CFR, Part 11 of the FDA cGMP
regulations or _______________ Company policy and procedure. The supplier shall
stipulate the methods by which this criterion is met.
3.2.2 Interfaces
The Programmable Logic Controller / Operator-Interface Panel system (hereafter referred
to as the PLC/OIP system) shall include interfaces with the Operator, Supervisors,
external equipment, and the Users control system using commonly accepted standards.

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October 18, 2005
3.2.2.1 Interface with Operators

The PLC/OIP system shall include interfaces with the Operator that use
commonly accepted standards for operation.
An operator-interface panel shall be provided and mounted on the machine. This

panel shall provide the necessary switches, indicators, and devices to operate the
capsule filler. The following shall be displayed:
Machine drive controls

Utility controls
Alarms and warnings.
System status (e.g., ready, running, etc.)
Other (specify)

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October 18, 2005
3.2.3 Interface with Supervisors

The PLC/OIP system shall provide supervisory access to specific functions to ensure easy,
safe, and reliable configuration of the capsule filler. The following shall be accessible only
to Supervisors:
Machine configurations
Alarm settings
Other (specify)
3.2.4 Interface with Other Systems

Access to all input/output values and system status bits by an external computer system(s)
shall be provided through a data-communication link to the PLC and/or PLC/OIP.
Security for data and operator access is provided by ______________.
The PLC/OIP system shall include interfaces with the Users control system to facilitate
recipe download and configuration.
3.2.5 Interface with Equipment

The PLC/OIP system may include interfaces with external equipment to ensure safe,
continuous transfer of capsules without operator intervention.
3.2.6 Data Collection
3.2.6.1 Data required for collection

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October 18, 2005
Machine rate
Alarms and warnings.
System status (e.g. off, on, standby states, etc.)
Other (specify)
3.2.6.2 Data Collection and Storage Requirements

None
3.3 Environment
3.3.1 Layout
Allocated floor space for the capsule filler is _______ inches wide by ________ inches
deep with a _______ inch corridor around the periphery of the machine.
Vertical clearance is _________ inches.
See attached drawing #________________________ (if applicable). Attached drawing

shows location of utility connections (electricity, compressed air, vacuum).
3.3.2 Physical Conditions

The capsule filler shall be installed in an environment with a temperature range of
______ to ______ Fahrenheit and relative humidity range of ______ to _____ %.
Vibration levels are:

Negligible
Other (specify)
Electromagnetic interference levels are:

Negligible
Other (specify)
This area is classified as:

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October 18, 2005
Non-hazardous
Class I, Div II
Class I, Div I
Other (specify)
The rating requirements of the enclosures in this environment are:

NEMA 1
NEMA 4X
Other (specify)
3.3.3 Cleaning
The equipment will be cleaned using the following compounds/cleaning agents/detergents:

______________. It is anticipated the equipment will be cleaned on a _____________
basis.
4 CONSTRAINTS
4.1 Milestones and Timelines
The Supplier shall provide a written proposal within _______ weeks of receipt of this document
at the Suppliers local office.
The Supplier shall provide a Functional and Design Specifications within ________ weeks of
receipt of the purchase order.
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.
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.
The capsule filler shall be delivered to the Users receiving dock on or before
_________________.
The Preferred Format Is:

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October 18, 2005
Date written proposal/quote required:

Date purchase order will be placed by:
Functional and Design Specification delivery date:
Factory Acceptance Test Plan due for review:
Factory Acceptance Test Plan due for approval:
Date equipment is required on-site:

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October 18, 2005
4.2 Compatibility
4.2.1 PLC Controllers

The Supplier shall utilize _____________ manufactured programmable logic 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.
4.2.2 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 Drawing.
The Supplier shall specify utility data, which is marked with an asterisk ( ).
Utility requirements, which are not specified or marked with an asterisk, shall be brought
to the attention of the User. These requirements shall be approved by both the User and
the Supplier before system design begins.
4.2.2.1 Primary Conditions
Primary Electrical Service: _______ VAC, _______ amps, _______ ph, ______ Hz
Instrument Air: _______ cfm @ _______ _____ psig
Vacuum _______ cfm @ _______ _____ psig
Suction Air: _______ cfm @ _______ _____ psig

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October 18, 2005
4.3 Availability
The capsule filler is intended to be operated:
Continuously
Regularly
_________ hours per day
_________ hours per week
Other (specify)
_________________________________________________________________________
________________________________________________________________________
Operation of the capsule filler shall be shut down, and the machine shall be available for
maintenance or service:
_______ hours per week
_______ continuous hours per week
_______ days per month
_______ weeks per year
4.4 Procedural Constraints

The capsule filler shall be designed to meet the appropriate GMP regulations. e.g.: 21 CFR part
210 and 211 as published at the time of order.
Controls for the capsule filler shall meet the appropriate electrical requirements. e.g.: NFPA/NEC
70 and 79 for industrial machinery.
Control panels for the capsule filler shall meet the appropriate certifications. e.g.: Underwriters
Laboratories UL-508A certification for industrial equipment.
The capsule filler shall meet the appropriate safety regulations. e.g.: OSHA regulations for the
safety of operators of equipment with regards to safety, guarding and noise.
The capsule filler shall meet CE requirements if delivered to the European Community.
All piping welds shall meet the appropriate piping regulations. e.g.: ASME and 3A specification
requirements.

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October 18, 2005
Other standards are attached. The Supplier shall adhere to the indicated sections only.
Installation, operation, and maintenance instruction documentation for the system shall be
developed to a level that is comprehensible by a high school graduate.
4.5 Maintenance
4.5.1 The capsule filler shall be maintained on a schedule as indicated by the supplier. Supplier
is to provide (at minimum) the following maintenance instructions.
4.5.1.1 Maintenance activities for all sub-systems (maintenance and operation manuals
of vendor equipment).
4.5.1.2 A comprehensive lubrication list and recommended lubrication schedule.
4.5.1.3 A comprehensive recommended maintenance (regular recommended

inspection intervals, wear points, recommended spare parts list).
4.5.1.4 Supplier shall supply ________ copies of operation, installation, maintenance

and de-commissioning manuals.
5 LIFE-CYCLE
5.1 Development
The Supplier shall provide a Quality and Project Plan as part of its 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
In order to verify machine performance, the User shall witness the execution of the approved
Factory Acceptance Test (FAT) procedures. The Supplier shall notify the User _______ weeks in
advance of the start of this test.

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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.
Refer to the Equipment Validation Plan, attachment ______ , for applicable procedures.
5.3 Delivery
The capsule filler, with all options, equipment, and the documentation listed below, shall be
delivered to the Users receiving dock.
5.3.1 Documentation
The Supplier shall use the formats described in the current version of the GAMP Supplier
Guide 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 in the language of the destination country, and supplied with hard
copies and electronic versions supplied in the format identified for each document:
Project Plan
User Requirements Specification
Functional Specification
Design Specification
Software Module Test
Software Integration Test
Controls Test
Hardware Installation Test
Operational Test
Factory Acceptance Test
Operator, Maintenance and Service Manuals
Process and Instrumentation Diagram (P&ID)

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October 18, 2005
Instrument Listing
Control Schematics
Control Panel Assembly Drawings
Machine Assembly Drawings
Bill of Materials
Spare Parts List
Component Cut Sheets
PLC Program Printout and Disk File
OIP Configuration Printout and Disk File
5.4 Support
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 rigging, installation, start-up and commissioning.
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 support shall consist of monthly User site visits for a period of
_____ years after the completion of commissioning activities.
5.4.4 Technical Support
5.4.4.1 Technical support shall be provided via telephone for a period of _____ years
following the completion of commissioning.
5.4.4.2 A recommended replacement parts list including normal lead times shall be
provided for the machine and all sub-assemblies.

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5.4.5 User Site Support
5.4.5.1 The Supplier shall notify the User of preventative maintenance system
improvement availability.

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6 GLOSSARY
Table 6.0 Glossary

Acronym Definition
ASME American Society of Mechanical Engineers
CFR Code of Federal Regulations
FAT Factory Acceptance Test
GAMP Good Automated Manufacturing Practice
JETT Joint Equipment Transition Team
NEC National Electrical Code
NEMA National Electrical Manufacturers Association
NFPA National Fire Protection Agency
OIP Operator Interface Panel
OSHA Occupational Safety and Health Administration
PLC Programmable Logic Controller
UL Underwriters Laboratories
URS User Requirement Specification
VAC Volts Alternating Current

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7 REFERENCES
Table 7.0 References

Document Attached to URS (Yes / No)
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 Electrical Code

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October 18, 2005
8 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.

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Page 1 of 22

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

USER REQUIREMENTS SPECIFICATION

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

Project No.: _______________________

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

3.1.1.2 Capsules will be filled to the target weight +/- _____%.

3.1.1.5 Commodity Table

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

3.1.2 Product Output

3.1.3 Product Contact Parts

3.1.4 Power Failure and Recovery

A safe state shall be defined as:

All motion stopped on the machine.

3.1.5 Emergency Stop

All motion stopped on the machine.

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

3.1.6 Alarms and Warnings

Protective guards not in place X

Low product level X

Control power fault X

Main air fault X

PLC communication watchdog fault X

PLC battery low X

3.2 Data & Security

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

3.2.2.1 Interface with Operators

An operator-interface panel shall be provided and mounted on the machine. This

Machine drive controls

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

3.2.3 Interface with Supervisors

3.2.4 Interface with Other Systems

3.2.5 Interface with Equipment

3.2.6 Data Collection

3.2.6.1 Data required for collection

JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS SPECIFICATION Doc ID: Capsule Filler

October 18, 2005

3.2.6.2 Data Collection and Storage Requirements

Vertical clearance is _________ inches.

See attached drawing #________________________ (if applicable). Attached drawing

3.3.2 Physical Conditions

Vibration levels are:

Instrument Air: ___ cfm @ _ ___ psig

Vacuum ___ cfm @ _ ___ psig

Suction Air: ___ cfm @ _ ___ psig