Capsule Filler Urs

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JETT

USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

USER REQUIREMENTS SPECIFICATION for Capsule Filler

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JETT

USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 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

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JETT

USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

REVISION HISTORY Rev. 0

Date 10/18/2005

Approval TGP

Revision Summary Initial Release to JETT Website for use.

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JETT

USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 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 user’s 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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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 Capsule Size

Fill Medium

Fill Weight

Rate (Capsules/Min)

Comments

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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

3.1.6 Alarms and Warnings The capsule filler shall be equipped with the following alarms and warnings: Alarm Or Warning

Immediate*

Emergency stop

X

Protective guards not in place

X

Operator Alert**

No capsules

X

Low product level

X

Control power fault

X

Main air fault

X

PLC communication watchdog fault

X X

PLC battery low

* “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 User’s control system using commonly accepted standards.

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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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 User’s 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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JETT

Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

3.2.6.2



Machine rate



Alarms and warnings.



System status (e.g. “off,” “ on,” “standby” states, etc.)



Other (specify)

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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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 Supplier’s 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 User’s receiving dock on or before _________________. The Preferred Format Is:

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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 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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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 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 User’s 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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

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 User’s 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

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Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005



Process and Instrumentation Diagram (P&ID)



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 User’s 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.

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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

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.

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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Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

6 GLOSSARY Table 6.0 Glossary Acronym ASME

Definition 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 OSHA

Operator Interface Panel Occupational Safety and Health Administration

PLC

Programmable Logic Controller

UL

Underwriters Laboratories

URS

User Requirement Specification

VAC

Volts Alternating Current

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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 October 18, 2005

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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USER REQUIREMENTS SPECIFICATION

Capsule Filler

Doc ID: Capsule Filler Rev. 0 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.

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

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Date