Joint Equipment Transition Team

User Requirements Template

for a Vial Washer

Table of Contents

1Introduction

2Overview

3Operational Requirements

3.1Functions

3.2Data & Security

3.3Environment

4Constraints

4.1Milestones and Timelines

4.2Compatibility

4.3Availability

4.4Procedural Constraints

4.5Maintenance

5Life-Cycle

5.1Development

5.2Testing

5.3Delivery

5.4Support

6Glossary

7References

8Approval

REVISION HISTORY

Project No.:Vial Washer 1234

Document No.:8111234567

Document Description: Vial Washer User Requirements Description

1Introduction

This document was generated under the authority of the ______Company for the purpose of specifying the user requirement for an automatic vial washer that will wash packaged vials prior to filling in a pharmaceutical environment. The User Requirements Specification (URS) is provided to aid the user through the important components, variables and options necessary to procure a functional vial washer 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 the vial washer supply 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.

The vial washer will be interfaced to the input of a depyrogenation tunnel, and will be located in a designated operating area within a cGMP packaging operation.

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

2Overview

The vial washer shall wash pharmaceutical vials with the following functions:

• Ultrasonic Bath
• Vial Rinse with Recycled Water
• Vial Rinse with USP Water
• Filtered Air Blow-Off
• Silicone Application

3Operational Requirements

3.1Functions

3.1.1Operation

The vial washer is expected to satisfactorily wash vials at production speeds up to and including ______vials per minute. Satisfactory performance is defined by the following criteria:

3.1.1.1Vials are to be transferred through the vial washer without becoming disoriented, marred, scratched, broken or otherwise damaged in the process. Properly washed vials are defined as those not having any visually detectable levels of dirt, dust, packaging materials or other contaminates on the vial.

3.1.1.2The machine shall not experience more than _____ % downtime at production speeds up to and including the ______vials per rate specified, during an eight-hour production run.

3.1.1.3The machine changeover between vial sizes by a single operator is expected to take no longer than ____ minutes from the last vial out of the prior run to the first vial out of the next run.

3.1.1.4Commodity Table

3.1.1.5Vial Handling

The vial washer shall transfer, wash, air blow and siliconize pharmaceutical grade glass or plastic vials at the rates defined in the commodity table:

The vial washer 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.

3.1.1.6Ultrasonic Bath

Vials shall pass through an ultrasonic bath prior to the wash cycle to remove or loosen any large particulate.

The ultrasonic bath shall fill the entire vial with water and immerse the vial into the bath.

The controls shall have a monitoring circuit to verify that the ultrasonic generator is operating.

3.1.1.7Vial Washing

The Wash Cycle Table shall identify the wash cycle.

3.1.2Product Output

The vial washer shall have a machine efficiency rate of ______%, as measured by the actual number of good vials washed during a one hour test run, divided by the calculated number at the rate defined in the vial commodity table. Machine efficiency rate excludes downtime due to faulty commodities or supply issues.

3.1.3Product 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 that transport the USP water rinse, final air blow, and silicone.

3.1.4Power 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
• All wash functions are stopped

• 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.

3.1.5Emergency 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 wash functions are stopped
• 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.

3.1.6Alarms and Warnings

The vial washer shall be equipped with the following alarms and warnings:

* “Immediate alarms” shall take action immediately to stop the vial washer. The operator shall be required to acknowledge the alarm before the alarm can be reset and the machine restarted.

** “Cycle-Stop alarms” shall take action at the end of a wash cycle to stop the vial washer. 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.

3.2Data & Security

3.2.1Controls provided with a data collection systems 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.

3.2.2Interfaces

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.

3.2.2.1Interface 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 vial washer. The following shall be displayed:

• Machine Drive Controls
• Vial Transfer Controls
• Ultrasonic Bath Controls
• Washing Controls
• Utility Controls
• Alarms and Warnings.
• System Status (e.g., “ready,” “running,” etc.).
• Other (specify).

3.2.3Interface with Supervisors

The PLC/OIP system shall provide supervisory access to specific functions to ensure easy, safe, and reliable configuration of the vial washer. The following shall be accessible only to Supervisors:

• Ultrasonic Bath Level Adjustment
• Recycled Water Temperature Adjustment
• Spray Timing Adjustment
• Vial Counter Reset
• Alarm Settings.
• Other (specify).

3.2.4Interface 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.

The port shall be 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):

• Machine Rate
• Vial Count
• Alarms and Warnings.
• System Status (e.g. “off,” “ on,” “standby” states, etc.).
• Other (specify).

3.2.5Interface with Equipment

The PLC/OIP system may include interfaces with external equipment to ensure safe, continuous transfer of vials without operator intervention.

3.2.6Data Collection

3.2.6.1Data required for collection

• Machine Rate
• Vial Count
• Alarms and Warnings.
• System Status (e.g. “off,” “ on,” “standby” states, etc.).
• Other (specify).

3.2.6.2Data Collection and Storage Requirements

• None

3.3Environment

3.3.1Layout

Allocated floor space for the vial washer is ______inches wide by ______inches deep with a 24 inch corridor around the periphery of the machine.

Vertical clearance is ______inches.

See attached drawing #______(if applicable).

3.3.2Physical Conditions

The vial washer shall be installed in an environment with a temperature range of

______to ______°Fahrenheit and non-condensing humidity.

Vibration levels are:

• Negligible.
• Other (specify).

Electromagnetic interference levels are:

• Negligible.
• Other (specify).

This area is intended for the following use:

• Class D Cleanroom.
• Other (specify).

4Constraints

4.1Milestones 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 vial washer shall be delivered to the User’s receiving dock on or before ______.

The Preferred Format Is:

4.2Compatibility

4.2.1PLC 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.

The Supplier shall identify the impact of adhering to the attached Preferred Manufacturers List.

4.2.2Utilities

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

Secondary Electrical Service:______VAC, ______amps, ______ph, ______Hz

Instrument Air:______cfm @ ______± _____ psig (minimum: 2 cfm @ 80 psig).

Clean, Filtered Air:______cfm @ ______± _____ psig (minimum: 20 cfm @ 25 psig).

USP Water:______gpm @ ______± _____ psig (Minimum: 5 gpm @ 25 psig).

Silicone:______gpm @ ______± _____ psig (Minimum: 0.1 gpm @ 30 psig).

4.3Availability

The vial washer is intended to be operated:

• Continuously.
• Regularly.

______hours per day.

______hours per week.

• Other (specify).

______

• Operation of the vial washer 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.

4.4Procedural Constraints

The vial washer shall be designed to meet the appropriate GMP regulations. e.g.: cGMP 21 CFR part 210 and 211 as published at the time of order.

Controls for the vial washer shall meet the appropriate electrical requirements. e.g.: NFPA/NEC 70 and 79 for industrial machinery.

Control panels for the vial washer shall meet the appropriate certifications. e.g.: Underwriters Laboratories UL-508A certification for industrial equipment.

The vial washer 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 vial washer 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.

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.

4.5Maintenance

4.5.1The vial washer shall be maintained on a schedule as indicated by the supplier. Supplier is to provide (at minimum) the following maintenance instructions.

4.5.1.1Maintenance activities for all sub-systems (maintenance and operation manuals of vendor equipment).

4.5.1.2A comprehensive lubrication list and recommended lubrication schedule.

4.5.1.3A comprehensive recommended maintenance (regular recommended inspection intervals, wear points, recommended spare parts list)

4.5.1.4Supplier shall supply ______copies of operation, installation, maintenance and de-commissioning manuals.

5Life-Cycle

5.1Development

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.

5.2Testing

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.

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.

5.3Delivery

The vial washer, with all options, equipment, and the documentation listed below, shall be delivered to the User’s receiving dock.

5.3.1Documentation

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)
• 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

5.4Support

5.4.1Start-up Support

5.4.1.1Start-up support shall consist of ______weeks of full time assistance on the User’s site for rigging, installation, start-up and commissioning.

5.4.2Training

5.4.2.1User training shall consist of ______hours of Operator training and ______hours of Maintenance training.

5.4.3Post Start-up Support

5.4.3.1Post start-up support shall consist of monthly User site visits for a period of _____ years after the completion of commissioning activities.

5.4.4Technical Support

5.4.4.1Technical support shall be provided via telephone for a period of _____ years following the completion of commissioning.

5.4.4.2A recommended replacement parts list including normal lead times shall be provided for the machine and all sub-assemblies.

5.4.5User Site Support

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

6Glossary

7References