User Requirements Specification

Documents No ……………… V-blending mixer Page :

……………

Description ……………… ……………

Department ……………… Date :........

Table of Contents
1. Introduction
2. Overview
3. Operational Requirements
3.1 Commodities
3.2 Performance
3.3 Functions
3.4 Power Failure and Recovery
3.5 Emergency Stop
3.6 Alarms and Warnings
3.7 Data and Security
3.8 Interfaces
3.9 Supervisory interface
3.10 Data Collection
4. Environment
4.1 Layout
4.2 Physical Conditions
5. Constraints
5.1 Milestones and Timelines
6. Compatibility
6.1 Controls
6.2 Product Contact Parts
6.3 Utilities
7. Availability
7.1 Duty Cycle
8. Procedural constraints
8.1 Regulatory Compliance
9 Maintenance
9.1 Instructions
9.2 Tools
9.3 Spare Parts
10. Life-Cycle
10.1 Development
10.2 Testing
10.3 Delivery
10.4 Documentation
10.5 Support
11. Glossary
12. References
13. Approval
 Revision History

Date Approval Revision

Summary

1. Introduction

This document was generated under the authority of the CPE Consortium for the purpose of
specifying the user requirement for a range of V-blender powder mixing from 20 kg to 250 kg
/batch in a pharmaceutical environment. The User Requirements Specification (URS) is provided
to define the important components, variables and options necessary for the Supplier to provide a
functional V-blender system that meets the CPE Consortium needs in the most cost-effective
method possible. The URS is also provided to the Supplier to provide a price quote for V-blender
supply including the design and manufacture of the equipment.

This URS is an integral part of the procurement agreement with the Supplier. The Supplier will
abide by the information and conditions set forth by this document as well as the standard
purchasing terms and conditions of the CPE Consortium.
The V-blender mixing will be located in a designated operating area within a cGMP operation.
An equipment validation plan has been developed to outline the planned tasks and expectations for
validation of the mixing from 20-250 kg/batch. This plan has been included as Attachment A. The
Supplier has specific responsibilities as outlined by the equipment validation plan and this
document.

2. Overview

The V-blender shall process pharmaceutical mixing of powder with the following functions
1. Manual operation for transfer powder premixing to V-blender
2. Operation of blender with set-up specific time and speed of rotation
3. Manual discharge from V-blender by outlet in bin-transfer

3. Operation requirements

3.1. Commodities or raw materials premixing

V-blender will be used for mixing APIs and excipients that have granular range from ……. Mesh to
……………. and density around ………. g/dm3 to …………..

3.2. Performances

1. The V-blender is expected to operate properly with minimum volume ………..L

to………..L at one time of mixing.
2. The duration of powder blending shall range from ……………. to ……………….
3. The operation of unloading and discharge mixing powder shall be operable by one person.
4. The % residual mixing powder is attached on the wall of the blender not over …………%.
5. Discharge valve of the V-blender shall be large enough for freely flow finished powder
 mixing (not an obstacle) within commodities 3.1 conditions.

3.3. Fonctions
1. A motor drives the blender and operates at a fixed speed, the two inclined cylinders
intermeshing their flows, causing a radical blending action.
2. As it rotates, the solid particles of powder will arrange thought by the main principle of bulk
transport, turbulent flow.
3. By predetermined of duration operating , the mixing powder will discharge throughout
discharge valve by only gravitation

3.4. Power Failure and Recovery

1. On power failure, the system shall fail into a “safe state”.
- All motion stopped on the machine.
- Reset required before the machine can be restarted.
- No damage to the machine will occur as a result of going to the safe state.
2. On power restoration, the system shall not restart without operator or communication-link
input
3. All equipment shall be designed to retain the PLC program in case of power loss, and be
recoverable with minimal operator actions.

3.5. 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 on the machine shall stop in a safe manner
+ No damage to the machine will occur as a result of an emergency stop
+ Emergency stop will seal product path or take actions to prevent product
contamination if so equipped
+ 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
+ All Emergency stops shall be hard wired to disconnect the device power.

3.6. Alarms and Warnings

The V-blender shall be equipped with the following alarms and warnings at a minimum:

Alarm Number Alarm Description Immediate Operate

Alarm Or Stop* Alert**
Warning

1 Emergency Stop ✓

2 Interlocked barrier guards Door ✓

3 Motor fault ✓

4 Alert operator after opening Inlet and outlet ✓

valve
 5 Alert operator after finish time running ✓

* “Immediate stop alarms” shall take action immediately to stop the V-blender.
The operator shall be required to acknowledge the alarm before the alarm can be reset and the
machine restarted
** “Operator Alert alarms” allow the machine to continue to run, but display an
“alert” message on the operator screen. The operator shall be required to acknowledge the alert in
order to remove the message from the operator screen

In addition to the alarms in the above table, the following controls require alarms:
- All machine safeties that control the equipment to a stop require alarms
- All motion overtravel faults require alarms
- All motion control not running faults require alarms
- All communication faults require alarms

3.7. Data & Security

- Controls provided with data collection systems intended for use in the manufacture of
pharmaceutical products shall comply with 21 CFR, Part 11 of the FDA cGMP regulations.
- The Supplier shall stipulate the methods by which 21 CFR, Part 11 is met
- Control panels housing PLCs or data processors shall be provided with the capability of
being locked externally.

3.8. Interfaces

The Programmable Logic Controller / Human Machine Interface system (hereafter referred to as
the“PLC/HMI system”) shall include interfaces with the Operator, Supervisors, external equipment,
and the User’s control system to ensure safe, reliable, continuous, automatic operation and easy,
safe, reliable configuration.

- Interface with Operators

+ The HMI shall control all machine functions
+ The HMI shall display all alarms resulting from the machine controls
+ The HMI shall include provisions for configuration of current settings, time and
date operation
3.9. Supervisory Interface

Interface to the Supervisor

Batch data shall be available to the Supervisor from the HMI. Accessible data shall include:
- Name of drugs
- Lot
- Duration
- Date operation
- Name of operator

3.10. Data Collection

Data Collection and Storage Requirements : None

4. Environment
- Layout
 + Allocated floor space for the V-blender is 2.5 m long by 2 m wide and high 3 m
with a 0.5 m corridor around the periphery of the machine
- Physical Conditions
+ The V-blender shall be installed in a class D clean-room environment , a temperature
range of 20-25 0C and humidity 15-65%
+ Maximum displacement of the machine due to vibration is 0.5 cm.

5. Constraints

5.1 Milestones and Timelines

Baseline : Equipment acquisition model

User ( Consultant if applicable ) Supplier

Master Validation Plan User Audit of Supplier

• User Initiates

Equipment Validation Plan Proposal

• Explanation to Supplier • Quality Plan
(Living Document) • Project Plan

User Requirements Specification Functional Specification

(URS) (Traceable to URS)
(Living Document)

Proposal Analysis Functional Specification

(Traceable to URS)

Review Functional Specification Detailed Design

Documentation
(traceable to Functional Specification)

Review Detailed Design System Acceptance Test

Specifications (IQ/OQ)
• Hardware
• Software

Review System System Acceptance

Acceptance Test Specifications Testing and Results
(User Witness Optional)

Integrate with Validation Maintenance & Support

Documentation (as appropriate) Documentation

- The Supplier shall provide a written proposal within 3 weeks of receipt of this document at
the Supplier’s local office.
- The Supplier shall provide a Functional Specification within 4 weeks of receipt of the
purchase order
- The User shall review, comment and/or approve, and return the Functional Specification to
the Supplier within 3 weeks of receipt from the Supplier
- The Factory Acceptance Test shall be executed at the Supplier’s site on or before
- The wide range filler shall be delivered to the User’s receiving dock on or before
6. Compatibility
1. Controls
- The Supplier shall utilize Allen Bradley manufactured programmable logic
controllers that shall include communications capabilities
- The Supplier shall provide documentation that the program (embedded software) was
developed and coded following the GAMP Guidelines for program development and
software documentation.
- The Supplier shall identify the impact of adhering to the attached Preferred
Manufacturers List

2. Product Contact Parts

- Product contact parts are defined as those parts that come into direct contact with the
materials being processed. This includes parts contacting the powder and stoppers
- All product contact parts shall be constructed from 316L stainless steel or approved
plastics. Stainless steel components will have a finish of < 30 Ra and be
electropolished
- All product contact parts shall be marked with a lot identification that is traceable to
product contact part documentation
- Material certification shall be provided for all product contact parts
- Weld certification shall be provided for all product contact parts, including weld
maps, inspection reports and welder certifications where applicable.
- Surface treatment reports or certificates shall be provided for all product contact
parts.

3. Utilities
- The electrical services available are:
+ 440-480 volt, 3 phase, 60 Hz delta with ground
+ 208 volt, 3 phase, 60 Hz with ground
+ 120 volt, 1 phase, 60 Hz with ground
+ If a source other than listed above is required, the transformer must be
supplied in the controls
- The compressed air services available are:
+ If the equipment requires regulated and/or oiled compressed air, the
regulators and oilers must be supplied with the equipment.
7. Availability
1. Duty Cycle
- The Wide Range Filler is intended to be operated two shifts daily for five days per
week
- Operation of the wide range filler shall be shut down, and the machine shall be
available for maintenance or service:
+ Third shift during the week.
+ Saturday, Sunday and holidays

8. Procedural constraints
1. Regulatory Compliance:
- The wide range filler shall be designed to meet the appropriate GMP regulations
including cGMP 21 CFR part 210 and 211 as published at the time of order
- Controls shall meet the National Electrical Code NFPA/NEC 70 and 79 for industrial
machinery, as applicable
- Control panels shall have Underwriters Laboratories UL-508A certification for
 industrial equipment
- All piping and welds for the product path shall meet the ASME and 3A specification
requirements, as applicable.
- Wiring on the machine and in the control cabinets shall be terminated at both ends
and match the numbering shown in the documentation.
- Control components shall be identified with a tag number consistent with the
documentation.
- Format change parts shall be identified with the part number and commodity size it
will be used for.
- Installation, operation, and maintenance instruction documentation for the system
shall be developed to a level that is comprehensible by a high school graduate

9. Maintenance
1. Instructions
- A schedule will be provided that identifies maintenance items and duration intervals
- Adjustment points shall be identified, and instructions provided on the adjustment
- Lubrication points are to be identified with the type and quantity of lubrication
included.
- Installation, operation, and maintenance instruction documentation for the system
shall be developed to a level that is comprehensible by a high school graduate.
2. Tools
- The equipment shall be designed to use standard, readily available tools for
maintenance and repairs
- Any special tools required for maintenance of equipment shall be identified, with a
source for that tool provided
3. Spare Parts
- A suggested spare parts listing will be provided that includes:
+ Normal wear parts
+ Parts that are easily broken
+ Parts that can wear out, and are long lead time availability.
+ Electronic components that are not readily available from a local source to
the User.
- The Supplier will either stock frequently required spare parts, or provide the
manufacturer name and part number for those parts
10. Life-cycle
- 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.
- Testing
+ In order to verify machine performance, the Supplier shall provide an
approved Factory Acceptance Test (FAT) protocol to the User for review and
approval 4 weeks prior to FAT.
+ The Supplier shall notify the User 2 weeks in advance of the start of this test
- Delivery .
 + The wide range filler, with all options, equipment, and the documentation
listed in section 10.4, shall be delivered to the User’s receiving dock.
- 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 documents shall be in the language of the destination country
+ All documents shall be supplied in the format identified for each document as
listed below:
1. Project Plan (Paper or .pdf)
2. Functional Specification (Paper or .pdf)
3. Design Specification (Paper or .pdf)
4. Software Integration Test (Paper or .pdf)
5. Controls Test(Paper or .pdf)
6. Operator, Maintenance and Service Manuals(Paper or .pdf)
7. Process and Instrumentation Diagram (P&ID) (Paper or .pdf)
8. Instrument Listing (Paper or .pdf)
9. Control Schematics (Paper or .pdf)
10. Control Panel Assembly Drawings (Paper or .pdf)
11. Machine Assembly Drawings (Paper or .pdf)
12. Bill of Materials (Paper or .pdf)
13. Spare Parts List (Paper or .pdf)
14. Component Cut Sheets (Paper)
15. PLC Program Printout and Disk File (Electronic downloadable)
16. HMI Configuration Printout and Disk File (Electronic downloadable)
- Support
+ Start-up Support
Start-up support shall consist of 2 weeks of full time assistance on the User’s
site for rigging, installation, start-up and commissioning
+ Training
User training shall consist of 8 hours of classroom training and 16 hours of
equipment training.
Formal training materials specific to the equipment shall be provided for 8
personnel.
Certificates of training shall be provided for each person completing the
training program.
The training shall be given by certified instructors and technicians familiar
with the equipment.
+ Post Start-up Support
Post start-up support shall consist of monthly User site visits for a period of 1
year after the completion of commissioning activities
+ Technical Support
Technical support shall be available via telephone for a period of 5 years
following the completion of commissioning
A recommended replacement parts list including normal lead times shall be
provided for the machine and all sub-assemblies
 + User Site Support
The Supplier shall notify the User of preventative maintenance system
improvement availability.

11. Glossary

Acronym Definition

°C Degrees Celsius

ASME American Society of Mechanical Engineering

CFR Code of Federal Regulations

cGMP Common Good Manufacturing Practices

FAT Factory Acceptance Test

FDA Food and Drug Administration

GAMP Good Automation Manufacturing Practices

HEPA High Efficiency Particulate Array filter

HMI Human – Machine Interface

Hp Horsepower

Hz Hertz

JETT Joint Equipment Transition Team

NEC Joint Equipment Transition Team

NFPA National Fire Protection Association

OSHA Occupational Safety and Hazards Administration

P&ID Piping and Instrument Diagram

PLC Programmable Logic Controller

PSI Pounds per Square Inch

SAT Site Acceptance Test

SCADA Supervisory Control and Data Acquisition

URS User Requirement Specification

WFI Water For Injection

12. References
 Table references

Document Attached to URS (Yes / No)

Equipment Validation Plan Yes

Room Layout Drawing Yes

Commodity Drawings Yes

User Preferred Component Listing Yes

Current revision of GAMP Guidelines No

21 CFR part 210 and 211 No

21 CFR Part 11 No

NFPA/NEC 70 and 79 No

13. Approval

This document has been reviewed by the CPE Consortium Project Manager and approved for use
by the Supplier

……………………………….., ………………………………………….,
…………………………….
Printed/Typed Name Signature Date

This document has been reviewed by the CPE Consortium 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