PHARMA SCHOLARS

PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 1 of 12

USER REQUIREMENT SPECIFICATION

NAME OF THE ITEM: CP-150 CARTON PACKING MACHINE

FUNCTIONAL AREA: PRODUCTION

PROTOCOL No. :

Page 1 of 12
 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 2 of 12
CONTENT

Sr. No. Description

1.0 URS Approval

2.0 Objective
3.0 Responsibilities
4.0 Equipment Description & Identification
5.0 User Requirements
6.0 Complementary aspects
7.0 Safety and environmental Protection
8.0 Cleaning maintenance and service
9.0 Rules and Regulation
10.0 Scope of Delivery
11.0 Installation ,Commissioning and Tests
12.0 Qualification/Validation
13.0 Guarantee/Warrantee

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 3 of 12
1.0 URS APPROVAL:

Protocol Prepared By:

Functional area Name Signature Date

Production

URS Reviewed By:

Functional area Name Signature Date

Production

Quality Assurance

Engineering

URS Approved By:

Functional area Name Signature Date

Head Engineering

Head Manufacturing

Head Quality

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 4 of 12
2.0 Objective:

The purpose of this document is to ensure that all the critical aspects of the Equipment, cGMP & Safety
features have been considered in designing the equipment/instrument and is properly documented.

3.0 Responsibilities:

In accordance with the document, following functions shall be responsible for initiation and finalization of
Equipment user requirement specification. When the work is carried by contract/ consulting staff, all the work
is to be performed under the oversight of …………….

3.1 Preparation of Document

• User department to prepare the URS

• Ensures that the document is in compliance with current policies and procedures of cGMP regulations.
• Ensures that the content is sufficient, clearly defined, technically sound and accurate.
• It is a Guidance document to prepare the URS.

3.2 Review of Document

• To be reviewed by Head of the user department and functional department ( Engineering & Quality assurance)

3.3 Approval of Document

• Approval of document by Head Manufacturing/Head Engineering/Head Quality.

4.0 Equipment Description & Identification:

4.1 Scope:
This document covers all aspects of Users requirements for the Equipment along with all Attachment,
Spare Parts, Change Parts and Accessories to be used in …………………

Scope incorporates understanding and documentation of critical requirements such as system

requirements, cGMP requirements, safety requirements, documentation requirements and operational
requirements.

4.2 Purpose:
Purpose of equipment is to carry out the Carton packing in oral Packing area .

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 5 of 12
5.0 USER REQUIREMENTS

5.1 System Requirements:

Sr. No. SYSTEM COMPONENTS SYSTEM REQUIREMENTS

01. Identification Details of Make, Name, Serial. No., Capacity, Model and Year of
(In case of
manufacture should be available
Equipment /Instrument)
02. Model/Type As per current CGMP requirements.

03. Capacity UP to 150 carton/minute

04. Potential Suppliers 1.Pam-Pac

05. Contact parts (In case of SS304 with Matt finish

Equipment)
06. Non contact parts (In case of SS304 with matt finish
Equipment)
07. Non metallic contact parts 1. Any material with food grade quality having no
(In case of
Potential impact on the products.
Equipment /Instrument)
2. Durable.
3. Must be easily cleanable.
08. Motor & Electrical installations (In case As per machine requirement
of
Equipment /Instrument)
09. Machine assemblies (In case of Must be covered with SS 304 with matt finish.
Equipment /Instrument)
10. Machine adjustments (In case of Setting with Zero clearance with good accuracy.
Equipment /Instrument)
11. Packaging & Transport Should be packed and transported in such a way to avoid any
damage during transportation.
12. No. of requirements 01

13. Requirements for any power failure To be backed up by installed in-house DG set.
backup’s (In case of
Equipment /Instrument)

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 6 of 12
5.2 Technical Description

Sr. No. Specification SYSTEM REQUIREMENTS

1. Carton Magazine should be provide with Capacitive sensor for the YES
sensing of carton level.
2. Fallowing system available in machine:- YES
1.Carton positioning system
2. Rear side flaps folding station
3. Front side flap opening station
4. Product pushing system
5. Front side flap closing system
6.Tuck-in flap closing system(front and rear side)
7. Carton discharge
8. Carton chain
90. Product chain
10. Product pusher
11. Product sensor
12. Product top support
13. Empty carton rejection system
14. Embossing unit
15. Printing unit
16. Leaflet folding and transfer system
17. Pre folded leaflet insertion system.
18. Counting and collating system.
29. Gluing system
20. Vial / bottle transfer system
21. Printing unit

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 7 of 12

6.0 COMPLEMENTARY ASPECTS

6.1 Training

Sr. No. Specification SYSTEM REQUIREMENTS

6.1.1 The vendor Shall supply all available information for the YES
adequate exploitation of equipment. For the Compliance of
this purpose at the Job site and/ or at the Vendors Shop.
Vendor’s technical staff shall train customer’s personnel.
The scope of the
Training will be agreed during the contract signature.
6.1.2 The supplier is to include the personnel training activities. YES
The contractor is to specify the foreseen time for:
• Operator/Supervisor training
• Manager Training
• Electrical maintenance training
• Mechanical Maintenance training
6.1.3 The contractor is to specify the personnel background YES
needed for each of the operators maintenance.

6.2 Pre Delivery Qualifications (FAT)

Sr. No. Specification SYSTEM REQUIREMENTS

6.2.1 The System or its parts as provided for in the scope of supply YES
shall be pre-installed at the vendors shop prior to delivery to
customer site. Installation will be completed and documented
including mechanical parts as well as electrical connections
of all parts to facilitate taking over tests at Vendors shop
prior to delivery.

6.3 Supplier Technical Documentation Requirements:

Sr. No. COMPONENTS REQUIREMENTS

6.3.1 Drawings Pre Installation Requirements will be supplied
• Equipment/Systems electrical drawing.
by Vendor
• Point to point wiring diagram
6.3.2 LIST.
• Equipment and instrument list with Component
YES
description.
• Electrical component parts list with
Description. YES
• Function check list.
YES
• Documentation list. YES

• Spare part list List of spares required for smooth operation will
be
provided by the Vendor at the time of ordering.

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 8 of 12
6.4 Technical Manuals

Sr. No. Specification Requirements

6.4.1 Operating handbook YES
6.4.2 Trouble Shooting Guide YES
6.4.3 Equipment Description YES
6.4.4 Equipment specification YES
6.4.5 Calibration Instruction YES
6.4.6 Maintenance Instruction YES
6.4.7 Maintenance Handbook YES

7.0 SAFETY AND ENVIRONMENTAL PROTECTION

Sr. No. Specification Requirements

7.1 All motors have to be thermally Protected. YES
7.2 All the Installation must be in accordance with the cGMP. YES
7.3 The cGMP concerning safety must be applied. YES

8.0 CLEANING MAINTENANCE AND SERVICE

Sr. No. Specification

8.1 In accordance with cGMP guidelines the units must be easy to clean, to disinfect, and where necessary, to
sterilize.
8.2 The Supplier should guarantee that, if required, a service team can be on site within one working day.

8.3 The design should be such as to allow mechanical cleaning of the surface and that the cleanliness of the
surface can be checked easily.
8.4 All machine parts, in particular instrumentation, should be constructed so that they can be easily removed and
calibrated.
8.5 All special tools required for running and maintenance should be best.

8.6 A spare parts delivery guarantee with in time.

9.0 RULES AND REGULATION

These standards, recommendation and requirements are considered the minimum. Specifications that are more
stringent or expansive take the precedence. In case of conflict between published requirements, final determination is
the responsibility of the Owners Representative.

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 9 of 12
10. SCOPE OF DELIVERY

Sr. No. Specification Requirements

10.1 Units described in the specific system requirements including all necessary controls YES
and instrumentation.
10.2 The complete mechanical and electrical installation. YES

10.3 The Connections to all the necessary utilities, exhaust, and waste lines necessary for Yes
its operation.
10.4 All piping and cabling of the units itself. YES

10.5 Wiring and cable run: all wiring and cable run is part of the supply. ……………….. YES
will supply the main power switches to be located in correspondence to the electrical
and control cabinets delivered by the equipment supplier.
10.6 All internal contacts of the supplied equipment for the required utilities. YES

10.7 Unload on site of the equipment: the supplier is required to define all the necessary YES
handling devices required to the unloading operation.
The supplier will inform at least 4 weeks in advance the day of delivery and the list of
required handling devices.
10.8 Assembling operation: the required consumable, the internal transportation, the YES
assembling tools and the required personal are part of the supply.
10.9 A complete set of commissioning spare parts. YES

10.10 All special tools necessary for use and maintenance of the supplied equipment. YES

10.11 A complete set of two years spare parts should be listed quoted and offered as option. YES

10.12 All test activities as specified in this document. YES

10.13 Training in the use and maintenance of the equipment. YES

10.14 A complete set of documentation as specified YES

In this document.

11.0 INSTALLATION, COMMISSIONING AND TESTS

11.1 General

Sr. No. Specification Requirements

11.1.1 The Contractor must specify for each piece of equipment the Guaranteed YES
performance and the guaranteed system performance. These values will be tested
during the acceptance tests.
11.1.2 In addition the functionality described in the user requirements and detailed in the YES
system specifications will be tested.

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 10 of 12
11.2 INSTALLATION , COMMISSION

Sr. No. Specification Requirements

11.2.1 The commissioning tests will be carried out in accordance with a written test plan YES
developed by the supplier with clearly stated test procedures and acceptance criteria.
11.2.2 The contractor will approve successfully completed tests and will specify items YES
requiring additional work. Representatives from …………… Will attend and
participate in the commissioning tests as required.
11.2.3 The installation and commissioning of the system will be performed at the YES
………………… Facility by the contractor.
11.2.4 The commissioning can only start once all the foreseen documents have been YES
delivered by the supplier to ……………………
11.2.5 All equipment should be properly installed, adjusted, leveled, tagged, and connected YES
with utilities.
11.2.6 Point to point checks on wiring and pneumatic should be performed. YES

11.2.7 All instruments should be properly calibrated. YES

11.2.8 A equipment ( instrument) used for qualification must be listed and approved by YES
………………………
11.2.9 The calibration equipment must have all the necessary documents to demonstrate YES
their maintenance & use.
11.2.10 The last calibration of all this equipment must be less than 6 months old, and YES
evidenced by certificate.
11.2.11 Verification that the interior surfaces of equipment are free of practices and dirt and YES
all points of product contact meet the specified material requirements.
11.2.12 All the clearances and tolerances specified in the drawing or recommended by YES
component manufacturers are correct.
11.2.13 On site verification that valves and other equipment with moving parts are in their YES
normal position if in a power down condition and move in the correct direction with
the correct speed and precision.
11.2.14 Verification that all the Input and Output points are connected and labeled according YES
to the documentation and that all the along the input values have been scaled in
accordance with the system specification and process requirements. That all
equipment components requiring configuration
11.2.15 The commissioning should demonstrate that the system supplied by the contractor YES
has been properly installed and that the functions are in accordance with

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 11 of 12
Sr. No. Specification Requirements

…………… User Requirements specifications, Vendors System specifications

Manuals and other Documentation.

11.3 Site Acceptance Test (SAT)

Sr. No. Specification Requirements

11.3.1 This test will be carried out once the commissioning will be completed. The scope YES
will be to verify the performance and the functionality of the system integrated with
the other factory systems (Including sterility testing of at least 02 days).
11.3.2 The test will be carried out to verify the system response with the expected YES
productivity of the system.
11.3.3 Details on the test realization will be defined during the project Phase. The supplier YES
is asked to specify the proposed duration for SAT and the standard procedure
proposed.
11.3.4 During SAT the required functionality, performances and system reliability are met. YES

11.3.5 The Functionality described in the User Requirements Specification and in the YES
System Specifications are verified and met.
11..3.6 All the documentation agreed has been delivered. YES

12.0 QUALIFICATION / VALIDATION

Sr. No. Specification Requirements

12.1 The maintenance Qualification is responsibility of the customer. However, the YES
supplier is responsible for delivering the basic documents for maintenance
qualification.
12.2 This includes all side costs such as : calibration measuring equipment and YES
instruments: manpower (IQ and OQ will take place completely on ………………
12.3 Time Schedule for IQ/OQ execution will be developed by ……………. With the YES
supplier.
12.4 Suppliers personnel used for IQ/OQ must be well trained and experienced. This YES
should be documented.
12.5 The onsite test run performed by the supplier might become part of the IQ. YES

12.6 Main IQ/OQ steps such as calibration must be performed and documented in YES
accordance to a SOP approved by ………………….
12.7 All equipment used for qualification must be listed and approved by …………… YES
The calibration equipment should be well documented.
12.8 The last Recalibration of all this equipment should be less than 06 month old. YES
Proofed by Certificate.
12.9 OQ can only start after IQ approved by …………………. YES

12.10 IQ will be carried out by ……………….. During Installation phase. IQ will include YES
the tests performed by the contractor.
12.11 Part of the OQ will be carried out by ……………. During commissioning and SAT YES
phase. OQ will include the tests performed by the contractor.
12.12 After installation of the equipment at customers site. Complementary IQ & OQ tests YES
will be performed by the Customer and may be supervised by a member of

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 PHARMA SCHOLARS
PRODUCTION DEPARTMENT

USER REQUIREMENT SPECIFICATION

NAME OF ITEM: CARTON PACKING MACHINE PROTOCOL No..........................
FUNCTIONAL AREA: PRODUCTION Page No.: 12 of 12
Sr. No. Specification Requirements

Technical staff.

12.13 Qualification documents DQ, IQ, OQ & PQ

(In case of equipments/Instruments)

13.0 GAURANTEE/WARRANTEE

Sr. No. Specification Requirements

14.1 The System must be guaranteed including all the sub- system and components for a YES
period of 12 months from the date of the system acceptance for a 03- shift operation.
14.2 The servicing companies involved for the Sub- systems maintenance must be YES
declared and the maintenance group organization described. Furthermore, the
contractor will be directly responsible of the system assistance and the required
operation will be co- ordinate by him.
14.3 In case of failures, the intervention will be guaranteed by the contractor within a YES
maximum time limit. The contractor is asked to specify the maximum time limit.
14.4 The supplier is asked to propose as option maintenance and assistance contract after YES
the guarantee expiration.

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