URS DRY HEAT STERILIZER

ANNEXURE III

User Requirement Specifications

MACHINE :DRY HEAT STERILIZER

CAPACITY: 102 Trays / CYCLE

CLIENT:NDB HEALTHCARE

SUPPLIED BY:AEROVANCE SYSTEMS

Table of Contents

1.0 APPROVAL SIGNATURES.........................................................................03

2.0 INTRODUCTION…...............................................................................................04

3.0 OVERVIEW.................................................................................................. 04

4.0 PROCESS DESCRIPTION.........................................................................05

5.0 DESIGN REQUIREMENT.............................................................................05

6.0 SAFETY REQUIREMENT...........................................................................08

7.0 TESTING & DELIVERY........................................................................................09

8.0 QUALIFICATION REQUIREMENT.............................................................10

..
9.0 TRAINING & TECHNICAL SUPPORT.......................................................11

10.0 GOOD ENGINEERING PRACTICES.......................................................11

11.0 CONSTRAINTS....................................................................................................11

12.0 SCOPE OF SUPPLY..........................................................................................12

.
13.0 ABBREVIATIONS.................................................................................................13
 1.0 APPROVAL SIGNATURES

This document has been prepared and reviewed by the technical team of project management and
approved by following officials of NDB.

Prepared by
Name/ Designation Signature Date

Checked by
Name/ Designation Signature Date

Approved by

Name/ Designation Signature Date

Authorized by
Name/ Designation Signature Date
2.0 INTRODUCTION

This document was generated under the authority of the for the purpose of specifying the
user requirement for an DHS that will sterilize Vials required for Dry product filling. The
User Requirements Specification (URS) is provided to aid the user through the important
components, variables and options necessary to procure a functional bottle washer that
meets the users needs in the most cost-effective method possible. The URS shall be
provided to the Supplier to provide a price quote for machine supply including the design
and manufacture of the equipment.

This URS shall 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 machine shall be installed and operated adjacent to existing conveyor systems as an
integrated Vial filling line and will be located in a designated operating area of DRY filling
and packing facility at production department.

3.0 OVERVIEW

3.1 Project Standard

The facilities, upon completion, shall be in compliance with the cGMP requirement of Drugs
And Cosmetic Act-1940/ WHO and also the NDB’s internal quality standards.

The DHS must be capable of continuous operation over a 8 hour shift, in 3 shifts basis.

3.2 Equipment description

The DHSwill be used for Sterilize of vials to be used for filling of Dry formulation. The
equipment should provide.

• loading: Vials will be loaded to feeding tray and manually pushed.

• Sterilization: Vial Will be sterilized in DHS chamber in the temperature more than 250
deg.

• unloading: Sterilized Vials to be unloaded on the turntable of existing filling line.

3..3 Standard guidelines for equipment

The equipment should comply with the current Good Manufacturing Practice for
Pharmaceuticals
4.0 Technical Specifications
Temperature Range: 100°C to 300°C
Sterilization Temperature: Typically 250°C to 260°C
Uniformity: ±5°C across the chamber
Sterilization Time: Programmable (e.g., 30–120 minutes)
Heating Method: Electric heating elements with forced air circulation
Material: Stainless steel (SS 316 for chamber, SS 304 for outer body)
Insulation: High-grade thermal insulation to prevent heat loss

5.0 DESIGN REQUIREMENT

5.1 Capacity

 Desired speed: 102 Trys/Cycle ◻Yes ◻no

 Loading of Vials on chamber ◻Yes ◻no

 Facility for transfer of Sterilized Vials from machine to chamber should

be provided. ◻Yes
◻no

 Machine to operate with minimal/no change parts for different Vial sizes
with similar neck diameter ◻Yes ◻no

 Vials to be sterilized internally as well as externally on completion of

washing cycle. ◻Yes
◻no

 Vials Sterilization should be achieved uniformly. ◻Yes ◻no

5.2 Control systems

 PLC Based Control

 Real time temperature monitoring
 Alarm systems for Deviation
5.3 Material of construction
 Machine main structure of SS316. ◻Yes ◻no
 Machine external finish :mirror finish ◻Yes ◻no
 Water Tanks & trays made from SS 316 mirror finish. ◻Yes ◻no
 Water contact parts and for Heat generation strictly of SS 316L
◻Yes◻no
 Welding: argon arc type. ◻Yes◻no
 Water transfer pump: SS 316 with mechanical seal( TC toTC) ◻Yes◻no
 All Parts coming in contact to be made from SS316.

◻Yes◻no
 SS filter housing : SS 316. ◻Yes◻no
 Other Exposed parts SS304.r
 Preferred makes for Motor:Kirloskar /Compton Greaves/ Siemens ◻Yes ◻no
 Other mechanical parts/ Motors: non corrosive material

5.4 Design specification

 Pressure guages to be provide at all Chamber stations to detect pressure
of washing jets. ◻Yes ◻no

 Provision for of controller to check the heating temperature ◻Yes ◻no

 Pumps and tanks required to be preferably inbuilt ◻Yes ◻no

5.5 Quality requirement

 No water stagnation in any part of the machine at any given time during
operation /non-operation ◻Yes ◻no
 There should be no water leakage through machine except for drain water.
 Appropriate provision to be made for draining off all the rinse water from
the interior of the Vials is to ensure that there is no residual rinse water left
in the bottle prior to sending for product filling. ◻Yes ◻no

5.6 Utility requirement

 Vendor should state the utilities required for the normal operation of the
machine

 Vendor should provide consumption details for Electricity, water,

Compressed air and Other utilities

o Cables, air tubes, etc required from the point (single utility point) to
equipment is in scope of vendor.
5.7 Operation

 Single operator is expected to operate the machine ◻Yes ◻no

 Machine shall be safe from an Operator and environmental

standpoint. The equipment shall have proper safeguards

 Control System Requirements

Manual/automatic ◻Yes ◻no

5.8 Cleaning and Maintenance

 Filters & spray nozzles should be easy to dismantle & clean whenever
required. ◻Yes
◻no

 Vendor to give information on the cleaning procedure for the machine .

Yes no
 The equipment shall be easily accessible for cleaning the non-product
contact part at maintenance side of the equipment. Yes no

 Vendor shall provide special tools for maintenance of the equipment.

◻Yes ◻no
 Vendor shall give recommended spare parts list. Yes no
 6.0 SAFETY REQUIREMENT

6.1 General

Following facilities must be provided to protect personnel, article and equipment:

 In the event of equipment malfunction or loss of utilities, the unit must contain all
necessary protection devices to ensure that the equipment and the article
remain in a safe condition. ◻Yes ◻no

 Noise level below 75 db at a distance of 1 m from the equipment ◻Yes ◻no

 Emergency stop function on all accessible areas ◻Yes ◻no

 Appropriate failure detection / alarm notification ◻Yes ◻no

 5.1.5 Appropriate closure of all the rotating parts. ◻Yes ◻no

 5.1.6 Proper earthing of the equipment. ◻Yes ◻no

 5.1.7 All electrical/ wirings properly insulated and cancelled ◻Yes ◻no

6.2 Power failure and recovery

 On power failure equipment shall come to rest, to protect operator, equipment

the material and surroundings. ◻Yes ◻no

 On power resumption machine shall operate only after manual starting not directly
◻Yes ◻no

6.3 Failure mode detection

Equipment shall be capable to detect the following failure, notify the operator with
alarm:

 6.2.1. pressure drop at washing stations ◻Yes ◻no

 6.2. 2 Feed water tank level low ◻Yes ◻no

7.0 TESTING AND DELIVERY

7.1 In order to verify labeler performance, the User shall witness the execution of the
Factory Acceptance Test (FAT) procedures. ◻Yes
◻no
7.2 Vendor shall prepare FAT and SAT protocol and get approved from NDB. ◻Yes ◻no

7.3 Delivery

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

7.3.1 Documentation

Installation, operation, and maintenance instruction documentation for the labeling

machine shall be developed

7.3.2 Document format shall comply with the following requirements.

User Requirements Specification
Functional Specification/Requirements Design
Specifications
Controls Test
Hardware Installation Test Operational
Test
Factory Acceptance Test
Operator, Maintenance and Service Manuals
Process and Instrumentation Diagram
(P&ID) Control Schematics
Control Panel Assembly Drawings
Equipment Assembly Drawings
Spare Parts List
other relevant documents
8.0 QUALIFICATION REQUIREMENT

8.1 General

8.1.1 Equipment shall be qualified for design phase (DQ), installation phase (IQ),
Operational phase (OQ) and the performance phase (PQ). ◻Yes ◻no

8.1.2 Vendor shall support client in execution of all the qualification phases. ◻Yes ◻no

8.2 Desired documents

8.2.1 Supply package

Following documents, but not limited to these, are expected from the vendor as part of the
supply package

 Filled in URS ◻Yes ◻no

 Equipment layout drawing fitted in the room layout block ◻Yes ◻no
 Detail technical offer that support the compliance of the URS ◻Yes ◻no
 Critical list of major component, devices and instruments with their
specific functions, specifications data sheet ◻Yes ◻no
 Schematic diagram of the equipment. ◻Yes ◻no

8.2.2 Post ordering

Functional design specification and technical specification, that should contain the following:

• Equipment descriptions and its function ◻Yes ◻no

• Equipment operation steps ◻Yes ◻no
• List of failure indications ◻Yes ◻no
• List of input/outputs and its functions ◻Yes ◻no

8.2.3 Delivery of the equipment

Vendor shall provide the following documents in the delivery package

 Operation and maintenance manuals, preventive maintenance schedule for

equipment major component as well as the operating system. ◻Yes
◻no
 Installation instructions/ guideline for equipment. ◻Yes ◻no
 Detailed drawing marking clearly all the necessary dimensions and locations of
utilities along with requirement of utilities on the drawing along with the offer.
◻Yes ◻no
 Spare and/ or change parts list with ordering information. ◻Yes ◻no
 Types of Lubricants used for lubrication and specification. ◻Yes ◻no
 Instrument calibration certificates. ◻Yes ◻no
 Guaranty/ warranty certificates for each equipment. ◻Yes ◻no
 MOC certificates for S316 material used for the machine. ◻Yes ◻no
9.0 TRAINING & TECHNICAL SUPPORT

9.1 User training shall consist of minimum 2 days of Operator

training and 1 day of Maintenance training.

9.2 Technical support shall be provided by personnel visit via telephone / electronic
media for a period of one years following the completion of validation activities.

9.3 A recommended replacement parts list including normal lead times shall be provided
for the machine

10.0 GOOD ENGINEERING PRACTICES

10.1 Equipment must be fabricated following all Good Engineering Practices. The
vendor’s Quality System must follow applicable national standards

10.3 All sensors, controllers, PLC, indicators and will have to be calibrated,
Original calibration certificate to be submitted by the vendor ◻Yes ◻no

10.4 All material of construction should have test certificates. ◻Yes ◻no

11.0 CONSTRAINTS

Equipment location and available space at NDB

11.1 This equipment will be installed in the existing available area -

 L X B X H: 1000 X 900 X 880 mm

 Floor: Ground Floor
 Department: DPI (Production)
 location : Jet vial Washing Area

11.2 Site visit preferred for the confirmation of exact location for new installation of the
machine
12.0 SCOPE OF SUPPLY

1. The supply, installation, commissioning and validation has to be done by

the supplier at ‘NDB Healthcare. However FAT will be perform by NDB
team at manufacture site.

2. Vender shall depute their technical person for installation, commissioning

and validation of machine.

3. All utility points such as electrical, compressed air line shall be provided
by NDB.

4. Utilities such as vaccum is in scope of the manufacturer

5. All the cabling, electrical fittings , transfer pipes etc., up to the functional
point ( single utility point) is in the scope of NDB and from functional point
to the respective machine shall be in the scope of manufacturer.

6. Proper Concealing/ aesthetics of all electrical cables used for the machine is in
the scope of manufacturer/supplier

7. Vendor shall prepare FAT protocol and get approved from NDB.

8. Vendor shall prepare qualification document protocol and get approved from
NDB
.
9. Calibration of instruments/ components is in the scope of vendor.

10. Vendor shall provide necessary test certificates at the time of installation.

11. Warrantee - 12 months from the date of commissioning.

12. Proper earthing to the machine is in the scope of the manufacturer/ supplier

13. DQ/IQ/OQ is in the scope of manufacturer/ supplier

14. Specific requirement for motor - Kirloskar / Compton Greaves/ Remi / Bharat
Bijlee
13.00 ABBREVIATIONS

01. URS : User Requirement Specifications

02. cGMP : Current good manufacturing practices

03. UV : Ultra Violet

04. FAT : Factory Acceptance test

05. SA : Site acceptance Test

06. DQ : Design Qualification

10. OQ : Operational Qualification

11. PQ : Performance Qualification

12. IQ : Installation Qualification

13. WHO : World health Organization

14. SS : Stainless Steel

15. TC : Technetium

16. µ : Micron

17. NLT : Not Less Than

18. SAT - Site Acceptance Test

19. DHS - Dry heat Sterilizer