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URS OF COMPRESSION MACHINE 37 STATION DOUBLE ROTARY

URS OF COMPRESSION MACHINE 37 STATION DOUBLE ROTARY

S. No. Table of Contents
1 General
2 Salient Features
3 Operational Requirements
4 Utilities
5 Maintenance
6 Inspection and Testing
7 Commissioning and Documentation
8 Training
9 Packaging
10 Deviations
11 Delivery

TECHNICAL

S. No. Parameters Required Specifications
1.

1.1

General

Equipment No.

 

To be embossed / imprinted conspicuously on the equipment

1.2 Description  37-station double rotary compression machine, D tooling PLC controlled compaction force measurement and it’s monitoring.
1.3 Use The equipment will be used for compression of different product tablets (max. dimension 25 mm), Monolayer and bi layer tablets.
1.4

 

Field Identification

 

 

To be installed in Compression Area of Production Block

(i)       Room Temperature 300C and RH less than 60%

(ii)     Non flame proof area

1.5 Glossary As per Annexure-1
2.

2.1

Salient Features

General

2.2 Material of Construction All the contact part should be of SS 316 and non-contact parts preferrably of SS 304.
2.3 Electrical Construction Non flameproof, the panels and other parts shall be of SS 304.
3.

3.1

Operational requirements

Capacity

 

Output 200000 tablets per hour for Monolayer

Output 44000 tablets per hour for Bilayer

 3.2

 

 

 

 Control

 

Through PLC

PLC based with minimum following features:

i. Recipe management

ii.Initial ON/OFF starter with emergency stop of inching facility

iii.Hour meter for the accumulated running hours.

iv.Initial machine start-up and stop rejection device.

3.2.1

 

 

 

 

Data & Security

 

 

 

 

 

 

 

 

Data controls should address the following issues (preferably)

·Operator interface access levels

·Frequency of data point collection

·Hardcopy/electronic data collection requirements

·Data retention time on the system

·Data storage media

·Language requirement: Information shall be in ‘English’

·Access to all Input/Output values and system status bits shall be provided through a data-communication link.  Security for data and operator access is provided by User ID/Password.

3.2.2

 

 

 

 

User interface with supervisors and operators for the control platform

 

 

This panel shall provide the necessary switches, indicators, and devices to operate.  The following shall be displayed:

·Air pressure.

·Time duration for each stage.

· Alarms and Warnings

· System status ( Ready, Running etc.)

3.2.3

 

 

 

Interface with other equipments and systems

 

The port shall be capable of being configured to communicate the following data to a supervisory control and data acquisition (SCADA) node.  Available shall be:

·All process variables

·Alarms and Warnings

·System status

3.2.4

 

 

Security level

 

 

 

List the total number of different access levels that will be required (minimum three levels). Provide a general description of the access rights for each level (screen navigation, operational control, control loop variable manipulation, alarm set point manipulation, etc.).
3.2.5 Data collection The following shall be recorded:

·Time duration

·Recipe based data

  • Air pressure
3.3 Component Reference details Mentioned here with make
3.4

3.4.1

Functional Requirements

Operation

 

The system shall operate with a minimum of operator involvement. Operation shall be safe form an operator and environmental standpoint.

The system shall be operated locally at the equipment itself.

  • Manual and automatic
3.4.2

 

 

 

 

 

 

 

 

 

 

 

 

Process requirement

 

 

 

 

 

 

  • Type D tooling.
  • Max. tablet diameter 25 mm
  • Max. depth of fill 20 mm
  • Main compaction force data.
  • Auto weight control.
  • Auto tablet rejection.
  • Tablet sampling device.
  • Tight punch monitoring device (Upper Punch)
  • Powder level alarm message.
  • Menu screens to convenient machine set up.
  • Batch documentation / printing option

Ø  Batch data report.

Ø  Recipe report

Ø  Force data report

Ø  Alarm history report.

Ø  On time alarm

  • Security
3.4.3

 

 

 

 

 

 

 

 

 

 

Other requirement

 

 

 

 

 

 

 

 

 

  • Computer integrated and / or PLC control with touch screen operation
  • First aid spare parts shall be supplied along with the machine.
  • Lower punch scrapper seals to be fitted.
  • Overload pressure release to be incorporated as a safety feature, it should be adjusted to relieve the pressure with minimum effort.
  • variable speed drive.
  • Maximum operating pressure for compression station to be 10 ton.
  • Gravity feed frame also to be incorporated in addition to force feeding device.
  • Initial machine start up and stop tablet rejection device.
3.4.4 Alarm System Preferably the sound alarms / beep shall be provided alongwith light indication.
3.4.5 Power failure / recovery In the event of a power failure, the system shall protect product against damage.

Depending upon the options chose in the overview section, the system will:

i. Manually restart based on operator inputs (operator initiates power recovery sequence)

3.4.6 Emergency stop The emergency stop mechanism(s) shall be provided.
4. Utilities

 

 

 

To provide utilities at ONE POINT is user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity etc. of the utilities required.
5. Maintenance

Supplier should provide (at minimum) the following maintenance instructions,

i.      Maintenance and operation manuals alongwith as built drawings

ii.    Lubrication instructions

iii.  Daily checks on machine

iv.  Cleaning procedures

6. Inspection and Testing

 

Equipment shall be inspected and tested by the user at the supplier’s factory w.r.t DQ prepared by Supplier and approved from pharma company before execution.

In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test procedures.  The Supplier shall notify the User two weeks in advance of the start of this test.

The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution.  A minimum of two weeks shall be allowed for the User to review and to comment and/or approve the Factory Acceptance Test Specification.

7.

 

 

 

 

 

 

 

Commissioning and Documentation

 

 

 

 

 

 

 

· IQ/OQ/PQ to be completed by the supplier along with M/s Company representatives.

·The Supplier to demonstrate the Performance of the machine at site as per agreed terms.

·The Supplier to submit the following certificates:

·Exact use in the equipment designed

·Calibration certificates of all the instruments used having traceability to NPL / NIST

·Performance certificates of Tests conducted

·At manufacturers end for Motors / Gear Box / Fan and other critical bought out items with Serial nos.

7.1 Development The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.
8.

8.1

Training

Start up support

 

Supplier to train the respective technical associates of pharma company on operation, maintenance and cleaning of the equipment wherever applicable

8.2 Post start up support Telephone / Fax / E mail ID / Address

Replacement parts availability list (normal lead times shall be listed)

System improvements (supplier shall notify user of any improvements

9. Packaging  Supplier to specify packaging of machine for safe transportation and delivery at the site
10. Deviations Any deviation from URS shall be highlighted.
11. Delivery  As per purchase order. To be delivered at

Company Address

Annexure-1

GLOSSARY

URS User requirement specifications
DQ Design Qualification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
dB Decibels
0C Degree Celsius
OFC Over Fill Capacity
MCB Miniature Circuit Beaker
PLC Programmable Logic Control
CFM Cubic Feet per minute
RH Relative Humidity
Pa Pascals
NPL National Physical Laboratory
NIST National Institute of Standards & Technology
P & ID Process and Instrumentation Diagrams
MS Microsoft
O/L Over Load
SFU Switch Fuse Unit
SPP Single Phase Preventor
MPCB Motor Protection Circuit Breaker
RTD Resistance Temperature Detector
KWH Kilowatthour
TEFC Totally Enclosed Fan Cooled
SCADA Supervisory Control and Data Acquisition
AISI American Iron and Steel Institute
CI Cast Iron
L & T Larson & Toubro
BCH Bhartia Cuttler Hammer
MOC Material of Construction
SS Stainless Steel
MS Mild Steel
MMI Man Machine Interface
RCC Reinforced Cement Concrete
RMG Rapid Mixer Granulator

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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