URS OF COMPRESSION MACHINE 37 STATION DOUBLE ROTARY

1.1

Equipment No.

To be embossed / imprinted conspicuously on the equipment

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

(ii)     Non flame proof area

2.1

General

3.1

Capacity

Output 200000 tablets per hour for Monolayer

Output 44000 tablets per hour for Bilayer

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.

·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.

·Air pressure.

·Time duration for each stage.

· Alarms and Warnings

· System status ( Ready, Running etc.)

·All process variables

·Alarms and Warnings

·System status

·Time duration

·Recipe based data

• Air pressure

3.4.1

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

• 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

• 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.

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

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

i.      Maintenance and operation manuals alongwith as built drawings

ii.    Lubrication instructions

iii.  Daily checks on machine

iv.  Cleaning procedures

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.

·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.

8.1

Start up support

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

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

System improvements (supplier shall notify user of any improvements

Company Address