URL of a Tablet compression machine.

 Basic Requirements

Tablet press is used for compressing granules to form tablet. Tablet line comprises with tablet press, deduster, dust collector, metal detector and vacuum transfer system. Tablet press also to be used for compression of slugs (without deduster & metal detector). Close system delivery of granules from IBC to the hopper of the Tablet compression machine. The design must meet all cGMP guidelines and legislation.

    Quantity: 100,000 Tablet/ Hour (Working Capacity)

800,000 Tablet/ Hour (Working he Working Capacity (Tablet/Hour).

  • Products and Forecasts ( if applicable to this item )

(100,000/H) = 10.4 mm dia, Normal concave tablet. Compression weight 370-380 mg per tablet.

800,000/H) = 5.7 mm dia. Deep concave tablet. Compression weight 70-90 mg per tablet.

Round & shaped tablets to be produced.

  • Machine Functions

    • B type tablet tooling (Supplier will ensure). Upper punch guides to be keyed for shaped upper punches. Major seals must be of Food grade silicon rubber.

    • Required output is up to 100,000 and 800,000 tablets per hour (Working Capacity).

    • Turret to be chromed.

    • Tightness monitoring of upper & lower punches with alarms.

    • Technical zone to be completely separated from pressing zone.

    • Pre-compression & adjustable upper punch penetration to be fitted.

    • Automatic punch lubrication system while machine is running.

    • Product contact parts to be either stainless steel 316L or other FDA approved materials.

    • Machine body to be stainless steel 304.

    • Compaction force monitoring system, with print out facility, based on strain gauges to be fitted, with feedback to press. System should be capable of stopping machine automatically, with alarm to alert operator. Complete with ‘fast gate’ mechanism or similar to divert tablets which are outside pre-set force range.

    • Suitable dust extraction connections to be provided for connection to customers’ dust extraction system.

    • Rotary paddle feeder, with variable speed paddles.

    • Powder hopper to be min. capacity 15 litres. The hopper will be fed by vacuum transfer system from a Bin/drum. Low level alarm sensor to be mounted in hopper to warn operator when granule supply is running out.

    • Manual controls to adjust depth of fill (weight), main compression force, pre-compression force & upper punch penetration.

Control panel to display the following: machine speed / tablets per minute, actual main & pre compression load settings, hours run, tablets produced, alarms for compression overload exceeded, lubrication, tight punches etc.

  • Material should be transferred to hopper from IBC Bin through vacuum transfer.

  • There should be a PLC based control panel equipped with necessary electrical and electronic component.

  • All text signs on control buttons, switches, operator panel etc shall be in English language.

  • Tablet thickness and filling depth can be adjusted by the motor through the touch screen control.

  • Online weight measurement & control.

  • Sorting of ‘out of specification’ tablets at high speed.

  • All the required condition and data values are displayed on the touch screen as like-

  1. Depth of Fill

  2. Tablet thickness

  3. Main & Pre compression force

  4. Turret & feeder revolution (with synchronization).

  5. Upper punch penetration

  6. Lubrication point monitoring system

  7. Compressed air availability in the machine

  8. Electrical Power indication of the machine

  9. Total output (tab/min) etc.

  • Options: Supplier to quote separate price for each option:

    • Additional depth of fill cams for different tablet / slug sizes (assuming one cam is supplied with tablet press).

    • Tablet deduster. Deduster outfeed height should be adjustable. The deduster will not be used when compressing slugs. Dust collector.

    • Metal detector, for inline use with tablet press & deduster when producing tablets only. Alternatively, deduster & metal detector may be offered on one stand as a combination unit. Metal detector to be supplied with calibration test pieces (sizes to be identified with any order placed). The metal detector will not be used when compressing slugs.

    • Upper punch oil drip caps / cups.

    • On line weight, thickness and hardness test units providing weight feedback control to the force control unit.

    • Die and Punch one set for each machine.

     “Wear and Tear” Spare Parts

The supplier will provide recommended spare parts and electrical and electronic spares for two years normal (Single Shift) operation.  List to be itemized with unit prices.

      URS Revision History

Rev. No.

Date

Developed By:

Revision Summery

01

11 June’ 12

ESL

Original

02

07.12.2013

ESL

03

09.03.2016

ESL

 

 GENERAL CHARACTERISTICS

  Type of Construction

The Equipment defined in this specification shall conform to:

–           The current state of the art GMP

–           European Medicine Agency (EMA) and FDA regulations and guidelines, as may be applied to this type of equipment.

Thus, the supplier shall in the design and construction of the equipment, be obliged to separate the purely technical parts (motors, etc.) from the purely pharmaceutical parts in direct contact with the product, so far as is practicable.

Stainless steel must be welded under inert gas (argon or nitrogen) and the welds treated by pickling and passivation, to prevent any subsequent corrosion.  All welds to be crack and crevice free.  Internal welds and welds likely to be in contact with the product shall be ground smooth and flush.  All other welds to be ground smooth.  All welds shall be polished to the same standard as the surrounding areas.

Stainless steel fabrication areas should be totally segregated from any areas where carbon steel machining, grinding or similar operations are carried out.

   Materials to be used

 Turret

  • Die table should be stainless steel AISI 316L or hard chrome plate

  • Upper and lower part should be hard chrome plate.

Product Contact parts

  • All parts of equipment in contact with the product shall be stainless steel AISI 316 or AISI 316L or as otherwise requested in the User Requirement Specification [URS] (Article 1) of this Specification. Surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive, so as to adversely affect product quality

  • Other materials compliant with FDA Regulation eg. PTFE, Silicon or rubber.

  • Surface that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive.

  • Product contact surface shall have a surface better than Ra 0.5

  • All product contact lubricants shall be food grade

  • Die & punches

  • Required number of die & punched will be provided later on

  • Upper punch guides with keyway for shaped upper punches.

  • Tightness monitoring of upper & lower punches with alarm.

  • Upper punch oil drip cups / seal & lower punch seal. Major seals must be of Food grade silicon Rubber.

 Interchangeability

       .  Incase of several machines of same type must have to interchange facility of

Changeable parts of machine such as hoppers, feeder, cam etc.

Cover/Guard

  • Top of the machine should be guarded by hinged viewing panels made of acrylic sheet or Toughened glass with SS-304 frame and bottom will be fully covered by SS-304 sheet.

  • Guard will be opened with the help of pneumatic cylinder.

  • Machine should be completely enclosed with access doors interlocking for safety.

With the exclusion of certain ancillary items in the technical area, the use of materials requiring painting to resist corrosion shall be avoided.

   Cleaning

The design and construction of the equipment shall be such that sharp angles and corners and other parts, not easily accessible for cleaning are avoided. All parts have to be designed in such a way that it can be dismantled easily for cleaning.

Any requirement for clean-in-place (CIP) or wash-in-place (WIP) is defined in the URS.

 Interchangeability (In the case of several machines of the same type).

As a general rule, all equipment and machines of the same type shall be identical, unless otherwise specified.  All mechanical, electrical and electronic parts, and accessories including spares, should be capable of being fitted to any of the machines of the same type, without any sort of adaption.   An exception to this is where matched sets are vital to the balancing of specific items of rotating equipment.

 Format or Product Change

In order to reduce the time taken for a format or product change, the supplier shall make every effort to standardise the types of fixing for the change parts required for each format.  All the change-parts relative to a particular format shall be engraved with the same reference, to aid identification.

The facility to change format parts with the use of tools and positive location of change parts is preferred wherever practical.

 Effectiveness of Seals

For normal operation with the services defined in Article 4, there must be no escape of product, water or other fluid.

In the case where some loss is inherent in the normal functioning of the equipment, this loss should be contained in such a way as to prevent the escape of product etc. onto the walls and floors of the production area.

   Heat Insulation

During normal operation, no external part of the equipment should reach a temperature in excess of 550C.

Where parts are likely to attain a temperature in excess of 550C, they should be insulated with mineral or chemical insulating materials and clad.  For those parts in the pharmaceutical zone, this cladding shall be in stainless steel (AISI 304).

Note:  No asbestos, in any form, shall be permitted for any purpose.

 Electrical Requirements

All wiring shall be carried out in accordance with the latest edition of CENELEC/IEC Regulations.

All electrical equipment located in process areas should be rated to IP55 (dust proof and protected against water jets) unless specified otherwise in User Requirement Specification and terminations within the machine made in sealed junction boxes.

Electrical equipment located in non-process technical (plant) areas should be rated to IP41 minimum.

All equipment should be fitted with an hour’s run meter and should be designed to interface with the ‘whole’ line to include emergency stop buttons.

Control devices 4 to 20 mA for analogue signals. 24 Vdc for digital.

PLC preference is Siemens.

Safety Features: Power fluctuation to be considered during design of electrical installations. Voltage stabilizer for PLC to be taken in consideration

SUPPLIER’S RESPONSIBILITIES

The supplier guarantees that all calculations, plans, estimates and other documents shall comply with the standards of the trade.  Examinations and signature by the CUSTOMER of any document prepared by the supplier shall not on any account exempt the supplier, even in part, from responsibility.

The machine must be installed in the designated room as identified in the attached layout. The supplier must confirm that their machine will be placed in the room as defined.

Supplier will ensure full warranty of the machine for one year.

Machine/ Equipment supplier shall have one year maintenance contract with after commissioning.

Installation, testing, commissioning, validation, qualification & training along with relevant documentation.

Supplier will responsible for successful trail run of first three batches of product.

The supplier guarantees that the equipment supplied shall conform to the standards of the trade, the relevant Manufacturing Standard including Safety Standards, and the requirements of legislative or regulatory provisions applicable.  In particular:-

   Noise

The noise levels at the work place for each machine, operating at maximum speed must be below 75 dB(A) at operator work position, or 1 metre from machine.  The supplier shall state noise levels during normal operation of the equipment.

   Machinery Safety & Guarding of Dangerous Parts

The machine guarding shall satisfy the requirements of BS 5304 (1988) or equivalent national standard. Guards shall be fitted so that machine will not run with an interlocked guard open.

Interlocking

  • There should be process security for no batch failure by interlocking all the process key parameters.

  • There should be interlocking between low powder level, guard opening, or any system failure etc.

   Utility failure

·                  PLC and HMI programs must retain on electric power failure. System recovery

after power failure must be possible for operator via HMI and without any

Programming tools.

·                  When reconnected after an electric power failure, the machine must not

start automatically without operator input.

·                  In a case of any other utility failure, the machine should stop.

·                  If a hardware failure occurs, the complete machine must stop immediately in a

safe way.

Alarms

·                  Error messages on HMI shall be in plain text with fault code.

·                  Error messages shall be printed clearly.

·                  A light on the machine shall indicate all alarms.

·                  Emergency stop activated.

·                  Pressure sensors out of range

·                  The process cannot complete the current task. The current task shall be specified on the alarm report.

 Power failure/ Recovery:

On power failure, the system shall fall into a “safe state”. A “safe state” shall be defined as:

  • All motion stopped on the machine.

  • Reset required before machine to be restarted.

  • No damage to machine will occur.

  • No product loss.

  • Re-start based on last state before loss of power.

The supplier shall ensure that the equipment is designed as a minimum, where applicable, in accordance with the following:

ISO/TR 12100 :           1992    Safety of Machinery (Basic concepts, general principles

for design), Parts 1 & 2

ISO 15534       :           2000    Ergonomic Design for the Safety of Machinery, Parts 1

& 2

ISO 13849-1   :           1999    Safety of Machinery – Safety related parts of control

systems – Parts 1:  General principles for design

ISO 13850       :           1996    Safety of Machinery – Emergency Stop – Principles of

Design

ISO 13852       :           1996    Safety of Machinery – Safety distances to prevent danger

zones being reached by the upper limbs

ISO 13853       :           1998    Safety of Machinery – Safe distances to prevent danger

zones being reached by the lower limbs

ISO 13854       :           1996    Safety of Machinery – Minimum gaps to avoid crushing

of parts of the human body

ISO14119        :           1998    Safety of Machinery – Interlocking devices associated

With guards – Principles for design and selection

  Certification of Pressure Vessels, Lifting Equipment

Equipment shall be tested and certificated by the National Inspection Authority of the country of origin, eg. B.S. 5500, TUV, ASME, ISPESL. In addition, EDCL’S Insurers may carry out any tests deemed necessary at the supplier‘s works.

  Pressure Reducing Valves

The supplier shall include Pressure Reducing Valves (e.g. for steam and compressed air), that he considers necessary.

       Alarms

  • Error messages on HMI shall be in plain text with fault code.

  • Error messages shall be printed clearly.

  • A light on the machine shall indicate all alarms.

  • Emergency stop activated.

  • Pressure sensors out of range.

  • The process can not complete the current task. The current task shall be specified on the alarm report.

SERVICES

SUPPLIER MUST ENSURE THE FOLLOWING INFORMATION WITH

Following information to be confirmed by the supplier.

  Characteristics of Services on Site

Consumption                                                  Max (peak)      Mean

  • Electricity 400V (+6%, -6%) 3-phase          __________    _______

4-wire N & Earth 50Hz

–           Electricity 230V Single-phase 50 Hz __________   _______

–           Compressed Air

(Instrument) 8 barg                            __________    _______

–           Compressed Air

(Product Contact) 8 barg                    __________    _______

–           Factory Steam 8 barg                         __________    _______

–           Pure Steam 3 bar                                __________    _______

  • Chilled Water 7ºC / flow

12ºC / return                  __________    _______

Consumption                                                              Max (peak)    Mean

  • Potable Water Hot 55ºC __________    _______

  • Potable Water Cold 20ºC __________    _______

  • Purified Water Cold 20ºC                 __________    _______

  • WFI Hot 75ºC __________    _______

  • Other Gases ________        __________    _______

________        __________    _______

  • Dust Extraction __________    _______

   Main Physical Data

–           Maximum size installed (mm)                                  Lx        Wx      H

–           Note of any additional access requirements (mm)    _______________

–           Maximum weight installed (kg)                    _________

–           Minimum size of access openings for

transfer/positioning (mm)                                          Lx        Wx      H

 Changes to Services or Main Physical Data

Changes in any of the information shown in Section 4.1 and 4.2 above shall be advised immediately  in writing by letter (as well as by confirmation drawing). This applies to all suppliers.

 PLANS & DOCUMENTS

The supplier shall issue a detailed programme for the supply of the equipment.

Programme to detail the equipment supply and the following:

  1. a) Proposed issue dates of documents

    b) Approval dates of documents

    c) Key activities

    d) The critical path

The supplier shall furnish P & IDs and plans and drawings of the equipment showing front elevation, side elevation and plan view (footprint).  The plans should show:-

–           Overall dimensions which shall identify any skids, etc.

–           Position and types of connection for all services including any remote service requirements.

–           Confirmed characteristics and consumption of all services – (Article4).

–           Fixing points of the equipment for unloading and for moving into position.

–           The weight of each item of equipment.

–           Access requirements around the equipment for Operation, cleaning, maintenance.

Copies or samples of any check lists or documentation used to record tests and checks normally conducted at installation and commissioning, i.e. installation and commissioning method statements.

Copies or samples of any checklists or documentation used to record tests and checks normally conducted at pre-delivery inspection (PDI) Factory Acceptance Tests (FAT).

The supplier shall provide, at the time of the inspection visit/acceptance trials 2 copies of the following documents, all in English language (professionally/technically translated, if necessary).

  • Suppliers own documentation of the following:

  1. Equipment completeness and compliance to the specifications and design

  2. b) Equipment operational compliance

–           All Mechanical Plans “As built Drawings”

  • All Electrical Plans “As built Drawings”

–           Instruction Manual for installation, start up, operation, preventive maintenance, format change over, calibration, fault finding and rectification.

–           Approved, amended or modified installation and commissioning methods  statements.

–           Approved validation documentation for Installation Qualification (IQ) and Operational Qualification (OQ).

  • Equipment Details:-

  1. a) Manufacturer’s name

  2. b) Model No./frame size

  3. c) Serial No.

  4. d) Drawing No. (s)

  5. e) Date of manufacture

  6. f) Test certificates and statutory documentation

  7. g) Performance curves for pumps, fans, etc.

  8. h) Technical Information: This shall include technical specifications and design duties

  9. i) Suppliers’ spares lists for 2 years operation

  10. Lubrication schedule

  11. Preventive maintenance schedule

  12. List of all instruments

 SAMPLES OF MATERIALS & COMPONENTS FOR TESTS

The supplier shall specify the quantity of material and components required for acceptance trial including delivery date and method of packaging.

undertake to supply free of charge the materials/components requested by the supplier for tests and trials by the date specified.

Supplier will carry the materials by own cost.

INSPECTION VISIT/ACCEPTANCE TRIALS

Factory Acceptance Test (FAT) shall be conducted on the premises of the supplier or nominated company in the presence of the representative(s)  at a date fixed by mutual agreement. The supplier is asked to give at least 4 weeks advance notice, when equipment/ machinery is ready for such visit/FAT.

Supplier shall be responsible to bear FAT related all expense for 3 (Three) persons

During this visit the equipment will be inspected and examined for its compliance with this specification; and appropriate tests performed:-e.g.

–           Wherever possible a complete production run at normal operating rate for a period of not less than 2 hours duration using materials supplied.

–           Product change-over including cleaning, dismantling and reassembly of pumps and valves, etc.

The Acceptance Trials shall be considered to be satisfactory if the overall levels of performance of output and quality specified in User Requirement Specification -specific requirements are achieved.

Only after satisfactory Inspection (FAT) the equipment may be packed and dispatched to the SITE.

For any revisit as a result of a failure at Inspection visit and/or FAT; the costs including travel and hotel shall be at the supplier’s expense.

 INSTALLATION

The supplier shall be responsible for unloading and positioning of machine/equipment in the respective room as per layout and mechanical, electrical & pneumatic installation of supplied machine at site.

ON SITE COMMISSIONING, VALIDATION AND TRAINING OF OWNER’S PERSONNEL

The supplier shall be responsible to arrange competent English speaking, Commissioning Engineer (or Engineers) from manufacturer company site to carry out SAT.

The supplier shall be responsible for Installation, commissioning and qualification of their supplied machine/equipment.

The supplier shall also be responsible for the calibration of critical instruments during qualification. Commissioning Engineer will carry the standard certified equipment for calibration.

–           Demonstrate compliance with the Specification.

–           Provide documentation showing that computer software has been developed according to agreed protocols to comply with Good Automated Manufacturing Practice (GAMP), in particular to comply with the document GAMP-5 or the latest current version, prepared by the GAMP forum.

–           Provide drawings for Design Qualification at agreed dates
–           Record all changes and advise the client of any changes made.
–           Allow inspection during construction and testing
–           Advise the client of their test procedures.
–           Ensure the item operates to specification.
–           Provide documented proof of testing.
–           Provide accurate as built drawings at agreed dates.
–           Provide startup, operating and maintenance instructions at agreed

dates.
–           Provide certificates of calibration for gauges and sensors and Materials

–           Compliance Certificates when requested.

–           Provide certificates of calibration for all testing equipment at agreed dates.

Installation Qualification (IQ) is the formal, documented inspection of the installation to verify all installation specifications have been met and that the equipment conforms to the specification.

IQ Protocols should include, but not be confined to:

Description of item and function.

  1. Objectives of IQ and scope.

  2. Record and verification of components and documentation availability check.

  • Verification of as built drawings and installation.

  1. Verification of services and connections.

  2. Certificates of compliance for product contact materials.

  3. Pressure test certificates (where appropriate).

  • Certificates of all Ex-rated components (where appropriate).

  • Test equipment used and date of calibration.

  1. Calibration of all critical instruments.

  2. Conclusions including a clear statement on whether the item has been successfully qualified or not.

Operational Qualification demonstrates according to a formal protocol that the equipment will operate as intended throughout all anticipated operating ranges.

OQ Protocols should include:-

  1. Description of item and function.

  2. Objectives of OQ and scope.

  • References to manuals, guidelines etc. required to carry out OQ.

  1. Test equipment used and date of calibration.

  2. Test objectives, methods and acceptance criteria.

  3. Test results.

  • Conclusions including a clear statement on whether the item has been successfully qualified or not.

The supplier would be required to undertake the validation tests and record all data in the prepared protocols on site, witnessed representative.

It will be the supplier’s responsibility to ensure the equipment conforms to the test procedures, and if a failure occurs, make such modifications as may be necessary and re-test the equipment to prove the equipment meets the requirements, at the supplier’s expense.

 Documentation Standards

  All certificates must be dated and signed.

   Calibration certificates for testing instruments shall show the period of validity.

   All checklists must have a signature and date by each item. (A tick or cross is not sufficient).

 Acceptable limits must be indicated for each design parameter.

 Full explanations must follow any results that deviate from design parameters.

Any alterations or corrections to the documents should be initialed and dated.

Correction   fluid should not be used. Corrections must be made by deleting with a single line and signed and dated.

   A statement shall be incorporated into the documentation which details the qualification and position of every signatory.

  Drawings must be annotated to show that they have been checked.

The position (Job title) and affiliation (company) of all persons signing protocols must be shown.

COMMERCIAL CONDITIONS

  • Offer must be based on tender document.

  • Payment terms as per tender document.

  • It will remain the supplier’s responsibility to adequately protect equipment under his supply whilst in transportation, off loading and final positioning up to and including installation and commissioning at site, if not mentioned otherwise in the tender

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