USER REQUIREMENTS SPECIFICATION (URS) FOR AUTOMATIC POWDER FOR SUSPENSION FILLING LINE

APPROVALS 
  
Name 
Signature 
Date 
Production 
  
  
  
Engineering 
  
  
  
QA 
  
  
  
 
CONTENTS 
ARTICLE 1: USER REQUIREMENT SPECIFICATION 
1.1 Basic Requirements 
A complete filling & packaging line to fill powder for suspension into bottles in Penicillin Plant. 
1.2.          Products and Forecasts ( if applicable to this item ) 
Sl. 
No. 
Product Name 
Filling Weight 
Dosing Accuracy 
Packing 
1. 
 
 
 
 
2. 
 
 
 
3. 
 
 
 
4. 
 
 
 
  1. Machine Functions 
  1. The line should be capable of performing the following in-line functions: 
Washing, rinsing & drying empty bottles Filling the bottles with powder 
Plugging the bottles 
Capping & Sealing the bottles Labelling the bottles 
( Upstream cartonning will be performed manually ) 
  1. Maximum output required is 80 bottles per minute. 
  1. Bottle sizes are 125ml, 70ml & 25ml. Samples will be provided with any order. 
1.3.4       Bottle washer & dryer 
Either one unit or individual washing & drying units linked by conveyor. 
Bottles for washing to be loaded manually at machine infeed table. Bottles to be handled by spring loaded grippers, capable of dealing with different bottle sizes without change parts. 
Stage 1: Bottles to be inverted ready for washing. 
Stage 2: Bottles to be washed inside & out with hot potable water using needles ( interior ) & spray jets ( exterior ). 
Stage3: Bottles to be rinsed with hot Purified Water at 80°C ( supplier to state whether they can provide heat exchanger to achieve this or whether customer should provide heated P.W. supply ). 
Stage 4: Bottles to be dryed using hot air blowing and/or compressed air. The unit for drying should be of suitable length to guarantee dry bottles, both inside & out. 
Supplier may recommend improvements to this specification to achieve dry bottle status. 
Purified Water used for rinsing should be recycled to first stage washing to save water if possible. 
Equipment to be fabricated from stainless steel 304. 
Emergency stop button should be located within easy reach of the operator ( for both machines if 2 are offered ). 
Control panels to be mounted on machines. 
Air handling equipment for hot air blowing system to be sited in separate technical area adjacent to production area. (room layout to be provided with order ). Absolute HEPA filter classified H13 (according to EN 1822) equipped with relevant pre filter classified F6 (according to EN779). Such filters are designed to withstand a maximum temperature of the equipment. 
1.3.5       Rotary accumulation turntable 
Infeed from drying unit. 
Outfeed to monobloc filler & capper. Machine body in stainless steel 304. 
Maximum product sensor system, with auto stop signal to washer / dryer when table is full. It should have a variable speed drive to adjust with speed of the filling machine. 
Guides for one bottle size. 
1.3.6       Filler, plugging & capper 
Monobloc machine for both filling, plugging & capping. Machine body to be fabricated from stainless steel 304. 
Control panel to be mounted on machine, including digital display with error messages. Password entry required for different functions. 
Filler 
Powder to be transferred from IBC to hopper of the filling machine through vacuum transfer system. 
Vacuum / pressure filling technique, using dosing disc with adjustable pistons for accurate weight control. Dosing disc to be stainless steel 316, with filters ( also s.s. 316 ) suitable for the powder to be filled. 
Samples to be provided with order. 
Vacuum pump to be supplied to provide vacuum for forming powder slugs in the dosing disc, including all required piping & filters. 
Compressed air system for powder ejection from disc to bottle, including all piping & filters. Manometer to be fitted either to machine or control panel to monitor the system. 
Dosing disc cleaning system, comprising stand-alone vacuum cleaner, with all necessary connections to machine. 
Hopper to have stirring blade, feeding material into secondary hopper, also fitted with blades to ensure consistent fill to dosing disc. 
Minimum powder level probe to be mounted in hopper, with auto machine stop & message on control panel. 
Starwheels for transporting bottles from machine infeed to main filling area. 
Main filling area to be fitted with vibrating cones / funnels to ensure complete discharge of powder into bottles at filling head. 
Vibratiing mesh may be required to achieve full discharge through each cone / funnel. 
No bottle/no fill sensor/detection system to avoid powder losses, with error message/alarm on control panel. 
Plugging & Capper 
Dedicated Vibrating feed bowl with feeding chute to plugging & capping station. 
Capping head suitable for Roll on pilfer proof ( ROPP ) aluminium caps. 
Cap samples to be provided with order. Infeed & oufeed starwheels to handle bottles. 
Detector for uncapped bottles, with auto machine stop & messgae on control panel. 
  1. Rotary accumulation turntable Infeed from monobloc filler & capper. Outfeed to labeller. 
Machine body in stainless steel 304. 
Maximum product sensor system, with auto stop signal to filler & capper when table is full. 
Guides for one bottle size. 
1.3.8       Inspection 
There should be manual inspection points at the end of filling/ plug insertion and sealing point. Brush cleaning facility to be provided before inspection. 
1.3.9       Labeller 
For use with self adhesive reel fed labels at 80 labels per minute. Bottle sizes as stated in 1.3.3. Samples to be supplied with order. Label overprinting using hot foil system; batch no., mfg & exp dates required. 
Infeed will be from rotary accumulation table. 
Outfeed will be directly onto manual packing table ( by others ). Overprint run-out sensor to be included, with auto stop & alarm display. 
Machine should be prepared for retrofit of bar code reader ( pharmacodes ). 
Label height adjustment system. 
Label skew to be controllable within +/- 1mm. End of label reel alarm system. 
Variable speed control. 
Control panel featuring emergency stop button & digital display with alarm messages / machine status. Product count required. 
Machine body to be fabricated from stainless steel 304. Missing label detector / reject system 
1.4.          Options: 
Supplier to quote separate price for each option: 
Complete set of size change parts for line for a different bottle size, including bottle guides, star wheels etc. 
Bar code reader for pharmacodes ( labelling machine ). 
Cap elevator to cap hopper ( to supply caps from floor level to machine ). Nitrogen purging system for empty & filled bottle before plug insertion. Air jet cleaning before filling for HDPE container . 
1.5.  “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. 
  1. URS Revision History
Rev. 
Date 
Developed By 
Revision Summary 
01 
 
 
New 
02 
 
 
  
03 
 
 
  
ARTICLE 2: GENERAL CHARACTERISTICS 
2.1 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. 
2.2  Materials to be used 
Machine body to be fabricated from stainless steel AISI 304. All parts of the equipment in contact with the product should be stainless steel AISI 316 and polished or, as otherwise requested in the User Requirement Specification [URS] (Article 1) of this Specification, or other materials compliant with FDA Regulations 21 CFR 311.65, e.g. PTFE, silicone or viton rubber. Surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive, so as to adversely affect product quality. 
Product contact surfaces shall have a surface better than Ra 0.5 micron. All product contact lubricants shall be food grade. 
With the exclusion of certain ancillary items in the technical area, the use of materials requiring painting to resist corrosion shall be avoided. 
2.3   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. 
Any requirement for clean-in-place (CIP) or wash-in-place (WIP) is defined in the URS. 
2.4  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. 
2.5  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. 
2.6 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. 
2.7  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.  
2.8  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 hours 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. 24Vdc 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 
 ARTICLE 3: 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 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:- 
  3.1  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. 
  3.2  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. 
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 
3.3  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.  
3.4 Pressure Reducing Valves 
The supplier shall include Pressure Reducing Valves (e.g. for steam and compressed air), that he considers necessary. 
  ARTICLE 4: SERVICES 
SUPPLIER MUST ENSURE THE FOLLOWING INFORMATION WITH EDCL 
Following information to be confirmed by the supplier. 
 4.1  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 barg     
  • Chilled Water 7ºC / flow 
12ºC / return     
Consumption 
Max (peak) 
Mean 
-Potable Water Hot 55ºC 
  
  
-Potable Water Cold 20ºC 
  
  
-Purified Water USP 24 Cold 20ºC 
  
  
-WFI Hot 75ºC 
  
  
-Other Gases 
  
  
-Dust Extraction 
  
  
4.2   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 
4.3   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 to EDCL in writing by letter (as well as by confirmation drawing). This applies to all suppliers. 
  ARTICLE 5: PLANS & DOCUMENTS 
  1. The supplier shall issue a detailed programme for the supply of the equipment. Programme to detail the equipment supply and the following: 
  1. Proposed issue dates of documents 
  1. Approval dates of documents 
  1. Key activities 
  1. The critical path
  1. 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 – (Article 4). 
  • 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). 
  1. 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 
  1. 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. Manufacturer’s name 
  1. Model No./frame size 
  1. Serial No. 
  1. Drawing No.(s) 
  1. Date of manufacture 
  1. Test certificates and statutory documentation 
  1. Performance curves for pumps, fans, etc. 
  1. Technical Information: This shall include technical specifications and design duties 
  1. Suppliers’ spares lists for 2 years operation 
  1. Lubrication schedule 
  1. Preventive maintenance schedule 
  1. List of all instruments 
  ARTICLE 6: 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. 
  ARTICLE 7: 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 by EDCL 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.  
ARTICLE 8: 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.  
ARTICLE 9: 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 on EDCL 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.  
The training of client’s maintenance personnel by commissioning Engineering: 
  1. at supplier‘s works 
A training programme should be approved  
Supplier will ensure detailed DQ, IQ and OQ Protocols (for both hardware and software) 
qualification. The performance of practical IQ and OQ. 
Note: The supplier should comply with the following validation requirements as appropriate: 
  • 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(if required by EDCL) 
  • 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 start-up, 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: 
  1. Description of item and function. 
  1. Objectives of IQ and scope. 
  1. Record and verification of components and documentation availability check. 
  1. Verification of as built drawings and installation. 
  1. Verification of services and connections. 
  1. Certificates of compliance for product contact materials. 
  1. Pressure test certificates (where appropriate). 
  1. Certificates of all Ex-rated components (where appropriate). 
  1. Test equipment used and date of calibration. 
  1. Calibration of all critical instruments. 
  1. 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. 
  1. Objectives of OQ and scope. 
  1. References to manuals, guidelines etc. required to carry out OQ. 
  1. Test equipment used and date of calibration.
  1. Test objectives, methods and acceptance criteria. 
  1. Test results. 
  1. 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,  
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.  
9.1            Documentation Standards 
  1. All certificates must be dated and signed. 
  1. Calibration certificates for testing instruments shall show the period of validity. 
  1. All checklists must have a signature and date by each item. (A tick or cross is not sufficient). 
  1. Acceptable limits must be indicated for each design parameter. 
  1. Full explanations must follow any results that deviate from design parameters. 
  1. 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. 
  1. A statement shall be incorporated into the documentation which details the qualification and position of every signatory. 
  1. Drawings must be annotated to show that they have been checked. 
  1. The position (Job title) and affiliation (company) of all persons signing protocols must be shown. 
  ARTICLE 10: 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 document. 
  
  • Part shipment is not allowed. 
 
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