«Company» «Address1» «Address2» «City» Sub.: Purchase of Capsule Polishing Machine. 01 No. Detailed Specifications as given below.

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1 INDIAN INSTITUTE OF INTEGRATIVE MEDICINE (Formerly known as RRL) (Council of Scientific & Industrial Research CANAL ROAD, JAMMU Phones: , , to 10 (11 Lines) Telefax: , , No. 2(693)-12/ Pur Dated: «Company» «Address1» «Address2» «City» Sub.: Purchase of Capsule Polishing Machine Dear Sirs, We are interested to purchase the below mentioned items for our research work. You are requested to send us the quotes along with the terms & conditions giving our tender reference No. and date of opening of Tender in one envelop. S. No. Description of the material Qty 1. Capsule Polishing Machine Detailed Specifications as given below You are requested to furnish your quotation with literature/ catalogue etc. superscribing quotation for Capsule Polishing Machine duly mailed by courier /speed post so as to reach on or before upto 2.30 PM to the address of the Director (Attn. Stores & Purchase Officer), Indian Institute of Integrative Medicine Canal Road, Jammu and the same will be opened on the same day at 3.30PM in the presence of the authorized representatives of the bidders, if any desire to attend Tender Opening. In the event of the date specified for bid receipt and opening being declared as a closed holiday for purchaser s office, the due date for submission of bids and opening of bids will be the following working day at the appointed time. Prices should be quoted on FOR IIIM, Jammu Discount: Institutional Discount, if any allowed should be mentioned specifically Taxes and Levies: Should be mentioned in the offer. Entry Tax exempted on scientific and Research equipments/ Instruments Excise Duty: We are exempted for payment of Excise duty and necessary Duty Exemption Certificate can be issued accordingly. Delivery: Within the lead-time is the essence of the order and is to be specifically mentioned in the order. Payment: Our standard mode of payment is Payment after Delivery, inspection and satisfactory acceptance of material. However following terms can also be considered,if mutually agreed a. 20% Advance payment against Advance Bank Guarantee of equivalent amount b. 60%payment against receipt of material at site c. 20% payment after satisfactory installation and acceptance of material Validity of rates: A certificate of rates is also to be attached by the supplier with the quotation that the rates quoted to IIIM, Jammu is not higher than the rates quoted to any other CSIR Laboratory/Institute or Govt. Organization. Warranty/Guarantee: Quotation should specifically mention the warranty clause. Other terms, if any, can be made applicable only after mutual consent / acceptance of IIIM & Supplier. The quotation should be unambiguous and Terms and Conditions are to be specified clearly. Right of acceptance / rejection of tender is reserved with Director, IIIM, Jammu. Note: - In case the parties want to quote as Indian agents of foreign suppliers, the following terms may be specified in clear terms in their offers. 1. FOB / CIF Price. 2. Country of origin, 3.Shipping details, 4. Agency commission if any. Other terms & Conditions as per Annexure enclosed Yours faithfully, 01 No Stores & Purchase Officer

2 USER REQUIREMENT SPECIFICATIONS (URS) CAPSULE POLISHING MACHINE

3 TABLE OF CONTENTS S.No. Particulars Page no. 1. INTRODUCTION 1.1 ABOUT THE PROJECT SCOPE PURPOSE EQUIPMENT GENERAL DESCRIPTION GUIDELINE FOR EQUIPMENT 3 2. OPERATIONAL REQUIREMENT 2.1 CAPACITY PROCESS PARAMETER CONTROL SAFETY FEATURES POWER FAILURE & RECOVERY CLEANING REQUIREMENT INSTRUMENTATION SPECIFIC REQUIREMENT TECHNICAL REQUIREMENT 5 4. DOCUMENTATION CONSTRAINTS MATERIAL OF CONSTRUCTION 6 MILE STONE & TIMELINES 8 6. LIFE CYCLE 6.1 INSPECTION & TESTING 7

4 6.2 SUPPORT 7 7. GLOSSARY 8 Vendor Should specify their comments as Yes or No in remarks column Specifications 1.0 INTRODUCTION: 1.1 About The Project: Indian Institute of Integrative Medicine (IIIM) is a national Institute of the Council of Scientific & Industrial Research (CSIR) of India, with primary focus of research on drug discovery from natural products (medicinal plants and microbial species). Now IIIM wishes to construct a state of art cgmp compliant pilot herbal extraction, formulation and packaging facility for R&D studies & for small and medium manufactures to get their products (botanical/ herbal drugs and reference standards, drugs for clinical trials) manufactured under GMP conditions. For this purpose J D Pharma Consultants is engaged as a project consultant. 1.2 Scope: This user requirement specification will 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 IIIM. 1.3 Purpose: This document was generated under the authority of the IIIM for the purpose of specifying the user requirement for capsule polishing machine. The machine shall be used for polishing of capsules. 1.4 Equipment General Description: The capsule polishing machine will be operated independently of other equipment and systems and will be located in a designated operating area. 1.5 Guidelines for equipment: The equipment should comply with following guidelines/standard: Schedule M,WHO & USFDA Guidelines Remarks

5 Specifications Remarks 2.0 Operational Requirement 2.1 Capacity: 500 capsule/min 2.2 Process control features: 1. Variable frequency drive of main motor for speed adjustment 2.3 Safety Features: Following safety features required: 1. Emergency stop function 2. Closure of all rotating part 3. Wherever possible, warning symbols should be provided 2.4 Power failure & recovery: Machine settings should not get disturbed due to power failure. Machine should not restart without human intervention. 2.5 Cleaning requirement: All contact parts should be easily dismantled and cleanable, for contact part CIP shall be considered. 2.6 Instrumentation: Following instrumentation is required for process control: Type of control Speed of machine VFD 2.8 Specific requirement: 1. Preferred make of motor: Crompton/ Kirloskar Instrumentation 2. The polishing machine should be able to polish 500 capsules per minute 3. There should be separation of product area and mechanically lubricated area. 4. All product contact part should be SS316L. 5. The machine should have safety guard and interlocking 6. Machine should be able to accommodate size of capsule from 00 to 5 7. Should equipped with capsule conveying system for transfer of filled capsule from filling machine to polishing machine 8. Dust extraction system is required for collecting loose powder from capsule 9. Damaged capsule sorter is required for separation of diametrically defective filled capsule. 10. Should be online process without operator intervention 11. Machine should equipped with control panel

6 12. All contact gaskets and other material should be FDA grade. 13. Complete set of change part should be provided. Specifications Remarks 3.0 Technical requirement: 1. Utilities consumption: A: Electricity:.(Specify by supplier) B: Air Pressure:.(Specify by supplier) C: Vacuum: (Specify by supplier) 2. Vendor should specify weight, size & heat given of machine. 3. Vendor shall provide special tools for maintenance of equipment 4. Industrial plug, cable, air tube is in scope of vendor 5. Suitable for Interface with SCADA system RS232 LAN. 6. Arrangement for printing with necessary parameters (Optional) 4.0 Documentation: List of all Documents (Not limited to this) to be supplied along with equipment. Document shall be supplied in hard copy & electronic editable version in English language. Sr. No. Document to be supplied Qty Remarks 1 Design and operational qualification 2 sets 2 SAT/FAT procedures 2 sets 3 Operation manual 2 sets 4 Maintenance manual, type of lubricants, lubrication instruction 2 sets 5 Spare parts manual 2 sets 6 All engineering drawings, P&ID, As built drawings 2 sets 7 List of instruments 2 sets 8 Calibration certificates 2 sets 9 Warranty / Guarantee 2 sets 10 List of all components with referencing 2 sets 11 P& I process flow diagrams 2 sets 12 Civil foundation drawings 2 sets 13 Pre installation requirements 2 sets 14 Installation requirements 2 sets 15 Installation manual 2 sets 16 Technical literature, data sheets and equipment catalogues 2 sets 17 DQ, IQ, OQ documents. 2 sets 18 Calibration Report of all sensors, controllers, PLC, transmitters, 2 sets indicators etc. 19 Test certificates of all material of construction 2 sets

7 20 Test Certificates of software used in machine control / monitoring system. 2 sets 5.0 Constraints: 5.1 Material of construction: 1. All contact parts: SS 316 with mirror finish 2. All non contact parts: SS 304 with mat finish 3. Gasket/seal/O ring: Food grade 5.2 Time lines: 1. Response to URS & submission of quotation: Within 2 weeks 2. Delivery of machine: within 2 month of finalization of order 3. Submission of detail design specification & electrical, mechanical drawing: within 3 weeks of order finalization. 4. Submission of FAT/SAT specifications: three weeks before FAT 5. IQ & OQ protocol: With delivery 6.0 Life Cycle 6.1 Inspection & Testing: FAT(Factory acceptance test) at supplier site, The supplier should notify the end user 2 weeks in advance of the beginning of FAT, Vendor shall also perform SAT (Site acceptance test) After delivery & successful installation. 6.2 Support: Training program for operator & technical staff has to be included in offer. 7.0 Glossary: 1. URS : User Requirement Specification. 2. IIIM : Indian Institute of Integrative medicines 3. DQ : Design Qualification 4. IQ : Installation Qualification 5. OQ : Operational Qualification 6. PQ : Performance Qualification 7. SS : Stainless Steel 8. MOC : Material of Construction 9. HP : Horse Power 10. RPM : Rotation Per Minute 11. cgmp : Current Goods Manufacturing Practices 12. P& ID : Piping and instrumentation diagram 13. VFD : Variable frequency drive 14. PLC : Programmable logic controller 15. HMI : Human Machine Interface 16. UPS : Uninterrupted Power Supply

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