URS No.: H/URS/HB/032 PURE & CURE HEALTHCARE USER REQUIREMENT PVT. LTD., SPECIFICATION REVISION No.:00 “unas mansronwen [EFFECTIVE DaTE:t\o}| PAGE No.: 1 of 9 USER REQUIREMENT SPECIFICATION FOR TRANSFORMER LOCATION H Block SUPERSEDES URS No. NIL FORMAT No. : QAH-093/F05.02PURE & CURE URS No.: H/URS/HB/032 | HEALTHCARE USER REQUIREME | PVT. LTD., SPECIFICATION REVISION No.:00 HARIDWAR Fan SOnRRERT EFFECTIVE DATE: } Jahy PAGE No.2 of 9 URS CONTENTS S.No. i 10 APPROVAL 5 20 | OBJECTIVE a 3.0 | SCOPE ee 40 | RESPONSIBILITY 5 | 50 | GMP/ REGULATORY REQUIREMENTS 6 60 SYSTEM OVERVIEW 6 6A ‘TECHNICAL SPECIFICATION 67 7.0 | OTHER REQUIREMENT AND CONSTRAINTS 7 8.0 LIFE CYCLE 7 81 DEVELOPMENT 7 32 | TESTING 7 83 SUPPORT 7 | 34 | DELIVERY ; 9.0 | DOCUMENTS TO BE ATTACHED 8 10.0 | REVIEW COMMENTS 3 11.0 | ABBREVIATIONS FORMAT No, : QAH-093/F05-02PURE & CURE Se AUN 24 (URSNSE HORSERACE HEALTHCARE PVT.LTD., SPECIFICATION REVISION No.:00 HARIDWAR FOR ; TRANSFORMER EFFECTIVE DATE: 43}2)14 PAGE No.3 of 9 1.0 PREPARARTION , REVIEW APPROVAL AND AUTHORIZATIOI PREPARED BY: DESIGNATION NAME | _SIGNATURE ] OFFICER/EXECUTIVE (ENGINEERING) ‘HA St Pou] Bee REVIEWED BY: DESIGNATION NAME SIGNATURE DATE OPERATING MANGER F (ENGINEERING ) PRASHANT fuer iL 18/02/21 HEAD : (ENGINEERING) ND Vieni WL 18/ 07/2 1 HEAD > 3 (PRODUCTION) FP. MewTy9 Cy 1@lo2| 24 APPROVED BY: DESIGNATION NAME SIGNATURE DATE HEAD a ee eae FORMAT No. : QAH-093/F05-02PURE & CURE userRegumemenr | URSNosUURSATBI2 HEALTHCARE PVT. LTD., SPECIFICATION REVISION No.:00 FOR BAR TRANSFORMER EFFECTIVE DATE: )1\s] PAGE No.: 4 of 9 a 2.0 OBJECTIVE: This URS has been initiated by Pure & Cure Pvt. Ltd., Haridwar and pertains é Cast nt of Transformer in H Block. wel i The URS is then provided to vendor to submit a technical specification for procurement of transformer. ‘The URS shall help vendor in understanding the end user requirement in details. this document shall help vendor for developing the design specification, which on approval by Pure & Cure Pvt. Ltd., Haridwar, will become a contractual agreement between vendor and Pure & Cure Pvt. Ltd., Haridwar. This URS will be recognized as an integral part of the procurement agreement with the vendor. ‘The vendor will abide by the information and conditions set forth by this document as well as the standard purchase terms and conditions of the Pure & Cure Pvt. Ltd., Haridwar. 3.0 SCOPE: The scope of this document is limited to the User Requirement Specification (URS) of transformer in H Block for providing adequate electrical power supply as per system requirement to users of H Block of Pure & Cure Pvt. Ltd., Haridwar. The URS shall be used as a reference document for considering all aspects of current good manufacturing practices (cGMP) and safety. The scope of this protocol is to decide & record User Requirement Specification to meet the criteria of electrical power supply for intended purpose. Demonstrate that the URS of the transformer is accordingly to the IS 10028-2(1981). FORMAT No. : QAH-093/F05-02PURE & CURE userrequmemenr | URSNos /URSMDes2 HEALTHCARE PVT.LTD., SPECIFICATION REVISION No.:00 FOR HARIDWAR TRANSEORMER! EFFECTIVE DATE: j{} The Purpose of procuring transformer system is to increasing low agfes current (a step-up transformer) or decreasing high AC voltages at lov iu down transformer) and provide constant voltage supply as per requirement.X various process activities in H Block at Pure & Cure Pvt. Ltd. Haridwar. > WHO GMP- “Good Manufacturing for Pharmaceutical Products”. } Schedule-M - “Good Manufacturing Practices and Requirements of Premises, Plant & Equipments for Pharmaceuticals Products”. 6.0 SYSTEM OVERVIEW 61 TECHNICAL SPECIFICATION Sr. Description Moc Technical Specification No. specifications 1. Type of transformer 3 Phase, oil cooler power zB ‘Normal continuous rating (KVA) 3000 KVA (As per IS-2026) 3. No load voltage ration (In KV) a High voltage 33KV b. Low voltage 0.433 KV 4, ‘Winding material 99.9 % electrolytic copper [s. Connection (V/V) mA High voltage Delta lb. Low voltage ‘Star i Vector Group Dyn 7. Frequesicy 50 Hz 8 Tapping on HV Winding for HV +5% to -15% in step of 1.25% each variation 9 ‘Type of tap changer ‘On load tap changer + RTCC + AVR 10. Steps / positions of tap changer 16 steps / 17 position 11, | Permissible temperature rises (above ambient 50°Q, z Top oil 50°C a ‘Average winding xa FORMAT No. : QAH-093/F 05-02PURE & CURE i H/URS/HB/032 HEALTHCARE PVT.LTD, SPECIFICATION REVISION No.:00 HARIDWAR FOR eu] TRANSFORMER EFFECTIVE DATE: | ¥o J PAGE No.: 7 of 9 12. | Termination (AV/LW/ | Orientation) a High voltage Cable Box b. Tow vollage Bus Duct Flange c Orientation 180°C 13.__| Type of cooling Oil natural air natural (ONAN) 14. oan Outdoor 75, | Altitude above sea level Up to 1000 M 16. No Toad losses 3.2 KW (IS TOL) 17. | Fllload Tosses 31 KW (IS TOL) [18. Impedance at 75°C 7% (+10% to -10 % TOL) 19, | Insulation level HV & LV Uniform 20. HV (KVp/ KVrms) 75/28 2a. | EV (KVp/K Vrms) 2B 7.0 OTHER REQUIREMENTS AND CONSTRAINTS: ‘+ MAINTENANCE: ‘© The equipment shall allow for maintenance by trained site personnel with supplier recommended tools and practices. © Recommended spare parts list shall be provided. © The supplier shall replace the parts found to be damaged/ broken during installation. © The supplier shall be available at the site when asked in case of major breakdown. 8.0 LIFECYCLE: 8.1 DEVELOPMENT ‘| The supplier shall follow safety, CGMP & GEP practices in design, development, construction and Installation of the system. 8.2 TESTING © The system shall be Factory tested by the supplier with approval witness. © The system shall be commissioned and qualified at site for Installation and Operation by the supplier with approval witness. 83 SUPPORT Supplier shall provide support during Installation or in case of any discrepancy. FORMAT No. : QAH-093/F05.02PURE & CURE USER REQUIREMENT — |URSNos HIURSABA32 HEALTHCARE PVT.LTD, SPECIFICATION REVISION No.:00 HARIDWAR FANGRORNIER FFECTIVE DAT GE Noa 8 of 9 84 DELIVERY All parts of the system shall be sourced, delivered and installed by the Supplier. ‘The supplier shall provide Functional design specification (MOC) and other qualifi 9.0 DOCUMENTS TO BE ATTACHED: © Electrical Drawing © Operating & Service Manual * Recommended Spare Part List. Note: The whole URS is a tentative document. Manufacturer or Vendor will be solely responsible for performance of transformer as specified in the catalogue or during discussion at the time of finalization of purchase order. Specifications and details mentioned in the DQ, dually signed by Vendor/ Manufacturer and dually signed by Head Engineering / QA will be treated as final specifications. ‘The said URS will be treated as an integral part of purchase order. 10.0 REVIEW COMMENTS: © The supplier should make/design transformer as per technical specification mentioned in the URS. © Forany changes in the design/make, if not as per the URS, prior intimation/approval should be taken by the supplier from Pure & Cure Pvt. Ltd., Haridwar. REVIEWED BY SIGN & DATE FORMAT No, : QAH-095/F05-02PURE & CURE HEALTHCARE PVT. LTD., HARIDWAR USER REQUIREMENT SPECIFICATION FOR TRANSFORMER ‘URS No.: H/URS/HB/032 REVISION No.:00 EFFECTIVE DATE: J) leu Bl PAGE No.: 9 of 9 11.0 ABBREVIATIONS: URS GMP cGEP Moc. Qa No, HV LV User requirement specification Current good manufacturing practices Current good engineering practices Material of construction Quality assurance Number Design qualification High voltage Low voltage FORMAT No. : QAH+093/F05-02