\ Project / Projekt: Albumina dożylna nowej generacji oparta o wielostopniowy proces inaktywacji wirusów Plasma Fractionation Department BIOMED-LUBLIN Wytwórnia Surowic i Szczepionek S.A. ALBUMINA / ALBUMIN Document Name: User Requirement Specification Specyfikacja Wymagań Użytkownika Equipment: Liquid products packaging line Linia pakowania produktów płynnych BIOMED-LUBLIN Wytwórnia Surowic i Szczepionek Spółka Akcyjna w Lublinie, ul. Uniwersytecka 10, 20-029 Lublin Poland Elaborated by: Opracował: Name and Family name Imię i Nazwisko Position Funkcja Date / Signature Data / Podpis Checked by: Sprawdził: Checked by: Sprawdził: Approved by: Zatwierdził: Document no.: Dokument nr : Version: Wersja:
1 PROJECT DESCRIPTION 1.1 Project Scope BIOMED-LUBLIN intends to launch Plasma Fractionation Department (hereafter called the PROJECT). The existing building is located at 39-300 Mielec; ul. Wojska Polskiego 3, Poland. The new Plasma Fractionation Department have to comply with the current GMPregulation of EU and Poland. Polish GMP is equivalent to European GMP. This User Requirements Specification defines a certain SCOPE OF DELIVERY for a VENDOR that is the part of PROJECT. 2 DOCUMENT OBJECTIVE The objective of the User Requirements Specification (URS) is to outline technical requirements for design, manufacture, supply, delivery and installation of the Filling Line. This URS will serve as a technical base for a VENDOR selection, purchase orders and qualification practices. 3 GENERAL The equipment shall be quoted as specified in the URS. VENDOR shall bring to CLIENT S attention for resolution any conflict that may occur between this specification and codes, standards or proven design practice. CLIENT S review of drawings and documents shall in no way lessen VENDOR S responsibility for completeness and accuracy of the submitted drawings and documents and to provide a complete and operating system in compliance to all applicable codes and regulations. In all cases the SCOPE of SUPPLY shall be capable of performing according to the requirements of this specification. VENDOR shall specifically remain liable for any errors and/or omissions contained in VENDOR S design and shall be responsible for all costs to remedy such defects in the design. VENDOR S obligation is also co-operation and liaison with other subcontractors involved in the PROJECT and responsibility for functionality of related equipment. 4 PRODUCT DESCRIPTION 4.1 Product Features and Production Program Information about products is listed in the table below. The main features are: All products are liquids, plasma fractionation protein products: 4.2 Primary Packaging All products will be filled In glass vials, closed with stoppers or with lyo-stoppers (+ filter + solvent) 2015-11-03 p. 2
and crimped with aluminum caps. 5 SYSTEM DESCRIPTION CARTONING PACKAGING LINE FOR GLASS VIALS WORKING WITH OUTPUT 50-100 cartons / min (depends of vial format) Format parts for following containers should be included in delivery scope: Vials dimensions: Size 1 ) 20 H Dia. 32,0; h.58,8 [mm] Carton 36x36x50 [mm] Size 2 ) 50 H Dia. 42,0; h.73 [mm] Carton 46,5x46,5x80 [mm] Size 3 ) 100 H Dia. 49,0; h.104 [mm] Carton 53x53x111 [mm] Size 4 ) 250 H Dia. 69,0; h.125 [mm] Carton 73x73x132 [mm] Size 5 ) 500 H Dia. 88,0; h.147 [mm] Carton 92x92x154 [mm] The line should be composed: a) Rotary table for feeding product ( diameter min. 1000 mm) - Manual in-feed tray - Safety and soundproof hood b) Inspection machine Optical inspection machine suitable for two operators. c) Rotary table after inspection machine d) Automatic labeling machine contains: - luminescent photocell, - unwinding device, - Hot foil printing unit, - Hot foil printing presence control, - rejection system with rejection control, - bar code laser scanner. e) e) buffer and rotary accumulation table before cartoning machine. The same like in item a). f) Cartoning machine contain: - folding unit of leaflets, - code reading head to leaflet ( both side) plus cartons, - printing unit wolke to print 2D code plus 5 lines (even though it will be used for now 3 lines), - camera for verify printing. Machine should have possibility to work on the glued cartons from two sides. g) Automatic case packer machine contains: - Station of rejection cases not complete. - verification of full layers of cartons (only presence camera), - case closing unit by PVC adhesive tape. h) Labeling machine base on PLC controllers with appropriate interface and screen. 2015-11-03 p. 3
6 Fixation and Clean Room Finishes 6.1.1 Fixations and penetrations The fixation of the fline on the final position will be specified by VENDOR. Any other mounting elements (as bolts, anchors, screws, steel structures etc. or it s counterparts) are within the SCOPE OF SUPPLY of VENDOR. If required, CLIENT will integrate these elements or it s counterparts into the concrete structure. 6.1.2 Penetrations through walls Penetrations through concrete walls/ceiling and clean room partition walls or suspended ceiling are provided by CLIENT, following VENDOR S specifications and according to current law regulations. 6.1.3 Elements of clean rooms For penetration through clean room partition walls, ceiling, floor of the clean room VENDOR shall provide the required GMP-conforming sealing elements (stainless steel plates, rosette, etc.). VENDOR ensures that no part of the SCOPE of SUPPLY is mounted on clean room partition walls. 6.2 Battery limits for utility and electrical systems The battery limits, defined below, describe the interfaces of the SCOPE OF SUPPLY as defined by this specification and the other parts of the PROJECT. VENDOR is completely responsible for any components, elements and equipment within the SCOPE OF SUPPLY. The following battery limits are defined below: Unit Utility Parameter Air for Control System Connection size Scope of supply by VENDOR 6-8 bar Manual valve Power 230/400 V/50 Hz As utility connections generally disconnectedly solutions shall be applied. 7 DOCUMENTATION REQUIREMENTS 7.1 The Documentation is a part of SCOPE OF SUPPLY: A Layout of whole line with all dimensions have to be delivered with the offer B draft of validation documentation and FAT protocols should be delivered 30 days before FAT execution C final documentation As-built before commissioning 7.2 Deliveries language Qualification documentation will be delivered in English language. Final reports will be translated into Polish. 2015-11-03 p. 4
7.3 Documents to be delivered in Polish language: Safety Manual Installation & Maintenance Manual Opearation Manual DCS 7.4 Number of copies: Printed documents have to be delivered at least in one ( 1) hardcopy.; 7.5 File deliveries All documents which are delivered with offer shall be also supplied as electronic computer files; Allowed Format: MS-Software Word, Excel, Access Acrobat -.pdf AutoCAD Data on CD data carrier After start-up all machine documents will be corrected and pass on with changes. 8 Approval and commissioning VENDOR should provide all the documentation for PED, CE Mark certification of the unit. 9 List of materials and spare parts List of materials and spare parts should be supplied at the end of the project. 10 Inspection and Commissioning 10.1.1 Inspection and commissioning tests at VENDOR S site (FAT) Work inspection and functional tests of constructed equipment will be carried out at VENDOR'S premises (Factory Acceptance Test FAT) by the CLIENT. CLIENT reserve the right to inspect VENDOR any time of contract duration. Before Factory Acceptance Test (FAT) VENDOR shall prepare written FAT Protocol containing all required inspection and testing activities. FAT protocol will be delivered to CLIENT. FAT tests will be executed and completed by VENDOR. VENDOR shall supply utilities and any auxiliary tools. Empty vials for testing of loading system will be supplied by CLIENT. Tests will be carried out by VENDOR personnel. Any costs which are caused by a prolongation of FAT due to permanent failure of certain tests shall be borne by VENDOR. VENDOR shall also produce the report upon completion of FAT (factory acceptance test) and shall commit to resolve any discrepancies taking during the FAT execution. FAT positive completion is a condition to release shipment. 10.1.2 Inspection and commissioning tests at CLIENT S site (SAT) Commissioning and SAT should be provided and carry out by VENDOR specialist with the presence of CLIENT specialist in a mutually agreed date. 2015-11-03 p. 5
Work inspection and functional tests of constructed equipment will be carried out at CLIENT'S premises (Site Acceptance Test FAT) by the CONTRACTOR. CONTRACTOR and CLIENT reserve the right to inspect VENDOR any time of contract duration. Before Site Acceptance Test (SAT) VENDOR shall prepare a test program. This proposal of test program will be checked and if required modified by CLIENT and CONTRACTOR. SAT test will be executed and completed by VENDOR. VENDOR shall supply utilities and any auxiliary tools. Primary packages will be supplied by CLIENT. Tests will be carried out by VENDOR personnel. Any costs which are caused by a prolongation of SAT due to permanent failure of certain tests shall be borne by VENDOR. VENDOR shall also produce the report upon completion of SAT (site acceptance test) and shall commit to resolve any discrepancies taking during the SAT execution. VENDORS is allowed to use qualification tests results during SAT procedure and to use SAT procedure tests results during qualification. 11 Shipment Vendor will be responsible for the transport acc. to: DAP (INCOTERMS 2010) rule (EU) Mielec or DDP (INCOTERMS 2010) rule (exeu) Mielec Place of destination is Plasma Fractionation Plant building located at 39-300 Mielec; ul. Wojska Polskiego 3, Poland VENDOR is responsible to fulfill all importing requirements and custom regulations of Poland. In case Polish authorities require additional information and certifications to accept an equipment to be imported to Poland, this shall be provided by VENDOR at no cost to CLIENT. 12 Installation After having received the shipment on site, equipment will be stored in the building. VENDOR will be also responsible for delivery of all auxiliary materials and means of transportation. CLIENT will be responsible for all connections and transfer of equipment in the building. After bringing equipment to the building, VENDOR will start installation of it. All necessary auxiliary materials are included in SCOPE OF SUPPLY. CLIENT will provide utilities connection acc. to Chapter 8.4. After acceptance of required documentation VENDOR shall prepare an Installation Plan containing the following information: 1. Installation Schedule 2. Methods of transfer and assembling 3. Required tools 4. Required personel 2015-11-03 p. 6
13 Qualification services The following activities shall take place during qualification; detailed requirements will be listed in qualification documentation - FAT by VENDOR (with vials delivered by CLIENT) - Computer system/software validation according to GAMP 5 - Risk analysis for the line will be done during project phase - IQ, OQ - qualification documentation (blank protocols, forms of reports) - to be elaborated and delivered by VENDOR Minimum scope of tests is as follows:. Each unit of the line o Formal proofing of calibration status o Problem alarming test und function test o Easy access to all motors, filters and pumps o Changing of formats o Measuring and regulating devices easy accessible 10.11.1 Risk Analysis CONTRACTOR will be carrying out a detailed Risk Analysis for the equipment defined in SCOPE OF SUPPLY. It will be done after the order and defined in time schedule 10.11.2 Design Qualification DDesign Qualification will be carried out by VENDOR. VENDOR shall deliver all required for this purpose documents. 10.11.3 Installation Qualification VAll necessary qualification documents (blank forms) will be supplied by VENDOR and delivered to CLIENT. 10.11.4 Operation Qualification All necessary qualification documents (blank forms) will be supplied by VENDOR and delivered to CLIENT. 10.11.5 Commissioning documents Commissioning will be done after: Fully successful and completed start-up, commissioning and SAT Hand over a complete As-Built Documentation 10.11.6 Acceptance criteria The following acceptance criteria shall be fulfilled: Effective capacity -100 % of nominal capacity during time test acc. to DIN 8743. No system defects Change of formats reduced to minimum All other detailed acceptance criteria established and agreed together with CLIENT and CONTRACTOR 2015-11-03 p. 7
14 Warranties VENDOR shall propose the duration of warrant and should be not less than 12 months from SAT. 15 APPLICABLE RULES AND STANDARDS 15.1 General Norms and Standards Equipment covered by SCOPE OF SUPPLY shall comply with all actual technical Norms and Standards. 15.2 Internal Requirements of CLIENT and CONTRACTOR VENDOR S personnel responsible for installation at CLIENT S site must take part in training organized by the CLIENT for people temporary working at CLIENT S site. VENDOR S personnel must obey rules and requirements of the CLIENT (no smoking restriction, safety rules, fire protection requirements, GMP). There are not any CLIENTS and CONTRACTORS special requirements. Requirements of VMP must be fulfilled. 16 GMP-compliance regulations The SCOPE OF SUPPLY must comply with the following regulations: 1. Actual cgmp regulations 2. GMP requirements for automatic systems 2015-11-03 p. 8