TURNKEYPHARMACEUTICALPROJECTSPLANTS FOR I.V. SOLUTIONSPLANTS FOR DIALYSISPRODUCTSPLANTS FOR BLOOD BAGSPLASMA FRACTIONATION PLANTSBIOTECHNOLOGY PLANTSMULTIPURPOSE PLANTS
2We are proud to grant a complete design, engineering, construction, start-upnew pharmaceutical facilities, even assisting the Clients through scouting ac-tivities of potential Know How Licensor, transferring the Know How, providingValidation Master Plans and Standard Operating Procedures, validating, aligningindustrial processes to URS and regulatory requirements.We propose reliable know-how & technologies about: - LVP (Large Volume Parenterals) in PVC or PP bags - LVP in Glass or Plastic Bottles - SVP (Small Volume Parenterals) in Glass or Plastic vials and ampoules - Pre-filled Syringes - Dialysis concentrate solutions and powders (Canisters, Bags, Cartridges) - Plasma Fractionation - Biotechnological Plants - Multipurpose Pharmaceutical PlantsWe perform a turnkey project through: a Procurement of Licensors and Know How Transfers aConceptual Design and Design Qualification (DQ) aDetailed Engineering aValidation Master Plan & S.O.P. aEquipment Construction & Procurement aFactory Acceptance Test aShipment and Installation aSite Acceptance Test aStandard & Validation Documentation (IQ/OQ/PQ Protocols) aTraining aCommissioning, Calibration & Start up aRegulatory SupportBRAM-CORTURNKEYPHARMACEUTICALPROJECT
3TURNKEY PLANTS FOR I.V. SOLUTIONS 4TURNKEY PLANTS FOR DIALYSIS PRODUCTS 6TURNKEY PLANTS FOR BLOOD BAGS 7TURNKEY PLASMA FRACTIONATION PLANTS 8TURNKEY BIOTECHNOLOGY PLANTS 9TURNKEY MULTIPURPOSEPHARMACEUTICAL PLANTS10TURNKEY PROJECT DRIVERS 11GEP Good Engineering Practice QA Quality Assurance URS Users Requirements SpecificationDQ Design Qualification IQ Installation Qualification OQ Operational Qualification PQ Performance Qualification
4Complete facilities to produce Intravenous (IV) Solutions both in Small (SVP) and in Large (LVP) volumes throughstandard or even modular configuration with capacities from 500 upto 24.000 pcs/h.iv forms- Bags (both PVC and PP)- Glass Bottles- Plastic Bottles with Blow Fill Seal(BFS) Technology- Plastic Bottles with Stretch Blow Molding(SBM) Technologystandard solutions invarious concentrations- Water For Injection- Sodium Chloride- Glucose / Dextrose- Dextrose Solutions- Mannitol- Ringer Lactate- Hartmanspecialistic solutions- Fat Emulsions- Aminoacids- Plasma expanders- Pre-mixed heparine- Ciprofloxacin- Metrodinazole- ParacetamolTURNKEY PLANTS FOR I.V. SOLUTIONS
5from designto validationThe scope of the project is the design, construction,equipment supply, installation, commissioning,training and validation of the production lines formanufacturing Intra Venous Solution Products.These lines include:- PHARMACEUTICAL WATER PROCESSING(WFI/PW/PS)- SOLUTION PREPARATION- FILLING, SEALING, STERILIZING,PRINTING, INSPECTING- PACKAGINGThe main factors to be considered in preparing thelayouts which determine “Flow Routes” are:- Required production capacity- GMP compliance- Flexible accomodation- Quality of working environment- Operational efficiency- Ease of access for maintenance and validationConsideration of the segregation of the flow of- Materials- People- Wastes- Finished productis essential to achieving GMP compliance.
6TURNKEY DIALYSIS PRODUCTS PLANTSComplete facilities to produce Products for Haemodialysis and Perito-neal Dialysis. In several cases these manufacturing lines are installed indevoted areas of Intravenous Solutions Projects.forms- Canisters- Bags- Multichamber bags- Cartridgesproducts- 3.4 / 5 L Diacetate Bags- 5 / 8 / 10 L Diacetateand Bicarbonate canisters- CAPD bags- Bicarbonate cartridges- Priming solutions bags- Multichamber bags
7TURNKEY PLANTS FOR BLOOD BAGSComplete facilities to produce Blood Bags with anticoagulantsolutions. The plants can be designed for a full automatic pro-duction/assembling of the bags or through a semi-automaticprocess. It is possible to integrate the Blood Bags through Leu-cocyte filters.products- Single Bags- Double Bags- Triple Bags- Tetra Bags Top-Top- Tetra Bags Top-Bottom
8Complete facilities to produce Haemoderivatives from Plasma. High efficiency extraction deriving from properKnow How Licensing by primary pharmaceutical industries that fractionate the plasma in top quality plants thatalso ensure the best virus inactivation processes.basicproduct- Antihemophilic (Factor VIII and Factor IX)- Immune Globulin (IG) Hyperimmune (Tetanus, Rh, etc.)- Immune Globulin Intravenous (IGIV)- Albumin- Plasma Protein Fraction (PPF)- Anti-Inhibitor Coagulant Complex (AICC)- Antithrombin III- Fibrin Sealant- C1 InhibitorTURNKEY PLASMA FRACTIONATION PLANTS
9Complete facilities to produce biotechnological products with standard, disposable or mixed technology. Mostadvanced fermentation technologies deriving from proper Know How Licensing by primary pharmaceutical indus-tries that also ensure the top QA controls.example of products- Interferon- EPO (Erythropoietin)- EFG (Epidermal Growth Factor)- Insulin- hGh (Human Growth Hormone)- Monoclonal AntibodiesTURNKEY BIOTECHNOLOGY PLANTS
10TURNKEY MULTIPURPOSE PHARMACEUTICAL PLANTSOn specific request we can provide com-plete pharmaceutical facilities coveringmost of the available technologies, suchas:- Antibiotics Projects- Veterinary Projects- Multipurpose Generics plants(oncology, cardiology, etc.)- Etc.
11All Pharmaceutical Facilities need to be up-dated, competitive and efficient in operation, to diversifyproduction programs, to reduce life-cycle costs and, above all, to comply to the appropriate pharmaceu-tical GMP regulation. BRAM-COR project drivers are aimed at satisfying all pharmaceutical regulatoryand QA requirements, aligning the final product to the international Pharmacopoeias and capitaliz-ing upon a careful, customer-oriented proj-ect management. Equipment and processesare designed to allow a logical flow in orderto avoid mix-ups of components, drug prod-uct, closures, labeling, in-process materialsor cross contamination achieved through thedevelopment ofConceptual Designdescribing the general project organizationDetailed Engineeringconsidering all process flows (raw materials,finished products, personnel, waste, etc.) anddetailed project specifications.During the initial phases of the process we as-sist our Clients with a feasibility study and anengineering support due to optimize the en-tire project from the overall investment pointof view, considering operational costs reduc-tion. Through our software we can performall necessary simulations and recommendthe best solutions. Either counting or not onour initial engineering support, we provide acomplete set of specifications in our DESIGNQUALIFICATION protocols, which are submit-ted to our Customer for approval before start-ing the equipment construction.Professionalism in installation is a basic re-quirement in all pharmaceutical technolo-gies. We provide installation teams composedof qualified supervisors, patented weldersand skilled piping assemblers working in ac-cordance to BRAM-COR sanitary piping pro-cedures all over the world. All product criti-cal parameters are carefully monitored, suchas: fluid flows, pump duties, alarms, valves,emergency power and software modules.Our FAT and SAT protocols provide a completedocumentation of testing activities.The necessary training for operation andmaintenance of BRAM-COR pharmaceuticalsystems is provided by our expert techniciansat the system start-up, ensuring a full under-standing of how the equipment works andhow to operate for effective sanitization/ster-ilization and troubleshooting.TURNKEY PROJECT DRIVERSinstallation,start-up andtraining
052012BRAM-COR S.P.A - V. MERCALLI 12/A - 43122 PARMA - ITALY - TEL +39 0521 538711 - FAX +39 0521 firstname.lastname@example.org - www.bram-cor.com - P.IVA 01699350342WORLDWIDE SERVICESWe are currently delivering our machines and building complete processing lines all over theworld. Top quality GMP equipment must necessarily be integrated through a proper high level ofprofessional services including: Technical Documentation, Factory Acceptance Test, Installation,Commissioning, Site Acceptance Test & Start-up, Training, Validation, After Sales Service. Ourworldwide network of skilled agents and our affiliated companies ensure assistance to our Clientsin over 50 countries, from the very beginning of a pharmaceutical project throughout decades afterstart-up. Our After Sales Dept. grants punctual and quick deliveries of spares and ongoing technicalsupport.A full understanding of the drug production process is the key concept for correct design. BRAM-COR engineering focuses specially on production processes for sterile injectables, such as paren-teral solutions, oral solutions, ophtalmic solutions. The definition, assessment and monitoring ofcritical parameters directly affecting product quality are the baseline for the application of suitableProcess Analytical Technologies for in-line and at-line quality control. BRAM-COR work breakdownstructure consists in following main activities:- Design- Construction (mechanical, electro-pneumatic, SW configuration)- Testing- Documentation- Installation- Validation- ServiceEvery process follows rigorous cGMP-compliant Standard Operative Procedures. Specification, con-struction, and verification steps within the lifecycle are carried out according to GAMP “V-model”,considering risk assessment, architecture of system components, functional specification, sanitiza-tion and validation issues with special overview to a sustainable maintenance of the system.BRAM-COR KEY DESIGN CONCEPTS