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TURNKEYPHARMACEUTICAL
PROJECTS PLANTS FOR I.V. SOLUTIONS PLANTS FOR DIALYSIS PRODUCTS
PLANTS FOR BLOOD BAGS
PLASMA FRACTIONATION PLANTS
BIOTECHNOLOGY PLANTS
MULTIPURPOSE PLANTS
22
LVP LVP SVP Pre-filled Syringes Dialysis concentrate solutions and powders Plasma Fractionation Biotechnological Plants Multipurpose Pharmaceutical Plants
a Procurement of Licensors and Know How Transfers aConceptual Design and Design Qualification aDetailed Engineering aValidation Master Plan & S.O.P. aEquipment Construction & Procurement aFactory Acceptance Test aShipment and Installation aSite Acceptance Test aStandard & Validation Documentation aTraining aCommissioning, Calibration & Start up aRegulatory Support
BRAM-COR TURNKEY
PHARMACEUTICAL PROJECT
33
TURNKEY PLANTS FOR I.V. SOLUTIONS 4
TURNKEY PLANTS FOR DIALYSIS PRODUCTS 6
TURNKEY PLANTS FOR BLOOD BAGS 7
TURNKEY PLASMA FRACTIONATION PLANTS 8
TURNKEY BIOTECHNOLOGY PLANTS 9
TURNKEY MULTIPURPOSE PHARMACEUTICAL PLANTS
10
TURNKEY PROJECT DRIVERS 11
GEP QA URS DQ IQ OQ PQ
44
4
iv forms- Bags - Glass Bottles- Plastic Bottles - Plastic Bottles standard solutions in various concentrations- Water For Injection- Sodium Chloride- Glucose / Dextrose- Dextrose Solutions- Mannitol- Ringer Lactate- Hartman specialistic solutions- Fat Emulsions- Aminoacids- Plasma expanders- Pre-mixed heparine- Ciprofloxacin- Metrodinazole- Paracetamol
TURNKEY PLANTS FOR I.V. SOLUTIONS
55
from design to validation
production lines
- PHARMACEUTICAL WATER PROCESSING (WFI/PW/PS)- SOLUTION PREPARATION- FILLING, SEALING, STERILIZING, PRINTING, INSPECTING - PACKAGING
- Required production capacity- GMP compliance- Flexible accomodation - Quality of working environment- Operational efficiency- Ease of access for maintenance and validation
- Materials- People- Wastes - Finished product
6
TURNKEY DIALYSIS PRODUCTS PLANTS
6
forms- Canisters- Bags- Multichamber bags- Cartridges
products- 3.4 / 5 L Diacetate Bags- 5 / 8 / 10 L Diacetate and Bicarbonate canisters- CAPD bags- Bicarbonate cartridges- Priming solutions bags- Multichamber bags
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TURNKEY PLANTS FOR BLOOD BAGS
products- Single Bags- Double Bags- Triple Bags- Tetra Bags Top-Top- Tetra Bags Top-Bottom
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basic product- Antihemophilic - Immune Globulin Hyperimmune - Immune Globulin Intravenous - Albumin- Plasma Protein Fraction - Anti-Inhibitor Coagulant Complex - Antithrombin III- Fibrin Sealant- C1 Inhibitor
TURNKEY PLASMA FRACTIONATION PLANTS
8
- C1 Inhibitor
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example of products- Interferon- EPO - EFG - Insulin- hGh - Monoclonal Antibodies
TURNKEY BIOTECHNOLOGY PLANTS
10
TURNKEY MULTIPURPOSE PHARMACEUTICAL PLANTS
10
- Antibiotics Projects- Veterinary Projects- Multipurpose Generics plants - Etc.
11
Conceptual Design
Detailed Engineering
and skilled piping assemblers working in ac
11
TURNKEY PROJECT DRIVERS
installation, start-up and training
4
4
BRAM-COR S.P.A - V. MERCALLI 12/A - 43122 PARMA - ITALY - TEL +39 0521 538711 - FAX +39 0521 [email protected] - www.bram-cor.com - P.IVA 01699350342
WORLDWIDE SERVICES
Technical Documentation, Factory Acceptance Test, Installation, Commissioning, Site Acceptance Test & Start-up, Training, Validation, After Sales Service
After Sales Dept
- Design- Construction (mechanical, electro-pneumatic, SW configuration)- Testing- Documentation- Installation- Validation- Service
BRAM-COR KEY DESIGN CONCEPTS