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

77

TURNKEY PLANTS FOR BLOOD BAGS

products- Single Bags- Double Bags- Triple Bags- Tetra Bags Top-Top- Tetra Bags Top-Bottom

8

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

99

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 538770info@bram-cor.com - 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