Modular Clean Room System

Transcription

1 Modular Clean Room System

2 The correct preparation and administration of compounded sterile preparations (CSPs) is a complex process that must be conducted by highly skilled professionals in a specialized environment. Grifols is a global healthcare company with more than 75 years of experience and a record of maintaining the highest quality and safety standards in all of its manufacturing processes. Grifols is therefore uniquely qualified to help make compounding safer. Grifols i.v.tools is the set of products, technologies, processes, management tools, and related services designed to enhance quality, safety, and efficiency in compounding. i.v.tools products are designed to improve institutional compliance with guidelines and regulations. In addition, we provide customized services and consultation on all aspects of compounding, including environmental design and monitoring, operational analysis and workflow, process implementation, and regulatory compliance. Grifols high standards of quality and excellent service make a decisive contribution to minimizing the risks associated with sterile compounding.

3 Misterium is our line of high quality modular clean rooms that can be configured to fit any space and location. Misterium clean rooms are specifically designed for use in the laboratory or the hospital pharmacy to handle cell cultures, and in other settings that require an easy-to-clean, isolated enclosure. Grifols Engineering specializes in biopharmaceutical engineering and has valuable experience in the design and construction of sterile manufacturing areas. A Complete Clean Room Solution Misterium is a new concept that offers a complete solution from initial design to the operation of a fully functioning clean room. Our clean room system has been uniquely designed to enhance safety and efficiency in the compounding pharmacy. 1. CONSULTING 2. CONCEPTUAL AND DETAILED ENGINEERING DESIGN 3. CONSTRUCTION 4. ENVIRONMENTAL MONITORING SYSTEM 5. EQUIPMENT AND AUTOMATION 6. CERTIFICATION AND TRAINING

4 Easy Installation & Maintenance The materials and accessories used are suitable for aseptic cleaning. The unique design makes cleaning easy: Flat surfaces and rounded corners Solid walls, ceilings, and floors Flush and coved joints with no ridges, to prevent the accumulation of dust Only the filters need to be replaced, no additional maintenance is required Versatility Turnkey projects Fast and clean construction process Flexible solution that adapts to any existing space Installation qualification Positive or Negative pressure environments Cleanroom classifications (ISO class levels 5,6,7, and 8) Controlled Environment Design and installation of an advanced monitoring system that controls: Particle count Temperature Humidity Pressure Compliance Complies with federal, state, and international regulations and recommendations on the preparation of sterile compounding products and cleanrooms (GMP, ISO14644, ASHP, OSHA, USP 797, USP 800, PIC/S, Quapos). Certification upon clean room completion.

5 System Components Panels The module is built with 2 inch thick, fully flush wall panels comprised of upvc coated galvanized steel skins, laminated to an aluminum honeycomb core. The upvc finished walls are used for FDA approved clean rooms due to their smooth and easily cleaned surfaces. Panel surfaces are resistant to degradation by UV light, and traditional sterilizing compounds such as bleach, alcohol, and special cleaning compounds. The ceiling panels are also manufactured with same materials and characteristics. They are strong enough to walk on for maintenance procedures. Floors Heat-welded sheet vinyl is a quality floor finish material with a long-life surface and high resistance to breakdown. Floor covering is bonded to the subfloor in strict accordance to the manufacturer s specifications. PVC coving is used at wall, floor, and ceiling junctions within the clean room. Doors The doors are flush on both sides and are made of a 2 1/3 inch thick sandwiched panel mounted on a rim that is integrated with the wall panels. Windows Windows are double glazed and fit flush to the panel. They are made as a mono-block and assembled in the factory. Light fittings The light fittings are airtight and flush to the ceiling; they are specifically designed for use in clean rooms.

6 Applications Hospital Pharmacy, Intravenous Mixtures (sterile products, parenteral nutrition, cytostatic drugs in accordance with USP 797 and USP 800) Tissue Banks (in accordance with FDA 21 CFR 1271). Blood Banks (in accordance with RD 1088/2005 & 1301/2006) Gene & Cell Therapies (in accordance with GMP) Microbiological & Sterility Control, Pharmaceutical Laboratories (in accordance with GMP) Microbiological Containment Laboratories (in accordance with EN 12128) Misterium Reverse: Infection control setting that creates and monitors negative pressure conditions for specific patients to prevent transmission of infectious agents in healthcare settings

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8 Grifols sterile manufacturing expertise applied to the compounding pharmacy GRIFOLS USA, LLC 2410 Lillyvale Avenue Los Angeles, CA USA Ph US/HP/1115/ /11/15 Grifols International, S.A. Parc empresarial Can Sant Joan Av. de la Generalitat, Sant Cugat del Vallès Barcelona - SPAIN Tel. (34)