Production and Test Facilities Via Romagnoli, Fiorenzuola d Arda (PC) - Italy - Tel Fax Containment Systems

Transcription

1 Containment Systems

2 our approach FPS containment approach FPS is specialized in containment systems and fine size reduction equipment for many industrial applications. Our approach to a containment system is to discuss with the end user the specific needs in terms of protection, quality, and productivity in order to identify the solution that best fits the specifications: Isolators for highest protection levels Laminar flow booths for small volumes protections Pack-off to safely discharge, weigh and pack powders Cleanrooms as general operation environment Local extraction arms to reduce dust generation in general applications Inert Gas Containment systems. Analysis and Design 1 Containment: a full spectrum approach FPS designs and manufactures containments systems around customers needs. Different solutions are proposed with variable containment strategies. Flexibility and experience guarantee customized projects with competitive costs and delivery time. Solutions and Services Rigid or flexible solutions Glove ports or half suit configurations Wide range of transfer devices SMEPAC testing Maintenance and Assistance. 2 Mock up We offer a complete range of containment systems that satisfies all possible needs and requirements.

3 our approach We project your solutions Manufacturing and Quality control 3 4 Testing 5 After Sales / Lifetime assistance A dedicated Project team takes care of each machine during the production process. Analysis and Design After discussing with the customers FPS Technical Sales Managers cooperate with the Engineering Department to realize detailed 3D models and P&IDs of the proposed solutions. Mock up FPS Project Managers work together with the Production Team to realize full-scale mock-ups of the proposed solutions to check the ergonomics related to the intended operations. At this stage the customers can make any necessary modification. Manufacturing and Quality control When the customer approves the project our Production Team manufactures the equipment according to the Highest Quality Standards. FPS Quality Management System assures that the whole process follows ISO 9001 operating procedures, according to GMP standards. Testing Each machine is tested at FPS facility (FAT Test) to ascertain that the functioning is in accordance with the URS. FPS Testing Center is equipped to execute SMEPAC Test in order in order to assess the performances of the equipment as part of FAT. After Sales / Lifetime assistance FPS keeps on assisting its customers after the delivery of the equipment. Maintenance and installation services provide continuous and precise after-sales care. As FPS machines are constantly evolving our Technical Team always suggests possible upgrades and improvements.

4 Isolators for HPAPI Production Production and handling of HPAPI or toxic products (in gas, liquid or powder form) need the total product separation from the environment to protect the operators. A negative pressure regime is maintained within the internal volume of the isolator. Turbulent airflow is generally adopted. The operator accesses to the inside of the isolator via glove ports or half-suit. Containment levels from 10µg/m 3 down to 0,01µg/m 3 are available, with different manufacturing solutions and configurations. Isolators for HPAPI Production are available for many applications: Laboratory, Synthesis, Filtration & Drying, Production Reactor Charging, Process vessel discharging, Pilot Milling & Micronization, Production Milling & Micronization, Dispensing, Quantity handled Micro (<10g) Small (<10.000g) Medium (<100 kg) Large (>100 kg) Task duration Dustiness Potential Low Medium High EP0 EP0 EP1 EP0 EP2 EP0 EP1 EP1 EP2 EP1 EP3 EP2 EP2 EP1 EP3 EP2 EP4 EP3 EP3 EP2 EP4 EP3 EP4 EP3 Long Short Filtration & Drying Synthesis Milling & Micronization Pilot Size

5 range Containment system for API Pilot Plant It includes Filtration, Drying, Milling, Micronization, Dispensing and Packaging systems Hazard group Exposure limit OEB (solids) EP0 EP1 EP2 EP3 EP4 A 1,000-10,000 μg/m 3 dust OEB B 100-1,000 μg/m 3 dust OEB C μg/m 3 dust OEB D 1-10 μg/m 3 dust OEB E μg/m 3 dust OEB F <0.01 μg/m 3 dust N/A LOW HIGH Process vessel charging Milling & Micronization Production Size Process vessel discharging Laboratory

6 Isolators for HPAPI Formulation and Packaging The containment of the formulation activities of HPAPI Oral Solid Form requires high integration with the process machines without affecting their functionalities and performance. The goal is to guarantee to the operator the best use of the process machines assuring high containment capability. FPS collaborates with top worldwide OEMs since many years to provide the most up-to-date technologies. The process is kept separated from the environment by means of closed rigid walls around the formulation machines. When continuous operations are requested, air barriers are provided when continuous operations are requested. Dedusting machines and powder suction units are proposed to be integrated inside the isolators to provide a higher containment. Negative pressure regimes with turbulent airflows are generally adopted. Isolators are generally supplied with glove ports configuration. It is possible to reach containment levels down to 0,01mg/m 3. Typical applications are spray dryers, granulators, extruders, mixers, powder screens, tablet presses, capsules filling and pan coating machines. Isolators for additional services in OSD departments include: dispensing, In Process Quality Control (IPC) and HPLC preparations. Formulation Dispensing units Tablet press, complete with metal checker and de-dusters Capsule filling Pan coating

7 range Containment systems for formulation line It includes Dispensing, Blending, Sieving, Capsule Filling, Capsule Counting and Final Packaging Laboratory IPQC Laboratory Packaging Blistering

8 Sterile Isolators and RABS Containment systems for sterile applications are proposed in the form of closed isolators or Restricted Access Barrier Systems. A sterile isolator allows avoiding the use of sterile cleanrooms, reducing the sterile volume around the process. Turbulent or unidirectional airflows can be adopted for ventilation. FPS can provide isolators for the following applications: Sterility testing Aseptic filling lines (pharmaceutical or food applications) Vessel charging of sterile products Dispensing Sterile milling and micronization Vessel discharge of sterile products. Integrated decontamination systems (VHP generator) are generally adopted. The RABS is the right choice for flexible and secure production in existing cleanrooms. A RABS can be designed as open or closed system (i.e. for toxic products), in active or passive execution. Each RABS is engineered and optimized according to the process requirements. FPS proposes: Active RABS, complete with HVAC and T/RH control Passive RABS, with control integration for process machine (filling line) Retrofitting of existing units is possible within limited timeframe. Sterile solutions HPAPI Sterile Dispensing Isolator Sterile caps discharge isolator Sterility test isolator

9 range HPAPI Sterility Test Isolator The barrier isolator operates under a positive pressure regime, as required for sterile manufacturing processes RABS solution Sterile / toxic isolator RABS for filling line

10 Additional containment solutions FPS offers a complete range of containment systems to satisfy any possible need and requirement. We approach a project discussing with the customer about the specific needs in terms of protection, quality, and productivity in order to identify the equipment that best fits the specifications. In addition to Isolator Systems, FPS can propose additional containment solutions as: Isolators for highest protection levels Laminar flow booths for small volumes protections Pack-off to safely discharge, weigh and pack powders Cleanrooms as general operation environment Local extraction arms to reduce dust generation in general applications Inert Gas Containment systems. Cleanroom Cleanrooms solutions allow product protection in a variety of materials and configurations. FPS designs and installs turnkey solutions, classified up to ISO5, complete with: Partitioning walls, manufactured with high pressure laminated sheets, stainless steel, carbon steel, complete with coving and accessories when required, access doors, windows. The whole system is designed assuring co-planar surfaces with best cleaning results. HVAC systems, with required airflows and HEPA filtration according to the desired ISO class and containment need. The HVAC is complete with the Temperature and Relative Humidity control system; it is possible to design the cleanroom assuring special thermo-hygrometric conditions, down to RH<20%. Flooring, with PVC mats or epoxy resins lining. Illumination of rooms with LED or neon lamps. Access control system, to prevent direct communication of external environment with working areas (available even in ATEX rated areas). Qualification documentation. Qualification service. Laminar flow booths Laminar flow booths assure the respect of specific air quality requirements in a confined space They are a convenient solution for process protection, dispensing or sampling activities. FPS proposes a standard modular solutions for: Vertical Laminar Air Flow units Horizontal laminar flow booths Down-Cross units. Laminar flow booths Cleanroom

11 range Cleanroom applications: Pharmaceuticals Cosmetic Electronics Aerospace Hospitals and laboratories Research centrer Pack off station Pack-off stations assure product protection and reduce operator dust exposure during discharging operations from silos, bins, cyclones, driers, reactors, centrifuges, It is possible to install pack-off systems on existing equipment, reducing to a minimum the requested modification Custom designed configurations are also available integrated with: Weighting platforms Dosing valves Sampling systems Continuous liners Inflating heads Horizontal flow booths. Pack off station Inert gas containment Inert solutions allow the execution of activities within the enclosure without contamination or exposure to atmospheric conditions. Nitrogen and Argon are typically adopted as ventilation gas. Possible applications are: Electronics Aerospace Research Centers Laser welding Lithium applications Medical devices. Inert gas containment

12 Mc_ F.P.S. Food and Pharma Systems S.r.l. - info@foodpharmasystems.com Headquarters Via Vandelli, Como (CO) - Italy - Tel Fax Production and Test Facilities Via Romagnoli, Fiorenzuola d Arda (PC) - Italy - Tel Fax