Uncategorised

Showing all 17 results

  • Aseptic Isolator

    For a reliable, sterile environment for the processing of pharmaceutical products, you need a solution that provides uncompromised, total barrier isolation.   Download Product Catalogue

  • Construction

    During the process construction activities, CSV Life Science provides the following services: Coordination of Construction Activities. Safety Coordination. Scheduling and Cost Control. Contract Definition and Management. Commmissioning and Validation Integration. Our project activity COORDINATION OF CONSTRUCTION ACTIVITIES The construction activities are executed in a rational sequence, taking into account spaces and materials availability. SAFETY Safety aspects of construction are continuously checked vs. the Safety Plan. Pocket leaflet on Safety is given to all companies working at site. Safety statistics are regularly done. CHECK OF QUALITY Execution of erection works is checked vs. engineering documentation, assuring that construction activities are consistent with the design. On site Changes are properly managed. CHECK OF SCHEDULE Physical progress of erection works is evaluated, and compared to overall project schedule; remedial actions are taken if delays are identified. ADMINISTRATIVE ACTIVITIES Work Progress Reports of Subcontractors are evaluated and approved, before the issue of relevant invoices. INTEGRATION WITH VALIDATION Collection of suppliers technical documentation in order to build up the Site Mechanical Catalogue (the basis of the future vTOP file). Tests documentation: Tests normally performed during Construction, pre-Commissioning and Commissioning are documented in proper forms, in order to be a valuable support for writing IQ/OQ Protocols writing and execution.   Download Product Catalogue

  • Containment Cleaning Chamber

    This cleaning chamber has a special design, because the needed opening mechanism are integrated into the cleaning process. As a rule, it’s not possible to trigger containment by dismantling the double valve halves in front of the wash chamber. Thus this step must take place within the enclosed chamber. Servolift has developed a cleaning chamber for this which meets these special requirements. The needed opening mechanisms for the double valve system are found within the wash chamber. Cleaning media and drying air are fed from the underside through the opened double valve of the interior of the container. Also this chamber can be produced, like the cleaning chamber, in various designs. <aclass="downloadbtn"href="file:///D:/D%20Drive%20data/jeet%20data/Inos/Done/Containment/Catalogue/HIGH%20CONTAINMENT%20CLEANING%20CHAMBER.pdf">Download Product Brochure

  • Containment Isolators

    For a fully contained environment during active product handling, you need a solution that provides uncompromised total barrier isolation. Howorth designs and manufactures bespoke isolators, which combine containment levels of less than 1 μg/m3 with ergonomic and maintenance efficiency. To ensure total system integration, Howorth works in close co-operation with you, our customer. Particular attention is paid to the interface between the operator and your own process to ensure that all production and containment levels are fully achieved. Ergonomic Mock-ups We recommend the production of a full scale model that allows the ergonomic aspects to be addressed in addition to the optimum placement of ancillary and process equipment. Following client review, any modifications can take place with progression into manufacture. Equipment Integration Howorth has earned a strong reputation within the industry for our innovative integration of process equipment within barrier isolation systems. We have worked on a wide range of successful equipment integration projects, both with end users and OEMs. Applications Dispensing and sub-division. Reactor Product Charging. Pack Off/Off Loading. Sampling & Heel Recovery. Solids Charging. Chemical synthesis. Mills & Granulators. Fluid Beds. Filter Dryers.   Download Product Catalogue

  • Containment solutions

    CSV Life Science continues to be active in the pharmaceutical market as a leading company, always looking for the most innovative customized solutions in the pharmaceutical field, such as: Powder Containment (validated 10-9 g) classified from OEB1 (>1000 µg/m³) to OEB5 (<1 µg/m³). Smart flexible solutions. Introduction of containment systems suitable for an existing plant. The Compliance team offers specialist quality assurance competences that not only enable them to deliver an “internal quality guarantee service” for our engineering and validation projects, but also to provide our clients with expert support for the typical functions required of their own Quality Assurance and Quality Control organizations and systems. This service is in increasing demand as a result of the relentless pace of today’s technological innovations and constant amendment to the quality and safety requirements by regulatory bodies, which have inevitably led to increasingly rapid changes in the international standards applicable to the pharmaceutical sector. We respond to this need by ensuring that it always keeps pace with the times and is able to provide every client that needs to comply with these changes with a support service that delivers prompt and effective solutions. We offer our clients a full spectrum of services in this area, including: Process, cleaning and methods validation. Validation Documentation Review. Personnel training. QA & QC SOP writing. Internal and Supplier Audits. GMP reviews. Rules and guidelines (US & EU) consultancy. Regulatory Issues. We are able to provide the following services in accordance with the current regulations and guidelines for the sector (GAMP, PIC/S Guidance, FDA 21 CFR Part 11, etc.): Quality system outline. Policy outline. Computer system validation. VMP and VP of computerized systems. User requirements outline and project documents reviews. Suppliers audit. Risk analysis-based approach. Support to development and testing. Gap analysis of existing systems and corrective action plans. Validation and validation report. Administrative SOPs definition. Training on rules and guidelines.   Download Product Catalogue

  • Down flow Booths

    Howorth’s Downflow Containment Booths are engineered to provide high levels of personnel protection, with the flexibility to enable a multitude of process operations to be carried out. Depending upon the application, two main configurations are used: Re-circulatory booths are typically used for powder operations. Once-through booths are recommended where solvent or fume vapours are present. Flexibility Howorth’s engineers will work with you to develop an airflow containment solution that meets your exacting requirements. Our inherently flexible systems, together with our experience of equipment integration, will allow you to meet your safety needs without having to compromise on process efficiency.   Download Product Catalogue

  • ENGINEERING

    Engineering there is an area dedicated to Facility Planning. This activity consists of the analysis, study and design the lay-out, as a preliminary step, often strategic, of a process aimed at creating and / or restructuring of industrial sites (both individual departments of entire production sites). The proposed approach starts from a definition of the strategic concepts of a Site Master Plan that optimizes manufacturing processes, in relation to the flows (materials, people and vehicles), and comes to define the system solutions, technological and procedural optimal, consistent with the places constraints. The Site Master Plan does not invest only the technical side, but considering the economic parameters, research and development, acquisitions and transfers of production, marketing, presenting to the management or ownership proposals from which you immediately perceive the effectiveness of ' economic and technical operation. Furthermore, it constitutes a specific peculiarity of this study and the design of handling and storage systems and installations (Material Handling) in support of the above processes. CSV Life Science offers services Conceptual Engineering, Basic Engineering and Detail. The validation background allows CSV Life Science to follow all phases of the project taking into account the cGMP issues. Conceptual Engineering. Basic Engineering. Detailed Engineering and Supervision. The expertise gained in the pharmaceutical sector and the technical background of chemical engineers that make up the rich section of CSV Process, allows to deal with both the design in the secondary field of production and, therefore, relative to the finished and packaged products, both the design of installations and / or production sites of active ingredients (API), where the process (chemical or biotechnological synthesis) and the engineering of the same require specific technical skills and at the same time a GXP sensitivity. CONCEPTUAL ENGINEERING CSV Life Science is able to follow the development of a project from the early stages. The main activities during the Conceptual Engineering are: Definition of designated areas for the production plant and the support areas lay-out definition and possibly Process Flow Diagrams. Classification areas trails personnel / materials. Definition Main process equipment and utilities of the plant investment estimation (± 25 ÷ 30%). BASIC ENGINEERING The next step CSV Life Science is able to offer are services related to Engineering Base. In this phase all that has been set previously is consolidated, and can then initiate other actions aimed at the realization of the plant, such as for example: Lay-out equipment Process. Lay-Out generation equipment and storage utilities. Design Criteria HVAC. P & ID HVAC. P & ID Process Fluids and service. P & ID Process. Lay-Out pipes. Lay-out Channels. Pre-sizing major utilities generation equipment. Specifications Equipment Process. List Equipment. List Tools. List Fluids. Definition consumption. Activities program. Investment Estimation system (± 10 to 15%). The amount and type of documentation defines in this step the degree of accuracy of the estimate and therefore the development of basic engineering. DETAILED ENGINEERING AND SUPERVISION CSV Life Science is able to develop all the engineering activities of detail, which in addition to consolidating what has been proposed in phase of basic engineering, complement each other in terms of drawings and documents the remaining part of the plant object of activities. CSV Life Science so good, customers in the choice of different suppliers or contractors who will work in the construction of the plant, through an activity of collecting the various offers made homogeneous, and subsequent technical and economic tabulation of the same. The CSV Life Science activities continues with a follow up of the various contractors, checking the consistency of the proposals in relation to the shared project. During the realization phase CSV Life Science is able to provide support to the customer in overseeing the progress of the project even with an active presence (Construction Management), and starting up the same (Commissioning). The development of a number of commissioning procedures, which are approved by the client company, used to define how to check and to manage the data collection (using calibrated instrumentation), responds to the need to make the fastest possible qualification phase of the plant; the data collected in the process of commissioning are a decisive support for the subsequent qualification activities.   Download Product Catalogue

  • Flexible Containment

    The Flexible Glovebag/Isolator is a soft walled containment system that can be used as an alternative to a hard walled isolator in many applications. Flexible wall isolators offer a high degree of protection for both the operator and the product. Howorth’s unique flexible approach can offer design, manufacture and delivery at an affordable price within optimum timescales. Depending upon the application, two main configurations are used: Flexible Construction. Semi-flexible Construction. Flexibility Howorth’s engineers will work with you to develop an airflow containment solution that meets your exacting requirements. Our inherently flexible systems, together with our experience of equipment integration, will allow you to meet your safety needs without having to compromise on process efficiency.   Download Product Catalogue

  • Futorque X-1 Tablet press

    The all new Futorque X-1 is also available with containment. It is more flexible, quieter, more user friendly with "operation-by- process" control software and offers a max. Output of 108,000 tablets/h via impressive production capacities. Futorque X-1 thus meets many customer requirements in one. With its new flagship Futorque X-1, kg-pharma is offering an optimized rotary tablet press that sets new standards worldwide for R&D and production purposes. The system performance pays off from the preparation of clinical studies and orphan drugs all the way to medium-sized production batches, since thanks to the use of Futorque X-1 no major production machine has to be stopped and a high tablet output is nevertheless possible.   Download Product Catalogue

  • High Containment Screens

    Bringing a new dimension to containment with the HCS range of screens including the all new 5D Shield High Containment Screen. Howorth’s Shields (High Containment Screens) are a simple but effective way of boosting the containment capabilities of any downflow booth. With our latest range of shields, Howorth is able to offer previously unattainable levels of operator protection. NEW 5D Shield, High Containment Screen. Developed in collaboration with existing booth operators, the 5D Shield offers unparalleled levels of operator flexibility, making it the ideal solution for a wide range of processes. Independent testing has confirmed that OEL’s as low as 1 μg/m3 can be achieved. This means that for operations where an air suit or isolator were previously the only option, a downflow booth combined with a Howorth Shield is now a viable solution.   Download Product Catalogue

  • LIFTERS WITH PROCESSING COMPONENTS

    These types of machines are used for a variety of applications when combined with process machines. The use of cone mills, hammer mills, vibration sieves, sifters, mobile for various areas or stationary. The broad applications spectrum of these devices can be seen in weighing for raw materials preparation or granulation for calibration, to name two examples. The take-up system is designed and adapted depending upon the process machines and the specified runs.   Download Product Catalogue

  • RAB Systems

    Restricted Access Barrier Systems (RABS) are an effective alternative to isolators and clean rooms where product protection from contaminants is of paramount importance. Whether your developing brand new facilities or modifying existings ones, a full site survey from Howorth will ensure that you receive the optimum barrier solution for your facility. Modular Flexibility A Howorth RAB system consists of individual modules, each manufactured to a standard specification, but completely configurable depending on the space that you have to work with. It can cover small or large filling and packaging lines, by simply adding more modules. Benefits of choosing a RAB system: Improved contamination control and consequently improved product quality. Modular design facilitates speedy delivery, thereby ensuring minimum downtime. Simplicity of air handling making RABS easier to install. Flexible alternative to isolators and facilitate intervention where necessary. Lower initial cost out-lay in comparison with brand new clean room facilities. Suitable for integration into new and existing facilities. Assists in ensuring your compliance with current regulatory requirements.   Download Product Catalogue

  • Scientific services to research formulation problems

    Natoli Scientific is dedicated to providing the most beneficial solutions to our customer’s tableting problems, product formulation and tooling requirements. Natoli Scientific was founded to research new formulation techniques and tablet compression technology. We combine our four decades of experience with a network of university, consultant, and resident resources to investigate problems and offer our customers unique solutions to their product formulation and tooling requirements. Using the correct tablet tooling selection, tool steel, tool coating, and die configurations is crucial in combating common tableting problems such as sticking, picking, capping, lamination, and tool binding. Our goal is to modify configurations before larger problems arise and you lose more time and money. For these issues, Natoli Institute offers: Formulation Evaluation for Sticking Problems. Formulation Evaluation for Tool Steel and Coating Recommendation. Formulation Modification to Improve Tableting and Performance in the Tablet Press. Investigation of Tool Steel Failure. Recommendations on Coatings for Abrasive and Corrosive Formulations. Troubleshooting for any other problems you’re having. By teaming up with Natoli Institute, you’ll combine your resources with ours to troubleshoot the issues you’re having. Working closely with the Academic Research Consortium, we conduct designed experiments at Natoli Institute facilities and bring you straightforward solutions that actually work.   Download Product Catalogue

  • Syringe, Vial and Cartridge Filling System for Isolators – FSM

    COLANAR is proud to introduce the isolator version of our Filling System Type FSM. Like the standalone version, the isolator version provides syringe, vial and cartridge filling capabilities in one machine and is suitable for companies with limited production space. Both high accuracy rotary piston pump filling and peristaltic pump filling are available and can be easily combined with a nitrogen purging station and / or In-Process- Control system based on the user’s needs. Vacuum assisted stopper insertion allows for stoppering near the fluid level with a minimum of head space. The machine is operated via a user-friendly touch screen HMI, which is easily accessible from the outside of the isolator. Available Modules In-Process- Control. Nitrogen Purging. Vacuum Filling with Rotary Piston or Peristaltic Pump. Vacuum assisted Stopper Insertion. Surge Bag Monitoring.   Download Product Catalogue

  • Tool Metallurgy services

    Metallurgical analysis can help you troubleshoot tooling issues such as wear, breakage, corrosion, and fatigue. The analysis yields a wealth of useful information that will give us: A better understanding as to the root cause of your problem. The opportunity to reassess the steel type being used. Insight on how to avoid similar problems in the future. When failures occur, you can depend on our metallurgical testing services to assist you in determining the proper course of action to help you improve your process and increase profit. Reduce cost by testing steel before you buy! Wear testing is another metallurgical service that we offer. This service lets you: Test several different steels and coatings – prior to purchase. Ensure you’re choosing the right material and wear coatings for your process. Be confident in the informed and cost-effective decisions you make.   Download Product Catalogue

  • Placeholder

    Validation and Compliance

    The Compliance area of CSV Life Science, having specific expertise in quality assurance, as well as providing an internal service of "quality assurance" of engineering design and validation, provides a service to its customers to support the functions of a 'pharmaceutical company: Quality Assurance and Quality Control. This service is increasingly required in this time in which the continuous technological innovation evolve and the quality and safety aspects inevitably involve an increasingly rapid and progressive change in the international rules relating to the pharmaceutical sector. In this scenario, the business operator must be continuously and constantly updated. For this CSV Life Science, able to keep up with the times, can provide a support service to all img_chi_siamocustomers who have, in a short time, face these changes. The activities performedfor our clients are: Process, cleaning and methods validation. Validation Documentation Review. Personnel training. QA & QC SOP writing. Internal and Supplier Audits. GMP reviews. Rules and guidelines (US & EU) consultancy. Regulatory Issues. COMPUTER SYSTEM VALIDATION By operating in accordance with existing laws and guidelines in the field (GAMP, PIC / S Guidance, FDA 21 CFR Part 11, etc.), CSV Life Science can provide the following services: Quality system outline. Policy outline. Computer system validation. VMP and VP of computerized systems. User requirements outline and project documents reviews. Suppliers audits. Risk analysis-based approach. Support to development and testing. GAP analysis of existing systems and corrective action plans (CAPA plan). Validation and validation reports. Administrative SOPs definition. Training on rules and guidelines.

  • Warehousing product

    Warehousing product Short Description.