CONSULTING

CONSULTING INTRODUCTION

The life science segment serves the pharmaceutical market with engineering and machinery solutions. At Inos, we provide training, troubleshooting and equipment to the pharmaceutical Industry. We offer complete service for solid dosage manufacturing including equipment selection and training programs for the manufacturing team. We also provide GAP analysis, cGMP training and customized programs for small hands-on groups or a complete manufacturing process presentation for the entire company. Moreover our range of services include: Facility planning, Engineering design, Equipment’s, Plant validation, and Computer System Validation, Specific applications based on flexible technology, custom-tailor and studied for containing high potent drugs (safety), and creating classified (GMP) or humidity controlled areas surrounding exposed operations in contamination background.

CHOOSE YOUR PROCESS

PRODUCTS

  • 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. Download Product Brochure

  • 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 Download Product Brochure

  • 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%) Download Product Brochure

  • 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 • Commissioning and validation integration Our Various Project Activities: • 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 and 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 Brochure

  • 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 Brochure

  • 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 Brochure

  • Engineering Design

    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. a. Conceptual Engineering b. Basic Engineering c. 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. Download Product Brochure

  • Tool Services

    TSAR PREDICT Is A Revolutionary New Service For I Holland Customers The TSAR PREDICT service is the culmination of two years' research in association with the University of Nottingham to investigate the root causes of why formulations stick to tablet tooling surfaces. It takes into account the interactions between various parameters such as Van der Waals Forces; capillary action and deformation mechanics. This research has been a key part of I Holland's Tabletting Science Programme. WHAT DOES IT DO? TSAR PREDICT forecasts the best anti-stick PharmaCote® coating solution for your formulation. It calculates single particle adhesion to the punch tip face without time consuming and expensive field trials. WHO IS IT AIMED AT? Any tablet manufacturer experiencing sticking problems including pharmaceutical, nutraceutical, industrial, confectionery, veterinary applications. WHAT DOES IT COST? TSAR PREDICT is a free of charge service available to all I Holland customers. WHAT INFORMATION DOES I HOLLAND NEED FROM ME? All we need from you is the name of the API or main component of the formulation. Even if this API is confidential we can work with basic characteristic information on key physical properties. Download Product Brochure

  • Training

    We support our customers through a programme of training and education including seminars, webinars and installation training. We are able to offer a wide range of tuition and support whether it be at our training facility in Nottingham, England or on-site at customer premises. Our tablet tooling maintenance experts can help customers recognise, diagnose and correct many tooling and tabletting issues before they become a problem that will seriously affect tablet press downtime and tablet output. Download Product Brochure

  • 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 performed for 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 Download Product Brochure