Our experts have the in-depth knowledge to support you in chemical, microbiological and cell culture production – for example, in chemical production of active ingredients or biopharmaceutical production of recombinant proteins, monoclonal antibodies, mRNA, vaccines and antibody drug conjugates (ADC). 

We evaluate technologies ranging from single-use systems and hybrid systems to stainless steel systems for organisms rated BSL1 to BSL3 as well as systems for highly potent active ingredients. Our team of experts develop plans to address the challenges of active pharmaceutical ingredient production, provide support with cost analysis and site selection and maximize the benefits of stainless steel systems or single-use systems.

We offer customized filling strategies and solutions that meet specific product and process needs, including aseptic and sterile filling and handling of highly active substances. Our comprehensive range of services embraces solid, semi-solid and liquid forms as well as packaging and logistics. As a long-term partner in pharmaceutical manufacturing, we offer continuity and innovation in all aspects of your project.

Our comprehensive planning services for production facilities, clean rooms and technical building services are adapted to appropriate regulatory requirements such as ISO 13485, MDR. Naturally, this includes the documentation required for approvals and audits. We also carry out qualification and validation processes to ensure compliance with all relevant regulations.

We offer specialized process and layout planning and develop tailor-made solutions to suit your needs. Our services range from analyzing and optimizing production processes to identifying potential for efficiency savings along the entire value chain.

We also help you design your production facilities, taking into account optimized material flows and ergonomic workplaces in compliance with regulations and standards in force (e.g. ISO 22716 for cosmetics).

We offer specialized process and layout planning, developing tailor-made solutions to meet your needs. Our services include analyzing and optimizing production processes to identifying potential for efficiency savings along the entire value chain.

We also help you design your production facilities, taking into account optimized material flows and ergonomic workplaces in compliance with regulations and standards (e.g. EU regulations, the German Food Hygiene Directive (LMHV) and the FSSC 22000 certification system).

The first step towards successful qualification and commissioning of a system comes in the early planning phases.

We use our in-depth knowledge of regulations and guidelines currently in force to create tender documents, risk analyses, validation master plans and risk-based test plans for successful implementation and commissioning with DQ/IQ/OQ. This means you can be assured that your systems meet the highest quality standards – for safe and efficient operation in the pharmaceutical GMP, electrical engineering, medical technology, food and cosmetics industries.

Safety and quality are vital in pharmaceutical production, especially for highly active substances or biotechnological organisms up to biosafety level BSL3. io uses leading containment technologies to ensure maximum security. These technologies meet the requirements for purity and efficacy of highly active ingredients as well as employee safety (HSE). We draw on our many years of experience to develop individual protection strategies based on GMP guidelines and OEB classifications.

EPCMV stands for Engineering, Procurement, Construction Management, and Validation. io operates according to this comprehensive project execution model. It encompasses all phases of a project, starting from the planning phase through procurement, implementation to commissioning and qualification & validation. This enables efficient collaboration across all trades throughout the entire project lifecycle.

A process-related needs assessment forms the basis of specific, customized solutions we develop for you and the systems and technologies we recommend that ideally suit your requirements. The clean media are integrated into your overall planning to ensure maximum efficiency and security of supply. We support you in selecting the right technology and preparing tender documents. We steer the  clean media system projects all the way through to installation, commissioning and qualification.

Our experts have many years of experience in planning automation technology for the process and pharmaceutical industry and the interfaces to related functions such as intralogistics, laboratory equipment or technical building equipment.

We advise you on automation and digitalization strategies, draw up specifications and user requirements specifications (URS) and manage the projects from the tendering processes, with award recommendations and bidder selection through to commissioning and validation activities (CSV) in accordance with GAMP5 requirements.

io integrates the requirements from production and logistics with integrated solutions for pharmaceutical logistics that meet the stringent requirements for traceability, storage, temperature control and monitoring.

Our experts are experienced in a wide range of storage types, including room-temperature and cold storage, hazardous goods storage and the storage of controlled substances like narcotics. We support you in planning and modernizing your logistics processes and systems throughout all project phases.

io facilitates comprehensive planning and design of laboratories, taking into account the relevant guidelines (Laboratory Facilities Directive, Workplace Directive). We prepare tender documents and take into account all necessary safety aspects such as ATEX, Genetic Engineering Act (GenTG), Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (BioStoffV) requirements. We ensure that the laboratory areas are seamlessly connected to the requirements and process flows.

io offers comprehensive 3D planning of rooms and pipelines for the pharmaceutical and life science industries. Our precise models integrate all trades involved, including architecture, electrics, HVAC and plumbing. Early collision checks enable fast and efficient planning and implementation of your projects. This improves visualization, detects faults at an early stage, uses resources efficiently and saves time and costs. Our experienced team supports you in all project phases, from concept development to implementation, and ensures that your project is implemented efficiently and quickly.

The clean room is a critical element when meeting quality and safety standards in GMP production. We undertake layouting, planning of rooms and HVAC, implementation and qualification of clean rooms, all compliant with regulatory standards.

Our comprehensive services include: analysis of process requirements and development of suitable designs. Creation of detailed layouts, plans and tender documents. Implementation support through to qualification and validation, ensuring compliance with all relevant standards and regulations.

Our integrative TGA planning combines the requirements of pharmaceutical and process plants, clean media and clean rooms with GMP requirements for the processes and the conditions of the building structures. We coordinate efficiently to ensure optimum, fully compliant performance, keeping oversight of all trades, including heating, ventilation, air conditioning (HVAC), electrics and plumbing, and integrates state-of-the-art technologies to ensure maximum efficiency and safety. Our many years of experience and holistic approach means you can be confident that we will ensure that all aspects of your technical building equipment work together seamlessly and that all systems will operate cost-effectively and sustainable.

EHSQ stands for Environment, Health, Safety, and Quality. This systematic approach includes measures to maintain health, strategies to prevent injuries and accidents, and initiatives to protect the environment. EHSQ integrates quality assurance into internal, operational planning, and implementation processes. As a general and specialized planner for the GMP-regulated life sciences industry, io integrates this approach into planning and implementation projects as well as internal quality assurance processes.