When you choose to work with us, you will always have the advantage of our unique experience from managing and designing projects in Sweden, as well worldwide, for both big pharma and smaller companies.
Your organization and your projects are complex. We offer you a range of expertise with the aim to cover every area from project planning and design at every stage of the project lifecycle. We bring our vast experience of project execution with us in order to strengthen the project team.
You can hire us for larger assignments or when you need an extra resource within your organization or project team.
We offer you our services within the following areas of Expertise:
GMP Facility Design
How do you transform your production requirements into a modern GMP-compliant manufacturing facility? Our process and facility engineers do it every day. All we need is a preliminary manufacturing method and a production volume, either as a preliminary batch size or a sales forecast.
Using modern design tools and the industry’s sharpest brains, we bring your product from idea to a GMP-compliant facility design. KeyPlants’ experienced in-house process architects can bring you on a journey starting from feasibility studies and site master planning, through conceptual and basic engineering, to a fully-detailed construction documentation package.
Our projects cover refurbishment and upgrades of existing facilities, to complete greenfield projects designed for conventional construction or modular off-site construction technology.
Our experienced project managers will ensure a successful project delivery through effective planning and with the right team behind them. We have executed a large number of projects in Sweden, as well as globally, and are used to working with both large and small clients, many of which are leading A/E’s and construction companies around the world.
We have the experience and tools in place for monitoring progress and maintaining robust control throughout the lifecycle of a project, ensuring any challenges are effectively addressed – to meet your time, cost and quality objectives.
Through our proven execution model, we reduce our clients’ risk and helps to deliver projects in a predicable manner, for any project phase at which we are consulted.
A successful design manager needs to understand the key design criteria for how product quality and GMP can be built into a design. Thanks to an extensive background from the pharmaceutical industry, and broad knowledge in all building disciplines attained through numerous project, our design managers will lead the design of your project around all possible obstacles, avoiding unnecessary gold-plating to meet schedule and budgets – and always with product quality as the top priority.
We are used to working in an international environment, complying with local building codes and guidelines and cooperating with local engineering firms all over the globe.
The main focus areas for a KeyPlants Design Manager are:
- Ensuring GMP and code compliance
- Leading the team efficiently towards the project goals
- Cost-effective execution with best practice
Commissioning & Validation
Key to successful compliant commissioning and validation execution is good planning and approval from relevant stakeholders, already in the early design phases. We have extensive experience in developing verification programs to meet international standards, our customers’ specific requirements and best practices. We build our C&Q strategies around our clients’ way of working to get the job completed efficiently. If it’s a greenfield site, we will develop the system based on KeyPlants’ standard.
We use proven GMP information management software with full traceability and audit trail.
We assure the success of your most complex and large-scale capital projects, as well as your small but critical retrofit/expansion projects. From construction quality assurance to automation systems, we’ll show you how to meet the most stringent quality, cost, and schedule requirements.
Our Project Delivery services:
- Development of master commissioning and qualification plans
- Design review and qualification
- FAT/ SAT planning and execution support
- Commissioning protocol development and site execution
- IQ/OQ protocol development and execution
- Validation support
Our process engineers can support your team and organization with expertise in areas such as:
- Aseptic formulation and filing
- Small molecule APIs
KeyPlants’ engineering experts will, when consulted, assist you in ensuring your design and operation complies with all regulatory requirements. We will perform efficient design reviews of your design in relation to GMP or other applicable regulations.
Using modern design tools and the industry’s sharpest engineers, we will develop your process from description to a GMP-compliant process design for procurement, installation and validation.
We offer installation services for complete clean room and process system installations. KeyPlants can supply all the equipment and material required for refurbishment of an existing facility or a new facility installation.
The service is provided with support from our fabrication workshop, Swedish Modules.