New pharmaceutical facilities or production lines projects

Aseptic process

We can accompany our customers in all key phases of the design, construction, qualification and commissioning of pharmaceutical facilities, both for sterile and oral forms. Our approach combines regulatory compliance, operational efficiency and adaptation to the real needs of the process.

Thanks to our experience in regulated environments, we ensure that every technical decision is aligned with European and American GMPs, Annex 1 and the expectations of health authorities.

  • URS
    We work with your team to define a clear, realistic and comprehensive URS document, covering the functional, regulatory and operational needs of your future plant. We provide recommendations based on our experience to anticipate critical requirements and ensure the technical and regulatory viability of the project.
  • Design consultancy
    We can advise you on the design of clean areas, material and personnel flows, ergonomics, selection of critical equipment and adaptation to GMP regulations. Our goal is to create a safe, efficient and validable work environment, where the design is at the service of the process and not the other way around.
  • Supervision and coordination
    We coordinate the construction, installation and qualification phases of equipment and facilities. We monitor compliance with quality standards, deadlines and budget, minimizing deviations and ensuring a smooth execution.
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If it is an aseptic new line or an aseptic new manufacturing facilities project:

  • Design and review of:
    • Autoclave cycles.
    • Peroxidation cycles.
    • CIP Cycles.
    • SIP cycles.
    • Environmental monitoring system. Design of viable and non-viable particle controls to be carried out within your cleanrooms.
  • Design of the aseptic process validation
  • Design and drafting of SOPs and training of operators.
    We draft the SOPs according to your facilities and your processes. We carry out the necessary training for your operators, both in the SOPs and in the correct practices to comply with GMPs.
  • Support in the design and execution of the commissioning.
    We design a start-up so that the transition is smooth and comfortable and we take care of supervising it to resolve any incidents that may arise and speed it up as much as possible.
  • Preparation of health authorities audits
    We can carry out a preliminary audit, propose an action plan for the improvements to be implemented and we can even train your entire staff to face a health authority audit with the maximum guarantees.
  • Data integrity
    We can monitor that the information stream is robust and meets the expectations of regulators and operators training on how to maintain correct data integrity and make them aware of the great importance of maintaining it.
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Frequently Asked Questions (FAQ)

Do you take care of the engineering of the project or can you work with our internal or external engineering?
We have a team of collaborators specialized in pharmaceutical engineering who can assume the complete design and development of the project if required. However, we can also integrate seamlessly with your in-house team or with an external engineering company you trust, bringing our regulatory and operational expertise to ensure that all decisions are aligned with GMPs and industry regulatory requirements. We adapt to the model that best suits your project.
In what phases of the project can you accompany us?
We can participate in all the key stages: from the definition of the URS (User Requirement Specification), through the technical and regulatory design of facilities, construction supervision and qualification, to commissioning, drafting of SOPs, training of operators and preparation for regulatory audits. Our comprehensive approach ensures consistency and compliance from inception to final validation.
What regulations and standards are taken into account during the project?
All our projects are aligned with European and American GMPs, Annex 1, ISO 14644 and other international standards applicable to aseptic environments or classified areas. We ensure that the design, procedures and documentation are prepared to pass audits by authorities such as FDA, EMA, AEMPS or ANVISA.
How do you ensure an efficient start-up without surprises?
We design a structured start-up strategy, anticipating common incidents and ensuring coordination between the technical, quality and production teams. We monitor key moments on-site so that the transition from construction to actual operation is smooth, safe, and compliant with regulatory requirements from day one.
Can you help us prepare a health audit after the plant start-up?
Yes. We carry out an internal diagnostic audit, propose improvements, train your team and accompany you throughout the process to face regulatory inspections with the maximum guarantees. We also evaluate aspects such as data integrity and GMP documentation, ensuring that the entire system is ready and robust.