Validations

Aseptic process

Together with our partners, we coordinate and execute complete validation plans, adapted to your processes, facilities and products, complying with regulatory requirements and the expectations of health authorities, combining technical rigor, regulatory knowledge and a practical vision.

We design comprehensive, documented validation plans aligned with the risk management approach (according to ICH Q9), ranging from planning to the issuance of final reports, and ensuring the traceability in each stage of the process.

We can carry out validations in the following key areas:

  • Thermal validations: Studies of heat distribution and penetration in autoclaves, ovens and sterilization equipment. We use calibrated probes and recognized techniques to ensure the uniformity and effectiveness of thermal cycles.
  • SIP (Sterilization In Place) Validations: Verification of automatic in-line sterilization cycles on equipment, tanks, and process lines, ensuring effective removal of microbial load and avoiding cross-contamination without disassembly of the system.
  • Validation of the life cycle of garments: We evaluate the integrity of garments and the emission of particles throughout its useful life, and we try to extend the number of cleaning and sterilization cycles as much as possible, to increase sustainability.
  • Aseptic process validation: Using media fill studies (aseptic process simulation or APS) and air flows.
  • Cleaning and disinfection validation: Validation of the effectiveness of cleaning agents and disinfectants against microbiological loads, determination and validation of product residues, including swab/rinse analysis.
  • Validation of radiation sterilization processes: Initial validation, periodic revalidation and technical review of existing sterilization processes that use Gamma radiation, Beta radiation (accelerated electrons) and X-rays, in accordance with the requirements of ISO 11137 (Parts 1, 2 and 3) and other applicable guidelines of the regulated environment.

In addition, we can help you define:

  • Periodic revalidation strategies
  • Protocol Development (IQ/OQ/PQ)

All our services are developed in collaboration with your team, promoting knowledge transfer and operational autonomy. We adapt to both new facilities and operating plants that need to validate new equipment, modify existing processes or update their validation strategy according to the latest regulatory guidelines.

Let's design your validation plan!
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Frequently Asked Questions (FAQ)

What types of validation can you perform?
We can design and execute complete validation plans that include validations of facilities and utilities, Aseptic Process Simulation (media fill), thermal and sterilization validations (autoclaves, SIP, CIP), cleaning and disinfection, as well as the qualification and validation of critical equipment. In addition, we help define a periodic revalidation strategy to keep your system always compliant and audit-ready.
Do you work only with new installations or also with plants that are already operational?
We adapt to both cases. We can participate from the design of the validation strategy for new facilities, as well as intervene in operating plants that need to validate new equipment, modify existing processes or update their validation approach according to the latest regulatory requirements.
What regulations or approach do you follow to design validation plans?
We design plans aligned with Good Manufacturing Practices (GMP) and risk management approach according to ICH Q9. All projects are documented in a traceable way, from planning to final reports, complying with the expectations of agencies such as EMA, FDA or AEMPS.
Can you also help us with the drafting of IQ/OQ/PQ protocols?
Yes. We develop complete and clear Installation (IQ), Operation (OQ) and Operation (PQ) protocols tailored to your specific equipment and processes. We can also assist in their execution and in the collection of documentary evidence necessary for audits.
Do you train staff during the validation process?
Yes. We involve your team at every stage to promote knowledge transfer and ensure operational autonomy after the project is completed. We also offer specific training to reinforce the technical understanding of the validated procedures and ensure their correct execution.