Qualification and validation services

As subject matter experts (SME) with decades of experience in solid and liquid manufacturing operations, we offer a wide range of EU GMP/PICs and US cGMP-compliant qualification and validation services. You can choose from our different activities according to your needs. With several workshop offers and a clear communication, we make sure you always have an understanding and full control of all Syntegon activities regarding your project. We deliver what you need while providing full transparency concerning all your ordered services.

Key benefits

Full service

We deliver the full array of GMP-compliant qualification and validation services from a single expert source.

High flexibility

Thanks to decades of experience from projects all over the world, we can flexibly adapt to specific customer requirements.

Joint qualification approach

Benefit from reduced time to market, as well as economic and regulatory expertise in close collaboration with your Syntegon experts.

Syntegon qualification philosophy

Do it once, and do it right! In line with this philosophy, we make sure you receive exactly the documented evidence you require for compliance inspections. Our dedicated experts will be happy to execute your IQ and calibration, as well as OQ after final installation at your site. They will of course also assume responsibility for task and time management. They are accompanied by a team of SMEs to cover all commissioning and qualification (C&Q) areas. Our offer includes workshops for various project stages and the use of calibrated measuring devices.

Experience and reliability

Syntegon has 25 years of experience in isolator filling line qualification and validation. We have brought almost a thousand qualification projects to a successful close. How do we do it? Our team comprises close to 100 experts with a background in engineering or natural sciences. Our designated qualification project managers are available for projects of different levels of complexity – from start through qualification to lifecycle support. Based on the proven Syntegon SOPs (Standard Operating Procedures), they are supported by design engineers, programmers, technicians, electricians, and further skilled staff according to project demand.

Recommended qualification and validation activities

Backed by our long-standing expertise, we have compiled an overview of qualification and validation activities for your pharmaceutical liquid filling processes:

Project Quality Plan (PQP) incl. workshop
Design Qualification (DQ) workshop
Risk analysis (RA) incl. workshop
Disaster Recovery procedure testing
Installation Qualification (IQ)
Calibration
Operational Qualification (OQ)
Computer System Validation (CSV)
Isolator Process Development (PD) and Validation (PV), incl. incoming goods inspection for biological indicators (BI)
Requirement Traceability Matrix (RTM)

All our recommended activities are part of the equipment lifecycle. If you need more information or expert advice, we will be happy to help!

Our services have got you covered

Optimized isolator bio-decontamination process

Syntegon considers the isolator and the associated machine as one functional unit and ensures short cycle times and low residual H₂O₂ concentrations after aeration. Physical and chemical analysis are paired with BI investigations identifying worst-case locations for the process. Our approach includes your customized isolator loading and your requirements for routine operations, leading to a reproducible and efficient 6-log reduction of BIs for your specific system.

Performance Qualification (PQ) and Process Validation

Syntegon offers further value-adding services such as extensive airflow pattern studies for isolators and RABS according to EU GMP/Appendix 1, and various studies for cleaning and sterilization using particles, endotoxin, riboflavin or biological indicators (BI).

Customized H2O2 low concentration studies

You want to know which H₂O₂ concentrations can affect your filling process? We perform risk assessments and provide supportive analytical studies regarding the impact of residual H₂O₂ concentration on your production cycle.