Conquering the challenges of developing and validating of isolators

Process development and validation of isolators are technical challenges. For Valicare's isolator experts, these services are daily routine.

When developing a biodecontamination process, it is important to optimize the parameters for isolators and biodecontamination systems using physical, chemical, and microbiological test methods so that microbiological indicators (BIs) are inactivated according to the given specifications.

As a subsidiary of Syntegon, Valicare consultants and engineers have detailed knowledge of process development and validation of isolators including sterility tests, and compounding isolators.

Methods for parameter determination

Our capabilities include setting of parameters like concentration and distribution of hydrogen peroxide, gassing time, temperature and humidity, subsequent aeration time, and measurement of the residual hydrogen peroxide concentration. The initial qualification of the BIs includes germ identification and quantification as well as a D-value determination in Valicare's own pharma-grade isolator.

Service packages for sterility test isolators

Valicare developed a straightforward validation approach for biodecontamination processes using hydrogen peroxide for the sterility test isolators (STI) from Klenzaids, a leading manufacturer of aseptic, bioclean, and containment equipment in India and a joint venture partner of Syntegon. This concept includes protocols, advice on the loading scheme, provision of the necessary equipment and indicators, as well as on-site implementation. The concept can also be applied to sterility test isolators of other manufacturers.

Take advantage of our expert support in the development of biodecontamination processes and GMP-compliant validation of your isolator systems.

Ensuring the sterility in the insulator through airflow visualization studies - with absolute precision!

The conditions in the filling area of liquid pharmaceuticals must be proven to be aseptic, the facilities qualified and the processes validated (EU GMP Annex 1). Air flow in critical areas, especially where open sterile products are handled, must be provably unidirectional and free from turbulence.

Your benefits when Valicare performs the airflow visualization studies:

Regulatory assurance: Conduct and document EU-GMP Annex 1 airflow performance, easy to interpret and deploy in any inspection.

Avoidance of undiscovered contamination paths: Valicare’s isolator experts conduct airflow visualization studies with the utmost precision under manufacturing conditions.

Resource conservation: Personnel and time relief by outsourcing the activities to experienced isolator experts who have qualified and validated more than 150 worldwide.

Performing airflow visualization by unexperienced carries risks

The selection of devices, their competent handling, meaningful camera coverage, and an appropriate process simulation of ongoing operations are some of the points that reduce the precision of the results. In the worst case, contamination pathways remain undetected, leading to regulatory observations, product loss, rework, and delays.

Why should you choose our airflow visualization studies?

State-of-the-art visualization technology

Clear visualization of unidirectional airflow with a water-based fog liquid.
Our remote-controlled, wall-mounted fog generation system shows no interference with the airflow and gives you reliable, reproducible results.
Precise, reliable images from multiple camera angles ensure full coverage of the inspection points.

Designed for real-case applications

Our dynamic assembly system allows flexible adjustment and multi-point detection, while the machine is running and during the visualization process.
Tailor-made solutions for different areas of application with their individual functions and interventions.

GMP-compliant documentation

Execution and documentation are compliant with the requirements of EU-GMP Annex 1
Deliver inspection-grade results that your QA team will appreciate

Intuitive & interactive interface:

Quick and effortless browsing of all test points
Synchronized split screen view, for direct comparison of test points
All data will be given to you for storage on your own devices
Clear, comprehensive representation of your airflow performance, easy to interpret and applicable in any inspection

Reach out to us for:

State-of-the-art airflow visualization to demonstrate regulatory compliance
Airflow Re-validation of your filling line
A trusted partner with proven isolator expertise

Downloads on Process Development and Validation

One Pager: Process Development Biodecontamination

One Pager: Process Revalidation Biodecontamination

One Pager: Verification of Particle Probe Positions in Isolators

One Pager: Airflow Visualization Studies

Free first consultation now!

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

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Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.