Subject

Our client is a pioneering Polish biotechnology company specializing in the development, production, and commercialization of biopharmaceuticals, particularly biosimilar oncology and immunomodulatory drugs. They are a leader in the Polish biotech market, with a strong focus on producing biosimilar medications.

The client’s goal was to qualify their clean steam installation and verify that it meets the requirements defined in the URS and risk analysis, ensuring it provides clean steam with the desired specifications.

The decision to choose eCValidation for this project was influenced by our ability to offer a comprehensive solution. We provided complete support, from preparing the qualification documentation to carrying out the qualification process, including all necessary measurements.

Scope

Our comprehensive scope of work included the following:

1. Measurement of clean steam dryness

2. Measurement of clean steam superheat

3. Measurement of non-condensable gases in clean steam

4. Measurement of the quality parameters of clean steam (conductivity, total Organic Carbon (TOC) content, bacterial endotoxin content and measurement of microbiological contaminants).

The project consisted of nine steps:

1. Verification and documentation of legal requirements for clean steam.

2. Verification of measurement methods used to confirm the requirements from the first step.

3. Assembly of the necessary measurement equipment for the selected methods.

4. Training on the operation of the steam installation, culminating in certification.

5. Preparation of internal instructions for equipment operation and measurement methods.

6. Training of the staff.

7. Conducting measurements at the client’s site.

8. Preparation of measurement reports.

9. Incorporation of the completed measurements into the qualification of the clean steam installation.

The client was actively involved throughout the project. We coordinated via email to schedule the dates and times for our team to conduct the measurements. The client’s project manager oversaw our team while they worked in the technical and production areas, and during the laboratory testing of the collected condensate samples (TOC, conductivity, endotoxin, and microbiological measurements).

Results

The client was satisfied with our collaboration, appreciating our comprehensive service, technical expertise, and flexibility regarding scheduling.

Our work enabled the deployment of the installation into operation and confirmed its effective and correct functioning.

If you require assistance with your qualification and validation processes, please don’t hesitate to contact us. We offer a wide range of measurement capabilities.