Home Unsere Projekte Life Sciences Multidisciplinary team delivers high quality support at Plasma Industries Belgium

Multidisciplinary team delivers high quality support at Plasma Industries Belgium

Plasma Industries Belgium - Belgien
Markt Life Sciences
Umfang
Land Belgien

Plasma Industries Belgium (formerly CAF-DCF), located in Neder-Over-Heembeek (Belgium), specializes in blood plasma fractionation and the preparation of stable plasma derivatives (coagulation factors, immunoglobulins and albumin solutions). All the plasma derivatives need to answer the highest quality and safety standards imaginable. An Agidens Life Sciences team helps Plasma Industries Belgium to constantly improve the quality levels in various fields.

The use of the plasma drawn from donors and the preparation of products intended for patients are the cornerstone of Plasma Industries Belgium’s ‘human-to-human approach’. Evidently, patient safety is crucial. Validation and compliance are an important part in every quality system of high-tech production plants.

Advice and support in various fields of expertise

At the start-up of the plant in Neder-Over-Heembeek, Agidens provided automation support. In 2010, we delivered qualification support in a production expansion project. Both parties have extended the collaboration considerably in recent years, and nowadays Agidens provides a team of consultants with a wide range of specialisms. Trust and a continuity have been the drivers of the successful partnership.

Agidens delivers consultancy & project support in the following fields:

  • Compliance
  • Validation
  • Qualification
  • Maintenance & Reliability
  • Technical safety

Multidisciplinary consulting support

Compliance

The Compliance Enhancement Program (CEP) is crucial within the organization of the client. Agidens consultants perform supporting roles in the CEP teams that have as main goal to sustain a high-level cGMP compliant quality system.

We deliver GMP support, follow up training of Standard Operating Procedures, follow up of overdue CAPA’s, execution of GAP analyses, update of validation plans, etc.

Validation

Within the CEP program, high level validation procedures are key. Agidens is involved in process-, cleaning- and thermal validation.

Our support involves the setup of standardized validation procedures, assessment procedures, validation documentation, etc. Next to that, we support the client in harmonizing the Plasma Industries Belgium templates with the ones of the Sanquin headquarters in the Netherlands.

Qualification

Since 2010 an Agidens/Plasma Industries Belgium team works together to constantly improve the qualification procedures on different levels. Our consultants deliver specialized know-how and practical support in various qualification fields.

In five years’ time the qualification team has supported several major extensions of production capacity. This includes various tasks: set up of qualification methods, coordination of trainings, review of User Requirement Specifications (URS), writing & executing qualification protocols and reports, organization of change control, support during inspections, etc.

Maintenance & Reliability

Agidens delivers maintenance support by setting up and executing a well thought maintenance program.

This involves the execution of SAP tasks, work order coordination, work preparation, support in the setup of a maintenance/calibration policy, development of an assessment plan, etc.

Technical safety

Agidens supports Plasma Industries Belgium with advice in the fields of ATEX conformity and CE certification.