Product Description Qualification

Quality and performance issues are important, especially for pharmaceutical production and increasingly for the research work which leads to a product due to an emphasis on PAT (Process Analytical Technology).

Validation is the provision of objective evidence in agreement with the principles of Good Manufacturing Practice (GMP) to the effect that methods, processes, equipment items, materials, work cycles or systems actually achieve the expected results.

It requires documented evidence (proof), that processes, systems, equipment and processing steps:

• correspond to the desired requirements to create a product.
• achieve the necessary performance criteria, reproducibly.

As a manufacturer, INFORS HT can help with the validation process, with regard to the actual equipment used, in the following areas:

• Qualification
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)
• Performance Qualification (PQ)

All sizes and types of bioreactors in the INFORS HT range can be qualified according to customer requirements. Of course, the nature of the equipment will affect what can actually be tested eg autoclavable systems clearly do not have a sterilisation cycle built in.

Also, INFORS HT incubator shakers can be qualified for validation and this is a service much more in demand in recent times. A standard package is available and we can provide a fully customised service, according to requirements.