Validation of microbial inactivation studies

Evaluation of the inactivation or elimination of viruses or bacteria attending to the demand of public and private customers. Expert reports on microbial inactivation or biosafety issues, biocontainment facility management, or inactivation capabilities are also available upon request

• Designing the validation study attending to the specific nature of the product to be tested.
• Evaluation of the inactivation or elimination of viruses and bacteria by disinfectants, antiseptics, or decontamination processes or in any other step of a defined manufacturing process.
• Performing and validating the microbial inactivation procedures.
• IRTA-CReSA collects a broad range of viral (SARSCoV, SARSCoV2, Chikungunya virus, African Swine Fever Virus, Classical Swine Fever Virus, among others) and bacterial pathogens both belonging to culture collections but also field isolates.
• All the equipment used in inactivation studies is fully maintained following GLP regulations.
• GLP quality regulations also affects the rest of the activities regarding the study: protocol, amendment issues, raw data handling and final report.
• Studies subjected to confidentiality and following the specific European guidelines regarding the design, contribution and interpretation of studies validating the inactivation and removal of viruses.
• IRTA-CReSA can provide with expert reports on inactivation procedures, viral risks assessment for starting material and final products, etc.
• Expert reports on biosafety issues, management of facilities, inactivation capabilities are also available upon request.

Examples of previous achievements

• Validation studies on viral inactivation for several blood derivative companies and other pharmaceutical enterprises.
• Redaction of expert reports regarding viral safety of raw materials or starting materials.
• Preparation of validation reports confirming the viral inactivation capabilities of a specific manufacturing step.

Download all the services at IRTA-CReSA (PDF)