In order to ensure medical devices are safe for use, regulatory bodies require manufacturers to demonstrate adequate inactivation and removal of viruses. Perfectus Biomed, now part of NAMSA, can help you with this key validation step.
A crucial element in the product development process for medical devices is to ensure safety and performance/ efficacy requirements satisfy regulatory submissions. Providing data that validates the removal of viral contaminants during raw material processing is essential to establish the safety of biological products. Regulatory bodies require manufacturers to ensure adequate inactivation and removal of viruses, via assessment of the processing methods and sterilization techniques used in product manufacture. EN ISO 22442 standard is the validation of the elimination/ inactivation of viruses on medical devices using animal tissues and their derivatives. Our viral inactivation testing program can be performed to GLP and provides an assessment of each stage of your disinfection process. Contact us to find out more.
Animal tissue and their derivatives are commonly used in the design and manufacture of medical devices, to provide performance characteristics, stabilize formulations and enhance properties. The range and quantities of the materials of animal origin in medical devices vary, such as bovine/porcine heart valves and haemostatic sponges amongst many other examples. The materials could envelope the device itself, interact with a device coating or be utilised in the overall manufacturing process. The EN ISO 22442 standard method is necessary to minimize viral contamination and demonstrate device safety.1
The EN ISO 22442 standard was revised in 2019, and the newer guidance replaces the 1998 document. The revised guidance provides recommendations related to viral pathogens and all TSE’s not just BSE, outlines information regarding animal sourcing and manufacturing that regulatory bodies require and recommends how viral inactivation studies should demonstrate the sum of multiple log reductions.2
Contact us to find out more about our viral inactivation testing solutions. With Perfectus Biomed Group, now part of NAMSA, you receive:
- An expansive list of viruses that reflect viral contaminants that may be present in the source animal tissue, these include Single stranded and double stranded DNA viruses, RNA viruses and cover enveloped and non-enveloped viruses.
- Extensive experience in designing testing solutions that support medical device manufacturing.
- Our expert team can guide you to build an assessment that specifically supports your device requirements.
1) https://www.fda.gov/media/87251/download
2) fda.gov/media/123373/download