Sterility testing
Sterility Testing under GMP Conditions
Microorganisms are present almost everywhere in our environment. If one counts the cells of our body and puts this number in relation to the number of microorganisms living on the skin and in the digestive tract, one finds that only 10 % of our body is human. The remaining 90 % are our microbiome. Almost every day, these micro-organisms give us faithful service in food intake and protection of our skin or in numerous industrial applications such as food production or biotechnology.
However, this contact is particularly critical in the case of direct exposure of the immune system, for example in medical applications (parenteral application, medical implants, dialysis or surgery) or in chronic exposure to the working environment (dermal or inhalation). Because of this particularly high sensitivity in medical applications release tests for sterility are prescribed in Chapter EP 2.6.1 (Sterility) and more specifically for cell based preparations in EP 2.6.27.
Our Assays | Overview
Bact Prime - Bacterial Rapid Sterility Testing for Research and Development
BactPrime is ideal for Research and development applications. It is state-of-the-art proprietary bacterial DNA-free qPCR system and stringent DNA-extraction conditions make a rapid bacterial sterility test possible. With the help of this semiquantitative test service, you can assess bacterial contamination in your system within shortest possible time and from low volumes. More information: BactPrime
FungiPrime - Fungi RAPID Sterility Testing for Research and Development
FungiPrime is ideal for Research and Development applications. It is the state-of-the-art BactPrime's twin brother, a special fungal DNA-free qPCR system, and stringent DNA-extraction conditions make a fungal rapid sterility test possible. With the help of this test service, you can detect fungal contamination in your system within a very short time and from low volumes. More information: FungiPrime
SteriPrime - Bacteria and Fungi RAPID Sterility Testing combined for Research and Development
SteriPrime is ideal for Research and Development applications. It is state-of-the-art and combines both tests BactPrime and FungiPrime in one rapid testing scheme. With the help of this test service, you can detect fungal contamination in your system within a very short time and from low volumes.
Sterility EP - rapid sterility testing according to EP 2.6.1, alternative Method
The SterilityEP service was specially tailored to the needs of ATMP and biologics manufacturers. It is a combination of a bacterial and fungal DNA-free extraction system and a corresponding qPCR system. Maximum batch stringency and process controls make this nucleic acid amplification-based (NAT) rapid sterility test possible. SterilityEP is used when time matters, e.g. in the sterility testing of ATMPs. The service includes the necessary sample preparation and has been validated for cell cultures and other low-volume samples in terms of sensitivity, specificity and robustness, based on EP 2.6.1. More information: SteriEP
Specification
As a supplement to sterility testing or direct detection we offer you the possibility to specify your contamination. This is done within a few days by sequencing and results interpretation. More information: Specification
Sterility Validation
According to EP 2.6.1, sterility test procedures for release testing must be validated on a sample-matrix specific basis. Minerva Analytix GmbH offers customized method validation in a GMP environment with years of experience. We are happy to advise you regarding your sterility testing specific issues. More information: Validation