Microbiology and Sterilization
Overview
MDRA takes pride in our unparalleled expertise in all areas of microbiology including; pharmaceutical, mycology and sterilization. With highly proficient subject matter experts, we offer clients the confidence in the microbiological quality of their products. Our diverse team of microbiologists can help implement contamination prevention, control and remediation measures.
- Total microbiological control in manufacturing and laboratory
operations - Development of an overall contamination strategy
- Microbiology laboratory design, operations and optimization
- Standard operating procedures (SOP’s)
- Risk based environmental monitoring programs
- Microbiological specification development
- Microbiological test methods and validation In-house and contract microbiology laboratory audits
- Microbial contamination risk assessment, investigations and remediation
- Objectionable microorganisms/pathogen specific assessments
- Aseptic process simulation/media fill design, protocols, failure investigations and reports
- Troubleshooting biofilm formation in water systems and manufacturing equipment
- Sterilization consulting
– Gamma
– EtO
– E-Beam
– Chemical
– Steam
– Dry heat
US FDA 510(K) Consulting for Medical Devices & IVDs
CE Mark EU MDR 2017/745 & EU IVDR 2017/746
