Microbiology & Quality Associates provides custom manufacturing services for the biotechnology, pharmaceutical, medical device, and other life science industries. We are FDA registered and ISO/IEC 17025:2005 accredited. MQA is available 7 days a week to provide you with a fast turnaround time.
- Aseptic filling of injectables and IV bags for preclinical studies
- GLP & GMP cell bank preparation
- Aseptic assembly
- Steam sterilization
- Custom projects
- GxP compliance quality systems
- Validated clean room: ISO 5 BSC located in an ISO 7 cleanroom
- Validated equipment
- GMP trained personnel
- Qualification and media fill activities for aseptic filling follow FDA cGMP guidelines and are used to qualify aseptic process and personnel.
- Environmental controls, which include surface, viable, and non-viable particulate monitoring, the personnel who perform aseptic operations are glove sampled subsequent to completion of aseptic filling activities.
- QC testing