Microbiology Services for Pharmaceutical and Medical Device Industry

Pharmaceutical Microbiology is under the regulation focus for sterile and non-sterile production processes, taking place in the pharmaceutical, Bio-technology and medical device industry.

We are committed to leveraging our expertise in Pharmaceutical Microbiology to support and improve organizations in microbiological standards and microbiological knowledge, to achieve a high quality environment and processes while maintaining regulatory excellence

Basic microbiology

Ensure cGMP compliance in all microbiology related aspects
Developing Microbiological testing strategies and Method validations
Technical Writing (SOP, protocols, reports, policy documents, annual reports and other

Support for microbiological laboratory:

Microbiology laboratory design and flow
Intra lab process optimization
Laboratory investigations, and CAPA implementation
Data analysis and interpretations.
Professional training in Microbiology and Aseptic techniques
Internal audit and regulatory inspection preparation

Process / Clean rooms Microbiology Control

Risk based Contamination Control Strategy implementation
Risk based Environmental Monitoring Plan
Cleaning and Disinfecting regime determination or optimization for sterile and non-sterile manufacturing
Biocontamination incidents investigations, and CAPA implementation
APS/Media fill process validation
Clean room control and management
Aseptic technique training for clean room personnel