Microbiological Services

Pharmaceutical and Medical device industry scope is mostly products that are intended to be sterile or at minimum – with low microbial contamination. Objective of Microbiology is to ensure safety of pharmaceutical/medical products – from microbiological contamination perspective. Our Microbiology experts provide consultation and Hands-On services in the following areas:

Basic microbiology

Our experienced team will support you in different microbiological aspects such as:

Microbiological Method validation, including protocol writing, validation, method establishment.
Support in SOP writing and other documents preparation.
Internal audits in clean rooms and microbiological laboratory
External audits in microbiological laboratories
Establish microbial stability requirements
Trouble-shoot microbiology contamination problems in storage areas
Sterilization validation and sterilization

Support for microbiological laboratory:

Ability to ensure adequate provision of micro laboratory services, correct samples handling and proper analysis of the product is the key for efficient release of product to the market. We can support your microbiological laboratory (internal or external) in various ways:

Microbiology test method validation and testing
Microbiology media preparation and quality control
Microbiology laboratory practices
Laboratory investigation
Media fill (process validation)
Aseptic techniques
Out-of-specification/Investigation
Corrective and preventative actions
Cleaning and disinfecting
Microbial release and stability specifications
Microbial identification
Microbial cell storage and culture collection
Data evaluation and investigations
Microbiology Protocol establishment
SOP and other document preparation
Staff Training

Clean room support

Our team can provide you overall support in all the issues related to microbiological aspects of Cleanrooms:

Cleanroom requirements
Quality support in clean rooms IQ/OQ/PQ and re-qualification
Aseptic technique
Evaluate microbial control strategies and practices for non-sterile and sterile manufacturing processes
Establish, Review and manage environmental monitoring and gowning practices
Establish, Review and manage cleaning and disinfecting practices
Review, analyze and manage microbiological and environmental monitoring results and recommend mitigation activities (to process and product)
Determine environmental monitoring limits and microbial specifications for API, excipients, in-process materials and finished products
Evaluate and troubleshoot downstream process contamination issues and recommend control strategies
Cleanroom personnel training for Cleanroom gowning and clean room behavior
Establishment and preparation of Cleanroom procedures (gowning/cleaning/monitoring and etc)