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)