CMC

Microbiological Services

Our qualified and experienced microbiologists pride themselves on applying their knowledge and skills to ensuring that pharmaceutical products are safe and meet today’s rigorous quality specifications and regulatory standards.

Facilities and Equipment

Our purpose built microbiology suite comprises a media preparation area (including a media autoclave, two microbiology assay rooms with microbiological safety cabinets and a laminar air flow cabinet), a Grade C cleanroom with a Grade A positive pressure isolator and a waste disposal area complete with discard autoclave. The suite is equipped with a range of equipment such as continually monitored incubators, sterility testing apparatus, water baths, cold storage and microscopes.

Services

A full method development/validation service is offered to support application of the following key microbiological techniques and as method development, validation and testing can all be performed at one Arcinova facility, there is no need for time consuming technology transfer activities. In addition, we are equipped to perform microbiological testing on radiolabelled, highly potent, cytotoxic and controlled substances.

 

 Microbiological Aspects of Formulation Development:

  • Preservative Efficacy testing
  • Customised Challenge testing
  • In-use testing

 

 Clinical manufacturing support:

  • Environmental monitoring including settle plates, active air sampling, enumeration, isolation and if required, the identification of isolates
  • Microbiological aspects of process simulation tests (media fills) including turbidity examination and fertility checks on media
  • In-process Sample Analysis (bioburden testing)
  • Closure Integrity Testing by simple immersion or by pressure/vacuum.

 

Quality control release testing:

  • Microbial Enumeration (Total Aerobic Microbial Count & Total combined Yeasts/Moulds Count) by pour plate and membrane filtration
  • Test for Specified Microorganisms (Escherichia coli, Staphylococcus aureus, Salmonella species etc.)
  • Sterility Testing – testing performed in a positive pressure isolator with a validated VHP cycle
  • Closure Integrity Testing by simple immersion or by pressure/vacuum.
  • The identification of isolates
  • Bacterial Endotoxin Testing (gel-clot and kinetic)

 

Other microbiological services:

  • Drinking Water Testing
  • Pharmaceutical Water Testing
  • Microbiological Environmental Monitoring
  • Phenotypic Identification

 

Summary

Arcinova offers a comprehensive and high quality microbiological service encompassing a range of techniques and at all stages from their development through to their application. These services can be accessed on a transactional basis or as part of an integrated service offering such as pharmaceutical formulation development, manufacturing and quality control testing activities.