Our laboratory services

 

Our laboratory services contain a wide variety of studies and testing. To always assure a high level of quality, our laboratory follows procedures after GMP (§ 64 AMG; german pharmaceutical legislation). The organisation of our laboratory is furthermore certified through DIN ISO 9001:2008. In our opinion, only a steady improvement in line with our certifications ensures a high quality and accuracy of our work. This is why we take the implementation of improvements and elimination of errors very seriously throughout the whole organisation. To see our certificates, follow this link.

 

The laboratory is a state-of-the-art facility and characterized by its outstanding equipment. Any testing performed is regulated and checked very strictly within our quality system.

 

 

 

 

Laboratory services overview:

 

 Determination of Biological Indicators:

     

  • Determination of D-value in the BIER-Vessel (D-Value & Z-Value)

  • Determination of D-value in dry heat (D-Value & Z-Value)
  • Preparation of certified spore suspensions (D-Value & Z-Value determination in product)

  • Additional offers related to D-Value-determinations

  • Preparation and certification of customised bioindicators

  • Testing of sterilisers through biological indicators

 

 

 

 Chemical Indicators:

 

  • Testing of chemical indicators after ISO 11140

 

 

 

Microbiological standard-examinations:

 

  • Analysis of water for pharmaceutical purposes
  • Testing on microbiological contamination for non-sterile products (Ph. Eur. 2.6.12 / USP [61] & Ph. Eur. 2.6.13 / USP [62] )
  • Qualification of the examination method (validation)
  • Examination on sufficient conservation (Ph. Eur. 5.1.3 / USP [51])
  • Testing of bacterial endotoxins (LAL-Test, Ph. Eur. 2.6.14)
  • Qualification of culture medium
  • Analysis of environmental monitoring samples (hygiene monitoring)
 

 

 

Execution of validation studies:

 

  • Validation of desinfection-methods
  • Container Closure Integrity Test
  • Endotoxin-decrease-studies
 

 

 

Individual microbiological studies:

 

We also develop individual studies in close cooperation with our customers. These studies are tailored to our clients´ needs and demands. We always look forward to new challenges in this field. If you need an individual study on technical processes or methods, do not hesitate to contact us. We will provide you with an non-binding offer