Method development and validation
Method validation and process proficiency is critical for both micro-organisms detection and production.
OUR SERVICES: Provide you with method validation and development prior day-to-day use

1/ Few examples of services:

  • Cleaning and disinfection process validation: custom validation based on current standards.
  • Validation of bactericidal and/or bacteriostatic efficacy of disinfectants: surface or liquid method.
  • Development of microbiological Pharmacopeia methods including specific matrix, rapid microbiology, etc.
  • Validations of microbiological methods : specific, Pharmacopeia or ISO standards
  • Optimization of conservation process of micro-organisms: Bactup develops custom processes adapted to specific strains, by improvement of storage media or freezing/lyophilization techniques.
  • Challenge tests: Bactup performs challenge tests using reference or natural strains to evaluate the efficacy of your preservative.

See also:Microbiological control

 

2/ Custom services:

Bactup provides support at various levels, from protocol drafts and assays achievement on site or at your facility to staff training.

See also: Consulting/Support/Training

 

BACTUP ASSETS:

 

  • EXPERTISE: Bactup has expanded its expertise in industrial microbiology, especially regarding traditional techniques or rapid microbiology methods.
  • QUALITY: GMP compliance.
  • REACTIVITY: immediate processing of customers samples and requests.
  • FLEXIBILITY of services.
Développement et validation de méthodes - préparation d'échantillons
Développement et validation de méthodes - laboratoire
Développement et validation de méthodes - laboratoire

POUR QUELLES APPLICATIONS ?

You are:

R&D or Production laboratory

 

  • Development and validation of methods regarding production and control of industrial strain,
  • Validation of method for the culture of relevant strains,
  • Development and validation of methods for the conservation of relevant strains

You are:

Quality Control laboratory

 

  • Development and validation of usual methods for microbiological control: sterility testing, non-sterile product testing, search for pathogenic germs, control of process-related waters, etc.
  • Development and validation of alternative and rapid methods for microbiological control