Microbiology Sterility Testing Services

Discover our services portfolio supporting the Steritest™ family for sterility testing

Reduce your sterility testing workload and focus on critical activities

Microbiological sterility testing in the pharmaceutical industry is a highly regulated and complex field. With over 40 years of sterility testing expertise, we have pioneered and refined ground-breaking Steritest™ solutions, demonstrating the regulatory and technological expertise to make compliance as simple as possible, and help you save valuable resources.

Our sterility testing services include the following:

Method development & consultancy

Validation protocols: IQ/OQ/PQ & requalification

Steritest™ service plans

Steritest™ training services

Sterility testing system life cycle

 

 

With our best-in-class services you can:

  • Optimize your sterility testing workflow and ensure regulatory compliance
  • Rely on comprehensive and ready-to-use validation packages
  • Ensure the performance of your system while reducing the risk of breakdown

 

Steritest™ method development services

Sterility testing methodOptimize or simplify your sterility testing method for an easy validation and cost-effective testing.

Your benefits:

  • A name you know
  • People you can trust
  • Methods you can validate
  • Ready when you need us

Method development

Experimental study done in our application laboratory using your samples and microbial strain(s). Recommended in case of compatibility issues with standard protocol for testing new products. Development of an appropriate method to overcome any interference or to improve filterability.

Method development consultancy

Consultancy service by one of our application scientists to support your method development. Recommended in case of compatibility issues with standard protocol or for testing new products. One-day training at customer site covering pump use and how to develop an appropriate method. Customized test plan, real tests initiated on-site, then weekly follow-up calls to support customer.

Steritest™ validation services

Get ready to start PQ work in less than 5 days!

Your benefits:

  • Proven protocols and expertise to qualify your Steritest™ Symbio pump and closed filtration devices
  • Streamline the method validation process
  • Reduce the development time & cost of the validation
  • Keep the qualified status of your pump over its lifetime

Steritest™ validation protocols

Our sterility testing validation protocols are based on our internal product qualification test methods. These extensive protocols will enable the QC/QA Lab to quickly initiate your Validation Master Plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease. They follow international guidelines such as EP/USP and GMP.

On-site IQ/OQ service

Support for the qualification of your sterility testing equipment:

  • Execution of the test methods
  • Supply of calibrated tools
  • IQ/OQ Section of the Final Report is completed, ready for QA approval
  • Essential operator training

Essential PQ consultancy service

Consulting service for microbiological validation in order to plan and start the PQ:

  • On-site support for implementation of the PQ tests
  • Consumables and media calculation
  • Training on recovery test techniques
  • Data formatting and report finalization
  • Scheduling of the tests
  • Data interpretation, comments and conclusion

Advanced PQ consultancy service

Close coaching all along the PQ of the consumable and test method:

  • Presentation of the equipment, accessories and consumables
  • Regulation overview
  • Hands-on training
  • Setting up the lab, equipment, consumables
  • Test campaign – Supervision of the microbiological tests (several days):
    1. The Validation Engineer demonstrates the realization of the test with the first microorganism.
    2. The technician(s) repeat what has been demonstrated on the further replicates and microorganisms.
    3. Results reading and interpretation.

Essential requalification service1

Requalification work performed on laboratory equipment after the yearly preventative maintenance:

  • Requalification protocol to be ordered separately
  • IQ and OQ test procedures (physical tests) + data formatting and report finalization
  • Supply of calibrated tools (flow meter, stopwatch, etc.)

Advanced requalification service1

Requalification work and consulting service for laboratory equipment:

  • Requalification protocol to be ordered separately
  • SOP review
  • Maintenance review
  • IQ and OQ test procedures (physical tests) + data formatting and report finalization
  • Furniture of calibrated tools (flow meter, stopwatch, etc.)
  • Operators training review
  • OOS results review

Steritest™ service plans: on-site or at repair center

Rely on your Steritest™ Symbio pump and minimize the breakdown risk

Your benefits:

  • Ensure optimum performance and reliability of your pump
  • Increase the lifetime of your pump
  • Comprehensive documentation for auditability

Service plans

We offer a variety of service plans that can be executed either in our local repair center or on-site (where available). Preventive maintenance and pump verification ensure efficient operation of critical testing equipment. Every pump should be serviced regularly to ensure its performance remains compliant with the specifications. We recommend checking and adjusting the system on an annual basis as well as after repair service.

  • Preventive maintenance including as found and as left tests
  • Maintenance kits
  • Repair coverage
  • Genuine spare parts
  • Performance report and certificate of calibration (air samplers only)
  • Rush fee optional

End of life verification

We can verify your equipment in our local repair center or at your site. At the end of the service you receive a performance report including as found data of your equipment. Recommended before decommissioning your Steritest™ pump.

Steritest™ training services

Ensure your lab team can make the best out of your Steritest™ pump

  • Benefit from decades of expertise
  • Certify your lab staff
  • Avoid common handling issues
  • Get familiar with good sterility testing practices

You will find below our face-to-face training offerings. We also have a brand new range of remote solutions like e-learning, remote schools and remote validation consultancies. For more information, please visit our dedicated page.

Sterility Testing Remote School

You will find here our face-to-face training offerings. We also have a brand new range of remote solutions like e-learnings, remote schools and remote validation consultancies. For more information, please visit our dedicated page

Steritest™ school1

Theoretical aspects of sterility testing:

  • Regulatory aspect of sterility testing including environmental considerations
  • Sample considerations
  • Method development and validation
  • Interpretation of results

Interactive workshop:

  • Use of Steritest™ hardware
  • Use of Steritest™ units
  • Demonstration of general and specific sterility testing applications
  • Answers to specific user-related questions

Steritest™ advanced operator training1

This course Includes the theoretical aspects and interactive workshop in addition to a hands-on session on the best practices of use of the Steritest™ platform. A training certificate is delivered to each participant after evaluation.

BEST and on-site BEST microbiology training2

BEST is a 3-day innovative, interactive educational program designed specifically for you. This program will focus on both in-process and product release quality control, including bioburden, endotoxin, and sterility testing, and environmental monitoring. The training will provide an overview of relevant methods in each area; however, basic technical laboratory skills are assumed as a prerequisite for participation. The course will consist of class presentations and demonstrations of laboratory applications.

  • Understand the current requirements of pharmacopoeias and be familiar with good testing procedures from method development / validation through to routine test result interpretation
  • Take preventive actions to avoid false positive or false negative test results
  • Develop and optimize testing procedures
  • Understand and identify root causes for common issues
  • Hands-on training

Learn more about our BEST QC Microbiology Training

1 Not available in North America

2 Available in North America only