Pharmaceutical Microbiology Environmental Monitoring Services

Discover our services portfolio supporting the MAS-100® family for active microbial air monitoring and media for passive air and surface monitoring

Reduce the pharmaceutical and medical device microbiology workload to focus on critical activities

From less critical environments to highly critical cleanrooms and isolators, we offer a comprehensive range of monitoring and testing solutions for all levels of safety. With our long history of serving the pharmaceutical industry, we have pioneered and refined ground-breaking solutions, demonstrating the regulatory and technological expertise to make regulatory compliance as simple as possible, and help you save valuable resources.

With our best-in-class environmental monitoring services you can

  • Optimize your QC lab 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

BioM Pharma services – Environmental monitoring visual - system life cycle

 

Passive air monitoring and surface monitoring method development services

Discover our new disinfectant neutralization services for ICR/ICR+ contact and settle platesDiscover our new disinfectant neutralization services for ICR/ICR+ contact and settle plates.

Your benefits:

  • Avoid false negative results
  • Comply with regulations (ISO 14698, GMP)
  • Facilitate in-house validation of new media

Disinfectant neutralization efficiency study

Experimental study carried out in our application laboratory using specified ICR/ICR+ plates and a specified disinfectant. Assessment of the neutralization of the chosen disinfectant by the chosen ICR/ICR+ plates.

  • Assessment of the ability of the selected culture media to allow microbial growth by using the direct plating test protocol of disinfectant
  • Growth promotion test covers 5 challenging microorganisms, including 2 in their spore form
  • Possibility to use in-house isolates
  • Comparative study with same culture media plate without disinfectant as a control

MAS-100® validation services

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

Your benefits:

  • Proven protocols and expertise to qualify your air sampler & related media
  • Streamline the method validation process
  • Reduce the development time & cost of the validation

Validation protocols

Our 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 environmental monitoring equipment:

  • Execution of the test methods
  • Supply of calibrated tools (flow meter, stopwatch, etc.)
  • IQ/OQ Section of the Final Report is completed, ready for QA approval
  • Essential operator training

Essential PQ consultancy service1

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

MAS-100® service plans : on-site or at repair center

Rely on your MAS-100® air sampler and minimize the breakdown risk

Your benefits:

  • Ensure optimum performance and reliability of your air sampling system
  • Increase the lifetime of your air sampling system
  • Comprehensive documentation for auditability

Service plans

We offer a variety of service plans that can be executed either in our local repair center or at customer site (where available). Preventive maintenance, verification and calibration ensure efficient operation of critical testing equipment. Every air sampler 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 MAS-100® air sampling system.

Environmental monitoring training services

Ensure your lab team can make the best out of your MAS-100® air sampling system and take accurate passive and surface samples with our ICR and ICR+ contact and plates.

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

Environmental monitoring school2

Theoretical aspects of environmental monitoring (EM):

  • Regulatory aspect of EM (air monitoring, surface and personnel monitoring)
  • Critical handling steps
  • How to ensure reliable results

Interactive workshop:

  • Demonstration of best procedures for using microbial air samplers and agar plates media for surface, personnel and passive air sampling
  • A case study for implementing an environmental monitoring program in a cleanroom (air, surface and
  • personnel microbial monitoring)
  • Answers to specific user-related questions
  • Certificate of attendance

MAS-100® advanced operator training1

This course will cover the same theoretical aspects and interactive workshop as the EM School and, in addition, a hands-on session on the best practices of use of the MAS-100® air sampling systems will be covered. A training certificate is delivered to each participant after evaluation.

BEST and on-site BEST microbiology training3

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 Available for MAS-100® NT only

2 Not available in North America

3 Available in North America only