Maintenance and Service Plans for Microbiology Testing Systems
Be Compliant and Minimize Breakdown Risk
Preventive maintenance ensures efficient operation of critical microbiological testing equipment and minimize risk of breakdown and lab downtime. Every system should be serviced regularly to ensure its performance remains compliant with the specifications, as per GLP 21 CFR 58.63 (FDA) and EU GMP vol.4, 3.41.
- 21 CFR §211.67: Equipment cleaning and maintenance. “(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.”
- EU GMP Vol.4, 3.41: Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.
We recommend checking and calibrating your microbiological testing systems on an annual basis. We guarantee that your system meets our manufacturing specifications after preventive maintenance and services proposed in our service plans.
Service plans are more than a simple maintenance
We offer three levels of service plans (Essential, Advanced, and Total) that can be executed either in our local repair centers or on-site (where available).
Our Essential Service plan includes:
- As Found and As Left complete system check up
- Replacement of critical wear parts included in the service kit (when applicable)
- Priority at the repair center and for repair
- Performance report
- Shipping fees from the repair center
- Travel fees for on-site*
- Renewal process of service plan managed by our teams
*According to the region, travel fees might be quoted separately.
In addition, our Advanced Service plan includes:
- 1 repair visit per year (labor included)
In addition, our Total Service plan includes:
- Unlimited repair visits per year (labor and spare parts included)
Repair Coverage: No Extra Fees in Case of Breakdown
Our Total Service plan and Total Coverage include the labor and the replacement of all defective parts in case of a breakdown. There is no additional cost during the repair coverage period (1 year).
The complete list of spare parts included in the Total Service plan and Total coverage are listed in the technical Appendix of each system.
Comprehensive Documentation: Full Traceability and Auditability
Upon completion of the service, we will provide you with a performance report defining the service and tests performed on your equipment, critical tests results, traceability of instruments used during the service. In addition, this report guarantees that the equipment meets system specifications. For air samplers we also provide a certificate of calibration. These documents ensure compliance with regulation and have a validity of 1 year.
Genuine Spare Parts and Certified Service Engineers
All spare parts replaced during a service (preventive maintenance or repair operation) are guarantee genuine and identical to parts used during manufacturing of the system.
We have the technical expertise and qualified personnel to service your equipment in our service center or at customer site.
Our service engineers are recertified on regular basis to ensure that they will provide best in class service for your equipment.
Related Literature
Our service plans are available for a range of systems:
Air Sampling
Our Air sampler devices are the most complete and accurate system for reliable and easy monitoring of ambient air. To help maintain compliance while enhancing lab productivity and reducing down-time, we offer a full range of services.
- RCS® High Flow Touch
- MAS-100 ECO®, MAS-100 NT®, MAS-100 VF®, MAS-100 ISO NT® and MAS-100 ISO MH®
Sterility Testing
We are a renowned expert in sterility testing: reducing the risk of false positive and negative results, increasing reliability and improving workflow for lab technicians around the world. We provide an extensive portfolio of quality control products, and services.
- Steritest™ Equinox and Steritest™ Symbio
Bioburden Testing
The Milliflex® filtration system is an integrated solution for bioburden testing giving reliable and accurate results in high throughput production environments.
- Milliflex® Plus and Milliflex Oasis™
Rapid Detection
Innovative rapid technologies and instrument calibrations provide earlier results, increased assay sensitivity, ease-of-use, excellent accuracy and reliability.
- Milliflex® Quantum and EZ Fluo
- Milliflex® Rapid system
Pathogen Detection
Optimize or simplify your pathogen testing method for an easy validation and cost-effective testing
- PickPen™ PipetMax®
- Assurance® GDS Rotor-Gene®
- Gemini, ELISA automation
ATP Hygiene Monitoring
- The MVP ICON® is the first system to provide true HACCP management capabilities.
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